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

March 3, 2026 updated by: Hande Özlü Erdoğan, Medipol University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Hande Özlü Erdoğan, MSc, PhD Candidate, PT
  • Phone Number: +905367075474
  • Email: handeeozlu@gmail.com

Study Contact Backup

  • Name: Gülay Aras Bayram, Assoc. Prof. Dr., PhD, PT
  • Phone Number: +905054966284
  • Email: garas@medipol.edu.tr

Study Locations

  • Turkey (Türkiye)
    • Beykoz
      • Istanbul, Beykoz, Turkey (Türkiye), 34810
        • Recruiting
        • Istanbul Medipol University, Physiotherapy and Rehabilitation Department
        • Contact:
          • Gülay Aras Bayram, Assoc. Prof. Dr., PhD, PT
          • Phone Number: +905054966284
          • Email: garas@medipol.edu.tr

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
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).
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.
Experimental: NMES Group
Participants in this group will receive Neuromuscular Electrical Stimulation (NMES) applied to the wrist extensor muscles, in addition to conventional rehabilitation.
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.
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
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.
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

Outcome Measure
Measure Description
Time Frame
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).
Selective motor control will be assessed with Selective Control of the Upper Extremity Scale (SCUES). SCUES was developed to assess selective voluntary motor control (SVMC) of the upper extremity and represents the first scale specifically designed for this purpose. It is a practical and user-friendly, video-based assessment tool that can be administered in less than 15 minutes. The test provides the opportunity to assess selective movements in all upper extremity joints, including the shoulder, elbow, forearm, wrist, and fingers. Each of the five joint regions is scored on a four-point ordinal scale: absence of SVMC (0 points), moderately reduced SVMC (1 point), mildly reduced SVMC (2 points), and normal SVMC (3 points). The total SCUES score ranges from 0 to 15, with higher scores indicating better SVMC. In the present study, only the selective control of the wrist joint will be assessed bilaterally.
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).
The ABILHAND-Kids questionnaire will be used to assess hand use in daily life activities. ABILHAND-Kids is designed to measure upper extremity function in children with cerebral palsy aged 6-15 years and to evaluate unimanual and bimanual activities of the upper limbs as comprehensively as possible. The questionnaire consists of 21 items covering both unimanual and bimanual tasks and is completed by the child's parents using a three-point scale: 0-cannot perform the activity, 1-performs the activity with difficulty, and 2-performs the activity easily. Raw scores are converted to Rasch-based logit scores, with higher scores indicating better manual ability. ABILHAND-Kids is a test specifically developed for children with cerebral palsy and requires no preparatory phase.
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).
Surface electromyography (sEMG) is based on the principle that there is a linear relationship between sEMG signal amplitude and muscle contraction force, with signal amplitude increasing as muscle force increases. In the present study, muscle activation will be assessed using the Natus UltraPro® S100 (EMG/NCS/EP neurodiagnostic system). Surface electrodes will be applied to measure muscle activity. The child will be asked to perform maximum voluntary contraction (MVC), and the motor action potentials of the muscles will be recorded for 10-15 seconds, followed by a 10-second rest period. Each measurement will be repeated three times, and activation of the wrist extensor and flexor muscles will be recorded. sEMG assessments will be conducted with the support of neurology specialist.
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).
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).
Active wrist range of motion (ROM) will be assessed using an electronic goniometer (Joints Digital Goniometer 360), in addition to the Becure HandROM application integrated into the Leap Motion Controller (LMC). Wrist flexion, extension, ulnar deviation, and radial deviation ROM will be measured bilaterally. Each measurement will be repeated three times, and the mean value will be used for statistical analysis.
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).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medipol University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2026

Primary Completion (Estimated)

September 15, 2026

Study Completion (Estimated)

September 15, 2026

Study Registration Dates

First Submitted

November 25, 2025

First Submitted That Met QC Criteria

December 16, 2025

First Posted (Actual)

December 30, 2025

Study Record Updates

Last Update Posted (Actual)

March 5, 2026

Last Update Submitted That Met QC Criteria

March 3, 2026

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 10840098-202.3.02-4331

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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