NCT05305976

Brief Summary

Duchenne Muscular Dystrophy (DMD) is a progressive inherited disease that affects the muscles and causes functional limitations to varying degrees. It is vital to start physiotherapy follow-ups immediately after diagnosis. Patients with DMD are among the most vulnerable groups who have problems in accessing physiotherapy services during the COVID-19 pandemic. The aim of the study was to investigate the effects of the telerehabilitation program developed to protect the physical health of patients with DMD and not to interrupt their follow-up.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
43

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2021

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

January 11, 2021

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 15, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 14, 2022

Completed
17 days until next milestone

First Posted

Study publicly available on registry

March 31, 2022

Completed
Last Updated

March 31, 2022

Status Verified

March 1, 2022

Enrollment Period

10 months

First QC Date

March 14, 2022

Last Update Submit

March 23, 2022

Conditions

Keywords

Duchenne Muscular Dystrophytelerehabilitationsatisfaction

Outcome Measures

Primary Outcomes (12)

  • Functional level

    Brooke Function Classification System

    Before the intervention, up to one month

  • Socio-demographics

    gender, body weight, height

    Before the intervention, up to one month

  • Walking test (Before intervention)

    The distance of 10 m was determined in a suitable indoor environment.

    Before the intervention, up to one month.

  • Walking test (After intervention)

    The distance of 10 m was determined in a suitable indoor environment.

    After the intervention, average two weeks.

  • Time to stand up from the supine position (Before intervention)

    The time to stand up from the supine position was recorded.

    Before the intervention, up to one month.

  • Time to stand up from the supine position (After intervention)

    The time to stand up from the supine position was recorded.

    After the intervention, average two weeks.

  • Modified upper extremity performance test (Before intervention)

    Flexion the shoulder to 90 degrees, flexion the shoulder above 90 degrees (above eye level), abduction of the shoulder 90 degrees, abduction of the shoulder above 90 degrees, doing the same movements with weight, bringing the empty glass to the mouth in a sitting position, bringing the full glass to the mouth

    Before the intervention, up to one month.

  • Modified upper extremity performance test (After intervention)

    Flexion the shoulder to 90 degrees, flexion the shoulder above 90 degrees (above eye level), abduction of the shoulder 90 degrees, abduction of the shoulder above 90 degrees, doing the same movements with weight, bringing the empty glass to the mouth in a sitting position, bringing the full glass to the mouth

    After the intervention, average two weeks.

  • Endurance (Before intervention)

    The number of knee extensions and elbow flexions they can do in sitting position in 30 seconds

    Before the intervention, up to one month.

  • Endurance (After intervention)

    The number of knee extensions and elbow flexions they can do in sitting position in 30 seconds

    After the intervention, average two weeks.

  • Pulmonary Dysfunction Test (Before intervention)

    Value when the patient counts audibly in a single expiration after maximum inspiratory effort

    Before the intervention, up to one month.

  • Pulmonary Dysfunction Test (After intervention)

    Value when the patient counts audibly in a single expiration after maximum inspiratory effort

    After the intervention, average two weeks.

Secondary Outcomes (1)

  • Patient Satisfaction Survey

    After the intervention average two weeks

Study Arms (2)

Ambulant Group

EXPERIMENTAL

Individuals unable to walk according to the Brooke Function Classification System

Other: Telerehabilitation

Non-ambulant Group

EXPERIMENTAL

Individuals who can walk according to the Brooke Function Classification System

Other: Telerehabilitation

Interventions

The 8 week exercise program with telerehabilitation

Ambulant GroupNon-ambulant Group

Eligibility Criteria

Age5 Years+
Sexmale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Able to communicate verbally and visually
  • Older than 5 years old

You may not qualify if:

  • The children who had undergone any surgical operations in the past 6 months,
  • Having a severe cognitive and breathing impairment
  • Using mechanical ventilator continually or intermittent
  • Having a febrile infection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Karadeniz Technical University

Trabzon, Ortahisar, 61000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Muscular Dystrophy, DuchennePersonal Satisfaction

Interventions

Telerehabilitation

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

RehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and ServicesTelemedicineDelivery of Health CarePatient Care ManagementHealth Services Administration

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Grup 1: Ambulant Group Grup 2: Non-ambulant Group
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

March 14, 2022

First Posted

March 31, 2022

Study Start

January 11, 2021

Primary Completion

November 15, 2021

Study Completion

January 1, 2022

Last Updated

March 31, 2022

Record last verified: 2022-03

Locations