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Cerebral Palsy (CP)NCT07311018

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

A study testing Leap Motion-Based Exercise Program, NMES and Conventional Exercise Program in people with Cerebral Palsy (CP), run by Medipol University at 1 site in Turkey (Türkiye).

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 6 to 15 years
Conditions the study is for
Cerebral Palsy (CP)
What is being tested?
Leap Motion-Based Exercise Program, NMES and Conventional Exercise Program
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Jan 2026to 15 Sep 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 6 to 15 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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.
Show all 9Show fewer
  • 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 join

  • 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 locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Hande Özlü Erdoğan, MSc, PhD Candidate, PT contact

+905367075474

handeeozlu@gmail.com

Gülay Aras Bayram, Assoc. Prof. Dr., PhD, PT contact

+905054966284

garas@medipol.edu.tr

Turkey (Türkiye)1 site, 1 recruiting

  • Istanbul Medipol University, Physiotherapy and Rehabilitation Department

    Istanbul, Beykoz, 34810

    Gülay Aras Bayram, Assoc. Prof. Dr., PhD, PT, +905054966284, garas@medipol.edu.tr

    Recruiting

Other trials in Turkey (Türkiye)

About this study

Official title: 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.

Read more

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.

Being tested
Leap Motion-Based Exercise Program, NMES, Conventional Exercise Program
Keywords
cerebral palsy, leap motion controller, neuromuscular electrical stimulation, hand function, physiotherapy, virtual reality
Medical subject headings
Cerebral Palsy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Leap Motion-Based Exercise ProgramDevice

    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).

  • NMESDevice

    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 ProgramBehavioural

    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 groups in NCT07311018
Study groupRoleWhat they receive
Leap Motion GroupExperimentalParticipants in this group will perform upper extremity exercises using the Leap Motion Controller combined with virtual reality-based training, in addition to conventional rehabilitation.
Receives: Device: Leap Motion-Based Exercise Program; Behavioral: Conventional Exercise Program
NMES GroupExperimentalParticipants in this group will receive Neuromuscular Electrical Stimulation (NMES) applied to the wrist extensor muscles, in addition to conventional rehabilitation.
Receives: Device: NMES; Behavioral: Conventional Exercise Program

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Hand Function

    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.

    Measured: 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 outcomes (4)

  1. Goniometric Assessment

    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.

    Measured: 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).

  2. Selective Motor Control

    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.

    Measured: 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).

  3. Muscle Activation

    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.

    Measured: 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).

  4. Hand Use in Daily Activities

    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.

    Measured: 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).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Dec 2025
  2. Study start1 Jan 2026
  3. Primary completion15 Sep 2026 (estimated)
  4. Study completion15 Sep 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07311018
Sponsor's protocol ID
10840098-202.3.02-4331
Status last verified
Dec 2025
First submitted
25 Nov 2025
Last updated
5 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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/s11910-020-1022-z.

    PubMed 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. eCollection 2024.

    PubMed 38375076

  • Jebsen RH, Taylor N, Trieschmann RB, Trotter MJ, Howard LA. An objective and standardized test of hand function. Arch Phys Med Rehabil. 1969 Jun;50(6):311-9. No abstract available.

    PubMed 5788487

  • Herrero P, Carrera P, Garcia E, Gomez-Trullen EM, Olivan-Blazquez B. Reliability of goniometric measurements in children with cerebral palsy: a comparative analysis of universal goniometer and electronic inclinometer. A pilot study. BMC Musculoskelet Disord. 2011 Jul 10;12:155. doi: 10.1186/1471-2474-12-155.

    PubMed 21740600

  • Fowler EG, Staudt LA, Greenberg MB, Oppenheim WL. Selective Control Assessment of the Lower Extremity (SCALE): development, validation, and interrater reliability of a clinical tool for patients with cerebral palsy. Dev Med Child Neurol. 2009 Aug;51(8):607-14. doi: 10.1111/j.1469-8749.2008.03186.x. Epub 2009 Feb 12.

    PubMed 19220390

  • Cortes-Perez I, Zagalaz-Anula N, Montoro-Cardenas D, Lomas-Vega R, Obrero-Gaitan E, Osuna-Perez MC. Leap Motion Controller Video Game-Based Therapy for Upper Extremity Motor Recovery in Patients with Central Nervous System Diseases. A Systematic Review with Meta-Analysis. Sensors (Basel). 2021 Mar 15;21(6):2065. doi: 10.3390/s21062065.

    PubMed 33804247

  • Surveillance of Cerebral Palsy in Europe. Surveillance of cerebral palsy in Europe: a collaboration of cerebral palsy surveys and registers. Surveillance of Cerebral Palsy in Europe (SCPE). Dev Med Child Neurol. 2000 Dec;42(12):816-24. doi: 10.1017/s0012162200001511.

    PubMed 11132255

  • Bohannon RW, Smith MB. Interrater reliability of a modified Ashworth scale of muscle spasticity. Phys Ther. 1987 Feb;67(2):206-7. doi: 10.1093/ptj/67.2.206.

    PubMed 3809245

  • Arnould C, Penta M, Renders A, Thonnard JL. ABILHAND-Kids: a measure of manual ability in children with cerebral palsy. Neurology. 2004 Sep 28;63(6):1045-52. doi: 10.1212/01.wnl.0000138423.77640.37.

    PubMed 15452296

Questions about this trial

What is this clinical trial studying?

A study testing Leap Motion-Based Exercise Program, NMES and Conventional Exercise Program in people with Cerebral Palsy (CP), run by Medipol University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 5 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Hande Özlü Erdoğan, MSc, PhD Candidate, PT (+905367075474, handeeozlu@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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).). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07311018, which also lists 20 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2026.

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