Comparison of Robot-Assisted Gait Training and Conventional Therapy in
Comparison of Robot-Assisted Gait Training and Conventional Therapy in Multiple Sclerosis Patients
What it found
Results are posted in the registry, but without a statistical test of the main measure. See the numbers below.
What was tested
Treatment tested
- robot assisted gait therapy
Compared with
- Conventional rehabilitation
Results by group
Fatigue Severity Score
baseline
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Robot Assisted Training (RAT) | 5.5 score on a scale | 4.11–7 | 18 |
| Conventional Training (CT) | 6 score on a scale | 4.11–7 | 19 |
Robot Assisted Training (RAT)
Conventional Training (CT)
Fatigue Severity Score
after treatment (4th week)
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Robot Assisted Training (RAT) | 4.4 score on a scale | 3–6.44 | 18 |
| Conventional Training (CT) | 5.8 score on a scale | 3.89–6.89 | 19 |
Robot Assisted Training (RAT)
Conventional Training (CT)
Fatigue Severity Score
3 months after treatment
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Robot Assisted Training (RAT) | 5.5 score on a scale | 3.33–7 | 18 |
| Conventional Training (CT) | 5.7 score on a scale | 4–7 | 19 |
Robot Assisted Training (RAT)
Conventional Training (CT)
Hospital Anxiety Depression Scale-Depression Subscale (HADS-D)
Baseline
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Robot Assisted Training (RAT) | 8.5 score on a scale | 0–12 | 18 |
| Conventional Training (CT) | 10 score on a scale | 1–15 | 19 |
Robot Assisted Training (RAT)
Conventional Training (CT)
Hospital Anxiety Depression Scale- Depression Subscale (HADS-D)
After treatment (4th week)
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Robot Assisted Training (RAT) | 5.5 score on a scale | 0–12 | 18 |
| Conventional Training (CT) | 9 score on a scale | 1–15 | 19 |
Robot Assisted Training (RAT)
Conventional Training (CT)
Hospital Anxiety Depression Scale- Depression Subscale (HADS-D)
3 months after treatment
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Robot Assisted Training (RAT) | 6.5 score on a scale | 0–13 | 18 |
| Conventional Training (CT) | 9 score on a scale | 1–16 | 19 |
Robot Assisted Training (RAT)
Conventional Training (CT)
Hospital Anxiety Depression Scale- Anxiety Subscale (HADS-A)
baseline
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Robot Assisted Training (RAT) | 7.5 score on a scale | 3–13 | 18 |
| Conventional Training (CT) | 8 score on a scale | 3–16 | 19 |
Robot Assisted Training (RAT)
Conventional Training (CT)
Hospital Anxiety Depression Scale-Anxiety Subscale (HADS-A)
After treatment (4th week)
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Robot Assisted Training (RAT) | 5 score on a scale | 1–17 | 18 |
| Conventional Training (CT) | 8 score on a scale | 3–15 | 19 |
Robot Assisted Training (RAT)
Conventional Training (CT)
Hospital Anxiety Depression Scale-Anxiety Subscale (HADS-A)
3 months after treatment
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Robot Assisted Training (RAT) | 5 score on a scale | 2–15 | 18 |
| Conventional Training (CT) | 8 score on a scale | 2–16 | 19 |
Robot Assisted Training (RAT)
Conventional Training (CT)
Values as posted on ClinicalTrials.gov. Outcomes measured differently across trials are not directly comparable.
Safety
| Group | Participants at risk | Serious adverse events | Deaths |
|---|---|---|---|
| Robot Assisted Training (RAT) | 0 | 0 | 0 |
| Conventional Training (CT) | 0 | 0 | 0 |
As posted on ClinicalTrials.gov. Serious adverse events include any serious health event during the trial, whether or not the treatment caused it.
What it measured
Main measures
Fatigue Severity Score
baseline
FatigueQuality of life (reported by participants)Fatigue Severity Score
after treatment (4th week)
FatigueQuality of life (reported by participants)Fatigue Severity Score
3 months after treatment
FatigueQuality of life (reported by participants)Hospital Anxiety Depression Scale-Depression Subscale (HADS-D)
Baseline
Mood and sleepHospital Anxiety Depression Scale- Depression Subscale (HADS-D)
After treatment (4th week)
Mood and sleepHospital Anxiety Depression Scale- Depression Subscale (HADS-D)
3 months after treatment
Mood and sleepHospital Anxiety Depression Scale- Anxiety Subscale (HADS-A)
baseline
Mood and sleepHospital Anxiety Depression Scale-Anxiety Subscale (HADS-A)
After treatment (4th week)
Mood and sleepHospital Anxiety Depression Scale-Anxiety Subscale (HADS-A)
3 months after treatment
Mood and sleep
Other measures (15)
Multiple Sclerosis Quality of Life-54 (MSQOL-54)-Physical Health
baseline
Thinking and memoryBladder, bowel and sexual functionPainQuality of life (reported by participants)Multiple Sclerosis Quality of Life-54 (MSQOL-54)-Physical Health
after treatment (4th week)
Thinking and memoryBladder, bowel and sexual functionPainQuality of life (reported by participants)Multiple Sclerosis Quality of Life-54 (MSQOL-54)- Physical Health
3 months after treatment
Thinking and memoryBladder, bowel and sexual functionPainQuality of life (reported by participants)Expanded Disability Status Scale (EDSS)
baseline
Disability progressionExpanded Disability Status Scale (EDSS)
after treatment (4th week)
Disability progressionExpanded Disability Status Scale (EDSS)
3 months after treatment
Disability progressionFunctional Ambulation Classification
baseline
Functional Ambulation Classification
after treatment (4th week)
Functional Ambulation Classification
3 months after treatment
Walking Ability
baseline
Walking and mobilityPhysical function
Who could take part
MS (type not specified) · 18 to 70 · EDSS 5.5 to 7.5
Show the full 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
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
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.
Papers
Results
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.Background
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.Background
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/s13063Background
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.
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History
Started
Feb 2019
Main results due
Mar 2020
Finished
Mar 2020
Results posted
Feb 2021