NCT04782440

Brief Summary

The aim of this study is to investigate the effect of a telerehabilitation approach to patients with Duchenne Muscular Dystrophy and evaluate patients' motor function, parents' anxiety and depression levels before and after the intervention

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2021

Shorter than P25 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 2, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 4, 2021

Completed
28 days until next milestone

Study Start

First participant enrolled

April 1, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2021

Completed
Last Updated

March 4, 2021

Status Verified

March 1, 2021

Enrollment Period

4 months

First QC Date

March 2, 2021

Last Update Submit

March 2, 2021

Conditions

Duchenne Muscular Dystrophy

Outcome Measures

Primary Outcomes (1)

  • Quick motor function test

    2 months

Study Arms (2)

Telerehabilitation

EXPERIMENTAL
Other: Telerehabilitaton

Home exercise

ACTIVE COMPARATOR
Other: Home exercise

Interventions

TelerehabilitatonOTHER

Patients will receive telerehabilitation sessions that include strengthening, stretching and range of motion exercises

Telerehabilitation
Home exerciseOTHER

Patients will be given a home-based exercise program without telerehabilitation supervision

Home exercise

Eligibility Criteria

Age6 Years - 18 Years
Sexmale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Patients with Duchenne muscular dystrophy

You may not qualify if:

  • Patients without the ability of independent ambulation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Muscular Dystrophy, Duchenne

Condition Hierarchy (Ancestors)

Muscular DystrophiesMuscular Disorders, AtrophicMuscular DiseasesMusculoskeletal DiseasesNeuromuscular DiseasesNervous System DiseasesGenetic Diseases, X-LinkedGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 2, 2021

First Posted

March 4, 2021

Study Start

April 1, 2021

Primary Completion

August 1, 2021

Study Completion

September 1, 2021

Last Updated

March 4, 2021

Record last verified: 2021-03