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Change in MUNIX in Patients With CMT1A Undergoing a Home Ankle Strengthening Program Versus Standard of Care

NCT03715283 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 19

Last updated 2019-12-20

No results posted yet for this study

Summary

Here the investigators aim to show that a focused lower extremity resistance strength training program in patients with Charcot-Marie-Tooth disease (CMT) results in increased motor strength of ankle plantar- and dorsi-flexion. The investigators will use motor unit index MUNIX and hand held dynamometry to correlate strength changes. The investigators believe that increased strength will correlate with an increased motor unit number and as such will prove that axonal renervation or improved recruitment is possible with a focused exercises in patients with CMT. Additionally, the investigators will show that that MUNIX declines over a 12-week period in patients with CMT whom continue standard of care. This will identify MUNIX as a responsive marker for disease progression in addition to detecting functional improvement, which will be valuable for future clinical trials.

Conditions

  • Charcot-Marie-Tooth Disease

Interventions

OTHER

Home Ankle Strengthing Program

Patients in this arm will be given a USB or DVD video with description of ankle dorsi- and plantar- flexion resistance band exercise. They will also be given an outlined plan for there exercises, progression and an exercise diary. In general patients will start with a low resistance and low reps, over the 4 weeks they will increase the repetitions at the same resistance band. After the 4 weeks they will have the option to escalate the band resistance or continue at the same resistance and repetitions until comfortable progressing. The same 4 week progression will be used for each resistance band over the 12 weeks.

OTHER

Standard of Care

Patients in this arm will be directed to continue there standard care program. They will be asked to refrain from resistance exercise for 12 weeks.

Sponsors & Collaborators

  • Vanderbilt University Medical Center

    lead OTHER

Principal Investigators

  • Ryan J Castoro, D.O. · Vanderbilt University Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-01-15
Primary Completion
2019-09-01
Completion
2019-09-01

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03715283 on ClinicalTrials.gov