Spinal Cord Injury ThoracicNCT06527417
Electromyography-Triggered Electrical Stimulation on Trunk Balance and Muscle Thickness in SCI Patients
A study testing Neuro Trac Myo Plus Pro and Trunk eccentric exercises in people with Spinal Cord Injury Thoracic, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study was to investigate the effect of electromyography (EMG) triggered electrical stimulation (ES) applied to multifidus and erector spinae muscles on trunk balance in patients with complete thoracic spinal cord injury (SCI). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Spinal Cord Injury Thoracic
- What is being tested?
- Neuro Trac Myo Plus Pro and Trunk eccentric exercises
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 18 Aug 2023to 25 Jul 2024
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- have traumatic SCI and this injury occurred at least 3 months ago,
- be between the ages of 18 and 65,
- have a neurological injury level between thoracic 4 and thoracic 12
- be fully paraplegic according to the American Spinal Cord Injury Association (ASIA) impairment scale
- be able to sit unsupported in a wheelchair
Who cannot join
- patients with a diagnosis of heart failure
- malignancy
- intracardiac defibrillators
- epilepsy
- open wounds
- patients using trunk corsets
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Electromyography Triggered Electrical Stimulation on Trunk Balance and Muscle Thickness of Multifidus and Erector Spinae Muscles in Patients With Complete Spinal Cord Injury - A Randomised Controlled Study
The aim of this study was to investigate the effect of electromyography (EMG) triggered electrical stimulation (ES) applied to multifidus and erector spinae muscles on trunk balance in patients with complete thoracic spinal cord injury (SCI).
The fundamental questions that investigators want to answer are as follows:
- [question 1]: "Does multifidus and erector spinae EMG ES improve trunk balance in patients with complete SCI?"
- [question 2]: "Does multifidus and erector spinae EMG ES improve muscle thickness in patients with complete SCI?"
Read the detailed description
Spinal cord injury results in loss of sensory and motor function below the level of injury, causing difficulty with unaided sitting and activities of daily living, especially at the thoracic level in SCI patients. The paraspinal muscles that provide trunk balance are weakened in these patients. Methods such as neuromuscular electrical stimulation and EMG ES are used to improve trunk balance and restore muscle function. This study aims to investigate the effect of EMG ES applied to the multifidus and erector spinae muscles on trunk balance in patients with complete thoracic SCI.
- Conditions
- Spinal Cord Injury Thoracic
- Being tested
- Neuro Trac Myo Plus Pro, Trunk eccentric exercises
- Keywords
- spinal cord injury, trunk balance, electrical stimulation, multifidus, erector spinae
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neuro Trac Myo Plus ProDevice
Electrical stimulation parameters; stimuli were monophasic, rectangular, stimulus duration 300 µs, frequency 25 Hertz, amplitude was increased up to a maximum of 100 milliampere until contraction was seen.
Trunk eccentric exercisesOther
The control group performed back eccentric exercises for 4 weeks, 3 times a week, 3 times in each session
| Study group | Role | What they receive |
|---|---|---|
| electromyography-triggered electrical stimulation | Experimental | EMG ES was applied to the bilateral multifidus and erector spina muscles of the experimental group 3 times a week for 10 minutes in each session for 4 weeks. At the beginning of each session, the participants were instructed to position themselves in a comfortable sitting position.
EMG ES was performed using six self-adhesive electrodes (37 × 64 mm) and two Neuro Trac Myo Plus Pro devices. Receives: Device: Neuro Trac Myo Plus Pro |
| trunk eccentric exercises | Active comparator | The control group performed back eccentric exercises for 4 weeks, 3 times a week, 3 times in each session. Receives: Other: Trunk eccentric exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Trunk control test
The trunk control test is a useful tool in determining the prognosis of independence in activities of daily living and measuring trunk balance in individuals with spinal cord injury. It was applied to all participants before and after treatment. The test consisted of 3 parts; static control, dynamic control and dynamic control with upper extremity activities.
Measured: Baseline- Week 4
Modified functional reach test
The modified functional reach test is a reliable tool to assess sitting reaching in individuals with SCI and to provide immediate feedback to study personnel. It was applied to both groups before and after treatment.
Measured: Baseline- Week 4
Secondary outcomes (1)
Erector spinae muscle thickness
Erector spinae muscle thickness was measured with a real-time B-mode ultrasound device (General Electric Co., Wisconsin, USA). Measurements were performed bilaterally in the prone position with an 8-12 MegaHertz linear probe placed parallel to the muscle fibres. Gel was used between the probe and the skin during the measurements. The measurement site was defined as 7 cm lateral to the L3 spinous process of the lumbar erector spina muscle.
Measured: Baseline- Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2024
- Study start18 Aug 2023
- Primary completion18 Feb 2024
- Study completion25 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Spinal Cord Injury ThoracicStudies of the same condition, open and under way.
- More trials run by Ankara City Hospital BilkentThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- In this randomized controlled and prospective study, investigators included 15 participants with complete thoracic spinal cord injury. Investigators divided the participants into two groups, where one group received the electromyography-triggered electrical stimulation applied to the erector spinae and multifidus muscles, and the control group received trunk eccentric exercises only, applied three times a week for four weeks.
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara City Hospital Bilkent
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Handan Elif Nur BAYRAKTAR, Ankara City Hospital Bilkent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06527417
- Sponsor's protocol ID
- AnkaraCHBilkent-PMR-DRHENY-02
- Status last verified
- Jul 2024
- First submitted
- 25 Jul 2024
- Last updated
- 31 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bjerkefors A, Carpenter MG, Cresswell AG, Thorstensson A. Trunk muscle activation in a person with clinically complete thoracic spinal cord injury. J Rehabil Med. 2009 Apr;41(5):390-2. doi: 10.2340/16501977-0336.
PubMed 19363574Bergmann M, Zahharova A, Reinvee M, Asser T, Gapeyeva H, Vahtrik D. The Effect of Functional Electrical Stimulation and Therapeutic Exercises on Trunk Muscle Tone and Dynamic Sitting Balance in Persons with Chronic Spinal Cord Injury: A Crossover Trial. Medicina (Kaunas). 2019 Sep 21;55(10):619. doi: 10.3390/medicina55100619.
PubMed 31546613Gill M, Linde M, Fautsch K, Hale R, Lopez C, Veith D, Calvert J, Beck L, Garlanger K, Edgerton R, Sayenko D, Lavrov I, Thoreson A, Grahn P, Zhao K. Epidural Electrical Stimulation of the Lumbosacral Spinal Cord Improves Trunk Stability During Seated Reaching in Two Humans With Severe Thoracic Spinal Cord Injury. Front Syst Neurosci. 2020 Nov 19;14:79. doi: 10.3389/fnsys.2020.569337. eCollection 2020.
PubMed 33328910Shima D, Nishimura Y, Hashizaki T, Minoshima Y, Yoshikawa T, Umemoto Y, Kinoshita T, Kouda K, Tajima F, Kamijo YI. Surface electromyographic activity of the erector spinae and multifidus during arm- and leg-ergometer exercises in young healthy men. Front Physiol. 2022 Nov 25;13:974632. doi: 10.3389/fphys.2022.974632. eCollection 2022.
PubMed 36505070Wilson RD, Page SJ, Delahanty M, Knutson JS, Gunzler DD, Sheffler LR, Chae J. Upper-Limb Recovery After Stroke: A Randomized Controlled Trial Comparing EMG-Triggered, Cyclic, and Sensory Electrical Stimulation. Neurorehabil Neural Repair. 2016 Nov;30(10):978-987. doi: 10.1177/1545968316650278. Epub 2016 May 24.
PubMed 27225977Triolo RJ, Bailey SN, Foglyano KM, Kobetic R, Lombardo LM, Miller ME, Pinault G. Long-Term Performance and User Satisfaction With Implanted Neuroprostheses for Upright Mobility After Paraplegia: 2- to 14-Year Follow-Up. Arch Phys Med Rehabil. 2018 Feb;99(2):289-298. doi: 10.1016/j.apmr.2017.08.470. Epub 2017 Sep 9.
PubMed 28899825Qiu S, Draghici AE, Picard G, Taylor JA. Muscle Fatigue in Response to Electrical Stimulation Pattern and Frequency in Spinal Cord Injury. PM R. 2020 Jul;12(7):699-705. doi: 10.1002/pmrj.12282. Epub 2019 Dec 12.
PubMed 31702873Tharu NS, Alam M, Ling YT, Wong AY, Zheng YP. Combined Transcutaneous Electrical Spinal Cord Stimulation and Task-Specific Rehabilitation Improves Trunk and Sitting Functions in People with Chronic Tetraplegia. Biomedicines. 2022 Dec 23;11(1):34. doi: 10.3390/biomedicines11010034.
PubMed 36672542Lee HS, Akimoto T, Kim AR. Effects of trunk extensor eccentric exercise on lipid profile and glycaemic response. BMJ Open Sport Exerc Med. 2020 Oct 28;6(1):e000861. doi: 10.1136/bmjsem-2020-000861. eCollection 2020.
PubMed 33178444Quinzanos-Fresnedo J, Fratini-Escobar PC, Almaguer-Benavides KM, Aguirre-Guemez AV, Barrera-Ortiz A, Perez-Zavala R, Villa-Romero AR. Prognostic validity of a clinical trunk control test for independence and walking in individuals with spinal cord injury. J Spinal Cord Med. 2020 May;43(3):331-338. doi: 10.1080/10790268.2018.1518124. Epub 2018 Sep 12.
PubMed 30207875Arsh A, Darain H, Rahman MU, Ullah I, Shakil-Ur-Rehman S. Reliability of modified functional reach test in the assessment of balance function in people with spinal cord injury: A systematic review. J Pak Med Assoc. 2021 Aug;71(8):2040-2044. doi: 10.47391/JPMA.1276.
PubMed 34418026Masaki M, Aoyama T, Murakami T, Yanase K, Ji X, Tateuchi H, Ichihashi N. Association of low back pain with muscle stiffness and muscle mass of the lumbar back muscles, and sagittal spinal alignment in young and middle-aged medical workers. Clin Biomech (Bristol). 2017 Nov;49:128-133. doi: 10.1016/j.clinbiomech.2017.09.008. Epub 2017 Sep 14.
PubMed 28934633Masaki M, Ikezoe T, Fukumoto Y, Minami S, Tsukagoshi R, Sakuma K, Ibuki S, Yamada Y, Kimura M, Ichihashi N. Association of sagittal spinal alignment with thickness and echo intensity of lumbar back muscles in middle-aged and elderly women. Arch Gerontol Geriatr. 2015 Sep-Oct;61(2):197-201. doi: 10.1016/j.archger.2015.05.010. Epub 2015 May 28.
PubMed 26058723Bayraktar HEN, Yalcin E, Sipal MS, Akyuz M, Akinci MG, U Delialioglu S. The effect of electromyography triggered electrical stimulation to abdominal muscles on sitting balance, respiratory functions, and abdominal muscle thickness in complete spinal cord injury: a randomized controlled trial. Int J Rehabil Res. 2024 Jun 1;47(2):87-96. doi: 10.1097/MRR.0000000000000620. Epub 2024 Mar 19.
PubMed 38501227
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Electromyography Triggered Electrical Stimulation on Trunk Balance and Muscle Thickness of Multifidus and Erector Spinae Muscles in Patients With Complete Spinal Cord Injury - A Randomised Controlled Study
- ClinicalTrials.gov ID
- NCT06527417
- Acronym / sponsor ID
- AnkaraCHBilkent-PMR-DRHENY-02
- Conditions
- Spinal Cord Injury Thoracic
- Keywords
- spinal cord injury, trunk balance, electrical stimulation, multifidus, erector spinae
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Ankara City Hospital BilkentUniversity, hospital or other
- Study start
- 18 Aug 2023 (actual)
- Primary completion
- 18 Feb 2024 (actual)
- Study completion
- 25 Jul 2024 (actual)
- First posted
- 30 Jul 2024 (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.
The aim of this study was to investigate the effect of electromyography (EMG) triggered electrical stimulation (ES) applied to multifidus and erector spinae muscles on trunk balance in patients with complete thoracic spinal cord injury (SCI).
The fundamental questions that investigators want to answer are as follows:
- [question 1]: "Does multifidus and erector spinae EMG ES improve trunk balance in patients with complete SCI?"
- [question 2]: "Does multifidus and erector spinae EMG ES improve muscle thickness in patients with complete SCI?"
Detailed description
Spinal cord injury results in loss of sensory and motor function below the level of injury, causing difficulty with unaided sitting and activities of daily living, especially at the thoracic level in SCI patients. The paraspinal muscles that provide trunk balance are weakened in these patients. Methods such as neuromuscular electrical stimulation and EMG ES are used to improve trunk balance and restore muscle function. This study aims to investigate the effect of EMG ES applied to the multifidus and erector spinae muscles on trunk balance in patients with complete thoracic SCI.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- In this randomized controlled and prospective study, investigators included 15 participants with complete thoracic spinal cord injury. Investigators divided the participants into two groups, where one group received the electromyography-triggered electrical stimulation applied to the erector spinae and multifidus muscles, and the control group received trunk eccentric exercises only, applied three times a week for four weeks.
| Arm | Type | Receives |
|---|---|---|
| electromyography-triggered electrical stimulation | Experimental | Device: Neuro Trac Myo Plus ProEMG ES was applied to the bilateral multifidus and erector spina muscles of the experimental group 3 times a week for 10 minutes in each session for 4 weeks. At the beginning of each session, the participants were instructed to position themselves in a comfortable sitting position. EMG ES was performed using six self-adhesive electrodes (37 × 64 mm) and two Neuro Trac Myo Plus Pro devices. |
| trunk eccentric exercises | Active comparator | Other: Trunk eccentric exercisesThe control group performed back eccentric exercises for 4 weeks, 3 times a week, 3 times in each session. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- have traumatic SCI and this injury occurred at least 3 months ago,
- be between the ages of 18 and 65,
- have a neurological injury level between thoracic 4 and thoracic 12
- be fully paraplegic according to the American Spinal Cord Injury Association (ASIA) impairment scale
- be able to sit unsupported in a wheelchair
Key exclusion criteria (6 listed)
- patients with a diagnosis of heart failure
- malignancy
- intracardiac defibrillators
- epilepsy
- open wounds
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 |
|---|---|---|
| Neuro Trac Myo Plus ProElectrical stimulation parameters; stimuli were monophasic, rectangular, stimulus duration 300 µs, frequency 25 Hertz, amplitude was increased up to a maximum of 100 milliampere until contraction was seen. | Device | electromyography-triggered electrical stimulation |
| Trunk eccentric exercisesThe control group performed back eccentric exercises for 4 weeks, 3 times a week, 3 times in each session | Other | trunk eccentric exercises |
Primary outcome
Trunk control test
Time frame: Baseline- Week 4
The trunk control test is a useful tool in determining the prognosis of independence in activities of daily living and measuring trunk balance in individuals with spinal cord injury. It was applied to all participants before and after treatment. The test consisted of 3 parts; static control, dynamic control and dynamic control with upper extremity activities.
Modified functional reach test
Time frame: Baseline- Week 4
The modified functional reach test is a reliable tool to assess sitting reaching in individuals with SCI and to provide immediate feedback to study personnel. It was applied to both groups before and after treatment.
1 secondary outcome
Erector spinae muscle thickness
Time frame: Baseline- Week 4
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 Jul 2024.
- Background: PubMed 19363574Bjerkefors A, Carpenter MG, Cresswell AG, Thorstensson A. Trunk muscle activation in a person with clinically complete thoracic spinal cord injury. J Rehabil Med. 2009 Apr;41(5):390-2. doi: 10.2340/16501977-0336.
- Background: PubMed 31546613Bergmann M, Zahharova A, Reinvee M, Asser T, Gapeyeva H, Vahtrik D. The Effect of Functional Electrical Stimulation and Therapeutic Exercises on Trunk Muscle Tone and Dynamic Sitting Balance in Persons with Chronic Spinal Cord Injury: A Crossover Trial. Medicina (Kaunas). 2019 Sep 21;55(10):619. doi: 10.3390/medicina55100619.
- Background: PubMed 33328910Gill M, Linde M, Fautsch K, Hale R, Lopez C, Veith D, Calvert J, Beck L, Garlanger K, Edgerton R, Sayenko D, Lavrov I, Thoreson A, Grahn P, Zhao K. Epidural Electrical Stimulation of the Lumbosacral Spinal Cord Improves Trunk Stability During Seated Reaching in Two Humans With Severe Thoracic Spinal Cord Injury. Front Syst Neurosci. 2020 Nov 19;14:79. doi: 10.3389/fnsys.2020.569337. eCollection 2020.
- Background: PubMed 36505070Shima D, Nishimura Y, Hashizaki T, Minoshima Y, Yoshikawa T, Umemoto Y, Kinoshita T, Kouda K, Tajima F, Kamijo YI. Surface electromyographic activity of the erector spinae and multifidus during arm- and leg-ergometer exercises in young healthy men. Front Physiol. 2022 Nov 25;13:974632. doi: 10.3389/fphys.2022.974632. eCollection 2022.
- Background: PubMed 27225977Wilson RD, Page SJ, Delahanty M, Knutson JS, Gunzler DD, Sheffler LR, Chae J. Upper-Limb Recovery After Stroke: A Randomized Controlled Trial Comparing EMG-Triggered, Cyclic, and Sensory Electrical Stimulation. Neurorehabil Neural Repair. 2016 Nov;30(10):978-987. doi: 10.1177/1545968316650278. Epub 2016 May 24.
- Background: PubMed 28899825Triolo RJ, Bailey SN, Foglyano KM, Kobetic R, Lombardo LM, Miller ME, Pinault G. Long-Term Performance and User Satisfaction With Implanted Neuroprostheses for Upright Mobility After Paraplegia: 2- to 14-Year Follow-Up. Arch Phys Med Rehabil. 2018 Feb;99(2):289-298. doi: 10.1016/j.apmr.2017.08.470. Epub 2017 Sep 9.
- Background: PubMed 31702873Qiu S, Draghici AE, Picard G, Taylor JA. Muscle Fatigue in Response to Electrical Stimulation Pattern and Frequency in Spinal Cord Injury. PM R. 2020 Jul;12(7):699-705. doi: 10.1002/pmrj.12282. Epub 2019 Dec 12.
- Background: PubMed 36672542Tharu NS, Alam M, Ling YT, Wong AY, Zheng YP. Combined Transcutaneous Electrical Spinal Cord Stimulation and Task-Specific Rehabilitation Improves Trunk and Sitting Functions in People with Chronic Tetraplegia. Biomedicines. 2022 Dec 23;11(1):34. doi: 10.3390/biomedicines11010034.
- Background: PubMed 33178444Lee HS, Akimoto T, Kim AR. Effects of trunk extensor eccentric exercise on lipid profile and glycaemic response. BMJ Open Sport Exerc Med. 2020 Oct 28;6(1):e000861. doi: 10.1136/bmjsem-2020-000861. eCollection 2020.
- Background: PubMed 30207875Quinzanos-Fresnedo J, Fratini-Escobar PC, Almaguer-Benavides KM, Aguirre-Guemez AV, Barrera-Ortiz A, Perez-Zavala R, Villa-Romero AR. Prognostic validity of a clinical trunk control test for independence and walking in individuals with spinal cord injury. J Spinal Cord Med. 2020 May;43(3):331-338. doi: 10.1080/10790268.2018.1518124. Epub 2018 Sep 12.
- Background: PubMed 34418026Arsh A, Darain H, Rahman MU, Ullah I, Shakil-Ur-Rehman S. Reliability of modified functional reach test in the assessment of balance function in people with spinal cord injury: A systematic review. J Pak Med Assoc. 2021 Aug;71(8):2040-2044. doi: 10.47391/JPMA.1276.
- Background: PubMed 28934633Masaki M, Aoyama T, Murakami T, Yanase K, Ji X, Tateuchi H, Ichihashi N. Association of low back pain with muscle stiffness and muscle mass of the lumbar back muscles, and sagittal spinal alignment in young and middle-aged medical workers. Clin Biomech (Bristol). 2017 Nov;49:128-133. doi: 10.1016/j.clinbiomech.2017.09.008. Epub 2017 Sep 14.
- Individual participant dataSharing planned: No
Related trials for Spinal Cord Injury Thoracic
RecruitingPhase 1
Safety of CRT100 on Treatment Spinal Cord Injury
Thoracic Spinal Cord Injury
Active, not recruiting
Electrical Neuromodulation for Modifying Spinal Network Involved in Spasticity
Spinal Cord Injuries (Complete and Incomplete), Spinal Cord Injury
Active, not recruiting
Spinal Cord Stimulation (SCS) for Spinal Cord Injury (SCI)
Spinal Cord Injury at T1-T12 Level, Traumatic Thoracic Spinal Cord Contusion
Recruiting
Transcutaneous Spinal Cord Stimulation Combined With Arm Bike for Cardiovascular Recovery in SCI
Spinal Cord Injuries
RecruitingObservational study
Clariance ErYs Registry
Spine Degeneration, Spine Spondylosis Thoracic
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 Neuro Trac Myo Plus Pro and Trunk eccentric exercises in people with Spinal Cord Injury Thoracic, run by Ankara City Hospital Bilkent 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 5 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 31 Jul 2024. 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?
Trunk control test (time frame: Baseline- Week 4). The study lists 2 primary outcomes in all. 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 NCT06527417, which also lists 14 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 31 Jul 2024.