Neuromuscular Electrical Stimulation and Leap Motion-Based Exercises in Cerebral Palsy
NCT ID: NCT07311018
Last Updated: 2026-01-09
Study Results
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Basic Information
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NOT_YET_RECRUITING
NA
30 participants
INTERVENTIONAL
2026-01-01
2026-07-15
Brief Summary
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In addition to conventional rehabilitation methods, advances in technology have introduced various new modalities for upper extremity rehabilitation. The aim of the present project is to investigate the effects of Leap Motion-based exercise intervention and Neuromuscular Electrical Stimulation (NMES) on hand functions in children with spastic CP.
A total of 30 children aged 6-15 years with a diagnosis of spastic CP and distal upper extremity involvement will be included in the study. To evaluate eligibility according to the inclusion criteria, gross motor function level will be assessed using the Gross Motor Function Classification System (GMFCS); hand skills will be assessed using the Manual Ability Classification System (MACS); upper extremity muscle tone will be assessed using the Modified Ashworth Scale (MAS); and passive wrist extension range of motion (ROM) will be measured using an electronic goniometer.
Following eligibility confirmation, baseline assessments will be conducted. At baseline wrist ROM will be measured using an electronic goniometer; selective motor control of the wrist will be assessed using the Selective Control of the Upper Extremity Scale (SCUES); hand functions will be evaluated using the Jebsen-Taylor Hand Function Test; daily hand use will be assessed using the ABILHAND-Kids; and wrist extensor and flexor strength and activation will be evaluated via surface electromyography (sEMG).
All participants will then undergo a 4-week routine conventional exercise program (3 sessions per week, 40 minutes per session). At the end of this 4-week period assessments will be repeated (at week 4). Subsequently, the 30 children with CP will be randomly allocated into two groups: the Leap Motion Control group (n = 15) and the NMES group (n = 15). Both groups will receive an 8-week intervention consisting of 3 sessions per week, each lasting 60 minutes (20 minutes of Leap Motion-based exercises or 20 minutes of NMES application, in addition to 40 minutes of conventional exercises). At the end of the 8-week intervention, all assessments will be repeated ( at week 12).
For statistical analyses, the Statistical Package for the Social Sciences (SPSS) Version 23.0 for Windows will be used.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Leap Motion Group
Participants in this group will perform upper extremity exercises using the Leap Motion Controller combined with virtual reality-based training, in addition to conventional rehabilitation.
Leap Motion-Based Exercise Program
Participants assigned to the Leap Motion group will receive Leap Motion-based upper extremity exercise training. The program consists of interactive virtual reality tasks targeting wrist and hand movements. Each session includes 20 minutes of Leap Motion-based exercises, delivered three times per week for 8 weeks. In addition, participants will receive 40 minutes of conventional upper extremity exercises per session (one session is total 60 minutes).
Conventional Exercise Program
All participants will receive routine conventional upper extremity exercises. During the pre-intervention phase, participants will complete a 4-week program consisting of 40 minutes per session, three times per week. During the 8-week intervention period, both groups will continue to receive 40 minutes of conventional exercises in each session.
NMES Group
Participants in this group will receive Neuromuscular Electrical Stimulation (NMES) applied to the wrist extensor muscles, in addition to conventional rehabilitation.
NMES
Participants assigned to the NMES group will receive neuromuscular electrical stimulation applied to the wrist extensor muscles. NMES will be administered for 20 minutes per session, three times per week, for 8 weeks, following standard pediatric rehabilitation parameters. Each session will also include 40 minutes of conventional upper extremity exercises ( one session is total 60 minutes).
Conventional Exercise Program
All participants will receive routine conventional upper extremity exercises. During the pre-intervention phase, participants will complete a 4-week program consisting of 40 minutes per session, three times per week. During the 8-week intervention period, both groups will continue to receive 40 minutes of conventional exercises in each session.
Interventions
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Leap Motion-Based Exercise Program
Participants assigned to the Leap Motion group will receive Leap Motion-based upper extremity exercise training. The program consists of interactive virtual reality tasks targeting wrist and hand movements. Each session includes 20 minutes of Leap Motion-based exercises, delivered three times per week for 8 weeks. In addition, participants will receive 40 minutes of conventional upper extremity exercises per session (one session is total 60 minutes).
NMES
Participants assigned to the NMES group will receive neuromuscular electrical stimulation applied to the wrist extensor muscles. NMES will be administered for 20 minutes per session, three times per week, for 8 weeks, following standard pediatric rehabilitation parameters. Each session will also include 40 minutes of conventional upper extremity exercises ( one session is total 60 minutes).
Conventional Exercise Program
All participants will receive routine conventional upper extremity exercises. During the pre-intervention phase, participants will complete a 4-week program consisting of 40 minutes per session, three times per week. During the 8-week intervention period, both groups will continue to receive 40 minutes of conventional exercises in each session.
Eligibility Criteria
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Inclusion Criteria
* Involvement of the distal upper extremity (wrist and/or fingers).
* Aged between 6 and 15 years.
* No history of botulinum toxin injection or surgical intervention to the upper extremity within the past 6 months.
* Gross Motor Function Classification System (GMFCS) levels I-III.
* Manual Ability Classification System (MACS) levels I-III.
* Upper extremity spasticity corresponding to 0, 1, or 1+ on the Modified Ashworth Scale (MAS).
* Passive wrist extension limitation not exceeding 10 degrees.
* Ability to follow verbal instructions (mental level reported as "normal" or "mild mental retardation" in the medical record).
Exclusion Criteria
* Presence of visual or hearing impairment.
* History of epilepsy.
* Presence of chronic, orthopedic, or systemic conditions that may interfere with participation.
* GMFCS levels IV or V.
* MACS levels IV or V.
6 Years
15 Years
ALL
No
Sponsors
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Medipol University
OTHER
Responsible Party
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Hande Özlü Erdoğan
PhD Candidate- MSc. Physiotherapist- Principal Investigator
Locations
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Istanbul Medipol University, Physiotherapy and Rehabilitation Department
Istanbul, Beykoz, Turkey (Türkiye)
Countries
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Central Contacts
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Facility Contacts
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References
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Ou CH, Shiue CC, Kuan YC, Liou TH, Chen HC, Kuo TJ. Neuromuscular Electrical Stimulation of Upper Limbs in Patients With Cerebral Palsy: A Systematic Review and Meta-analysis of Randomized Controlled Trials. Am J Phys Med Rehabil. 2023 Feb 1;102(2):151-158. doi: 10.1097/PHM.0000000000002058. Epub 2022 Jun 9.
Rathinam C, Mohan V, Peirson J, Skinner J, Nethaji KS, Kuhn I. Effectiveness of virtual reality in the treatment of hand function in children with cerebral palsy: A systematic review. J Hand Ther. 2019 Oct-Dec;32(4):426-434.e1. doi: 10.1016/j.jht.2018.01.006. Epub 2018 Jul 14.
Schmidt, B. G., Gerzson, L. R., ve Almeida, C. S. D. 2020. "The use of surface electromiography as a measure of physiotherapy outcomes in children with Cerebral Palsy: a systematic review", Journal of Human Growth and Development, 30(2), 216-226.
Yildizgoren MT, Nakipoglu Yuzer GF, Ekiz T, Ozgirgin N. Effects of neuromuscular electrical stimulation on the wrist and finger flexor spasticity and hand functions in cerebral palsy. Pediatr Neurol. 2014 Sep;51(3):360-4. doi: 10.1016/j.pediatrneurol.2014.05.009. Epub 2014 May 21.
Tarakci E, Arman N, Tarakci D, Kasapcopur O. Leap Motion Controller-based training for upper extremity rehabilitation in children and adolescents with physical disabilities: A randomized controlled trial. J Hand Ther. 2020 Apr-Jun;33(2):220-228.e1. doi: 10.1016/j.jht.2019.03.012. Epub 2019 Apr 19.
Xu K, He L, Mai J, Yan X, Chen Y. Muscle Recruitment and Coordination following Constraint-Induced Movement Therapy with Electrical Stimulation on Children with Hemiplegic Cerebral Palsy: A Randomized Controlled Trial. PLoS One. 2015 Oct 9;10(10):e0138608. doi: 10.1371/journal.pone.0138608. eCollection 2015.
Novak I, Morgan C, Fahey M, Finch-Edmondson M, Galea C, Hines A, Langdon K, Namara MM, Paton MC, Popat H, Shore B, Khamis A, Stanton E, Finemore OP, Tricks A, Te Velde A, Dark L, Morton N, Badawi N. State of the Evidence Traffic Lights 2019: Systematic Review of Interventions for Preventing and Treating Children with Cerebral Palsy. Curr Neurol Neurosci Rep. 2020 Feb 21;20(2):3. doi: 10.1007/s11910-020-1022-z.
Komariah M, Amirah S, Abdurrahman MF, Handimulya MFS, Platini H, Maulana S, Nugrahani AD, Mulyana AM, Qadous SG, Mediani HS, Mago A. Effectivity of Virtual Reality to Improve Balance, Motor Function, Activities of Daily Living, and Upper Limb Function in Children with Cerebral Palsy: A Systematic Review and Meta-Analysis. Ther Clin Risk Manag. 2024 Feb 14;20:95-109. doi: 10.2147/TCRM.S432249. eCollection 2024.
Jebsen RH, Taylor N, Trieschmann RB, Trotter MJ, Howard LA. An objective and standardized test of hand function. Arch Phys Med Rehabil. 1969 Jun;50(6):311-9. No abstract available.
Herrero P, Carrera P, Garcia E, Gomez-Trullen EM, Olivan-Blazquez B. Reliability of goniometric measurements in children with cerebral palsy: a comparative analysis of universal goniometer and electronic inclinometer. A pilot study. BMC Musculoskelet Disord. 2011 Jul 10;12:155. doi: 10.1186/1471-2474-12-155.
Fowler EG, Staudt LA, Greenberg MB, Oppenheim WL. Selective Control Assessment of the Lower Extremity (SCALE): development, validation, and interrater reliability of a clinical tool for patients with cerebral palsy. Dev Med Child Neurol. 2009 Aug;51(8):607-14. doi: 10.1111/j.1469-8749.2008.03186.x. Epub 2009 Feb 12.
Cortes-Perez I, Zagalaz-Anula N, Montoro-Cardenas D, Lomas-Vega R, Obrero-Gaitan E, Osuna-Perez MC. Leap Motion Controller Video Game-Based Therapy for Upper Extremity Motor Recovery in Patients with Central Nervous System Diseases. A Systematic Review with Meta-Analysis. Sensors (Basel). 2021 Mar 15;21(6):2065. doi: 10.3390/s21062065.
Surveillance of Cerebral Palsy in Europe. Surveillance of cerebral palsy in Europe: a collaboration of cerebral palsy surveys and registers. Surveillance of Cerebral Palsy in Europe (SCPE). Dev Med Child Neurol. 2000 Dec;42(12):816-24. doi: 10.1017/s0012162200001511.
Bohannon RW, Smith MB. Interrater reliability of a modified Ashworth scale of muscle spasticity. Phys Ther. 1987 Feb;67(2):206-7. doi: 10.1093/ptj/67.2.206.
Arnould C, Penta M, Renders A, Thonnard JL. ABILHAND-Kids: a measure of manual ability in children with cerebral palsy. Neurology. 2004 Sep 28;63(6):1045-52. doi: 10.1212/01.wnl.0000138423.77640.37.
Akpinar P, Tezel CG, Eliasson AC, Icagasioglu A. Reliability and cross-cultural validation of the Turkish version of Manual Ability Classification System (MACS) for children with cerebral palsy. Disabil Rehabil. 2010;32(23):1910-6. doi: 10.3109/09638281003763796.
Avcil E, Tarakci D, Arman N, Tarakci E. Upper extremity rehabilitation using video games in cerebral palsy: a randomized clinical trial. Acta Neurol Belg. 2021 Aug;121(4):1053-1060. doi: 10.1007/s13760-020-01400-8. Epub 2020 Jun 11.
Daliri M, Moradi A, Fatorehchy S, Bakhshi E, Moradi E, Sabbaghi S. Investigating the Effect of Leap Motion on Upper Extremity Rehabilitation in Children with Cerebral Palsy: A Randomized Controlled Trial. Dev Neurorehabil. 2023 May;26(4):244-252. doi: 10.1080/17518423.2023.2203210. Epub 2023 Apr 25.
Acikbas, E., Tarakci, D., ve Budak, M. 2020. "Comparison of the effects of Kinesio tape and neuromuscular electrical stimulation on hand extensors in children with cerebral palsy", Int J Ther Rehabil,27:1-12,
Other Identifiers
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E-10840098-202.3.02-3234
Identifier Type: -
Identifier Source: org_study_id
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