Robotic Constraint Lokomat Training for Gait Rehabilitation in Patients With Stroke

PHYSICAL THERAPY TECHNIQUES Clinical Trial

Official title:

Uses of Robotic Constraint Lokomat Training on Gait Rehabilitation in Saudi Females Patients With Stroke- A Randomized Controlled Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05485727
• Other study ID #: (HAPO-02-K-012-2022-03-1024)
• Status: Recruiting
• Phase: N/A
• Start date: March 30, 2022
• Est. completion date: March 30, 2023

Study information

• Verified date: August 2022
• Source: Umm Al-Qura University
• Contact: Hayam Mahmoud, Doctoral
• Phone: 00966540872404
• Email: hmmehmoud[@]uqu.edu.sa
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 28
• Est. completion date: March 30, 2023
• Est. primary completion date: November 30, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 40 Years to 65 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

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

Related Conditions & MeSH terms

• PHYSICAL THERAPY TECHNIQUES
• Stroke

Intervention

Other:
• The Lokomat® Pro Hocoma USA & Conventional physical therapy
Lokomat Consists of robotic gait orthosis and an advanced body weight support system, combined with a Treadmill. (used for gait training) and Conventional Physical Therapy
• Conventional Physical Therapy
Balance Exercises , Gait training, Trunk control, Range of motion exercises for lower limbs

Locations

Country	Name	City	State
Saudi Arabia	Faculty of Applied Medical Science - UQU	Jeddah
Saudi Arabia	UQU- KSA	Jeddah

Sponsors (1)

Lead Sponsor	Collaborator
Umm Al-Qura University

Country where clinical trial is conducted

Saudi Arabia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	lower limb joint range of motion	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 lokomat usage)	3 months
Primary	Balance	Berg's Balance Scale (BBS) to measure balance	3 months
Primary	Activities of daily living	Modified Barthel Index (MBI) to measure activities of daily living	3 months
Primary	Spasticity of the lower limbs	Modified Ashowrth Scale (MAS) For muscle tone assessment (Spasticity	3 months
Primary	Gait speed	Timed-Up and Go test (TUG) will be used to assess gait speed with dynamic balance	3 months