Duchenne Muscular DystrophyNCT05967793
Effect of Kinesiology Taping on Head and Trunk Control in Children With Duchenne Muscular Dystrophy
A study testing kinesio tape in people with Duchenne Muscular Dystrophy, run by Egyptian Chinese University at 1 site in Egypt.
Trial summary
Muscular dystrophy (MD) is a group of muscle diseases that results in increasing weakening and breakdown of skeletal muscles over time. The disorders differ in which muscles are primarily affected, the degree of weakness, how fast they worsen, and when symptoms begin. Many people will eventually become unable to walk. Read more about this study
- Who is it for?
- Ages 8 to 12 years
- Conditions the study is for
- Duchenne Muscular Dystrophy
- What is being tested?
- kinesio tape
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- Jul 2023to Nov 2023
- 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 8 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- being at the age of 8-12 years
- being able to cooperate with the instructions of physiotherapist to perform the assessments and procedures.
Who cannot join
- having severe contracture at lower extremities
- having another neurological and/or musculoskeletal disease diagnosis in addition to DMD. c) having a history of any lower extremity injury or orthopedic/neurologic surgery within the past 6 months.
Trial locations and contacts
1 site in 1 country.
About this study
Muscular dystrophy (MD) is a group of muscle diseases that results in increasing weakening and breakdown of skeletal muscles over time. The disorders differ in which muscles are primarily affected, the degree of weakness, how fast they worsen, and when symptoms begin. Many people will eventually become unable to walk. Some types are also associated with problems in other organs. The muscular dystrophy group contains thirty different genetic disorders that are usually classified into nine main categories or types.
The signs and symptoms consistent with muscular dystrophy are: progressive muscular wasting, poor balance, scoliosis (curvature of the spine and the back), progressive inability to walk, waddling gait, Calf deformation, Limited range of movement, respiratory difficulty, cardiomyopathy and muscle spasms This study aimed to assess the efficacy of Kinesiology Taping on head and trunk control in patients with Duchenne muscular dystrophy
Read the detailed description
Duchenne Muscular Dystrophy (DMD) is the most common muscular dystrophy type in childhood. Trunk control is responsible for adaptation during weight transfers, provides and maintains the upright position of the body, organizes postural and correction reactions; and stabilizes the body to perform proximal and distal limb movements, trunk rotations, and making contact between the shoulder and pelvis. In neuromuscular diseases, the trunk is usually ignored both for assessment and treatment as muscle weakness of limbs attracts more attention. Therapists usually focus on activities of lower limb and overhead including standing, walking, climbing, and raising arms to maintain independent mobility in rehabilitation sessions. However, the trunk also gradually gets weaker as the child gets older and this may be associated with movement dysfunction of upper and lower limbs. The Kinesio Taping method is used in the rehabilitation of musculoskeletal disorders, providing either an increase or a decrease in the neural excitation of the muscle, depending on the therapeutic purpose determined after the clinical assessment.
- Conditions
- Duchenne Muscular Dystrophy
- Being tested
- kinesio tape
- Medical subject headings
- Muscular Dystrophy, Duchenne
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
kinesio tapeOther
Kinesio Tape will be applied on paraspinal trunk extensors muscles for 8 weeks, changed every 3 days.
| Study group | Role | What they receive |
|---|---|---|
| kinesio tape | Experimental | Kinesio Tape will be applied on paraspinal trunk extensors muscles for 8 weeks, changed every 3 days. Receives: Other: kinesio tape |
| Routine physical therapy program | Active comparator | routine physical therapy exercise Receives: Other: kinesio tape |
What is being measured
The primary outcome is the main question the study is designed to answer.
H-reflex latency and amplitude for trunk extensor
H- reflex will be measured by an electromyogram device, four channels electrodiagnostic system with built in amplifier will be used in prone position for levator scapulae muscles and iliocostalis lumborum muscles
Measured: through study completion, an average of 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2023
- Study startJul 2023 (estimated)
- Primary completionSep 2023 (estimated)
- Study completionNov 2023 (estimated)
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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Egyptian Chinese University
- Sponsor type
- University, hospital or other
- Collaborators
- Benha University
- Responsible party
- Principal investigator, Noha Elserty, Benha University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05967793
- Sponsor's protocol ID
- Benha University
- Status last verified
- Jul 2023
- First submitted
- 15 Jul 2023
- Last updated
- 1 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Kinesiology Taping on Head and Trunk Control in Children With Duchenne Muscular Dystrophy
- ClinicalTrials.gov ID
- NCT05967793
- Acronym / sponsor ID
- Benha University
- Conditions
- Duchenne Muscular Dystrophy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Egyptian Chinese UniversityUniversity, hospital or other
- Collaborators
- Benha University
- Study start
- Jul 2023 (estimated)
- Primary completion
- Sep 2023 (estimated)
- Study completion
- Nov 2023 (estimated)
- First posted
- 1 Aug 2023 (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.
Muscular dystrophy (MD) is a group of muscle diseases that results in increasing weakening and breakdown of skeletal muscles over time. The disorders differ in which muscles are primarily affected, the degree of weakness, how fast they worsen, and when symptoms begin. Many people will eventually become unable to walk. Some types are also associated with problems in other organs. The muscular dystrophy group contains thirty different genetic disorders that are usually classified into nine main categories or types.
The signs and symptoms consistent with muscular dystrophy are: progressive muscular wasting, poor balance, scoliosis (curvature of the spine and the back), progressive inability to walk, waddling gait, Calf deformation, Limited range of movement, respiratory difficulty, cardiomyopathy and muscle spasms This study aimed to assess the efficacy of Kinesiology Taping on head and trunk control in patients with Duchenne muscular dystrophy
Detailed description
Duchenne Muscular Dystrophy (DMD) is the most common muscular dystrophy type in childhood. Trunk control is responsible for adaptation during weight transfers, provides and maintains the upright position of the body, organizes postural and correction reactions; and stabilizes the body to perform proximal and distal limb movements, trunk rotations, and making contact between the shoulder and pelvis. In neuromuscular diseases, the trunk is usually ignored both for assessment and treatment as muscle weakness of limbs attracts more attention. Therapists usually focus on activities of lower limb and overhead including standing, walking, climbing, and raising arms to maintain independent mobility in rehabilitation sessions. However, the trunk also gradually gets weaker as the child gets older and this may be associated with movement dysfunction of upper and lower limbs. The Kinesio Taping method is used in the rehabilitation of musculoskeletal disorders, providing either an increase or a decrease in the neural excitation of the muscle, depending on the therapeutic purpose determined after the clinical assessment.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| kinesio tape | Experimental | Other: kinesio tapeKinesio Tape will be applied on paraspinal trunk extensors muscles for 8 weeks, changed every 3 days. |
| Routine physical therapy program | Active comparator | Other: kinesio taperoutine physical therapy exercise |
Who may qualify
- Ages
- 8 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- being at the age of 8-12 years
- being able to cooperate with the instructions of physiotherapist to perform the assessments and procedures.
Key exclusion criteria (2 listed)
- having severe contracture at lower extremities
- having another neurological and/or musculoskeletal disease diagnosis in addition to DMD. c) having a history of any lower extremity injury or orthopedic/neurologic surgery within the past 6 months.
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 |
|---|---|---|
| kinesio tapeKinesio Tape will be applied on paraspinal trunk extensors muscles for 8 weeks, changed every 3 days. | Other | Routine physical therapy program, kinesio tape |
Primary outcome
H-reflex latency and amplitude for trunk extensor
Time frame: through study completion, an average of 3 months
H- reflex will be measured by an electromyogram device, four channels electrodiagnostic system with built in amplifier will be used in prone position for levator scapulae muscles and iliocostalis lumborum muscles
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2023.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing kinesio tape in people with Duchenne Muscular Dystrophy, run by Egyptian Chinese University at 1 site in Egypt.
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 2 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: status not confirmed, as of the sponsor's last update on 1 Aug 2023. 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 Egypt. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Noha Elserty, ASS. prof. (01006709648, noha.serty@fpt.bu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
H-reflex latency and amplitude for trunk extensor (time frame: through study completion, an average of 3 months). 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 1 Aug 2023.