Telerehabilitation in Duchenne Muscular Dystrophy

Duchenne Muscular Dystrophy Clinical Trial

— Duchenne  

Official title:

Remote Physiotherapy Application to Protect Physical Health in Duchenne Muscular Dystrophy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05305976
• Other study ID #: KTU_FTR_AE_01
• Status: Completed
• Phase: N/A
• Start date: January 11, 2021
• Est. completion date: January 1, 2022

Study information

• Verified date: March 2022
• Source: Karadeniz Technical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: January 1, 2022
• Est. primary completion date: November 15, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 5 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Duchenne Muscular Dystrophy
• Muscular Dystrophies
• Muscular Dystrophy, Duchenne

Intervention

Other:
• Telerehabilitation
The 8 week exercise program with telerehabilitation

Locations

Country	Name	City	State
Turkey	Karadeniz Technical University	Trabzon	Ortahisar

Sponsors (1)

Lead Sponsor	Collaborator
Karadeniz Technical University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Functional level	Brooke Function Classification System	Before the intervention, up to one month
Primary	Socio-demographics	gender, body weight, height	Before the intervention, up to one month
Primary	Walking test (Before intervention)	The distance of 10 m was determined in a suitable indoor environment.	Before the intervention, up to one month.
Primary	Walking test (After intervention)	The distance of 10 m was determined in a suitable indoor environment.	After the intervention, average two weeks.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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	Patient Satisfaction Survey	General satisfaction, internet/connection, physiotherapist's guidance, timing, level of knowledge, reassurance, comfort, knowledge/advice, level of satisfaction with information clarity	After the intervention average two weeks