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Telerehabilitation in Duchenne Muscular Dystrophy (Duchenne)

Primary Purpose

Duchenne Muscular Dystrophy

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Telerehabilitation
Sponsored by
Karadeniz Technical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Duchenne Muscular Dystrophy focused on measuring Duchenne Muscular Dystrophy, telerehabilitation, satisfaction

Eligibility Criteria

5 Years - undefined (Child, Adult, Older Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Sites / Locations

  • Karadeniz Technical University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Ambulant Group

Non-ambulant Group

Arm Description

Individuals unable to walk according to the Brooke Function Classification System

Individuals who can walk according to the Brooke Function Classification System

Outcomes

Primary Outcome Measures

Functional level
Brooke Function Classification System
Socio-demographics
gender, body weight, height
Walking test (Before intervention)
The distance of 10 m was determined in a suitable indoor environment.
Walking test (After intervention)
The distance of 10 m was determined in a suitable indoor environment.
Time to stand up from the supine position (Before intervention)
The time to stand up from the supine position was recorded.
Time to stand up from the supine position (After intervention)
The time to stand up from the supine position was recorded.
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
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
Endurance (Before intervention)
The number of knee extensions and elbow flexions they can do in sitting position in 30 seconds
Endurance (After intervention)
The number of knee extensions and elbow flexions they can do in sitting position in 30 seconds
Pulmonary Dysfunction Test (Before intervention)
Value when the patient counts audibly in a single expiration after maximum inspiratory effort
Pulmonary Dysfunction Test (After intervention)
Value when the patient counts audibly in a single expiration after maximum inspiratory effort

Secondary Outcome Measures

Patient Satisfaction Survey
General satisfaction, internet/connection, physiotherapist's guidance, timing, level of knowledge, reassurance, comfort, knowledge/advice, level of satisfaction with information clarity

Full Information

First Posted
March 14, 2022
Last Updated
March 23, 2022
Sponsor
Karadeniz Technical University
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1. Study Identification

Unique Protocol Identification Number
NCT05305976
Brief Title
Telerehabilitation in Duchenne Muscular Dystrophy
Acronym
Duchenne
Official Title
Remote Physiotherapy Application to Protect Physical Health in Duchenne Muscular Dystrophy
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
January 11, 2021 (Actual)
Primary Completion Date
November 15, 2021 (Actual)
Study Completion Date
January 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karadeniz Technical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Forty two patients with DMD were included in the study. 30 of them were ambulant in group 1, and 12 were non-ambulant in group 2. Physiotherapy assessments were performed blindly before the program started. According to the functional levels of the individuals, 2 groups were formed. 9 physiotherapists applied the tele-rehabilitation program for 24 session (3 days in a week).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Duchenne Muscular Dystrophy
Keywords
Duchenne Muscular Dystrophy, telerehabilitation, satisfaction

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Grup 1: Ambulant Group Grup 2: Non-ambulant Group
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
43 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ambulant Group
Arm Type
Experimental
Arm Description
Individuals unable to walk according to the Brooke Function Classification System
Arm Title
Non-ambulant Group
Arm Type
Experimental
Arm Description
Individuals who can walk according to the Brooke Function Classification System
Intervention Type
Other
Intervention Name(s)
Telerehabilitation
Intervention Description
The 8 week exercise program with telerehabilitation
Primary Outcome Measure Information:
Title
Functional level
Description
Brooke Function Classification System
Time Frame
Before the intervention, up to one month
Title
Socio-demographics
Description
gender, body weight, height
Time Frame
Before the intervention, up to one month
Title
Walking test (Before intervention)
Description
The distance of 10 m was determined in a suitable indoor environment.
Time Frame
Before the intervention, up to one month.
Title
Walking test (After intervention)
Description
The distance of 10 m was determined in a suitable indoor environment.
Time Frame
After the intervention, average two weeks.
Title
Time to stand up from the supine position (Before intervention)
Description
The time to stand up from the supine position was recorded.
Time Frame
Before the intervention, up to one month.
Title
Time to stand up from the supine position (After intervention)
Description
The time to stand up from the supine position was recorded.
Time Frame
After the intervention, average two weeks.
Title
Modified upper extremity performance test (Before intervention)
Description
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
Time Frame
Before the intervention, up to one month.
Title
Modified upper extremity performance test (After intervention)
Description
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
Time Frame
After the intervention, average two weeks.
Title
Endurance (Before intervention)
Description
The number of knee extensions and elbow flexions they can do in sitting position in 30 seconds
Time Frame
Before the intervention, up to one month.
Title
Endurance (After intervention)
Description
The number of knee extensions and elbow flexions they can do in sitting position in 30 seconds
Time Frame
After the intervention, average two weeks.
Title
Pulmonary Dysfunction Test (Before intervention)
Description
Value when the patient counts audibly in a single expiration after maximum inspiratory effort
Time Frame
Before the intervention, up to one month.
Title
Pulmonary Dysfunction Test (After intervention)
Description
Value when the patient counts audibly in a single expiration after maximum inspiratory effort
Time Frame
After the intervention, average two weeks.
Secondary Outcome Measure Information:
Title
Patient Satisfaction Survey
Description
General satisfaction, internet/connection, physiotherapist's guidance, timing, level of knowledge, reassurance, comfort, knowledge/advice, level of satisfaction with information clarity
Time Frame
After the intervention average two weeks

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Able to communicate verbally and visually Older than 5 years old Exclusion Criteria: 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
Facility Information:
Facility Name
Karadeniz Technical University
City
Trabzon
State/Province
Ortahisar
ZIP/Postal Code
61000
Country
Turkey

12. IPD Sharing Statement

Learn more about this trial

Telerehabilitation in Duchenne Muscular Dystrophy

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