Muscle Vibration in MS to Improve Walking
Cyclical Muscle Vibration in MS to Improve Walking
What it found
The trial ended early for another reason (see below).
Reason given: Funding ran out
What was tested
Treatment tested
- muscle vibration during walking
Results by group
10MWT
baseline and after twelve 1 hour sessions in four weeks of gait training with muscle vibration. Outcome measures were tested both with and without muscle vibration and repeated measures were collected
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Subject A | 1.1 m/s | 0 (Standard Deviation) | 1 |
| Subject B | 0.75 m/s | 0.09 (Standard Deviation) | 1 |
| Subject C | 1.39 m/s | 0.2 (Standard Deviation) | 1 |
| Subject A | 1.295 m/s | 0.07 (Standard Deviation) | 1 |
| Subject B | 1.32 m/s | 0.009 (Standard Deviation) | 1 |
| Subject C | 2.18 m/s | 0.2 (Standard Deviation) | 1 |
| Subject A | 1.39 m/s | 0.05 (Standard Deviation) | 1 |
| Subject B | 1.38 m/s | 0.05 (Standard Deviation) | 1 |
| Subject C | 1.86 m/s | 0.17 (Standard Deviation) | 1 |
Kinematics
baseline and after twelve 1 hour sessions in four weeks of gait training with muscle vibration. Repeated measures were collected and averaged
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Subject A | 24 degrees | 2.4 (Standard Deviation) | 1 |
| Subject B | 57 degrees | 7.4 (Standard Deviation) | 1 |
| Subject C | 27 degrees | 2.3 (Standard Deviation) | 1 |
| Subject A | 38 degrees | 1.9 (Standard Deviation) | 1 |
| Subject B | 50 degrees | 5.8 (Standard Deviation) | 1 |
| Subject C | 30 degrees | 2.5 (Standard Deviation) | 1 |
| Subject A | 49 degrees | 2.4 (Standard Deviation) | 1 |
| Subject B | 38 degrees | 16.3 (Standard Deviation) | 1 |
| Subject C | 72 degrees | 3.5 (Standard Deviation) | 1 |
| Subject A | 61 degrees | 3.4 (Standard Deviation) | 1 |
| Subject B | 44 degrees | 15.8 (Standard Deviation) | 1 |
| Subject C | 74 degrees | 2.5 (Standard Deviation) | 1 |
| Subject A | 11 degrees | 2.7 (Standard Deviation) | 1 |
| Subject B | 13 degrees | 4.5 (Standard Deviation) | 1 |
| Subject C | 15 degrees | 4 (Standard Deviation) | 1 |
| Subject A | 14 degrees | 2.8 (Standard Deviation) | 1 |
| Subject B | 11 degrees | 3.2 (Standard Deviation) | 1 |
| Subject C | 15 degrees | 5.2 (Standard Deviation) | 1 |
Toe Clearance
baseline and after twelve 1 hour sessions in four weeks of gait training with muscle vibration. Repeated measures were collected and averaged
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Subject A | 19.8 mm | 4.4 (Standard Deviation) | 1 |
| Subject B | 30.6 mm | 7.8 (Standard Deviation) | 1 |
| Subject C | 21.3 mm | 3.5 (Standard Deviation) | 1 |
| Subject A | 17.6 mm | 4.4 (Standard Deviation) | 1 |
| Subject B | 9.1 mm | 2.5 (Standard Deviation) | 1 |
| Subject C | 21.5 mm | 3.4 (Standard Deviation) | 1 |
| Subject A | 30.2 mm | 5.8 (Standard Deviation) | 1 |
| Subject B | 32 mm | 5.8 (Standard Deviation) | 1 |
| Subject C | 25.5 mm | 3.6 (Standard Deviation) | 1 |
| Subject A | 25.4 mm | 7.9 (Standard Deviation) | 1 |
| Subject B | 9.3 mm | 3.6 (Standard Deviation) | 1 |
| Subject C | 24.7 mm | 4.7 (Standard Deviation) | 1 |
Walking Distance
baseline and after twelve 1 hour sessions in four weeks of gait training with muscle vibration. Repeated measures were collected and averaged
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Subject A | 347 meters | 0 (Standard Deviation) | 1 |
| Subject B | 252 meters | 0 (Standard Deviation) | 1 |
| Subject C | 338 meters | 0 (Standard Deviation) | 1 |
| Subject A | 361 meters | 12 (Standard Deviation) | 1 |
| Subject B | 387 meters | 11 (Standard Deviation) | 1 |
| Subject C | 406 meters | 0 (Standard Deviation) | 1 |
Values as posted on ClinicalTrials.gov. Outcomes measured differently across trials are not directly comparable.
Safety
| Group | Participants at risk | Serious adverse events | Deaths |
|---|---|---|---|
| Feasibility | 5 | 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
10MWT
baseline and after twelve 1 hour sessions in four weeks of gait training with muscle vibration. Outcome measures were tested both with and without muscle vibration and repeated measures were collected
Kinematics
baseline and after twelve 1 hour sessions in four weeks of gait training with muscle vibration. Repeated measures were collected and averaged
Toe Clearance
baseline and after twelve 1 hour sessions in four weeks of gait training with muscle vibration. Repeated measures were collected and averaged
How the body handles the medicineWalking Distance
baseline and after twelve 1 hour sessions in four weeks of gait training with muscle vibration. Repeated measures were collected and averaged
Walking and mobility
Who could take part
MS (type not specified) · 18 to 70
Show the full criteria
Inclusion criteria
* MS diagnosis reviewed and confirmed by neurologist per the revised McDonald criteria [ ] * EDDS>3 * Age 18-70 * Fixed gait deficiency defined as being present for at least 3 months without improvement * Hip, knee and ankle muscle weakness or increased extensor tone with difficulty to initiate a step * Ability to ambulate at least 10ft with contact guard. * Muscle vibration without untoward sensation. * Sufficient upper extremity function to use walking aids (walkers, crutches, canes). * Poor hip-knee-ankle coordination during swing * Hip, knee and ankle joint range within normal limits. * Ability to clearly understand written and oral direction in English to provide consent. * BMI \< 30 * Absence of psychological and cognitive problems or chemical dependency * No acute orthopedic or medical complications
Exclusion criteria
* Presence of demand pacemakers. * Edema of the affected limb/s. * Uncontrolled seizures/epilepsy. * Severe depression. * Botulin toxin treatment within 12 months. * Peripheral neuropathy. * Respiratory disease. * Chronic pain. * Rapidly progressive course suggestive of Marburg variant, Hurst encephalomyelitis or PPMS with three or more system involvement. * Concurrent treatment with Tysabri. * Cardiac arrhythmias with associated hemodynamic instability. * Lower extremity injuries that limit range of motion or function * Joint problems (hip or leg) that limit range of motion or cause pain with movement * Women during pregnancy * Patients with a relapse in the 3 months prior to presentation for study evaluation * Patients with more than two relapses within the past 12 months
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
The primary goal of this pilot study is to explore the feasibility of cyclic vibration (CV) of the lower extremity muscles to improve walking in individuals with gait deficits from multiple sclerosis (MS).
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History
Started
Jan 2017
Main results due
Dec 2018
Finished
Dec 2018
Results posted
May 2020