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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-02-04

Study Completion Date

2020-03-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Multiple Sclerosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Initial assessments will be performed by first clinician (EA). Then, patients will be randomly grouped. The outcome assessor, second clinician (TOU) will be blinded.

Study Groups

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robot assisted training (RAT)

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

Group Type EXPERIMENTAL

robot assisted gait therapy

Intervention Type OTHER

The Robogait is a fixed lower body hip-knee exoskeleton. The user's weight is supported by a combination of an overhead attached harness and the support from the exoskeleton.

conventional training (CT)

Participants in CT group had physiotherapist assisted walking exercises on the parallel bars and on the ground with aids/cane, tripod or walker.

Group Type ACTIVE_COMPARATOR

Conventional rehabilitation

Intervention Type OTHER

Conventional rehabilitation program. Exercise and walking education is performed by the physiotherapists.

Interventions

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robot assisted gait therapy

The Robogait is a fixed lower body hip-knee exoskeleton. The user's weight is supported by a combination of an overhead attached harness and the support from the exoskeleton.

Intervention Type OTHER

Conventional rehabilitation

Conventional rehabilitation program. Exercise and walking education is performed by the physiotherapists.

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No