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Robotic Constraint Lokomat Training for Gait Rehabilitation in Patients With Stroke

Primary Purpose

PHYSICAL THERAPY TECHNIQUES

Status
Recruiting
Phase
Not Applicable
Locations
Saudi Arabia
Study Type
Interventional
Intervention
The Lokomat® Pro Hocoma USA & Conventional physical therapy
Conventional Physical Therapy
Sponsored by
Umm Al-Qura University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for PHYSICAL THERAPY TECHNIQUES focused on measuring Stroke, Gait, Balance, Lokomat.

Eligibility Criteria

40 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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)

Sites / Locations

  • Faculty of Applied Medical Science - UQURecruiting
  • UQU- KSARecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

RG(Robotic group= study group)

& CG( Control group)

Arm Description

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

control group (CG) will only receive conventional physiotherapy

Outcomes

Primary Outcome Measures

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)
Balance
Berg's Balance Scale (BBS) to measure balance
Activities of daily living
Modified Barthel Index (MBI) to measure activities of daily living
Spasticity of the lower limbs
Modified Ashowrth Scale (MAS) For muscle tone assessment (Spasticity
Gait speed
Timed-Up and Go test (TUG) will be used to assess gait speed with dynamic balance

Secondary Outcome Measures

Full Information

First Posted
August 1, 2022
Last Updated
August 1, 2022
Sponsor
Umm Al-Qura University
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1. Study Identification

Unique Protocol Identification Number
NCT05485727
Brief Title
Robotic Constraint Lokomat Training for Gait Rehabilitation in Patients With Stroke
Official Title
Uses of Robotic Constraint Lokomat Training on Gait Rehabilitation in Saudi Females Patients With Stroke- A Randomized Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 30, 2022 (Actual)
Primary Completion Date
November 30, 2022 (Anticipated)
Study Completion Date
March 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Umm Al-Qura University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
PHYSICAL THERAPY TECHNIQUES
Keywords
Stroke, Gait, Balance, Lokomat.

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
Outcomes Assessor
Masking Description
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)
Allocation
Randomized
Enrollment
28 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
RG(Robotic group= study group)
Arm Type
Experimental
Arm Description
14, Robotic-assisted gait training group (RG) will receive Lokomat gait training and conventional physiotherapy
Arm Title
& CG( Control group)
Arm Type
Active Comparator
Arm Description
control group (CG) will only receive conventional physiotherapy
Intervention Type
Other
Intervention Name(s)
The Lokomat® Pro Hocoma USA & Conventional physical therapy
Other Intervention Name(s)
Robotic Constraint Lokomat Training, (Enhanced Functional Locomotion Therapy with Augmented Performance Feedback)
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Conventional Physical Therapy
Other Intervention Name(s)
Designed Program of physical therapy rehabilitation for stroke patients for lower limbs
Intervention Description
Balance Exercises , Gait training, Trunk control, Range of motion exercises for lower limbs
Primary Outcome Measure Information:
Title
lower limb joint range of motion
Description
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)
Time Frame
3 months
Title
Balance
Description
Berg's Balance Scale (BBS) to measure balance
Time Frame
3 months
Title
Activities of daily living
Description
Modified Barthel Index (MBI) to measure activities of daily living
Time Frame
3 months
Title
Spasticity of the lower limbs
Description
Modified Ashowrth Scale (MAS) For muscle tone assessment (Spasticity
Time Frame
3 months
Title
Gait speed
Description
Timed-Up and Go test (TUG) will be used to assess gait speed with dynamic balance
Time Frame
3 months

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
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.
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hayam Mahmoud, Doctoral
Phone
00966540872404
Email
hmmehmoud@uqu.edu.sa
First Name & Middle Initial & Last Name or Official Title & Degree
Hayam Mahmoud, Doctoral
Phone
00201022662957
Email
dr_hayam98@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hayam Mahmoud, professor
Organizational Affiliation
Umm Al-Qura University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of Applied Medical Science - UQU
City
Jeddah
Country
Saudi Arabia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hayam Mahmoud, Professor
Facility Name
UQU- KSA
City
Jeddah
Country
Saudi Arabia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hayam Mahmoud, Doctoral
Phone
00966540872404
Email
hmmehmoud@uqu.edu.sa

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Results , Methodology , Publication
IPD Sharing Time Frame
One year
IPD Sharing Access Criteria
Published article, or paper

Learn more about this trial

Robotic Constraint Lokomat Training for Gait Rehabilitation in Patients With Stroke

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