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Split-belt Treadmill Training for Multiple Sclerosis
N/A
Recruiting
Led By Brett W Fling, Ph.D.
Research Sponsored by Colorado State University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline session 1 (day 1), training session 1 (day 1), post-training session 1 (day 1), baseline session 2 (day 14), training session 2, and post-training session 2 (day 14)
Awards & highlights
Study Summary
This trial will study brain activity & nerve stimulation to help people with MS improve balance and mobility, reducing falls.
Who is the study for?
This trial is for adults aged 18-86 with relapsing-remitting multiple sclerosis who can walk three tenths of a mile unaided and are not in an active relapse. It's also open to neurotypical adults without MS. People with recent lower limb surgery, pregnancy, vestibular diseases, balance-affecting medications, traumatic brain injury or unrelated balance issues cannot participate.Check my eligibility
What is being tested?
The study investigates how the brain adapts during walking when each leg moves at different speeds on a treadmill (split-belt adaptation). It compares the effectiveness of this adaptation with and without Transcutaneous Electrical Nerve Stimulation (TENS) to improve walking in people with MS versus healthy individuals.See study design
What are the potential side effects?
While TENS is generally safe, potential side effects include skin irritation where the electrodes are placed, tingling sensation during stimulation that may be uncomfortable for some participants. The split-belt treadmill might cause temporary imbalance or dizziness.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline session 1 (day 1), training session 1 (day 1), post-training session 1 (day 1), baseline session 2 (day 14), training session 2, and post-training session 2 (day 14)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline session 1 (day 1), training session 1 (day 1), post-training session 1 (day 1), baseline session 2 (day 14), training session 2, and post-training session 2 (day 14)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Cortical Hemodynamics
Change in Phase Coordination Index
Change in Step Length Asymmetry
Secondary outcome measures
Change in Double Support Percent
Change in Limb Excursion Asymmetry
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Split-belt Treadmill Training with TENSExperimental Treatment2 Interventions
During this arm, participants will perform split-belt treadmill training with active sensory stimulation occuring simultaneously during all adaptation sessions.
Group II: Split-belt Treadmill Training without TENSPlacebo Group1 Intervention
During this arm, participants will perform split-belt treadmill training with sensory stimulation equipment outfitted but not active during all adaptation sessions.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Transcutaneous Electrical Nerve Stimulation (TENS)
2023
N/A
~680
Find a Location
Who is running the clinical trial?
Colorado State UniversityLead Sponsor
125 Previous Clinical Trials
38,319 Total Patients Enrolled
4 Trials studying Multiple Sclerosis
36 Patients Enrolled for Multiple Sclerosis
National Multiple Sclerosis SocietyOTHER
95 Previous Clinical Trials
9,443 Total Patients Enrolled
93 Trials studying Multiple Sclerosis
9,089 Patients Enrolled for Multiple Sclerosis
Brett W Fling, Ph.D.Principal InvestigatorColorado State University
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had a muscle or bone injury in the last 6 months.I can't walk 0.3 miles by myself.I have had surgery on my leg or foot in the last 6 months.I cannot stop taking my medication that affects my balance.I have had a condition affecting my inner ear balance.My condition is stable with no current flare-ups.I can stand and walk on my own without help.I have relapsing-remitting multiple sclerosis or I am a healthy adult aged 18-86.I can walk for three tenths of a mile without needing to rest.
Research Study Groups:
This trial has the following groups:- Group 1: Split-belt Treadmill Training without TENS
- Group 2: Split-belt Treadmill Training with TENS
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is the age limitation of this clinical trial set to exclude individuals over 75?
"The age range for this clinical trial is between 18 and 86 years old."
Answered by AI
Is it possible to join this investigation?
"This clinical trial is seeking around 40 people who have been diagnosed with multiple sclerosis and are within the age range of 18 to 86."
Answered by AI
Are there currently any opportunities to enroll in this experiment?
"Based on the information available via clinicaltrials.gov, this medical trial is no longer recruiting patients; it was initially posted in September of 2023 and last modified at the end of May that same year. Nevertheless, there are 547 other studies actively looking for volunteers now."
Answered by AI
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