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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05305976
Other study ID # KTU_FTR_AE_01
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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
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