G-EO Gait Rehabilitation Training in Progressive Multiple Sclerosis
G-EO Gait Rehabilitation Training in Progressive Multiple Sclerosis
What it found
The main measure showed a statistically significant benefit.
| Measure | Estimate | 95% CI | p |
|---|---|---|---|
| Multiple Sclerosis Impact Scale-29 | Mean Difference (Final Values) 14.21 | 9.367–19.04 | .000026 |
| Multiple Sclerosis Impact Scale-29 | Mean Difference (Final Values) 22.22 | 15.59–28.85 | .00018 |
| Multiple Sclerosis Impact Scale-29 | Mean Difference (Final Values) 13.19 | 7.013–19.38 | .00049 |
| Multiple Sclerosis Impact Scale-29 | Mean Difference (Final Values) 13.57 | 8.30–18.85 | .001 |
| Multiple Sclerosis Impact Scale-29 | Mean Difference (Final Values) 14.84 | 6.02–23.66 | .005 |
| Modified Fatigue Impact Scale | .010 | ||
| Modified Fatigue Impact Scale | Mean Difference (Final Values) 5.39 | 1.12–9.67 | .017 |
| Comfortable Walking Speed | Mean Difference (Final Values) .070 | .015–.124 | .017 |
| Fast Walking Speed | Mean Difference (Final Values) .058 | .001–.116 | .048 |
| Modified Fatigue Impact Scale | Mean Difference (Final Values) 1.313 | .016–2.619 | .048 |
| Comfortable Walking Speed | .050 | ||
| Modified Fatigue Impact Scale | .052 | ||
| Modified Fatigue Impact Scale | .056 | ||
| Modified Fatigue Impact Scale | .061 | ||
| Multiple Sclerosis Impact Scale-29 | .071 | ||
| Fast Walking Speed | .079 | ||
| Multiple Sclerosis Impact Scale-29 | .084 | ||
| Modified Fatigue Impact Scale | .089 | ||
| Modified Fatigue Impact Scale | Mean Difference (Final Values) 9.464 | 2.678–16.251 | 0.10 |
| Comfortable Walking Speed | .133 | ||
| Modified Fatigue Impact Scale | .165 | ||
| Modified Fatigue Impact Scale | .235 | ||
| Fast Walking Speed | .352 | ||
| Two Minute Walk Test | .369 | ||
| Fast Walking Speed | .393 | ||
| Comfortable Walking Speed | .405 | ||
| Multiple Sclerosis Impact Scale-29 | .412 | ||
| Modified Fatigue Impact Scale | .465 | ||
| Modified Fatigue Impact Scale | .483 | ||
| Modified Fatigue Impact Scale | .50 | ||
| Two Minute Walk Test | .568 | ||
| Modified Fatigue Impact Scale | .594 | ||
| Modified Fatigue Impact Scale | .682 | ||
| Two Minute Walk Test | .682 | ||
| Two Minute Walk Test | .710 | ||
| Modified Fatigue Impact Scale | .812 |
Statistical analysis as posted on ClinicalTrials.gov.
What was tested
Treatment tested
- G-EO System (Reha Technology AG: Olten, Switzerland)
Compared with
- Conventional Physical Therapy
Results by group
Comfortable Walking Speed
Gait speed for comfortable walking will be assessed prior to the start of the treatment (Pretest) and following study completion which occurred following 20 treatment visits (Posttest)
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Conventional Physical Therapy | .45 meters per second | 0.08 (Standard Error) | 7 |
| End-Effector Robotic Training | .60 meters per second | 0.137 (Standard Error) | 8 |
| Conventional Physical Therapy | .52 meters per second | 0.9 (Standard Error) | 7 |
| End-Effector Robotic Training | .67 meters per second | 0.163 (Standard Error) | 8 |
Conventional Physical Therapy
End-Effector Robotic Training
Conventional Physical Therapy
End-Effector Robotic Training
p = .405
Two Minute Walk Test
Walking distance will be assessed prior to the start of the treatment (Pretest) and following study completion (Posttest). Pretest represents a time point prior to intervention training. Posttest repr
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Conventional Physical Therapy | 66.57 Meters | 10.9 (Standard Error) | 7 |
| End-Effector Robotic Training | 89.35 Meters | 21.38 (Standard Error) | 8 |
| Conventional Physical Therapy | 72.62 Meters | 14.23 (Standard Error) | 7 |
| End-Effector Robotic Training | 93.21 Meters | 19.14 (Standard Error) | 8 |
Conventional Physical Therapy
End-Effector Robotic Training
Conventional Physical Therapy
End-Effector Robotic Training
p = .369
Modified Fatigue Impact Scale
Subjects perception of the their fatigue will be assessed prior to the start of the treatment and following study completion (at 10 weeks)
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Conventional Physical Therapy | 50.14 score on a scale | 4.93 (Standard Error) | 7 |
| End-Effector Robotic Training | 43.75 score on a scale | 4.61 (Standard Error) | 8 |
| Conventional Physical Therapy | 40.71 score on a scale | 5.2 (Standard Error) | 7 |
| End-Effector Robotic Training | 34.25 score on a scale | 4.87 (Standard Error) | 8 |
| Conventional Physical Therapy | 23.71 score on a scale | 3.74 (Standard Error) | 7 |
| End-Effector Robotic Training | 25.88 score on a scale | 1.74 (Standard Error) | 8 |
| Conventional Physical Therapy | 24.57 score on a scale | 1.55 (Standard Error) | 7 |
| End-Effector Robotic Training | 19.50 score on a scale | 2.33 (Standard Error) | 8 |
| Conventional Physical Therapy | 20.43 score on a scale | 1.78 (Standard Error) | 7 |
| End-Effector Robotic Training | 14.37 score on a scale | 4.04 (Standard Error) | 8 |
| Conventional Physical Therapy | 12.14 score on a scale | 2.86 (Standard Error) | 7 |
| End-Effector Robotic Training | 11.88 score on a scale | 3.54 (Standard Error) | 8 |
| Conventional Physical Therapy | 6.0 score on a scale | 0.436 (Standard Error) | 7 |
| End-Effector Robotic Training | 3.50 score on a scale | 0.964 (Standard Error) | 8 |
| Conventional Physical Therapy | 4.0 score on a scale | 0.535 (Standard Error) | 7 |
| End-Effector Robotic Training | 2.88 score on a scale | 0.766 (Standard Error) | 8 |
p = .594
Multiple Sclerosis Impact Scale-29
Subjects perception of the their disability will be assessed prior to the start of the treatment and following study completion (at 10 weeks)
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Conventional Physical Therapy | 65.89 units on a scale | 4.26 (Standard Error) | 7 |
| End-Effector Robotic Training | 47.97 units on a scale | 7.97 (Standard Error) | 8 |
| Conventional Physical Therapy | 52.32 units on a scale | 5.14 (Standard Error) | 7 |
| End-Effector Robotic Training | 33.13 units on a scale | 8.14 (Standard Error) | 8 |
| Conventional Physical Therapy | 55.16 units on a scale | 3.12 (Standard Error) | 7 |
| End-Effector Robotic Training | 30.56 units on a scale | 7.57 (Standard Error) | 8 |
| Conventional Physical Therapy | 32.94 units on a scale | 3.34 (Standard Error) | 7 |
| End-Effector Robotic Training | 26.39 units on a scale | 7.84 (Standard Error) | 8 |
p = .071
Fast Walking Speed
Fast walking speed will be assessed prior to the start of the treatment (Pretest) and following study completion (Posttest). Pretest represents a time point prior to intervention training. Posttest re
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Conventional Physical Therapy | .55 meters per second | 0.108 (Standard Error) | 7 |
| End-Effector Robotic Training | .81 meters per second | 0.19 (Standard Error) | 8 |
| Conventional Physical Therapy | .63 meters per second | 0.131 (Standard Error) | 7 |
| End-Effector Robotic Training | .84 meters per second | 0.205 (Standard Error) | 8 |
Conventional Physical Therapy
End-Effector Robotic Training
Conventional Physical Therapy
End-Effector Robotic Training
p = .352
Values as posted on ClinicalTrials.gov. Outcomes measured differently across trials are not directly comparable.
Safety
| Group | Participants at risk | Serious adverse events | Deaths |
|---|---|---|---|
| Conventional Physical Therapy | 7 | 0 (0.0%) | 0 |
| End-Effector Robotic Training | 8 | 0 (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
Comfortable Walking Speed
Gait speed for comfortable walking will be assessed prior to the start of the treatment (Pretest) and following study completion which occurred following 20 treatment visits (Posttest)
Walking and mobilityTwo Minute Walk Test
Walking distance will be assessed prior to the start of the treatment (Pretest) and following study completion (Posttest). Pretest represents a time point prior to intervention training. Posttest repr
Walking and mobilityModified Fatigue Impact Scale
Subjects perception of the their fatigue will be assessed prior to the start of the treatment and following study completion (at 10 weeks)
Thinking and memoryFatigueMultiple Sclerosis Impact Scale-29
Subjects perception of the their disability will be assessed prior to the start of the treatment and following study completion (at 10 weeks)
Quality of life (reported by participants)Fast Walking Speed
Fast walking speed will be assessed prior to the start of the treatment (Pretest) and following study completion (Posttest). Pretest represents a time point prior to intervention training. Posttest re
Walking and mobility
Other measures (4)
Hospital Anxiety and Depression Scale (HADS)
Subjects perception of the their anxiety and depression will be assessed prior to the start of the treatment and following study completion (at 10 weeks)
Mood and sleepShort Form McGill Pain Questionnaire
Subjects perception of the their pain will be assessed prior to the start of the treatment and following study completion (at 10 weeks)
PainLate-Life Disability Inventory (LLFDI)
Subjects perception of the their functional ability using the total score and dimensional scores will be assessed prior to the start of the treatment and following study completion (at 10 weeks)
Late-Life Function Inventory
Subjects perception of the their functional ability using all three domains will be assessed prior to the start of the treatment and following study completion (at 10 weeks)
Arm and hand function
Who could take part
Progressive MS · 18 to 64 · EDSS 4.0 to 7.522
Show the full criteria
Inclusion criteria
* 18-64 years * Confirmed diagnosis of Primary or Secondary Progressive Multiple Sclerosis (this will be confirmed by the referring physician) * EDSS 4.0-7.522 * Stable course of disease-modifying therapy over the past 6 months * Asymptomatic (i.e., no underlying cardiovascular disease) * Physician approval for exercise * Willingness to visit the IU Health Neurosciences Center for testing and training
Exclusion criteria
* Pregnancy * Current use of dalfampridine (Ampyra®) * Conventional physical therapy or G-EO training within the past 6 months * Height \<1m or >2m * Body weight >150 kg * Contraindications to G-EO gait training (e.g., bone instability)
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
The logistic advantages and advanced training capabilities of the G-EO System, as well as the benefits reported in other populations, support this strategy as a potentially potent rehabilitation tool for restoring and maintaining function in progressive Multiple Sclerosis (MS). This approach represents a paradigm shifting opportunity for improving current clinical practices for patients with progressive MS. If successful, this project will provide initial evidence for increasing patient access to the G-EO System, and this could be accomplished through "regional technology centers" using a rural health-delivery approach. There are several novel aspects of the proposed trial: (1) the examination of a novel gait rehabilitation stimulus (G-EO System) that could alter current clinical practices; (2) the focus on patients with progressive MS who have gait impairment (i.e., those who have received minimal research attention), which was recently described as the greatest therapeutic challenge facing the MS community; and (3) a study design that accounts for standard therapy. Specific Aims: The investigators designed a single-blinded, randomized pilot trial of electromechanically-assisted gait training using the G-EO System in patients with progressive MS with gait disability (EDSS=4.0-7.5). Specific Aim 1 will establish the safety and feasibility of gait training using the G-EO System. Specific Aim 2 will determine the efficacy of gait training using the G-EO System for improving mobility, symptomatic, quality of life, and participatory outcomes.
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History
Started
May 2017
Main results due
Mar 2020
Finished
Mar 2020
Results posted
Feb 2022