Telerehabilitation in Duchenne Muscular Dystrophy (Duchenne)

• ClinicalTrials.gov Identifier: NCT05305976
• Recruitment Status: Completed
• First Posted: March 31, 2022
• Sponsor: Karadeniz Technical University
• Information provided by (Responsible Party): Arzu ERDEN, Karadeniz Technical University

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.

Condition or disease	Intervention/treatment	Phase
Duchenne Muscular Dystrophy	Other: Telerehabilitation	Not Applicable

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).

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 43 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Grup 1: Ambulant Group Grup 2: Non-ambulant Group
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Remote Physiotherapy Application to Protect Physical Health in Duchenne Muscular Dystrophy
• Actual Study Start Date: January 11, 2021
• Actual Primary Completion Date: November 15, 2021
• Actual Study Completion Date: January 1, 2022

Arms and Interventions

Arm	Intervention/treatment
Experimental: Ambulant Group; Individuals unable to walk according to the Brooke Function Classification System	Other: Telerehabilitation; The 8 week exercise program with telerehabilitation
Experimental: Non-ambulant Group; Individuals who can walk according to the Brooke Function Classification System	Other: Telerehabilitation; The 8 week exercise program with telerehabilitation

Outcome Measures

Primary Outcome Measures :

1. Functional level [ Time Frame: Before the intervention, up to one month ]
   Brooke Function Classification System
2. Socio-demographics [ Time Frame: Before the intervention, up to one month ]
   gender, body weight, height
3. Walking test (Before intervention) [ Time Frame: Before the intervention, up to one month. ]
   The distance of 10 m was determined in a suitable indoor environment.
4. Walking test (After intervention) [ Time Frame: After the intervention, average two weeks. ]
   The distance of 10 m was determined in a suitable indoor environment.
5. Time to stand up from the supine position (Before intervention) [ Time Frame: Before the intervention, up to one month. ]
   The time to stand up from the supine position was recorded.
6. Time to stand up from the supine position (After intervention) [ Time Frame: After the intervention, average two weeks. ]
   The time to stand up from the supine position was recorded.
7. Modified upper extremity performance test (Before intervention) [ Time Frame: Before the intervention, up to one month. ]
   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
8. Modified upper extremity performance test (After intervention) [ Time Frame: After the intervention, average two weeks. ]
   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
9. Endurance (Before intervention) [ Time Frame: Before the intervention, up to one month. ]
   The number of knee extensions and elbow flexions they can do in sitting position in 30 seconds
10. Endurance (After intervention) [ Time Frame: After the intervention, average two weeks. ]
    The number of knee extensions and elbow flexions they can do in sitting position in 30 seconds
11. Pulmonary Dysfunction Test (Before intervention) [ Time Frame: Before the intervention, up to one month. ]
    Value when the patient counts audibly in a single expiration after maximum inspiratory effort
12. Pulmonary Dysfunction Test (After intervention) [ Time Frame: After the intervention, average two weeks. ]
    Value when the patient counts audibly in a single expiration after maximum inspiratory effort

Secondary Outcome Measures :

1. Patient Satisfaction Survey [ Time Frame: After the intervention average two weeks ]
   General satisfaction, internet/connection, physiotherapist's guidance, timing, level of knowledge, reassurance, comfort, knowledge/advice, level of satisfaction with information clarity

Eligibility Criteria

• Ages Eligible for Study: 5 Years and older (Child, Adult, Older Adult)
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

Turkey

Karadeniz Technical University

Trabzon, Ortahisar, Turkey, 61000

Sponsors and Collaborators

Karadeniz Technical University

More Information

• Responsible Party: Arzu ERDEN, Associate Professor, Karadeniz Technical University
• ClinicalTrials.gov Identifier: NCT05305976
• Other Study ID Numbers: KTU_FTR_AE_01
• First Posted: March 31, 2022
• Last Update Posted: March 31, 2022
• Last Verified: March 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Arzu ERDEN, Karadeniz Technical University:

Duchenne Muscular Dystrophy; telerehabilitation; satisfaction

Additional relevant MeSH terms:

Muscular Dystrophies; Muscular Dystrophy, Duchenne; Muscular Disorders, Atrophic; Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Diseases; Nervous System Diseases; Genetic Diseases, Inborn; Genetic Diseases, X-Linked