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Completed

NCT Number: NCT05305976

Telerehabilitation in Duchenne Muscular Dystrophy

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.

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Key information

Conditions

Duchenne Muscular Dystrophy Behavior Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Genetic Diseases, X-Linked Muscular Diseases Muscular Disorders, Atrophic Muscular Dystrophies Muscular Dystrophy, Duchenne Musculoskeletal Diseases Nervous System Diseases Neuromuscular Diseases Personal Satisfaction

Age range

5 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Karadeniz Technical University

Trabzon, Ortahisar, 61000, Turkey (Türkiye)

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

telerehabilitation

Other

The 8 week exercise program with telerehabilitation

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Karadeniz Technical University

Other

Registry information

Official study title

Remote Physiotherapy Application to Protect Physical Health in Duchenne Muscular Dystrophy

Acronym: Duchenne

Important dates

Study start
2021
Primary completion
2021
Study completion
2022
First posted
Mar 31, 2022
Registry last updated
Mar 31, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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