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

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

Study summary

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.

Eligibility

Primary outcome measure(s)

• Hand Function — 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 Function will be assessed with Jebsen-Taylor Hand Function Test. JTHFT is a timed, seven-subtest assessment designed to evaluate hand functionality. The test is derived from common daily activities and includes the following tasks: writing a standardized 24-letter sentence, turning five cards, picking up small objects, picking up five beans using a spoon, stacking four checkers on a test board, moving five large empty cans, and moving five full cans. Since the study population includes children who may not yet be literate according to the age criteria, the first subtest (writing a sentence) will be omitted from the evaluation. Each subtest allows a maximum of 120 seconds for successful completion. All subtests are first performed with the non-dominant hand, followed by the dominant hand. For each subtests shorter times indicate better performance. The validity and reliability of the JTHFT in children with cerebral palsy aged 6-18 years have been established by Tofani et al.

Trial sites (1)

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