Remote Physiotherapy to Protect Physical Health in Duchenne Muscular Dystrophy

NCT06103006 | Completed

• 1 other identifier: 003/2021
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

Duchenne Muscular Dystrophy (DMD) is a progressive genetic neuromuscular disease characterized by progressive loss of motor function, respiratory failure, and cardiomyopathy required regular physiotherapy. With the outbreak of the pandemic rehabilitation centers that make up the weekly physiotherapy routine of children with disabilities have slowed down or even stopped their activities. So DMD who have additional diseases such as respiratory muscle weakness, spinal deformity, obesity, and cardiac dysfunction have also been negatively affected. The 'telerehabilitation' method, which is well planned and prepared for the abilities and needs of patients and caregivers, is seen as a good option at this point. Studies, reporting the feasibility and safety of telerehabilitation in joint replacement, multiple sclerosis, and post-operative conditions, report that the length of stay was reduced, there was access to the same level of service regardless of the distance, and there was no travel cost. Despite these advantages, the framework and applicability of telerehabilitation programs have been investigated limited and not focused on effectiveness of telerehabilitation in patients with DMD. According to the current knowledge, telerehabilitation in DMD is a subject that needs to be investigated in terms of its benefits. So, in this study, it was aimed to show the telerehabilitation's feasibility and its effects on performance level, endurance, fall frequency, pulmonary functions, and satisfaction level with the program in individuals with DMD.

Conditions

Duchenne Muscular Dystrophy

Outcome Measures

Primary Outcomes (2)

• Endurance

  Number of times the individuals can flexed and extend their knees in a sitting position for 30 seconds. Also, the number of elbow flexion/extension was recorded

  Change from baseline at 8 weeks

• Modified Upper Extremity Performance Test

  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 were evaluated. It was scored as 0 point (cannot), 1 point (can do with compensation), 2 points (does independently). In addition, the time to pick up 5 coins (50 cents size coin or similar) on the table with one hand was recorded .

  Change from baseline at 8 weeks

Secondary Outcomes (7)

• 10 Meter (m) Walking Test

  Change from baseline at 8 weeks

• Stand Up from the Supine Position Test

  Change from baseline at 8 weeks

• Single Breath Count (SBC)

  Change from baseline at 8 weeks

• Patient Satisfaction Survey

  After 8 weeks

• Brooke Upper Extremity Scale

  Change from baseline at 8 weeks

Study Arms (1)

Telerehabilitation Group

EXPERIMENTAL

Participants in this group will receive telerehabilitation exercises.

Other: Telerehabilitation

Interventions

Telerehabilitation OTHER

The structured telerehabilitation program focused on 4 specific objectives: breathing, stretching, posture, and stability. The duration was between 20-30 minutes. Exercises involving the major muscle groups (upper, lower extremity, and trunk muscle groups) were applied by the physiotherapists. Strengthening and stretching sets and repetitions were started with 1 set of 8-15 reps (progress to \>1 set).

Telerehabilitation Group

Eligibility Criteria

• Age: 5 Years - 26 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• Individuals who had undergone any surgical operations in the past 6 months,
• Had a severe cognitive and breathing impairment,
• Using mechanical ventilator continually or intermittent,
• Having febrile infection

Sponsors & Collaborators

• Lokman Hekim University: lead

Study Sites (1)

Lokman Hekim University

Ankara, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Muscular Dystrophy, Duchenne

Interventions

Telerehabilitation

Condition Hierarchy (Ancestors)

Muscular Dystrophies; Muscular Disorders, Atrophic; Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Diseases; Nervous System Diseases; Genetic Diseases, X-Linked; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services; Telemedicine; Delivery of Health Care; Patient Care Management; Health Services Administration

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant

Study Record Dates

• First Submitted: October 22, 2023
• First Posted: October 26, 2023
• Study Start: January 1, 2021
• Primary Completion: January 1, 2022
• Study Completion: February 10, 2022
• Last Updated: October 27, 2023

Record last verified: 2023-10

Locations

TU (1)