Comparison of Robot-Assisted Gait Training and Conventional Therapy in Multiple Sclerosis Patients

Not Applicable

Completed

• Conditions: Multiple Sclerosis
• Interventions: Other: Conventional rehabilitation; Other: robot assisted gait therapy

• Registration Number: NCT03801473
• Lead Sponsor: Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey

Brief Summary

The aim of this study is to compare conventional neurorehabilitation with robot-assisted gait training program in terms of fatigue, anxiety, depression and quality of life.

Detailed Description

Gait disturbances are common in Multiple Sclerosis (MS) patients. Nowadays, gait training with robot assisted technology is used for rehabilitation. In several studies conventional rehabilitation was compared with robot assisted rehabilitation program, and they found no superior effects of robot assisted walking program. In this study we aimed to compare these modalities in terms of fatigue, anxiety and quality of life.

Study Timeline

• Study First Submitted: 2019-01-09
• Study First Submitted QC: 2019-01-10
• Study First Posted: 2019-01-11
• Study Start: 2019-02-04
• Primary Completion: 2020-03-01
• Study Completion: 2020-03-01
• Results First Submitted: 2020-12-30
• Results First Submitted QC: 2021-02-01
• Results First Posted: 2021-02-02
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-11
• Last Update Posted: 2021-05-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

Inclusion Criteria

• 18-70 years old Multiple Sclerosis patients
• EDSS score: 5.5-7.5
• Being oriented and cooperated
• Mini-mental score ≥24/30

Exclusion Criteria

• Modified Ashworth >3 in lower extremity muscles
• Cognitive impairment
• Botox injection within last 6-months
• Having another neurological disease
• Pregnancy or breast-feeding

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
conventional training (CT)	Conventional rehabilitation	Participants in CT group had physiotherapist assisted walking exercises on the parallel bars and on the ground with aids/cane, tripod or walker.
robot assisted training (RAT)	robot assisted gait therapy	RoboGait which is an automated locomotor therapy system was used for treating RAT group. The system composed of a robotic lower extremity orthosis, adjustable dynamic gait support, synchronized treadmill and biofeedback utilities

Primary Outcome Measures

Name	Time	Method
Fatigue Severity Score	3 months after treatment	Patient-reported outcome measure which is composed of 9 items and evaluates the severity of fatigue. The items are scored on a 7-point scale with 1=strongly disagree and 7=strongly agree. The minimum score is 9 and maximum possible score is 63. FSS score is calculated as total score/9. Higher score reflects greater fatigue severity.
Hospital Anxiety Depression Scale-Depression Subscale (HADS-D)	Baseline	Hospital Anxiety Depression Scale (HADS) s a 14 item questionnaire which consists two sub-scale evaluating anxiety (HADS-A) and depression (HADS-D).; HADS-D sub-scale has seven items and each item is scored on a scale of 0 to 3. Total score ranged from 0 to 21. Higher scores reflects more severe depression.
Hospital Anxiety Depression Scale- Depression Subscale (HADS-D)	3 months after treatment	Hospital Anxiety Depression Scale (HADS) s a 14 item questionnaire which consists two sub-scale evaluating anxiety (HADS-A) and depression (HADS-D).; HADS-D sub-scale has seven items and each item is scored on a scale of 0 to 3. Total score ranged from 0 to 21. Higher scores reflects more severe depression.
Hospital Anxiety Depression Scale- Anxiety Subscale (HADS-A)	baseline	Hospital Anxiety Depression Scale (HADS) s a 14 item questionnaire which consists two sub-scale evaluating anxiety (HADS-A) and depression (HADS-D).; HADS-A sub-scale has seven items and each item is scored on a scale of 0 to 3. Total sub-scale score ranged from 0 to 21. Higher score mean a worse outcome.
Hospital Anxiety Depression Scale-Anxiety Subscale (HADS-A)	3 months after treatment	Hospital Anxiety Depression Scale (HADS) s a 14 item questionnaire which consists two sub-scale evaluating anxiety (HADS-A) and depression (HADS-D).; HADS-A sub-scale has seven items and each item is scored on a scale of 0 to 3. Total sub-scale score ranged from 0 to 21. Higher score mean a worse outcome.

Secondary Outcome Measures

Name	Time	Method
Multiple Sclerosis Quality of Life-54 (MSQOL-54)-Physical Health	after treatment (4th week)	The MSQOL-54 is a multidimensional health-related quality of life measure that combines both generic and MS-specific items.; This 54-item instrument generates 12 subscales along with two summary scores, and two additional single-item measures. The subscales are: physical function, role limitations-physical, role limitations-emotional, pain, emotional well-being, energy, health perceptions, social function, cognitive function, health distress, overall quality of life, and sexual function.; The summary scores are the physical health composite summary and the mental health composite summary.; Each composite summary scored 0-100. Higher values indicate better QoL.
Multiple Sclerosis Quality of Life-54 (MSQOL-54)- Physical Health	3 months after treatment	The MSQOL-54 is a multidimensional health-related quality of life measure that combines both generic and MS-specific items.; This 54-item instrument generates 12 subscales along with two summary scores, and two additional single-item measures. The subscales are: physical function, role limitations-physical, role limitations-emotional, pain, emotional well-being, energy, health perceptions, social function, cognitive function, health distress, overall quality of life, and sexual function.; The summary scores are the physical health composite summary and the mental health composite summary.; Each composite summary scored 0-100. Higher values indicate better QoL.
Expanded Disability Status Scale (EDSS)	3 months after treatment	The EDSS assesses the disability status of MS patients on a scale range from 0 to 10 in 0.5 unit increments that represent higher levels of disability.
Functional Ambulation Classification	3 months after treatment	scored 0 to 5 (non functional ambulator to independant ambulator)
Walking Ability	3 months after treatment	The 6-min walk test (6 MWT) is a submaximal exercise test that entails measurement of distance walked over a span of 6 minutes.
Berg Balance Test (BBT)	3 months after treatment	Berg Balance Test (BBT) is a functional test with 14 items. Each item is scored on a five point scale (0 to 4) which is determined by ability to perform the task. The total score ranged 0 to 56. A higher score reflects better functional balance.

Trial Locations

Locations (1)

Sultan Abdulhamid Han Training and Research Hospital; 🇹🇷 Istanbul, Turkey