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

Medipol University

Status: Not yet enrolling

Conditions: Cerebral Palsy (CP)

Treatments: Device: Leap Motion-Based Exercise Program; Device: NMES; Behavioral: Conventional Exercise Program

Study type: Interventional

Funder types: Other

Identifiers

NCT07311018

E-10840098-202.3.02-3234

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 6 to 15 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

Leap Motion Group

Experimental group

Description:

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.

Treatment:

Behavioral: Conventional Exercise Program

Device: Leap Motion-Based Exercise Program

NMES Group

Experimental group

Description:

Participants in this group will receive Neuromuscular Electrical Stimulation (NMES) applied to the wrist extensor muscles, in addition to conventional rehabilitation.

Treatment:

Behavioral: Conventional Exercise Program

Device: NMES