Duchenne Muscular DystrophyNCT04287582
The Evaluation of Muscle Activation in Climbing up Stairs Activity in Children With Duchenne Muscular Dystrophy
An observational study of Duchenne Muscular Dystrophy, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
Children with Duchenne Muscular Dystrophy (DMD) have difficulties towards the end of the ambulatory period, especially in activities that require lower extremity proximal muscle strength such as walking, climbing stairs, standing up without sitting. Read more about this study
- Who is it for?
- Ages 5 to 12 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Duchenne Muscular Dystrophy
- What is being tested?
- Electromyographic device
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 3 Apr 2019to 1 Apr 2020
- Phase
- Observational
- 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 to 12 years
- Men only
- Healthy volunteers accepted
- Child
Study population: The study included 20 children with DMD applied in the Hacettepe University Pediatric Neuromuscular Disorders Unit and 10 children aged 5-12 years living in Ankara who do not have any disease.
Who may be able to join
- Children with DMD:
- Having been diagnosed with Duchenne Muscular Dystrophy by a pediatric neurologist,
- Volunteering to participate in the study,
- Being in the 5-12 age range
- According to the Brooke Lower Limb Functional Classification developed for classifying lower extremity functions of children with DMD, it should be between level 1-3 (children who continue ambulation and can go up and down with assisted / unassisted stairs),
- To be able to cooperate with the instructions of the physiotherapist
Show all 10Show fewer
- Healthy Group:
- Not having a known acute or chronic illness
- The children with DMD included in the study have similar demographic characteristics (age, height, weight, body mass index),
- The physiotherapist should cooperate with the instructions.
Who cannot join
- Children with DMD:
- Have undergone any lower limb injuries and / or surgery,
- Started steroid treatment in the last 6 months,
- Having any systemic disease other than DMD,
- Not having permission from his family and himself.
- Healthy Group:
Show all 9Show fewer
- Having had any injury and / or surgery ,
- Children with DMD have relatives,
- Not having permission from his family and himself
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Hacettepe University
Ankara, 06680
Merve Bora, PT, 05058625335, mervebora95@gmail.com
About this study
Children with Duchenne Muscular Dystrophy (DMD) have difficulties towards the end of the ambulatory period, especially in activities that require lower extremity proximal muscle strength such as walking, climbing stairs, standing up without sitting. Stair climbing / descending activity is a complex activity that requires joint stability, correct muscle synergy and timing. When the literature is examined; It has been observed that the performance of stair climb up and down activity in individuals with neuromuscular disease has been evaluated with various clinical applications. In recent studies, there are surface electromyography (EMG) studies evaluating various aspects of stair climbing and descending activity.
Surface EMG; is a technique for neuromuscular evaluations that is frequently used in both research and clinical applications, noninvasive, and can be used in areas such as neurophysiology, sports science and rehabilitation.
Read more
Our study was planned to examine the muscle activations in the lower limb muscles involved in climbing up stairs activity in children with DMD and to compare healthy children with children with DMD and children with different levels of DMD.
Hypothesis originating from the investigation:
H0: There is no difference in the muscle activations measured by surface electromyography (EMG) of the involved lower extremity muscles during climbing up stairs activity between level 1 and level 2-3 children with early DMD.
H1: There is a difference in the muscle activations measured by surface electromyography (EMG) of the involved lower extremity muscles during climbing up stairs activity between level 1 and level 2-3 children with early DMD.
H2: There is no difference in the muscle activations measured by surface electromyography (EMG) of the involved lower extremity muscles during climbing up stairs activity between children with DMD and healthy children.
H3: There is a difference in the muscle activations measured by surface electromyography (EMG) of the involved lower extremity muscles during climbing up stairs activity between children with DMD and healthy children.
Read the detailed description
In our study, children will be assessed using the surface Electromyography (EMG) device by using electrodes placed in the relevant lower limb muscles that take part during the stair climbing activity.
The study included 10 children with DMD levels were 1 and 10 children with DMD levels were 2-3 according to the Brooke Lower Limb Functional Classification scale and 10 healthy children.
Muscle activation of vastus lateralis, biceps femoris, tibialis anterior and gastrocnemius medialis muscles will be measured by superficial electromyographic measurement. Muscle activation according to SENIAM (surface EMG for a non-invasive assessment of muscles) for will be evaluated.
Stair climbing activity will be performed 3 times and at 1 minute intervals.
- Conditions
- Duchenne Muscular Dystrophy
- Being tested
- Electromyographic device
- Keywords
- duchenne muscular dystrophy, surface electromyography, muscle activation, stair climbing
- 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.
Electromyographic deviceOther
An 8-channel surface EMG system (DELSYS Trigno Wireless System) will be used to measure signals from muscles during stair climbing activity by surface electromyography measurements.Surface EMG measurements will be carried out during stair climbing activity without any intervention in the body. Surface EMG electrodes will be placed bilaterally in the vastus lateralis, biceps femoris, tibialis anterior and gastrocnemius medialis muscles.
| Study group | Role | What they receive |
|---|---|---|
| Level 1 DMD | According to Brooke Lower Extremity Functional Classification Level 1 Receives: Other: Electromyographic device | |
| Level 2-3 DMD | According to Brooke Lower Extremity Functional Classification Level 2 or 3 Receives: Other: Electromyographic device | |
| Healthy Group | healthy children with similar demographic characteristics with children with DMD Receives: Other: Electromyographic device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surface Electromyographic Measurement
Muscle Activation Measurement It is an 8-channel system for measuring signals come from muscles (Delsys)
Measured: 40 minutes
Secondary outcomes (4)
Muscle Strength Measurement
A quantitative and objective method for assessment of muscular strength using a portable hand held dynamometer. Muscle strength measurement included lower limb and trunk muscles.
Measured: 15 minutes
Timed Performance Test
Timed function tests included time taken to stand from a supine position, time taken to walk 10 m, time taken to climb 4 standard-sized stairs and time taken to descend 4 standard-sized stairs.
Measured: 20 minutes
Muscle shortness assessment
Shortening assessment of trunk and lower extremity muscles measurement included back extensors, hamstring, hip flexors, quadriceps and gastrocnemius muscles.
Measured: 10 minutes
Six minute walk test
Children were asked to walk during 6 minutes as fast as possible at a 25 meter corridor.
Measured: 6 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2020
- Study start3 Apr 2019
- Primary completion7 Mar 2020 (estimated)
- Study completion1 Apr 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Duchenne Muscular DystrophyStudies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Merve Bora, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04287582
- Sponsor's protocol ID
- GO 19/323
- Status last verified
- Feb 2020
- First submitted
- 23 Feb 2020
- Last updated
- 27 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Uchikawa K, Liu M, Hanayama K, Tsuji T, Fujiwara T, Chino N. Functional status and muscle strength in people with Duchenne muscular dystrophy living in the community. J Rehabil Med. 2004 May;36(3):124-9. doi: 10.1080/16501970410023461.
PubMed 15209455Bakker JP, De Groot IJ, Beelen A, Lankhorst GJ. Predictive factors of cessation of ambulation in patients with Duchenne muscular dystrophy. Am J Phys Med Rehabil. 2002 Dec;81(12):906-12. doi: 10.1097/00002060-200212000-00004.
PubMed 12447089Rainoldi A, Melchiorri G, Caruso I. A method for positioning electrodes during surface EMG recordings in lower limb muscles. J Neurosci Methods. 2004 Mar 15;134(1):37-43. doi: 10.1016/j.jneumeth.2003.10.014.
PubMed 15102501Ropars J, Lempereur M, Vuillerot C, Tiffreau V, Peudenier S, Cuisset JM, Pereon Y, Leboeuf F, Delporte L, Delpierre Y, Gross R, Brochard S. Muscle Activation during Gait in Children with Duchenne Muscular Dystrophy. PLoS One. 2016 Sep 13;11(9):e0161938. doi: 10.1371/journal.pone.0161938. eCollection 2016.
PubMed 27622734Hermens HJ, Freriks B, Disselhorst-Klug C, Rau G. Development of recommendations for SEMG sensors and sensor placement procedures. J Electromyogr Kinesiol. 2000 Oct;10(5):361-74. doi: 10.1016/s1050-6411(00)00027-4.
PubMed 11018445Bora M, Yalcin A, Bulut N, Yilmaz O, Karaduman A, Topuz S, Alemdaroglu-Gurbuz I. Investigation of surface electromyography amplitude values during stair climbing task in children with Duchenne muscular dystrophy. Neurol Sci. 2022 Apr;43(4):2791-2801. doi: 10.1007/s10072-021-05643-y. Epub 2021 Oct 4.
PubMed 34608577
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Evaluation of Muscle Activation in Climbing up Stairs Activity in Children With Duchenne Muscular Dystrophy
- ClinicalTrials.gov ID
- NCT04287582
- Acronym / sponsor ID
- GO 19/323
- Conditions
- Duchenne Muscular Dystrophy
- Keywords
- duchenne muscular dystrophy, surface electromyography, muscle activation, stair climbing
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 3 Apr 2019 (actual)
- Primary completion
- 7 Mar 2020 (estimated)
- Study completion
- 1 Apr 2020 (estimated)
- First posted
- 27 Feb 2020 (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.
Children with Duchenne Muscular Dystrophy (DMD) have difficulties towards the end of the ambulatory period, especially in activities that require lower extremity proximal muscle strength such as walking, climbing stairs, standing up without sitting. Stair climbing / descending activity is a complex activity that requires joint stability, correct muscle synergy and timing. When the literature is examined; It has been observed that the performance of stair climb up and down activity in individuals with neuromuscular disease has been evaluated with various clinical applications. In recent studies, there are surface electromyography (EMG) studies evaluating various aspects of stair climbing and descending activity.
Surface EMG; is a technique for neuromuscular evaluations that is frequently used in both research and clinical applications, noninvasive, and can be used in areas such as neurophysiology, sports science and rehabilitation.
Our study was planned to examine the muscle activations in the lower limb muscles involved in climbing up stairs activity in children with DMD and to compare healthy children with children with DMD and children with different levels of DMD.
Hypothesis originating from the investigation:
H0: There is no difference in the muscle activations measured by surface electromyography (EMG) of the involved lower extremity muscles during climbing up stairs activity between level 1 and level 2-3 children with early DMD.
H1: There is a difference in the muscle activations measured by surface electromyography (EMG) of the involved lower extremity muscles during climbing up stairs activity between level 1 and level 2-3 children with early DMD.
H2: There is no difference in the muscle activations measured by surface electromyography (EMG) of the involved lower extremity muscles during climbing up stairs activity between children with DMD and healthy children.
H3: There is a difference in the muscle activations measured by surface electromyography (EMG) of the involved lower extremity muscles during climbing up stairs activity between children with DMD and healthy children.
Detailed description
In our study, children will be assessed using the surface Electromyography (EMG) device by using electrodes placed in the relevant lower limb muscles that take part during the stair climbing activity.
The study included 10 children with DMD levels were 1 and 10 children with DMD levels were 2-3 according to the Brooke Lower Limb Functional Classification scale and 10 healthy children.
Muscle activation of vastus lateralis, biceps femoris, tibialis anterior and gastrocnemius medialis muscles will be measured by superficial electromyographic measurement. Muscle activation according to SENIAM (surface EMG for a non-invasive assessment of muscles) for will be evaluated.
Stair climbing activity will be performed 3 times and at 1 minute intervals.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Level 1 DMD | – | Other: Electromyographic deviceAccording to Brooke Lower Extremity Functional Classification Level 1 |
| Level 2-3 DMD | – | Other: Electromyographic deviceAccording to Brooke Lower Extremity Functional Classification Level 2 or 3 |
| Healthy Group | – | Other: Electromyographic devicehealthy children with similar demographic characteristics with children with DMD |
Who may qualify
- Ages
- 5 to 12 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- The study included 20 children with DMD applied in the Hacettepe University Pediatric Neuromuscular Disorders Unit and 10 children aged 5-12 years living in Ankara who do not have any disease.
Key inclusion criteria (10 listed)
- Having been diagnosed with Duchenne Muscular Dystrophy by a pediatric neurologist,
- Volunteering to participate in the study,
- Being in the 5-12 age range
- According to the Brooke Lower Limb Functional Classification developed for classifying lower extremity functions of children with DMD, it should be between level 1-3 (children who continue ambulation and can go up and down with assisted / unassisted stairs),
- To be able to cooperate with the instructions of the physiotherapist
Key exclusion criteria (9 listed)
- Have undergone any lower limb injuries and / or surgery,
- Started steroid treatment in the last 6 months,
- Having any systemic disease other than DMD,
- Not having permission from his family and himself.
- Having had any injury and / or surgery ,
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 |
|---|---|---|
| Electromyographic deviceAn 8-channel surface EMG system (DELSYS Trigno Wireless System) will be used to measure signals from muscles during stair climbing activity by surface electromyography measurements.Surface EMG measurements will be carried out during stair climbing activity without any intervention in the body. Surface EMG electrodes will be placed bilaterally in the vastus lateralis, biceps femoris, tibialis anterior and gastrocnemius medialis muscles. | Other | Healthy Group, Level 1 DMD, Level 2-3 DMD |
Primary outcome
Surface Electromyographic Measurement
Time frame: 40 minutes
Muscle Activation Measurement It is an 8-channel system for measuring signals come from muscles (Delsys)
4 secondary outcomes
Muscle Strength Measurement
Time frame: 15 minutes
Timed Performance Test
Time frame: 20 minutes
Muscle shortness assessment
Time frame: 10 minutes
Six minute walk test
Time frame: 6 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2020.
- Background: PubMed 15209455Uchikawa K, Liu M, Hanayama K, Tsuji T, Fujiwara T, Chino N. Functional status and muscle strength in people with Duchenne muscular dystrophy living in the community. J Rehabil Med. 2004 May;36(3):124-9. doi: 10.1080/16501970410023461.
- Background: PubMed 12447089Bakker JP, De Groot IJ, Beelen A, Lankhorst GJ. Predictive factors of cessation of ambulation in patients with Duchenne muscular dystrophy. Am J Phys Med Rehabil. 2002 Dec;81(12):906-12. doi: 10.1097/00002060-200212000-00004.
- Background: PubMed 15102501Rainoldi A, Melchiorri G, Caruso I. A method for positioning electrodes during surface EMG recordings in lower limb muscles. J Neurosci Methods. 2004 Mar 15;134(1):37-43. doi: 10.1016/j.jneumeth.2003.10.014.
- Background: PubMed 27622734Ropars J, Lempereur M, Vuillerot C, Tiffreau V, Peudenier S, Cuisset JM, Pereon Y, Leboeuf F, Delporte L, Delpierre Y, Gross R, Brochard S. Muscle Activation during Gait in Children with Duchenne Muscular Dystrophy. PLoS One. 2016 Sep 13;11(9):e0161938. doi: 10.1371/journal.pone.0161938. eCollection 2016.
- Background: PubMed 11018445Hermens HJ, Freriks B, Disselhorst-Klug C, Rau G. Development of recommendations for SEMG sensors and sensor placement procedures. J Electromyogr Kinesiol. 2000 Oct;10(5):361-74. doi: 10.1016/s1050-6411(00)00027-4.
- Derived from this study: PubMed 34608577Bora M, Yalcin A, Bulut N, Yilmaz O, Karaduman A, Topuz S, Alemdaroglu-Gurbuz I. Investigation of surface electromyography amplitude values during stair climbing task in children with Duchenne muscular dystrophy. Neurol Sci. 2022 Apr;43(4):2791-2801. doi: 10.1007/s10072-021-05643-y. Epub 2021 Oct 4.
- SENIAMLink provided by the sponsor.
- 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?
An observational study of Duchenne Muscular Dystrophy, run by Hacettepe 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 10 inclusion and 9 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 27 Feb 2020. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Merve B Bora, PT (5058625335 ext. +90, mervebora95@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Surface Electromyographic Measurement (time frame: 40 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04287582, which also lists 6 linked publications.
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 27 Feb 2020.