Neuromuscular Electrical Stimulation and Leap Motion-Based Exercises in Cerebral Palsy

Official title

The Effects of Neuromuscular Electrical Stimulation and Leap Motion-Based Exercises on Hand Function Parameters in Cerebral Palsy

Overview

Cerebral palsy (CP) is a group of disorders resulting from a permanent but non-progressive lesion in the developing brain, which affects the development of movement and posture and may lead to activity limitations. Upper extremity involvement is observed in approximately 60% of children with CP. Abnormal muscle tone, imbalance between agonist and antagonist muscles, spasticity, alignment problems, reduced muscle strength, and impaired motor control are among the upper extremity impairments seen in CP. As a result, hand use is typically affected in a way that negatively influences the performance of daily living activities. Upper extremity functionality and hand use are crucial for participation in daily life and overall quality of life in children with CP. 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.

Interventions

• Device 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).
• Device 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).
• Behavioral 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.

Primary outcome measures

• Hand Function [Time frame: Baseline (at week 0), after completion of a 4-week conventional exercise program (at week 4), and after completion of an additional 8-week intervention period (at week 12).]

Secondary outcome measures (4)

• Goniometric Assessment [Time frame: Baseline (at Week 0), after completion of a 4-week conventional exercise program (at Week 4), and after completion of an additional 8-week intervention period (at Week 12).]
• Selective Motor Control [Time frame: Baseline (at week 0), after completion of a 4-week conventional exercise program (at week 4), and after completion of an additional 8-week intervention period (at week 12).]
• Muscle Activation [Time frame: Baseline (at week 0), after completion of a 4-week conventional exercise program (at week 4), and after completion of an additional 8-week intervention period (at week 12).]
• Hand Use in Daily Activities [Time frame: Baseline (at week 0), after completion of a 4-week conventional exercise program (at week 4), and after completion of an additional 8-week intervention period (at week 12).]

Eligibility criteria

Inclusion criteria

• Diagnosis of spastic unilateral or bilateral cerebral palsy based on clinical and MRI findings.
• 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

• Currently participating in a specific hand rehabilitation program.
• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

Turkey (Türkiye) · 1 center

• Istanbul Medipol University, Physiotherapy and Rehabilitation Department — Istanbul

Publications

• 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. PMID 35687763
• 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. PMID 30017414
• 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. PMID 25011433
• 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. PMID 31010703
• 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. PMID 26452230
• 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/s1191 PMID 32086598
• 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. eCol PMID 38375076

Identifiers

NCT: NCT07311018 · 10840098-202.3.02-4331

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗