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  • Chair-bound Exergaming in Pre-frail/ Frail Older Adults in Nursing Home

    Objective To explore the effects of the chair-bound exergaming on the enjoyment of physical activity in in pre-frail/ frail nursing home residents. To evaluate the effects of the chair-bound exergaming in improving physical and cognitive function in pre-frail/ frail nursing home residents. Research plan and methodology Thirty nursing home residents will be recruited from the nursing homes. All the eligible participant will be randomly allocated to either one of the following 2 groups (i) Exergaming (intervention group), or (ii) wait list control. 1. Intervention group (exergaming group, ERG) Those allocated to the ERG will receive supervised chair-bound exercise programme for 12 weeks. 2. Control group (wait list control, CG) Those allocated to the CG will receive supervised chair-bound exercise programme for 12 weeks after post-assessment.

    Phase

    N/A

    Span

    39 weeks

    Sponsor

    Hong Kong Metropolitan University

    Kowloon

    Recruiting

  • Powering Up Stroke Rehabilitation Through HIIT

    Phase

    N/A

    Span

    89 weeks

    Sponsor

    The Hong Kong Polytechnic University

    Kowloon

    Recruiting

  • Treatment of Cantonese Speakers With Childhood Apraxia of Speech

    Four CE children with CAS will be recruited and receive two versions of the DTTC treatment (i.e., DTTC in English [DTTC-E] and DTTC in Cantonese [DTTC-C]). After the initial assessment and baseline probe sessions, all the participants will be randomly assigned to receive either DTTC-E or DTTC-C in the first 6-week treatment phase. Then, the between-treatment probe sessions will be conducted during a 2-week washout period. This will be followed by the second 6-week treatment phase, which will be the other version of DTTC. Post-treatment probe sessions will be conducted one week and one month after completion of the second treatment. Participants' speech productions will be transcribed and evaluated based on their accuracy in phonemes, stress, and tone. Growth curve analysis (Mirman, 2014) will be conducted to examine the group differences in the outcome measures across the treatment sessions.

    Phase

    N/A

    Span

    42 weeks

    Sponsor

    The Hong Kong Polytechnic University

    Kowloon

    Recruiting

  • Traditional Chinese Medicine Ultrasonic Atomization Treatment for Dry Eye Disease

    Phase

    N/A

    Span

    70 weeks

    Sponsor

    Chinese University of Hong Kong

    Kowloon

    Recruiting

  • Combining Physiotherapy Group Exercise With Acceptance and Commitment Therapy in Elderly With Chronic Low Back Pain

    Sample size: The sample size was calculated with reference to the effect size of 0.052 (partial eta square) being worked out from the primary outcome of Roland Morris Disability Questionnaire obtained from the pilot study. G*Power 3.1.9.4 was used to calculate the sample size. With power of 0.95 and alpha value of 0.05, the total sample size is 68. With reference to the attrition rate of approximately 20% in the pilot study, the sample size will become 43 subjects in each group and with total of 86 subjects will be recruited.Subjects will be recruited from local community elderly community centers. Randomization: The subjects will be randomly assigned by the principal investigator to either intervention group of GrExPACT or control group of GrEx using computerized randomization software. Permuted blocked randomization with a block size of four and stratified by gender and STarT Back category will be used as to ensure the groups are balanced. The allocation will be concealed and stored in an encrypted file storing in a password protected computer. Corresponding group therapy class will be arranged to the patient accordingly. Study design: 86 subjects with chronic nonspecific LBP subject will first receive a 30-minute triage screening by a physiotherapist for inclusion criteria, exclusion criteria and red flags as to confirm the subjects are belonging to chronic nonspecific LBP and is suitable for the study. The red flags include night pain, 24-hour pain, unexplained weight loss, night sweats, fever, change in bowel and urinary habits and saddle anesthesia. Subjective examination for body chart and physical examination include trunk range of motion, myotome, dermatome, reflexes, palpation, and neuro-tension test will be performed when applicable. Each subject will participate weekly group program for five consecutive weeks after the group randomization. The size of the group is about 10. Each session for both intervention group and control group will last for 105 min and will receive 60-minute group exercise therapy includes supervised stretching, mobilization, stabilization and strengthening exercise for the muscles around lumbar, hips and low limbs followed by functional and aerobic training. The exercises are selected with reference to the National Institute for health and care Excellence (NICE) guidelines, systematic review for physical activities for elderly with chronic LBP and experience from the previous pilot trial which is safe and effective for elderly with nonspecific chronic LBP. The exercise will be taught to patient progressively from lying to sitting in first two sessions and adding more advance standing to functional and aerobic training in subsequent sessions. The resistance of the TheraBand and step height for functional training will tailor made and increase according to individual capability. Each patient will be given an exercise pamphlet, goal setting worksheet and home exercise record sheet. Patients are encouraged to utilize local community exercise facilitates and bring back the home exercise record sheet each time for checking of compliance of practicing home exercise. Both groups of patients will have a physiotherapist leading discussion. For the GrEx group, the discussion will last for 45 minutes. It involves discussion for back care and exercise referencing to the back school that is a common educational and training program given to patients with low back pain. The content includes anatomy of the spine, cause for pain, self-management, correct manual lifting technique, ergonomic advice, and benefit of regular exercise. For the GrExPACT group, the discussion will use the Acceptance and Commitment Therapy (ACT) approach and will also last for 45 minutes. The content of the discussion will follow the protocol-based ACT extracted from the protocol for the contextual pain management by physiotherapy being used in INPUT center of St Thomas Hospital, London and physiotherapy informed by acceptance and commitment therapy protocol (PACT) . Qualification of the intervention provider: The intervention providers are registered physiotherapist in Hong Kong who had more than 30 years of clinical experience in treating patient with musculoskeletal problem at public physiotherapist outpatient clinic. For the background of ACT training, the physiotherapists had received training for taught course for ACT and had participated in a two-day clinical attachment for the contextual pain management program in INPUT Center at St. Thomas Hospital in London of United Kingdom in 2018. Besides the participation in the local pilot trial for GrExPACT study, they had also participated in the development for the local clinical service team for stratified care and combined the physical and psychological approach in management of high-risk back pain patients since 2015. Data processing and statistical analysis: The statistical analysis will be carried out using IBM SPSS version 28 software. The demographically data will be presented by descriptive statistics. For continuous data, it will be presented as mean, standard deviation and range. For categorical data, it will be presented as frequency and percentage. Normality will be first screened by Boxplot, and further assessed by the Shapiro-Wilk test. For the primary and secondary outcomes, two way repeated measure ANOVA will be carried out. For the effect of time, the post hoc test will be carried out for testing the differences of outcome scores for pre-intervention verse immediate after the program; pre-intervention verse at 3 months; and immediate after the program verse at 3 months. For the effect of intervention, post hoc tests at each time point will be carried out when necessary. Significance was set at p < 0.05. Intention-to-treat analysis will be used and missing data will be replaced with data from the nearest previous non-missing data. Effect sizes (Partial eta squared) will also be computed to establish the magnitude of the treatment effects. The effect sizes will interpreted as small (η2=0.01), medium (η2=0.06) or large (η2=0.14). Clinical significance: In the management of elderly patient with chronic nonspecific low back pain (LBP), to face the aging population, growing high patient volume and limited resources in health care, an effective and efficient service model is urged. The service model of GrExPACT in the present randomized control trial involve tailor made and resources saving strategy by using concept of stratified care with STarT Back Screening Tool, physical therapy with group exercise and psychological therapy with group ACT lead by physiotherapist. With the present study, the effectiveness, synergistic effect, and adaptability to local culture for combining physiotherapy group exercise with acceptance and commitment therapy delivered by physiotherapist (GrExPACT) could be studied. The potential positive finding may enhance the role of physiotherapist using the psychological approach in the management of chronic nonspecific LBP and provide evidence support for the proposed more comprehensive, tailor made and resources saving service model of GrExPACT. This may help to reform a more effective and efficient model of care in Hong Kong.

    Phase

    N/A

    Span

    53 weeks

    Sponsor

    The Hong Kong Polytechnic University

    Kowloon

    Recruiting

  • Voice-activated Intelligent Personal Assistant (VIPA) Intervention for People With Parkinson's Disease

    Background: Parkinson's disease (PD) is one of the two most common neurodegenerative diseases affecting millions worldwide. PD research generally focuses on motor functioning and calls for more psychosocial interventions for people with Parkinson's disease (PWP). The proposed VIPA intervention is an artificial intelligent personal assistant commonly used within Western society but not Asian countries, facilitating users' daily living by performing audio calls, messaging, and information searching. Recent literature showed VIPA Implementation is promising for rehabilitation in older adults but warrants more interventional studies to examine its efficacy and if it applies to other illnesses. Therefore, this study will formulate a positive health-orientated VIPA intervention protocol and investigate its efficacy in promoting PWP's sense of coherence and psychosocial well-being. Objectives of the study: This is a 2-phase study, and the objectives are: Phase 1: 1. To develop and validate the VIPA user protocol. 2. To examine the feasibility of the VIPA intervention. Phase 2: 1. To investigate the preliminary efficacy of the VIPA intervention on PWP's SOC 2. To explore the users' experience of VIPA intervention among PWP. Method: Phase 1: 3 semi-structured focus group interviews will be held to generate items in user protocol. Another 3 cognitive interviews will be held with PWP to test the face validity and feasibility of the user protocol. 5 healthcare and information technology experts will then be invited to assess the content validity of the protocol. Any item with an item content validity index (i-CVI) score lower than 0.78 will be discarded or revised. Phase 2: 60 participants will be randomized into the intervention group (IG) and control group (CG). During the 8-week intervention period, IG participants will receive the user protocol, a designated VIPA, a 30-minute VIPA training on day 1, and weekly technical support phone calls. CG participants will receive usual care (no intervention will be provided to CG participants), and they will continue their daily life during the intervention period. The 13-item Sense of Coherence Scale (SOC-13) will be set as the primary outcome, and secondary outcomes are: 1. University of California, Los Angeles (UCLA) three-item loneliness scale; 2. Parkinson's Disease Questionnaire (PDQ-8); 3. EuroQol-5 dimension-5 level; 4. Mental Health Continuum Short Form; 5. System Usability Scale; 6. Brief Resilient Coping Scale; 7. Montreal Cognitive Assessment; and 8. Self-report VIPA usage. 12 participants will then be selected through extreme case sampling to partake in explanatory, in-depth interviews based on their SOC-13 score differences between baseline and post-intervention tests to explore VIPA user experience. Data analysis: For qualitative data, content analysis will be used in phase 1, while in phase 2, in-depth interview data will be analyzed through deductive thematic analysis according to the salutogenic model. Quantitative data, such as demographic data, will be presented with descriptive statistics. Chi-square test and independent t-test will be performed for baseline comparison. Generalized Estimating Equations will be used to analyze group differences in all primary and secondary outcomes.

    Phase

    N/A

    Span

    52 weeks

    Sponsor

    The Hong Kong Polytechnic University

    Kowloon

    Recruiting

  • Adopting a Health-social Partnership Program to Promote Health and Self-care Management Among Older Adults in the Community

    This randomized type 2 effectiveness-implementation hybrid trial study aims to examine the effectiveness of a community-based health-social partnership program in promoting health and self-care management among older adults dwelling in the community and to explore the reach, adoption, implementation, maintenance aspects of the implementation process of the program in a real-life setting. This study has two parts. The first part involves a cluster randomized controlled trial with a two-arm, matched-pairs, equivalent allocation ratio, and parallel design to examine the effectiveness of this study. Based on socio-economic status, community centers will be matched into three comparable pair sets, and further randomized into three intervention and control groups. A total of 788 subjects (394 in each arm) aged 60 or above, dwelling in the community, and cognitively competent will be recruited. Three-time interval outcome measures will be collected. The second part of this study is an implementation research design concerning the implementation process of the program in a real-life setting. Focus group interviews with different stakeholders will be conducted and meeting minutes, and archives of documents will be studied. Summative data will be analyzed in the RE-AIM framework. The findings of this study are anticipated to shed some light on the effectiveness and implementation of integrated health-social service in Hong Kong context. It will make important contributions, not only to the individuals, but also to the policymakers and service providers advocating the concept of ageing in place and health-social partnership approach care. The informed the health-social partnership collaboration practice in real-world setting can facilitate the translation of research evidence into practice to tackle the health burdens and challenges.

    Phase

    N/A

    Span

    152 weeks

    Sponsor

    The Hong Kong Polytechnic University

    Kowloon

    Recruiting

    Healthy Volunteers

  • Effectiveness and Cost-effectiveness of PelviSense, a Novel Biofeedback Device for Stress Urinary Incontinence in Women

    Background Pelvic floor muscle (PFM) training (PFMT) is a common conservative first-line treatment for SUI in women. However, the success of PFMT alone, without adjunctive therapies, has been hampered by the lack of training adherence among patients, who report the inability to contract the correct PFMs and limited motivation to perform PFMT exercises. Therefore, PFMT is often combined with adjunctive therapies, such as electromyography (EMG) biofeedback via an intravaginal probe (referred to as conventional biofeedback), transvaginal electrical stimulation (TVES), or weighted vaginal cones. However, PFMT adjunctive therapies that involve intravaginal probes/ cones are not preferred by women because they are invasive, and the vaginal insertion of probes/ cones can cause pain and discomfort. In addition, older women with atrophic vaginas have difficulty retaining probe/cones within the vaginal canal due to weak PFM tone. To meet the existing need for a non-invasive PFMT adjunctive therapy, the research team developed the PelviSense. The PelviSense is an innovative, non-invasive biofeedback device with wearable EMG sensors, designed to assist individuals in isolating and strengthening PFMs by helping them distinguish correct PFM contractions (lifting or squeezing the muscles) from incorrect attempts (bearing down). A mixed-methods study, including a full-scale RCT and semi-structured focus groups, alongside an economic evaluation, will be conducted to evaluate both the effectiveness and cost-effectiveness of the newly developed PelviSense device for the treatment of SUI in women. Aims: Aim 1: Investigate the efficacy of PelviSense-assisted PFMT compared with PFMT alone for improving SUI symptom severity in women. Aim 2: Compare the cost-effectiveness of the PelviSense device against PFMT alone for treating SUI in women. Aim 3: Explore the views of women regarding the use of the PelviSense device as an adjunct to PFMT and the impacts of the PelviSense device on their lives and well-being. Methods Recruitment: Women with SUI who attend the outpatient Obstetrics and Gynecology Department of Kwong Wah Hospital (KWH) will be recruited for the study. In addition, potential participants will be recruited using a non-probability convenience sampling technique through public, KWH, elderly care centers, and HK Polytechnic University (PolyU) campus advertising. Advertising will consist of study flyers posted at KWH, around the university campus, in waiting rooms of university health services and physiotherapy clinics, in community churches, and in university-owned amenities, including sports centres and gyms. Randomisation and blinding: Computer-generated randomisation will be utilised to ensure that both study groups are assigned an equal number of participants at a 1:1 ratio. Sequentially numbered, sealed, opaque envelopes of similar size and shape will be utilised to conceal group allocation and avoid selection bias. Due to the nature of the intervention, it is not possible to blind the therapists or participants to the allocation of treatment; therefore, only the outcome assessor will be blinded. To minimise detection bias, the outcome assessors will not participate in the treatment, and all study outcomes will be assessed in a separate room without any knowledge of participant allocation. Statistical analysis will be performed in a blinded manner, with each group assigned a code (group A and group B). The group identities will be revealed after all analyses are completed. Procedure and baseline assessment: Potentially eligible women who contact research personnel will be invited to attend an in-person screening session. On this first day of contact, all women will undergo BMI measurement; complete the screening questionnaire, MMSE, and 1-h pad test to confirm eligibility; and provide written informed consent. Baseline assessments of study outcomes will be performed, and eligible and consenting participants will be randomised to intervention groups. Outcome measures Outcomes assessments will be completed at baseline (time point 1 [T1]), 1-month (T2) and 6-months (T3). Intervention. The interventions will be provided for 6 months, beginning with a 1-month supervised training period at KWH and PolyU. Following supervised training, women will be instructed to perform unsupervised home exercises for 5 months. Unsupervised home exercises will consist of at least eight contractions, performed 3 times per day, for 5 days of each week, with or without the biofeedback device according to group assignment. Each contraction will last for 10 seconds, followed by relaxation for 10 seconds. The PFMT exercise parameters are based on the National Institute for Health and Care Excellence PFMT guidelines for UI. Qualitative study (semi-structured focus groups). A computer-generated randomization schedule will be utilized to identify 20 participants (from the 71 participants included in the PelviSense-assisted PFMT group) to participate in the focus groups. Each focus group will last for 45-60 minutes. Focus groups will continue to be conducted until data saturation occurs. Focus groups will be scheduled for 8-months post-randomisation. A semi-structured focus group approach will be used, during which discussion will be guided by but not limited to a set of pre-determined, open-ended questions. Data processing and analysis: Statistical analysis will be performed on an intention-to-treat basis using the Statistical Package for the Social Sciences (v.25; Armonk, NY). Treatment effects for both primary and secondary outcomes between T1, T2, and T3 and across the intervention groups will be evaluated using a two-way analysis of covariance (ANCOVA) with age as the covariate. T1 and T2 will be compared to establish immediate treatment effects, and T1 and T3 will be compared to evaluate the retention of treatment effects. For significant group by time interaction effects, post-hoc analysis using Bonferroni correction will be performed. The unadjusted mean total and disaggregated costs and differences in costs between the PelviSense and PFMT alone groups will be calculated. Seemingly unrelated regression (SUR) analyses will be used to estimate total cost differences (ΔC) and effect differences (ΔE). The EQ-5D-5L responses will be converted into utility scores to estimate the gain or loss of quality-adjusted life-years (QUALYs). The incremental cost-effectiveness ratio (ICER) will be calculated using the formula ICER = ΔC / ΔE. Uncertainty surrounding ICERs and 95% confidence intervals for cost differences will be estimated using bias-corrected and accelerated bootstrapping with 5,000 replications. Qualitative data from the focus groups will be analysed using the six phases of thematic analysis recommended by Braun and Clarke. The identified themes will then be defined and named according to their contents. The final set of themes will be confirmed as coherent and comprehensive by review of the team.

    Phase

    N/A

    Span

    134 weeks

    Sponsor

    The Hong Kong Polytechnic University

    Hong Kong

    Recruiting

  • Effectiveness of Chest Wall Mobilization Program in Improving Respiratory Function for Patients With COPD

    I. Intervention for Study Group Structured Chest Wall Mobilization Program Chest Wall Mobilization Chest wall mobilization is one of the important techniques in chest physical therapy for increasing chest wall mobility and improving ventilation. Either passive or active chest mobilizations help to increase chest wall mobility, flexibility, and thoracic compliance. The mechanism of this technique increases the length of the intercostal muscles and therefore helps in performing effective muscle contraction. It improves the biomechanics of chest movement by enhancing direction of anterior-upward movement of lower costal and downward movement of diaphragm. Maximal relaxed recoiling of the chest wall helps in achieving effective contraction of intercostal muscle. Chest wall mobilization with breathing exercise was showed to effect clinical benefit in chronic lung disease especially COPD with lung hyperinflation or barrel-shaped chest. The technique of chest wall mobilization helps in chest wall flexibility, respiratory muscle function and ventilatory pumping, which helps to reduce dyspnoea and respiratory accessory muscle use. The chest wall mobilization techniques include: 1. Lateral flexion of chest wall 2. Chest wall extension 3. Lateral gliding of thoracic spine 4. Pectoralis major muscle stretching There is no standard of practice found on the current studied chest wall mobilization. As good practice for quality and safety assurance, the studied program was evaluated by two independent Physiotherapists expert with post-graduate qualification in Manual Therapy recognised by Physiotherapists Board of Hong Kong Government and the International Federation of Orthopaedic Manipulative Physical Therapists of World Confederation of Physical Therapy. Chest wall mobilization will be performed in a therapist-assisted manner by a single trained and certified American College of Sports Medicine (ACSM) Clinical Exercise Physiologist with more than 10 years' experience working in the speciality with chronic respiratory patients in respiratory medicine. Subjects will be placed in the sitting position, lying on the back or sidelying position with knees bent to correct the lumbar curve, repositioning of the scapular waist as well as scapular and arm abduction in order to prevent postural compensations. Stretching was performed bilaterally as follows: 1. Lateral flexion of chest wall Patient in supine and lateral position on a foam roller in the infra-axillary region, forearms flexed and hands resting on the occipital region; the therapist used both palmar region hand's to mobilize the ribs in the cranial and caudal direction. 2. Chest wall extension Patient in supine lying on a foam roller in the mid-thoracic region, raise the arm over the head and grasp hold on a fixed wall bar about 10 inches from the surface of the plinth. 3. Lateral gliding of thoracic spine It is a non-thrust transverse vertebral pressure as described by Maitland et al 2005. Patients in prone lying, arms to the side and head in a 'forehead rest position'. Mobilization was applied to the whole thoracic spine. The spinous process of T1 was identified by first locating C6 using the cervical extension method and then counting caudally. The therapist stood at the level of the vertebra to be mobilized on one side of the subject. The pad of the therapist's non-dominant thumb was placed in contact with the lateral aspect of the spinous process of T1, whereas the dominant thumb was placed on the dorsal side of the other thumb. Pressure was applied to the spinous process to produce small amplitude, low velocity oscillations into resistance to the end-range of the vertebra (Grades IV). This procedure was performed for 30 seconds, and then sequentially applied to the next caudal level. The same pattern of application was used on the patient's contralateral side. 4. Pectoralis major stretching Patient in supine position, on the side to be stretched, the patient´s arm was abducted, forearm flexed and hand resting on the occipital region. The displacement was performed with one of the therapist's hands on the upper third of the arm and the other on the lateral region of the upper chest, following the direction of muscle fibres. The therapist-assisted chest wall mobilization for stretching follow the guidelines of general stretching for skeletal muscles. Static stretching will be performed with the therapist assisted the movement to the available range and hold in that position with the muscle on tension to a point of a stretching sensation. The stretching will be carried out during the expiratory phase with two sets of ten consecutive incursions for each position and a one-minute rest between the series. The holding of the stretching sensation should last for 10 seconds. The intervention will be around 20 minutes in total. For the participants in the Control group, they will be asked to stay in supine, sidelying and prone positions for around 20 minutes to standardize the treatment time and effect of positioning. Intervention Group Home Exercise Program For maintenance of the intervention effect and further improvement of chest wall mobility as well as soft tissues elasticity. Self-stretching exercises of trunk extension, rotation, side flexion as well as stretching of the pectoralis major muscle will be taught to the patients as home exercise program. Participants will be asked to perform the home exercise program for 15 minutes, 3 days /week for 6 weeks. An individual exercise log-book with the diagram of the stretching exercises will be given to the subjects to follow the exercises and record down their participation. Weekly telephone contact to participant will be given for motivation and encouragement of program adherence and completing the log books. II. Intervention for Control Group Subjects in the control group will be asked to maintain their physical activity level as usual. A 15-minute simple stretching exercise on large muscle group will be taught for standardization as a home exercise program. Five stretching exercises for arms and legs will be taught to the patient as a home exercise program. Participants will be asked to perform the home exercise program for 15 minutes, 3 days /week for 6 weeks. An individual exercise log-book with the diagram of the stretching exercises will be given to the subjects to follow the exercises and record down their participation. Same weekly telephone contact to participant will be given for motivation and encouragement of program adherence and completing the log books as that in intervention group. III. Common Program for Both Groups Standardized Walking Exercise Exercise will be performed on a Gaitkeeper Mobility Research 2000T electronic treadmill (Cortland, New York) set at zero inclination during subject's follow-up visit at Physiotherapy Department of Kowloon Hospital. Each participant will perform 15 minutes supervised walking exercise at a speed maintain with the participant's target heart rate zone of 60-80% Heart Rate Maximum for cardiovascular training. Besides, the oxygen saturation during walking will be kept above 88%. An oximeter will be used to adjust walking speed and monitoring of HR and oxygen saturation. Standardized Educational Session Three educational sessions (30 minutes for each session) will be included for both intervention group and control group at Physiotherapy Department of Kowloon Hospital. The content of the education include self-management of bronchial hygiene, breathing re-training, relaxation techniques and the importance of exercise. Education pamphlets will be given to both groups of patients.

    Phase

    N/A

    Span

    92 weeks

    Sponsor

    The Hong Kong Polytechnic University

    Kowloon

    Recruiting

  • Effects of Rhythmic Auditory Stimulation on Movements in Individuals at Risk for Psychotic Onset and Schizophrenia Patients

    Phase

    N/A

    Span

    122 weeks

    Sponsor

    Dr WANG Shumei

    Kowloon

    Recruiting

    Healthy Volunteers

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