Robotic Constraint Lokomat Training for Gait Rehabilitation in Patients with Stroke

Last updated: January 29, 2025
Sponsor: Umm Al-Qura University
Overall Status: Completed

Phase

N/A

Condition

Stroke

Cerebral Ischemia

Treatment

Conventional Physical Therapy

The Lokomat® Pro Hocoma USA & Conventional physical therapy

Clinical Study ID

NCT05485727
(HAPO-02-K-012-2022-03-1024)
  • Ages 40-65
  • Female

Study Summary

The aim of this study is to investigate the effect of a lokomat training on gait performance in Saudi females with stroke. Design: A-Single blind randomized controlled trial. Methods: 28 females patients with stroke will be enrolled in this thesis (6-12 months after stroke); the patients will be randomly assigned into two equal groups of 14. Robotic-assisted gait training group (RG) will receive Lokomat gait training and conventional physiotherapy, while the other group is a control group (CG) will receive conventional physiotherapy. Duration of treatment will be 3 months. The lower limb joint range of motion, Balance, activities of daily living, walk speed, muscle tone of the lower limbs will be recorded before and after treatment and will compared between both groups.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • 28 stroke female patients, age ranged from 40- 65 years, Lower limb mild to moderatespasticity (Modified Ashwarth Scale 1+ to 3), be able to understand all instructionsduring intervention (Mini-Mental State Examination Score ≥24 points), & be able towalk 10 m independently or under supervision

Exclusion

Exclusion Criteria:

  • cognitive impairment, behavioral disturbance, serious independent chronic diseaselikely to interfere with the ability to cooperate with the study, major contractureaffecting muscles of the leg, Joint pathology of the lower limb other than thatdirectly related to hemiplegia (eg, previous fractures, severe articular blocks);Patients under antispastic drug. Heart failure, unstable angina, uncontrolledhypertension peripheral arteriovenous occlusive disease. Neurogenic condition (otherthan stroke) affecting the gait pattern (e.g. ataxia, peripheral neuropathy,vertebrobasilar insufficiency and myelopathy), and patients with advancedosteoarthritis, and obesity (BMI > 30)

Study Design

Total Participants: 28
Treatment Group(s): 2
Primary Treatment: Conventional Physical Therapy
Phase:
Study Start date:
March 30, 2022
Estimated Completion Date:
December 10, 2023

Study Description

Background: Stroke is considered one of the main causes of morbidity and mortality and the contributing cause of disability in human adults. Gait performances were dramatically affected and reduced after stroke. Purpose: The aim of this study is to investigate the effect of a lokomat training on gait performance in stroke patients of Saudi women. Design: A-Single blind randomized controlled trial. Methods: Twenty-eight females of stroke patients will be enrolled in this thesis (6-12 months after stroke); the patients will be randomly assigned into two equal groups of 14. Robotic-assisted gait training group (RG) will receive Lokomat gait training and conventional physiotherapy, while the other group is a control group (CG) will receive conventional physiotherapy. Duration of treatment will be of three months. Randomization was performed by random number generator of the Microsoft Office Excel Software. Intervention: Both groups will be evaluated before and after treatment (3-month duration). LokomatPro is designed to improve training efficiency, RG will be compared with conventional manually assisted therapy CG. The device has all the necessary elements to enable effective robotic gait training. On a treadmill, the Lokomat's powered robotic gait orthosis legs lead the subject through walking movements, supporting their body weight(with safe belts) and allowing them to use their legs more freely. Over time, the degree of body weight support and direction will be reduced to more closely resemble typical unsupported walking. The Lokomat is linked to a video game that provides feedback on the amount of force the subject will generate. The motions of the joint's angles and linear motion for lower limb (hip, knee, and ankle excursions) and Lokomat will be recorded when the patients walk on a treadmill and inside the Lokomat. Patients will walk for roughly 30 minutes three times a week for a total of twelve weeks. Instrumentations:3D Motion analysis system, with 10 cameras Bonita Model, connected with 2-force plate (AMTI), and EMG (8Channels), Nexus Version 2.5 (will used for gait analysis before and after use of lokomat). The Lokomat® Pro Hocoma USA (Enhanced Functional Locomotion Therapy with Augmented Performance Feedback) consists of the robotic gait orthosis and an advanced body weight support system, combined with a Treadmill. (used for gait training). Berg's Balance Scale (BBS) to measure balance. Modified Barthel Index (MBI) to measure activities of daily living, respectively, The Rivermead Mobility Index (RMI) will be used to assess the functional mobility of the patients (This 15-item test is a hierarchical mobility scale including rolling in bed to running, a higher score indicates better mobility performance), Modified Ashowrth Scale (MAS) For muscle tone assessment (Spasticity), Timed-Up and Go test (TUG) will be used to assess balance and functional mobility together, (a lower duration indicates better mobility performance). Outcome measure The lower limb joint range of motion, Balance, and activities of daily living, walk speed, muscle tone of the lower limbs will be recorded before and after treatment and will compared between both groups. Statistical analysis: Data calculated by using the computer package SPSS 8.0. Individual data will be expressed in mean and standard deviation (SD). Un Paired t-test will used to compare between the results of the same group before and after treatment. Paired t-test will used to compare between the results both groups after treatment with level of significance at P≤ 0.05.

Connect with a study center

  • Faculty of Applied Medical Science - UQU

    Jeddah,
    Saudi Arabia

    Site Not Available

  • UQU- KSA

    Jeddah,
    Saudi Arabia

    Site Not Available

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.