Robotic Constraint Lokomat Training for Gait Rehabilitation in Patients with Stroke

NCT05485727 | Completed

• 1 other identifier: (HAPO-02-K-012-2022-03-1024)
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

PHYSICAL THERAPY TECHNIQUES

Keywords

Stroke, Gait, Balance, Lokomat.

Outcome Measures

Primary Outcomes (5)

• 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

• Balance

  Berg's Balance Scale (BBS) to measure balance

  3 months

• Activities of daily living

  Modified Barthel Index (MBI) to measure activities of daily living

  3 months

• Spasticity of the lower limbs

  Modified Ashowrth Scale (MAS) For muscle tone assessment (Spasticity

  3 months

• Gait speed

  Timed-Up and Go test (TUG) will be used to assess gait speed with dynamic balance

  3 months

Study Arms (2)

RG(Robotic group= study group)

EXPERIMENTAL

14, Robotic-assisted gait training group (RG) will receive Lokomat gait training and conventional physiotherapy

Other: The Lokomat® Pro Hocoma USA & Conventional physical therapy; Other: Conventional Physical Therapy

& CG( Control group)

ACTIVE COMPARATOR

control group (CG) will only receive conventional physiotherapy

Other: Conventional Physical Therapy

Interventions

The Lokomat® Pro Hocoma USA & Conventional physical therapy OTHER

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

Also known as: Robotic Constraint Lokomat Training, (Enhanced Functional Locomotion Therapy with Augmented Performance Feedback)

RG(Robotic group= study group)

Conventional Physical Therapy OTHER

Balance Exercises , Gait training, Trunk control, Range of motion exercises for lower limbs

Also known as: Designed Program of physical therapy rehabilitation for stroke patients for lower limbs

& CG( Control group); RG(Robotic group= study group)

Eligibility Criteria

• Age: 40 Years - 65 Years
• Gender Eligibility Details: 28 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.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Umm Al-Qura University: lead

Study Sites (2)

Faculty of Applied Medical Science - UQU

Jeddah, Saudi Arabia

Location

UQU- KSA

Jeddah, Saudi Arabia

Location

Related Publications (1)

• Mahmoud H, El-Kafy EA, Alayat MS, Shalabi KM, Ebid AA, El Fiky AAR. The Effectiveness of Robotic Constraint Lokomat Training on Gait Rehabilitation in Saudi Females Patients with Stroke: A Randomized Controlled Trial. NeuroRehabilitation. 2025 Aug;57(1):70-79. doi: 10.1177/10538135251333349. Epub 2025 May 11.

  PMID: 40350663 DERIVED

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Hayam Mahmoud, professor

  Umm Al-Qura University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The outcomes assessors will not aware about the treatment procedures the participants had received before. The assessors also will be blinded about both groups( Treatment group or Control group)
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Physical Therapy-Faculty of applied Medical Science- Physical Therapy Department

Model Details: stroke patients(28) 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.

Study Record Dates

• First Submitted: August 1, 2022
• First Posted: August 3, 2022
• Study Start: March 30, 2022
• Primary Completion: September 30, 2023
• Study Completion: December 10, 2023
• Last Updated: February 3, 2025

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: One year
• Access Criteria: Published article, or paper

Locations

SA (2)