- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06103006
Remote Physiotherapy to Protect Physical Health in Duchenne Muscular Dystrophy
Remote Physiotherapy to Protect Physical Health in Duchenne Muscular Dystrophy: Telerehabilitation
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Ankara, Turkey
- Lokman Hekim University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Telerehabilitation Group
Participants in this group will receive telerehabilitation exercises.
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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).
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Endurance
Time Frame: Change from baseline at 8 weeks
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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
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Change from baseline at 8 weeks
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Modified Upper Extremity Performance Test
Time Frame: Change from baseline at 8 weeks
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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 .
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Change from baseline at 8 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
10 Meter (m) Walking Test
Time Frame: Change from baseline at 8 weeks
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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.
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Change from baseline at 8 weeks
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Stand Up from the Supine Position Test
Time Frame: Change from baseline at 8 weeks
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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.
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Change from baseline at 8 weeks
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Single Breath Count (SBC)
Time Frame: Change from baseline at 8 weeks
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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.
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Change from baseline at 8 weeks
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Patient Satisfaction Survey
Time Frame: After 8 weeks
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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].
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After 8 weeks
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Brooke Upper Extremity Scale
Time Frame: Change from baseline at 8 weeks
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The Brooke scale was used to classify upper extremity functioning with scores from 1 to 6 (higher scores indicate worse functionality).
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Change from baseline at 8 weeks
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Brooke Lower Extremity Scale
Time Frame: Change from baseline at 8 weeks
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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).
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Change from baseline at 8 weeks
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Frequency of falling
Time Frame: Change from baseline at 8 weeks
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The number of falls that occurred per day before the study and the frequency of falls after 8 weeks of exercise were questioned verbally.
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Change from baseline at 8 weeks
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 003/2021
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Duchenne Muscular Dystrophy
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Cairo UniversityCompletedMuscular Dystrophy, Duchenne TypeEgypt
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Medical University of GdanskRecruitingDuchenne Muscular Dystrophy (DMD)Poland
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ItalfarmacoCompletedDuchenne Muscular Dystrophy (DMD)Italy
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Santhera PharmaceuticalsTerminatedDuchenne Muscular Dystrophy (DMD)United States, Spain, Netherlands, Sweden, Germany, France, Belgium, United Kingdom, Italy, Ireland, Switzerland, Austria, Bulgaria, Hungary, Israel
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Sarepta Therapeutics, Inc.CompletedDuchenne Muscular Dystrophy (DMD)United States
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Hospital RudolfstiftungOesterreichische MuskelforschungCompletedCarrier of Duchenne Muscular DystrophyAustria
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General Hospital of Chinese Armed Police ForcesUnknownDuchenne Muscular Dystrophy (DMD)China
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Chaitanya Hospital, PuneUnknownMuscular Dystrophy | Duchenne Muscular Dystrophy,India
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University of FloridaU.S. Army Medical Research and Development CommandRecruitingDuchenne Muscular Dystrophy (DMD)United States
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PTC TherapeuticsCompletedNonsene Mutation Duchenne Muscular DystrophyUnited States
Clinical Trials on Telerehabilitation
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Saglik Bilimleri UniversitesiCompletedQuality of Life | Fatigue | Muscle Weakness | Pulmonary Disease | COPD | Respiratory Disease | Dyspnea | Muscle Strength | Functional Capacity | Severe Chronic Obstructive Pulmonary Disease | Motor Imagery | Muscle; AccessoryTurkey
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Marmara UniversityEnrolling by invitationHemiparetic Cerebral PalsyTurkey
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Bright Cloud International CorpNational Cancer Institute (NCI); Rutgers, The State University of New JerseyRecruitingCognitive Impairment, MildUnited States
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University of Eastern FinlandOulu University Hospital; Kuopio University HospitalNot yet recruitingCoronary Artery Disease
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Instituto Mexicano del Seguro SocialRecruitingNeck Pain | Neck SprainMexico
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University of MinnesotaRecruitingTemporomandibular Disorder | TMJ Disc Displacement With Reduction | TMJ Disc Displacement Without Reduction | Masticatory Myofascial Pain | TMJ Arthralgia | TMD HeadacheUnited States
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VA Office of Research and DevelopmentNot yet recruiting
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University Hospital, GrenobleNot yet recruitingChronic Thromboembolic Pulmonary Hypertension
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Aalborg UniversityViborg Regional Hospital; Aage and Johanne Louis-Hansens Foundation; Laboratory... and other collaboratorsRecruiting
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University of California, Los AngelesMoss Rehabilitation Research InstituteCompleted