Clinical trial NCT03801473: Comparison of Robot-Assisted Gait Training and Conventional Therapy in Multiple Sclerosis Patients
Official title: Comparison of Robot-Assisted Gait Training and Conventional Therapy in Multiple Sclerosis Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Sclerosis
Keywords: rehabilitation
robot assisted gait training
Lead sponsor: Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
Sponsor class: OTHER
First posted: 2019-01-11
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Fatigue Severity Score
timeFrame: baseline
measure: Fatigue Severity Score
timeFrame: after treatment (4th week)
measure: Fatigue Severity Score
timeFrame: 3 months after treatment
measure: Hospital Anxiety Depression Scale-Depression Subscale (HADS-D)
timeFrame: Baseline
measure: Hospital Anxiety Depression Scale- Depression Subscale (HADS-D)
timeFrame: After treatment (4th week)
measure: Hospital Anxiety Depression Scale- Depression Subscale (HADS-D)
timeFrame: 3 months after treatment
measure: Hospital Anxiety Depression Scale- Anxiety Subscale (HADS-A)
timeFrame: baseline
measure: Hospital Anxiety Depression Scale-Anxiety Subscale (HADS-A)
timeFrame: After treatment (4th week)
measure: Hospital Anxiety Depression Scale-Anxiety Subscale (HADS-A)
timeFrame: 3 months after treatment
Secondary outcomes:
measure: Multiple Sclerosis Quality of Life-54 (MSQOL-54)-Physical Health
timeFrame: baseline
measure: Multiple Sclerosis Quality of Life-54 (MSQOL-54)-Physical Health
timeFrame: after treatment (4th week)
measure: Multiple Sclerosis Quality of Life-54 (MSQOL-54)- Physical Health
timeFrame: 3 months after treatment
measure: Expanded Disability Status Scale (EDSS)
timeFrame: baseline
measure: Expanded Disability Status Scale (EDSS)
timeFrame: after treatment (4th week)
measure: Expanded Disability Status Scale (EDSS)
timeFrame: 3 months after treatment
measure: Functional Ambulation Classification
timeFrame: baseline
measure: Functional Ambulation Classification
timeFrame: after treatment (4th week)
measure: Functional Ambulation Classification
timeFrame: 3 months after treatment
measure: Walking Ability
timeFrame: baseline
measure: Walking Ability
timeFrame: after treatment (4th week)
measure: Walking Ability
timeFrame: 3 months after treatment
measure: Berg Balance Test (BBT)
timeFrame: Baseline
measure: Berg Balance Test (BBT)
timeFrame: After treatment (4th week)
measure: Berg Balance Test (BBT)
timeFrame: 3 months after treatment
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Sultan Abdulhamid Han Training and Research Hospital
Study officials:
References:
citation: Lefeber N, Swinnen E, Kerckhofs E. The immediate effects of robot-assistance on energy consumption and cardiorespiratory load during walking compared to walking without robot-assistance: a systematic review. Disabil Rehabil Assist Technol. 2017 Oct;12(7):657-671. doi: 10.1080/17483107.2016.1235620. Epub 2016 Oct 20.
citation: Straudi S, Manfredini F, Lamberti N, Zamboni P, Bernardi F, Marchetti G, Pinton P, Bonora M, Secchiero P, Tisato V, Volpato S, Basaglia N. The effectiveness of Robot-Assisted Gait Training versus conventional therapy on mobility in severely disabled progressIve MultiplE sclerosis patients (RAGTIME): study protocol for a randomized controlled trial. Trials. 2017 Feb 27;18(1):88. doi: 10.1186/s13063-017-1838-2.
citation: Gandolfi M, Geroin C, Picelli A, Munari D, Waldner A, Tamburin S, Marchioretto F, Smania N. Robot-assisted vs. sensory integration training in treating gait and balance dysfunctions in patients with multiple sclerosis: a randomized controlled trial. Front Hum Neurosci. 2014 May 22;8:318. doi: 10.3389/fnhum.2014.00318. eCollection 2014.
citation: Ozsoy-Unubol T, Ata E, Cavlak M, Demir S, Candan Z, Yilmaz F. Effects of Robot-Assisted Gait Training in Patients With Multiple Sclerosis: A Single-Blinded Randomized Controlled Study. Am J Phys Med Rehabil. 2022 Aug 1;101(8):768-774. doi: 10.1097/PHM.0000000000001913. Epub 2021 Oct 21.