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  • Feasibility of the Blended Care Pirate Group

    Phase

    N/A

    Span

    120 weeks

    Sponsor

    Sint Maartenskliniek

    Ubbergen, Gelderland

    Recruiting

  • Kinematics of Movements Provoked by an Augmented Reality App

    Phase

    N/A

    Span

    82 weeks

    Sponsor

    Sint Maartenskliniek

    Ubbergen, Gelderland

    Recruiting

    Healthy Volunteers

  • Cardiorespiratory Fitness Training in Patients with Incomplete Spinal Cord Injury

    Rationale: Despite advances in medical care, spinal cord injury (SCI) patients have significantly lower survival rates compared to the general population. The 'Koepelproject', an unique world-leading multi-center research project, discovered that SCI patients have a decreased pulmonary function, which is linked to poor cardiorespiratory fitness (CRF). This leads to respiratory and cardiovascular diseases, which are important predictors of death in SCI patients. However, there are limitations of the 'Koepelproject' which highlight the need for the proposed project 'FIT@HOME'. Rehabilitation knowledge in SCI patients is primarily focused on those with a complete lesion, while there has been changes in the characteristics of the SCI population over the last few decades. The diagnosis of an incomplete SCI (iSCI) is more common and requires different insights and skills compared to patients with complete lesions. Therefore, insight in the effect of personalized rehabilitation strategies focussed on CRF during primary rehabilitation will provide important information to support healthy ageing in iSCI patients. Objective: The primary aim of this study is to assess the effect of a personalized training intervention on CRF during primary rehabilitation and at follow-up. Secondary aims of this study are to determine the effect of this training intervention on gait capacity, pulmonary function, neurological status, muscle force, cardiometabolic risk factors, quality of life (QoL), functional independence and exercise self-efficacy. Study design: The proposed study design is an explorative randomized controlled trial. Study population: This study will include 32 iSCI patients classified with an American Spinal Injury Association (ASIA) C or D in the subacute phase (< 6 months post injury), who are referred for a primary, inpatient rehabilitation program at the Sint Maartenskliniek. Intervention: The intervention includes 2-3 personalized CRF-focused training sessions per week. The control group receives usual care. Main study parameters/endpoints: The primary endpoint is the change in CRF (expressed as VO2peak) after the 6-weeks intervention period and at follow-up. Secondary outcomes are gait assessments, pulmonary function, neurological status, muscle force, cardiometabolic risk factors, secondary complications, quality of life, functional independence and exercise self-efficacy. Measurements will be performed at: T0 - Baseline T1 - Following the 6-weeks intervention period during the primary rehabilitation program at the Sint Maartenskliniek T2* - At discharge from the primary rehabilitation program at the Sint Maartenskliniek (only if the period following T1 is more than 2 weeks) T3 - After 2 weeks in the outpatient rehabilitation program at the Sint Maartenskliniek T4 - At discharge from the outpatient rehabilitation program at the Sint Maartenskliniek T5 - 2 weeks following discharge from the outpatient rehabilitation program at the Sint Maartenskliniek (2 weeks after T4) T6 - 3 months following discharge from the outpatient rehabilitation program at the Sint Maartenskliniek (3 months after T4, 2.5 months after T5)

    Phase

    N/A

    Span

    112 weeks

    Sponsor

    Sint Maartenskliniek

    Ubbergen

    Recruiting

  • TrEatment Targets in Rheumatoid Arthritis: TETRA-study

    Phase

    N/A

    Span

    159 weeks

    Sponsor

    Sint Maartenskliniek

    Ubbergen

    Recruiting

  • Myosuit in Incomplete Spinal Cord Injury

    Rationale: People with incomplete spinal cord injury (iSCI) show often impairments and limitations related to gait, which negatively affects daily life gait performance (i.e. ambulation in home and community setting) and quality of life. As a consequence of limited gait capacity, these people are likely to develop a sedentary lifestyle resulting in a vicious circle, causing a further decline in gait capacity and daily life gait performance. One of the potential options to improve gait is the use of assistive technology, such as exoskeletons or exosuits. People with iSCI have voluntary control of the leg muscles may benefit more from light-weighted exosuits which provide assistance during walking. Recently, a lower extremity soft exosuit, the Myosuit (MyoSwiss AG), has been introduced. In a small sample study, participants showed an increased gait speed when using the Myosuit compared to their baseline gait speed. Moreover, only a small number of training sessions was required to use the Myosuit. Hence, the Myosuit seems to have a high potential to increase gait capacity and daily life gait performance in people with residual gait capacity. Objective: The study consists of two parts, randomized controlled trial (RCT) and experimental design. In the RCT, the primary objective is to test the efficacy of the Myosuit for increasing daily life gait performance in the home and community setting in people with iSCI. Secondary, the efficacy of the Myosuit program on gait capacity and its cost-utility will be investigated. Finally, the usability of the Myosuit for use in home and community setting will be evaluated. In the experimental design, we will investigate differences in gait capacity with and without wearing the Myosuit in people with iSCI, by conducting clinical tests. Secondary, differences in gait capacity measured on an instrumented treadmill with and without wearing the Myosuit will be examined. Study design: RCT and within subject experiment. Study population: Thirty-four people with chronic iSCI (>6 months after injury) and reduced gait capacity due to reduced knee and/or hip strength (MRC<5) will be recruited for this study. People with iSCI will be included when having an injury level of C or D on the American Spinal Injury Association Impairment Scale. In addition, participants need to have sufficient hand function to don and doff the Myosuit or they need a caregiver who is available to help the participant to use the Myosuit at home. Patients who have another (neurological) disease which can influence motor performance and/or patients who have small wounds, which can be worsened by wearing the Myosuit will be excluded. For the second objective of the experimental design, only people who are be able to walk consecutively for two minutes on a treadmill without any assistive device and without using the handrails will be included. Intervention: RCT: The intervention group will perform training sessions with the Myosuit at the Sint Maartenskliniek. Thereafter, they will receive the Myosuit at their disposal at home and a recommendation for physical activity for six weeks. The control group will receive a program of conventional physiotherapy at the Sint Maartenskliniek. Thereafter, they receive a recommendation for physical activity for at home for six weeks. Experimental design: Participants perform clinical tests and measurements on an instrumented treadmill with and without the Myosuit. Measurements intervention and control group: - Baseline: Week 1 (T0) - After clinical training program at the Sint Maartenskliniek: Week 5 (T1) - During 6 weeks home period: Week 6, 8, 11 (T2, T3, T4) - After the 6 weeks home period: Week 12 (T5) Additional measurements for the control group who receive the Myosuit intervention after the conventional program: - After clinical training program at the Sint Maartenskliniek: Week 16 (T6) - During 6 weeks home period: Week 17, 19, 22 (T7, T8, T9) - After the 6 weeks home period: Week 23 (T10)

    Phase

    N/A

    Span

    143 weeks

    Sponsor

    Sint Maartenskliniek

    Ubbergen

    Recruiting

  • ARC Therapy to Restore Hemodynamic Stability and Trunk Control in People With Spinal Cord Injury

    Phase

    N/A

    Span

    108 weeks

    Sponsor

    ONWARD Medical, Inc.

    Ubbergen

    Recruiting

  • Gait Adaptability Training, Using Augmented Reality, for Individuals in the Chronic Phase After Stroke

    Phase

    N/A

    Span

    119 weeks

    Sponsor

    Sint Maartenskliniek

    Ubbergen

    Recruiting

  • Rituximab Effect on Decreasing glUcoCorticoid Exposition in PolyMyalgia Rheumatica Patients Experiencing a PMR Relapse

    Phase

    3

    Span

    260 weeks

    Sponsor

    Sint Maartenskliniek

    Ubbergen, Gelderland

    Recruiting

  • Rituximab Effect on Decreasing glUcoCorticoid Exposition in PolyMyalgia Rheumatica Patients Recently Diagnosed

    Phase

    3

    Span

    209 weeks

    Sponsor

    Sint Maartenskliniek

    Ubbergen, Gelderland

    Recruiting

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