Taking people in TürkiyeNo phase

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

Key facts

Who runs it: Medipol University
Where: Istanbul, TürkiyeSee the site
Trial code: NCT07311018
Status: Recruiting
People taking part: 30 people, planned
Started: 1 Jan 2026
Planned end: 15 Sept 2026
Type of study: Interventional, 2 groups
Treatments tested: Leap Motion-Based Exercise Program
NMES
Conventional Exercise Program
Record updated: 5 March 2026

Who can take part

Age: 6 years to 15 years
Sex: Women and men
Healthy volunteers: Cannot take part

The registry criteria, word for word

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Who can take part

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)

Who cannot take part

Presence of visual or hearing impairment
History of epilepsy
Presence of chronic, orthopedic, or systemic conditions that may interfere with participation
Currently participating in a specific hand rehabilitation program
GMFCS levels IV or V
MACS levels IV or V

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

Are you between 6 and 15 years old?

Where in Türkiye

Istanbul Medipol University, Physiotherapy and Rehabilitation DepartmentIstanbul, TürkiyeContact: Gülay Aras Bayram, Assoc. Prof. Dr., PhD, PTTaking people

About the trial

What the trial wants to find out

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.

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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.

The 2 groups in the trial

Leap Motion GroupTreatment being tested
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: Leap Motion-Based Exercise Program and Conventional Exercise Program
NMES GroupTreatment being tested
Participants in this group will receive Neuromuscular Electrical Stimulation (NMES) applied to the wrist extensor muscles, in addition to conventional rehabilitation.
Treatment: NMES and Conventional Exercise Program