Duchenne Muscular DystrophyDuchenneNCT05305976
Telerehabilitation in Duchenne Muscular Dystrophy
A study testing Telerehabilitation in people with Duchenne Muscular Dystrophy, run by Karadeniz Technical University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 5 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Duchenne Muscular Dystrophy
- What is being tested?
- Telerehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 11 Jan 2021to 1 Jan 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 years and older
- Men only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Able to communicate verbally and visually
- Older than 5 years old
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Karadeniz Technical University
Trabzon, Ortahisar, 61000
About this study
Official title: Remote Physiotherapy Application to Protect Physical Health 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.
Read the detailed 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).
- Conditions
- Duchenne Muscular Dystrophy
- Being tested
- Telerehabilitation
- Keywords
- Duchenne Muscular Dystrophy, telerehabilitation, satisfaction
- Medical subject headings
- Muscular Dystrophy, Duchenne, Personal Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TelerehabilitationOther
The 8 week exercise program with telerehabilitation
| Study group | Role | What they receive |
|---|---|---|
| Ambulant Group | Experimental | Individuals unable to walk according to the Brooke Function Classification System Receives: Other: Telerehabilitation |
| Non-ambulant Group | Experimental | Individuals who can walk according to the Brooke Function Classification System Receives: Other: Telerehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional level
Brooke Function Classification System
Measured: Before the intervention, up to one month
Socio-demographics
gender, body weight, height
Measured: Before the intervention, up to one month
Walking test (Before intervention)
The distance of 10 m was determined in a suitable indoor environment.
Measured: Before the intervention, up to one month.
Walking test (After intervention)
The distance of 10 m was determined in a suitable indoor environment.
Measured: After the intervention, average two weeks.
Time to stand up from the supine position (Before intervention)
The time to stand up from the supine position was recorded.
Measured: Before the intervention, up to one month.
Time to stand up from the supine position (After intervention)
The time to stand up from the supine position was recorded.
Measured: After the intervention, average two weeks.
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
Measured: Before the intervention, up to one month.
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
Measured: After the intervention, average two weeks.
Endurance (Before intervention)
The number of knee extensions and elbow flexions they can do in sitting position in 30 seconds
Measured: Before the intervention, up to one month.
Endurance (After intervention)
The number of knee extensions and elbow flexions they can do in sitting position in 30 seconds
Measured: After the intervention, average two weeks.
Pulmonary Dysfunction Test (Before intervention)
Value when the patient counts audibly in a single expiration after maximum inspiratory effort
Measured: Before the intervention, up to one month.
Pulmonary Dysfunction Test (After intervention)
Value when the patient counts audibly in a single expiration after maximum inspiratory effort
Measured: After the intervention, average two weeks.
Secondary outcomes (1)
Patient Satisfaction Survey
General satisfaction, internet/connection, physiotherapist's guidance, timing, level of knowledge, reassurance, comfort, knowledge/advice, level of satisfaction with information clarity
Measured: After the intervention average two weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2022
- Study start11 Jan 2021
- Primary completion15 Nov 2021
- Study completion1 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Duchenne Muscular DystrophyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Grup 1: Ambulant Group Grup 2: Non-ambulant Group
- Masking
- None (open label)
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karadeniz Technical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Arzu ERDEN, Karadeniz Technical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05305976
- Sponsor's protocol ID
- KTU_FTR_AE_01
- Acronym
- Duchenne
- Status last verified
- Mar 2022
- First submitted
- 14 Mar 2022
- Last updated
- 31 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Remote Physiotherapy Application to Protect Physical Health in Duchenne Muscular Dystrophy
- ClinicalTrials.gov ID
- NCT05305976
- Acronym / sponsor ID
- Duchenne / KTU_FTR_AE_01
- Conditions
- Duchenne Muscular Dystrophy
- Keywords
- Duchenne Muscular Dystrophy, telerehabilitation, satisfaction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Karadeniz Technical UniversityUniversity, hospital or other
- Study start
- 11 Jan 2021 (actual)
- Primary completion
- 15 Nov 2021 (actual)
- Study completion
- 1 Jan 2022 (actual)
- First posted
- 31 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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).
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Grup 1: Ambulant Group Grup 2: Non-ambulant Group
| Arm | Type | Receives |
|---|---|---|
| Ambulant Group | Experimental | Other: TelerehabilitationIndividuals unable to walk according to the Brooke Function Classification System |
| Non-ambulant Group | Experimental | Other: TelerehabilitationIndividuals who can walk according to the Brooke Function Classification System |
Who may qualify
- Ages
- 5 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Able to communicate verbally and visually
- Older than 5 years old
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TelerehabilitationThe 8 week exercise program with telerehabilitation | Other | Ambulant Group, Non-ambulant Group |
Primary outcome
Functional level
Time frame: Before the intervention, up to one month
Brooke Function Classification System
Socio-demographics
Time frame: Before the intervention, up to one month
gender, body weight, height
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.
Walking test (After intervention)
Time frame: After the intervention, average two weeks.
The distance of 10 m was determined in a suitable indoor environment.
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.
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.
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
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
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
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
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
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
1 secondary outcome
Patient Satisfaction Survey
Time frame: After the intervention average two weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telerehabilitation in people with Duchenne Muscular Dystrophy, run by Karadeniz Technical University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional level (time frame: Before the intervention, up to one month). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2022.