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Movement-2-Music Exercise Program for Mobility Disabilities (M2M LEADERS Trial)

N/A
Waitlist Available
Research Sponsored by University of Alabama at Birmingham
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Primary diagnosis of head injury, stroke, multiple sclerosis, spinal cord injury, spina bifida, Parkinson disease, cerebral palsy by a physician
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and post 12-week intervention
Awards & highlights

M2M LEADERS Trial Summary

This trial is testing the effects of an innovative exercise program, movement-2-music (M2M), on health and fitness outcomes in adults with physical/mobility disabilities. One hundred and eight participants will be recruited and randomly enrolled into one of two groups: M2M or waitlist control. The primary aim of this study is to determine the effects of the 12-week M2M program on health and fitness in participants with physical/mobility disabilities. The study will also compare the observed effects of the program to a previous M2M study, and test whether adherence (attendance to the 12-week program) affects the

Who is the study for?
This trial is for adults with physical disabilities like multiple sclerosis, traumatic brain injury, cerebral palsy, spinal cord injury, Parkinson's disease, stroke or spina bifida. Participants must be able to exercise using their limbs and follow instructions in English. They need a doctor's approval to join but can't take part if they have significant hearing loss, poor vision that affects group activities, recent smoking history or cognitive impairments.Check my eligibility
What is being tested?
The study tests an exercise program called movement-2-music (M2M), comparing it against a waitlist control over 12 weeks. It aims to improve health and fitness for people with varying levels of mobility disability. The intervention is delivered remotely via videoconferencing due to COVID-19 precautions.See study design
What are the potential side effects?
Since M2M involves physical activity through an exercise program set to music, potential side effects may include typical exercise-related issues such as muscle soreness or strain. However specific risks aren't detailed here.

M2M LEADERS Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have been diagnosed with a neurological condition by a doctor.

M2M LEADERS Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and post 12-week intervention
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and post 12-week intervention for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change from baseline cardiorespiratory fitness at 3 months
Change from baseline muscle strength at 3 months
Secondary outcome measures
Change from baseline health-related quality of life at 3 months
Change from baseline lower extremity function at 3 months
Change from baseline physical activity at 3 months
+1 more
Other outcome measures
Change from baseline barriers in physical activity at 3 months
Change from baseline exercise goal-setting at 3 months
Change from baseline exercise self-efficacy at 3 months
+2 more

M2M LEADERS Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: eM2MExperimental Treatment1 Intervention
Participants in the eM2M arm will participate in an intervention that involves three 60-minute M2M sessions per week for 12 weeks. All sessions are delivered remotely in real-time through videoconferencing technology. At the beginning and end of each session, vital signs (heart rate, blood pressure and peripheral capillary oxygen saturation) are obtained from participants. Participants rate perceived exertion, pain, and fatigue level on a log. Participants set weekly exercise goals and expectations at first session of each week. Participants also record daily activities using a provided log.
Group II: Waitlist ControlActive Control1 Intervention
Participants in the waitlist control arm are instructed to maintain their usual activities during the 12-week intervention period and are asked to record their activities on a provided log.

Find a Location

Who is running the clinical trial?

University of Alabama at BirminghamLead Sponsor
1,581 Previous Clinical Trials
2,277,921 Total Patients Enrolled
Lakeshore FoundationOTHER
9 Previous Clinical Trials
1,765 Total Patients Enrolled
YMCA of Greater BirminghamUNKNOWN

Media Library

Movement-2-Music Clinical Trial Eligibility Overview. Trial Name: NCT03797378 — N/A
Traumatic Brain Injury Research Study Groups: eM2M, Waitlist Control
Traumatic Brain Injury Clinical Trial 2023: Movement-2-Music Highlights & Side Effects. Trial Name: NCT03797378 — N/A
Movement-2-Music 2023 Treatment Timeline for Medical Study. Trial Name: NCT03797378 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this clinical trial open to individuals under the age of fifty?

"Eligibility for this research study is confined to those between 18 and 70 years of age. For patients under the age of 18, there are 384 studies available; however, 2,531 trials exist for individuals over 65."

Answered by AI

Is enrollment still open for this research project?

"According to clinicaltrials.gov, the recruitment for this healthcare study is ongoing and has been since August 9th 2019. The data was last reviewed on October 13th 2022."

Answered by AI

How many individuals are being administered this therapy in the current experiment?

"Affirmative. Research hosted on clinicaltrials.gov demonstrates that this examination, which was inaugurated on August 9th 2019, is actively recruiting patients. Approximately 108 participants are needed to be recruited from two medical centres."

Answered by AI

What purpose is the clinical trial aiming to achieve?

"For the primary outcome assessment of this medical trial, cardiovascular health will be monitored from the start to 12 weeks post-intervention. Secondary objectives include tracking physical activity with a Godin Leisure Time Exercise Questionnaire and gauging lower extremity function using the Timed Up and Go test as well as measuring general wellbeing by means of National Institutes of Health Patient-Reported Outcomes Measurement Information System Global-10 Health Items."

Answered by AI

Am I eligible to participate in this clinical trial?

"Applicants with spina bifida, between 18 to 70 years old will be considered for this trial. 108 people are expected to participate in total."

Answered by AI

Who else is applying?

What state do they live in?
Mississippi
Alabama
How old are they?
18 - 65
What site did they apply to?
UAB/Lakeshore Research Collaborative
UAB Research Collaborative
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0

How responsive is this trial?

Average response time
  • < 2 Days
Typically responds via
Phone Call
Most responsive sites:
  1. UAB Research Collaborative: < 48 hours
  2. UAB/Lakeshore Research Collaborative: < 48 hours
Recent research and studies
TrialsJournal
The Movement-to-music (M2M) Study: Study Protocol for a Randomized Controlled Efficacy Trial Examining a Rhythmic Teleexercise Intervention for People with Physical Disabilities
Young, Hui-Ju, Byron Lai, Tapan Mehta, Mohanraj Thirumalai, Jereme Wilroy, Alex Yates, Brandon Kane, and James H. Rimmer. 2021. “The Movement-to-music (M2M) Study: Study Protocol for a Randomized Controlled Efficacy Trial Examining a Rhythmic Teleexercise Intervention for People with Physical Disabilities”. Trials. Springer Science and Business Media LLC. doi:10.1186/s13063-021-05751-2.
clinicaltrials.govStudy
Movement-2-Music: Lakeshore Examination of Activity, Disability, and Exercise Response Study
James Rimmer 2019. "Movement-2-Music: Lakeshore Examination of Activity, Disability, and Exercise Response Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03797378.
All > Spina Bifida > Cerebral Palsy
~19 spots leftby Apr 2025
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