Recruiting

Physical Activity

Sponsor:

Columbia University

Code:

NCT06084026

Conditions

Neuromuscular Diseases

Eligibility Criteria

Sex: All

Age: 1+

Healthy Volunteers: Accepted

Interventions

ActivPal

Study Details

Brief summary:

This study measures the level of physical activity in participants with neuromuscular disorders. The patient wears a small button like meter on their leg for a period of 1 week every 6 months over a period of 3 years. Participants will also have a physical exam, six minute walk test,vital signs and questionnaires.

Conditions

Neuromuscular Diseases

Study ID

NCT06084026

Start date

Nov 1, 2020

Status verified date

Jan, 2026

Completion date

Aug 31, 2026

Anticipated

Primary completion date

Aug 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 1+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Patients with a clinically or genetically confirmed neuromuscular disorder
  • Control subjects who do not have a neuromuscular disease.
  • Participants at least 1 years of age.

Exclusion Criteria:

  • Participant has a condition, which in the opinion of the Investigator may compromise safety
  • Participant has a condition, which in the opinion of the Investigator may compromise or compliance

Study Design

Enrollment

40 participants

Anticipated

Interventions and Outcome Measures

Arms

Neuromuscular Disease

Patients with confirmed neuromuscular disease

Control

Participants who do not have or are not expected to have neuromuscular disease

Interventions

ActivPal

Participants will wear the activity meter (a small button like device) on their thigh for a period of 7 days at the following time-points: baseline, 6, 12, 18, 24, 30 and 36 months. The meter will be placed on their thigh at a research visit and mailed back to the study team after 7 days.

Primary outcome measure

  • Mean Activity Profile (measures time spent at various raw activity levels) [ Time Frame: Up to 3 years ]

Central Contacts and Locations

Central contacts

Michio Hirano, MD

1-212-305-1319mh29@cumc.columbia.edu

Kris Engelstad, MS

1-212-342-5767ke4@cumc.columbia.edu

Locations

Columbia University Irving Medical Center

Recruiting

New York, New York, United States, 10032

Contacts

Kris Engelstad, MS

1-212-342-5767ke4@cumc.columbia.edu

Principal Investigator:

Michio Hirano, MD

More Information

Sponsor

Columbia University

Last update posted

Jan 23, 2026

Last verified

Jan, 2026

Keywords

  • muscle weakness
  • muscle
  • neuromuscular

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Columbia University on 2026-01-23.