Remote Physiotherapy to Protect Physical Health in Duchenne Muscular Dystrophy

Duchenne Muscular Dystrophy Clinical Trial

Official title:

Remote Physiotherapy to Protect Physical Health in Duchenne Muscular Dystrophy: Telerehabilitation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06103006
• Other study ID #: 003/2021
• Status: Completed
• Phase: N/A
• Start date: January 1, 2021
• Est. completion date: February 10, 2022

Study information

• Verified date: October 2023
• Source: Lokman Hekim Üniversitesi
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: February 10, 2022
• Est. primary completion date: January 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 26 Years

Eligibility

Inclusion Criteria:

• Able to communicate verbally and visually,

• Older than 5 years old

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

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

Intervention

Other:
• Telerehabilitation
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).

Locations

Country	Name	City	State
Turkey	Lokman Hekim University	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Lokman Hekim Üniversitesi

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	10 Meter (m) Walking Test	The distance of 10 m was determined in a suitable indoor environment, the individual was asked to walk this distance and the time that the patient walked was recorded.	Change from baseline at 8 weeks
Secondary	Stand Up from the Supine Position Test	Depending on the severity of the disease, this period is extended. Depending on the weakness of the hip and shoulder girdle and trunk muscles, there is a movement model that the individuals use by climbing over himself. While the individual is getting up from the ground, the mother and the physiotherapist keep time with a stopwatch.	Change from baseline at 8 weeks
Secondary	Single Breath Count (SBC)	Single breath count (SBC) is the maximum measure of serial counting of numbers in normal speaking voice after a maximal inhalation. SBC has good correlation with the gold standard measures of pulmonary function test (PFT), peak expiratory flow rate (PEFR), and forced expiratory volume in the first second (FEV1). The value reached is recorded when the patient counts audibly in a single expiration after maximum inspiratory effort. The instruction is: "Breathe well, count as many counts as possible while exhaling". The total number is recorded and evaluated in 4 categories: >30: 1, 20-29:2, 10-19: 3, <9:4.	Change from baseline at 8 weeks
Secondary	Patient Satisfaction Survey	15 items survey was developed by the researchers. 5 likert pointed scale range was "5: excellent" and "1=bad". The items were about internet/connection, physiotherapist's guidance, timing, level of knowledge, reassurance, comfort, information/suggestions, the intelligibility of information, and general satisfaction. A total score was used to calculate percent value [(100 X Total score)/15].	After 8 weeks
Secondary	Brooke Upper Extremity Scale	The Brooke scale was used to classify upper extremity functioning with scores from 1 to 6 (higher scores indicate worse functionality).	Change from baseline at 8 weeks
Secondary	Brooke Lower Extremity Scale	The functional ability for all of the subjects with DMD was also ranked by a physical therapist using the Brooke Lower Extremity Functional Scale. This scale ranges from a grade of 1 (able to walk and climb stairs independently) to a grade of 10 (confined to bed).	Change from baseline at 8 weeks
Secondary	Frequency of falling	The number of falls that occurred per day before the study and the frequency of falls after 8 weeks of exercise were questioned verbally.	Change from baseline at 8 weeks