StrokeNCT04181151
Investigation of Activation of Latissimus Dorsi Muscle Segments During Functional Reach Activity in Chronic Stroke Patients
An observational study of Stroke, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
Latissimus Dorsi (LD); Medial sacrum, lumbar vertebrae and lower thoracic vertebrae 10-12 lateral to the spinous processus. It is a fan-like wide muscle that connects to the inferior angle of the scapula and ribs, adheres to the anterior surface of the proximal humerus and continues with aponeurosis of the… Read more about this study
- Who is it for?
- Ages 30 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Stroke
- What is being tested?
- Electromyographic device
- How many people
- 12 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2019to 29 Dec 2020
- How long will I take part?
- 1 Day
- 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 30 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Hacettepe University Neurological Rehabilitation Unit
Who may be able to join
- diagnosed with stroke by a neurologist
- least 6 mounts after stroke
- Fugl Meyer Upper Extremity Motor Rating Scale with a value of 40 and above,
- independent sitting,
- Mini Mental Status Scale (MMSE)> 24,
- 30-67 age.
Who cannot join
- neurodegenerative disease other than stroke
- presence of neglect
- presence of apraxia
- uncorrected visual impairment
- neuromusculoskeletal pathologies
- neck and shoulder pain lasting more than 3 months
Trial locations and contacts
1 site in 1 country.
About this study
Latissimus Dorsi (LD); Medial sacrum, lumbar vertebrae and lower thoracic vertebrae 10-12 lateral to the spinous processus. It is a fan-like wide muscle that connects to the inferior angle of the scapula and ribs, adheres to the anterior surface of the proximal humerus and continues with aponeurosis of the contralateral Gluteus Maximus below. The activation of the LD muscle during the functional reach activity, which we use most frequently in daily living activities, affects the upper extremity and trunk movements. Therefore it is important muscle that affects the quality of movement.
The study include individuals with stroke that diagnosed by the neurologist and include healthy subjects. During sitting activity, they will be required to reach three different distances in the sagittal and scapular plane: arm length, 125% of the arm length and end point where it can reach the modified functional reach test. During the activity, electromyography (EMG) activation of latissimus dorsi, anterior deltoid and erector spina muscles will be examined with electromyographic device.
Read more
Hypothesis originating from the investigation:
H1: Latissimus dorsi muscle segments show different activation during functional reach activity.
H2: Activation of latissimus dorsi muscle segments is affected by reaching direction during functional reach activity.
H3: Activation of latissimus dorsi muscle segments is affected by reaching distance during functional reach activity.
Read the detailed description
Measurements will be made during the sitting activity of the individuals included in the study. Individuals will be asked to reach midsternal height cups in two separate planes, sagittal and scapular, at arm's end, 125% of arm's distance and end point where it can reach according to modified functional reach test.
Muscle activation of latissimus dorsi, erector spina and anterior deltoid muscles will be measured by superficial electromyographic measurement. Muscle activation according to SENIAM for erector spina and anterior deltoid will be evaluated. For latissimus dorsi, activation will be measured in six segments separated according to anatomic dissection.
Reach activity will be performed 3 times on each side and at 1 minute intervals.
- Conditions
- Stroke
- Being tested
- Electromyographic device
- Keywords
- latissimus dorsi, stroke, electromyography, reaching activity, muscle activation
- Medical subject headings
- Stroke
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 (Noraxon Telemyo DTS system, Scottsdale, USA) will be used to measure signals from muscles during surface electromyography measurements.
| Study group | Role | What they receive |
|---|---|---|
| Stroke patients | Not described Receives: Other: Electromyographic device | |
| Healthy Subjects | Not described 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 (Noraxon Telemyo DTS system, Scottsdale, USA).
Measured: 90 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2019
- Study start1 Jan 2019
- Primary completion7 Aug 2019
- Study completion29 Dec 2020
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 StrokeStudies 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
- 12 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tuba Kaya Benli, Hacettepe University
- Investigators
- Tuba KAYA, R.A., Principal investigator, Hacettepe UniversitySevil BİLGİN, Assoc. Prof., Study director, Hacettepe UniversityMuhammed KILINÇ, Assoc. Prof., Study chair, Hacettepe UniversityEsra DÜLGER, R.A., Study chair, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04181151
- Sponsor's protocol ID
- Hacettepe U
- Status last verified
- Apr 2022
- First submitted
- 25 Nov 2019
- Last updated
- 20 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bogduk N, Johnson G, Spalding D. The morphology and biomechanics of latissimus dorsi. Clin Biomech (Bristol). 1998 Sep;13(6):377-385. doi: 10.1016/s0268-0033(98)00102-8.
PubMed 11415812Dickstein R, Shefi S, Marcovitz E, Villa Y. Anticipatory postural adjustment in selected trunk muscles in post stroke hemiparetic patients. Arch Phys Med Rehabil. 2004 Feb;85(2):261-7. doi: 10.1016/j.apmr.2003.05.011.
PubMed 14966711Wickham JB, Brown JM. Muscles within muscles: the neuromotor control of intra-muscular segments. Eur J Appl Physiol Occup Physiol. 1998 Aug;78(3):219-25. doi: 10.1007/s004210050410.
PubMed 9720999Brown JM, Wickham JB, McAndrew DJ, Huang XF. Muscles within muscles: Coordination of 19 muscle segments within three shoulder muscles during isometric motor tasks. J Electromyogr Kinesiol. 2007 Feb;17(1):57-73. doi: 10.1016/j.jelekin.2005.10.007. Epub 2006 Feb 2.
PubMed 16458022Hermens 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 11018445Kaya Benli T, Kara D, Dulger E, Bilgin S. Electromyography study of six parts of the latissimus dorsi during reaching tasks while seated: A comparison between healthy subjects and stroke patients. J Electromyogr Kinesiol. 2023 Jun;70:102770. doi: 10.1016/j.jelekin.2023.102770. Epub 2023 Mar 25.
PubMed 37004380
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Activation of Latissimus Dorsi Muscle Segments During Functional Reach Activity in Chronic Stroke Patients
- ClinicalTrials.gov ID
- NCT04181151
- Acronym / sponsor ID
- Hacettepe U
- Conditions
- Stroke
- Keywords
- latissimus dorsi, stroke, electromyography, reaching activity, muscle activation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 7 Aug 2019 (actual)
- Study completion
- 29 Dec 2020 (actual)
- First posted
- 29 Nov 2019 (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.
Latissimus Dorsi (LD); Medial sacrum, lumbar vertebrae and lower thoracic vertebrae 10-12 lateral to the spinous processus. It is a fan-like wide muscle that connects to the inferior angle of the scapula and ribs, adheres to the anterior surface of the proximal humerus and continues with aponeurosis of the contralateral Gluteus Maximus below. The activation of the LD muscle during the functional reach activity, which we use most frequently in daily living activities, affects the upper extremity and trunk movements. Therefore it is important muscle that affects the quality of movement.
The study include individuals with stroke that diagnosed by the neurologist and include healthy subjects. During sitting activity, they will be required to reach three different distances in the sagittal and scapular plane: arm length, 125% of the arm length and end point where it can reach the modified functional reach test. During the activity, electromyography (EMG) activation of latissimus dorsi, anterior deltoid and erector spina muscles will be examined with electromyographic device.
Hypothesis originating from the investigation:
H1: Latissimus dorsi muscle segments show different activation during functional reach activity.
H2: Activation of latissimus dorsi muscle segments is affected by reaching direction during functional reach activity.
H3: Activation of latissimus dorsi muscle segments is affected by reaching distance during functional reach activity.
Detailed description
Measurements will be made during the sitting activity of the individuals included in the study. Individuals will be asked to reach midsternal height cups in two separate planes, sagittal and scapular, at arm's end, 125% of arm's distance and end point where it can reach according to modified functional reach test.
Muscle activation of latissimus dorsi, erector spina and anterior deltoid muscles will be measured by superficial electromyographic measurement. Muscle activation according to SENIAM for erector spina and anterior deltoid will be evaluated. For latissimus dorsi, activation will be measured in six segments separated according to anatomic dissection.
Reach activity will be performed 3 times on each side and at 1 minute intervals.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stroke patients | – | Other: Electromyographic device |
| Healthy Subjects | – | Other: Electromyographic device |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Hacettepe University Neurological Rehabilitation Unit
Key inclusion criteria (6 listed)
- diagnosed with stroke by a neurologist
- least 6 mounts after stroke
- Fugl Meyer Upper Extremity Motor Rating Scale with a value of 40 and above,
- independent sitting,
- Mini Mental Status Scale (MMSE)> 24,
Key exclusion criteria (6 listed)
- neurodegenerative disease other than stroke
- presence of neglect
- presence of apraxia
- uncorrected visual impairment
- neuromusculoskeletal pathologies
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 (Noraxon Telemyo DTS system, Scottsdale, USA) will be used to measure signals from muscles during surface electromyography measurements. | Other | Healthy Subjects, Stroke patients |
Primary outcome
Surface electromyographic measurement
Time frame: 90 minutes
Muscle activation measurement It is an 8-channel system for measuring signals come from muscles (Noraxon Telemyo DTS system, Scottsdale, USA).
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 20 Apr 2022.
- Background: PubMed 11415812Bogduk N, Johnson G, Spalding D. The morphology and biomechanics of latissimus dorsi. Clin Biomech (Bristol). 1998 Sep;13(6):377-385. doi: 10.1016/s0268-0033(98)00102-8.
- Background: PubMed 14966711Dickstein R, Shefi S, Marcovitz E, Villa Y. Anticipatory postural adjustment in selected trunk muscles in post stroke hemiparetic patients. Arch Phys Med Rehabil. 2004 Feb;85(2):261-7. doi: 10.1016/j.apmr.2003.05.011.
- Background: PubMed 9720999Wickham JB, Brown JM. Muscles within muscles: the neuromotor control of intra-muscular segments. Eur J Appl Physiol Occup Physiol. 1998 Aug;78(3):219-25. doi: 10.1007/s004210050410.
- Background: PubMed 16458022Brown JM, Wickham JB, McAndrew DJ, Huang XF. Muscles within muscles: Coordination of 19 muscle segments within three shoulder muscles during isometric motor tasks. J Electromyogr Kinesiol. 2007 Feb;17(1):57-73. doi: 10.1016/j.jelekin.2005.10.007. Epub 2006 Feb 2.
- 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 37004380Kaya Benli T, Kara D, Dulger E, Bilgin S. Electromyography study of six parts of the latissimus dorsi during reaching tasks while seated: A comparison between healthy subjects and stroke patients. J Electromyogr Kinesiol. 2023 Jun;70:102770. doi: 10.1016/j.jelekin.2023.102770. Epub 2023 Mar 25.
- SENIAMLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Tuba KAYA, R.A. principal investigator
Hacettepe University
Sevil BİLGİN, Assoc. Prof. study director
Hacettepe University
Muhammed KILINÇ, Assoc. Prof. study chair
Hacettepe University
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 Stroke, 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 6 inclusion and 6 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 20 Apr 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?
Surface electromyographic measurement (time frame: 90 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 NCT04181151, 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 20 Apr 2022.