The Neural Mechanisms of Split-belt Treadmill Adaptation in People Wit
The Neural Underpinnings and the Impact of Wearable Sensory Stimulation During Split-belt Treadmill Adaptation in People With Multiple Sclerosis
What it found
The main measure showed a statistically significant benefit.
| Measure | Estimate | 95% CI | p |
|---|---|---|---|
| Change in Cortical Activation | Mean Difference (Net) -0.078 | 0.007 | |
| Change in Cortical Activation | Mean Difference (Net) -0.089 | 0.008 | |
| Change in Adaptation Savings | Mean Difference (Net) 0.0420 | 0.014 | |
| Rate of Step Length Asymmetry Adaptation | Mean Difference (Final Values) -0.008 | 0.698 | |
| Change in Adaptation Savings | Mean Difference (Net) -0.0058 | 0.878 | |
| Rate of Step Length Asymmetry Adaptation | Mean Difference (Final Values) 0.002 | 0.898 |
Statistical analysis as posted on ClinicalTrials.gov.
What was tested
Treatment tested
- Transcutaneous Electrical Nerve Stimulation (TENS)
Given to everyone in the trial
- Split-belt Treadmill
Results by group
Change in Cortical Activation
Training session 1 (day 1), training session 2 (day 28)
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Split-belt Treadmill Training Without TENS | 0.054 Unitless GLM beta weight (HbO) | 0.021 (Standard Error) | 48 |
| Split-belt Treadmill Training With TENS | -0.024 Unitless GLM beta weight (HbO) | 0.021 (Standard Error) | 48 |
| Split-belt Treadmill Training Without TENS | 0.074 Unitless GLM beta weight (HbO) | 0.025 (Standard Error) | 48 |
| Split-belt Treadmill Training With TENS | -0.016 Unitless GLM beta weight (HbO) | 0.025 (Standard Error) | 48 |
Split-belt Treadmill Training Without TENS
Split-belt Treadmill Training With TENS
Split-belt Treadmill Training Without TENS
Split-belt Treadmill Training With TENS
p = 0.007; Mean Difference (Net) -0.078
Change in Adaptation Savings
Training session 1 (day 1), training session 2 (day 28)
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Split-belt Treadmill Training With TENS First | 0.0032 Unitless Relative Step Length Asymmetry | 0.0103 (Standard Error) | 22 |
| Split-belt Treadmill Training With TENS Second | 0.0451 Unitless Relative Step Length Asymmetry | 0.0096 (Standard Error) | 26 |
| Split-belt Treadmill Training With TENS First | 0.0221 Unitless Relative Step Length Asymmetry | 0.0124 (Standard Error) | 22 |
| Split-belt Treadmill Training With TENS Second | 0.0278 Unitless Relative Step Length Asymmetry | 0.0112 (Standard Error) | 26 |
Split-belt Treadmill Training With TENS First
Split-belt Treadmill Training With TENS Second
Split-belt Treadmill Training With TENS First
Split-belt Treadmill Training With TENS Second
p = 0.014; Mean Difference (Net) 0.0420
Rate of Step Length Asymmetry Adaptation
Training session 1 (day 1)
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Split-belt Treadmill Training Without TENS | -0.090 Unitless Relative Step Length Asymmetry | 0.012 (Standard Error) | 26 |
| Split-belt Treadmill Training With TENS | -0.088 Unitless Relative Step Length Asymmetry | 0.013 (Standard Error) | 22 |
| Split-belt Treadmill Training Without TENS | -0.095 Unitless Relative Step Length Asymmetry | 0.014 (Standard Error) | 26 |
| Split-belt Treadmill Training With TENS | -0.103 Unitless Relative Step Length Asymmetry | 0.016 (Standard Error) | 22 |
Split-belt Treadmill Training Without TENS
Split-belt Treadmill Training With TENS
Split-belt Treadmill Training Without TENS
Split-belt Treadmill Training With TENS
p = 0.898; Mean Difference (Final Values) 0.002
Values as posted on ClinicalTrials.gov. Outcomes measured differently across trials are not directly comparable.
Safety
| Group | Participants at risk | Serious adverse events | Deaths |
|---|---|---|---|
| Split-belt Treadmill Training With TENS: People With Multiple Sclerosis | 29 | 0 (0.0%) | 0 |
| Split-belt Treadmill Training Without TENS: People With Multiple Sclerosis | 29 | 0 (0.0%) | 0 |
| Split-belt Treadmill Training With TENS: Healthy Controls | 20 | 0 (0.0%) | 0 |
| Split-belt Treadmill Training Without TENS: Healthy Controls | 20 | 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
Change in Cortical Activation
Training session 1 (day 1), training session 2 (day 28)
Brain volume lossWalking and mobilityNerve conduction testsChange in Adaptation Savings
Training session 1 (day 1), training session 2 (day 28)
Walking and mobilityFeasibilityRate of Step Length Asymmetry Adaptation
Training session 1 (day 1)
Bladder, bowel and sexual function
Who could take part
Relapsing MS · 18 to 86
Show the full criteria
Inclusion criteria
* A diagnosis of relapsing remitting multiple sclerosis OR a neurotypical adult (ages 18-86) * Not experiencing an active relapse * Able to stand and walk without an assistive device * Able to walk for three tenths of a mile without stopping to rest
Exclusion criteria
* Unable to walk for three tenths of a mile without assistance * Musculoskeletal injury in past 6 months * Lower extremity surgery in past 6 months * Unable to abstain from medications that impair balance * Currently pregnant * History of traumatic brain injury * History of vestibular disease * History of any other balance impairment unrelated to multiple sclerosis
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
Majority of people with multiple sclerosis experience difficulty with balance and mobility, leading to an increased risk of falls. The goal of this clinical trial is to learn about brain activity during walking adaptation in people with multiple sclerosis. Also, this clinical trial will test a form of nerve stimulation to see if it can improve walking performance. The main questions it aims to answer are: * What areas of the brain are the most active during walking adaptation? * Can nerve stimulation make walking adaptation more effective? Participants will walk on a treadmill where each leg will go a different speed which will create walking adaptation. At the same time, brain scans will occur. There will be two sessions of walking adaptation, one with nerve stimulation, and one without nerve stimulation. Researchers will compare people with multiple sclerosis to healthy young adults to see if there are differences in brain activity.
Papers
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History
Started
Nov 2023
Main results due
Jun 2024
Finished
Jun 2024
Results posted
Jul 2025