NCT07491341

Brief Summary

This study investigates whether adding sensory-level electrical stimulation to an ongoing neurodevelopmental treatment program is associated with changes in ankle mobility, spasticity-related measures, muscle mechanical properties, and functional performance in children with spastic cerebral palsy. Children complete a 12-week rehabilitation program and are assessed at baseline, after 6 weeks of neurodevelopmental treatment alone, and after an additional 6 weeks during which sensory-level electrical stimulation is added to the ongoing treatment. The study aims to determine the feasibility of this combined approach and to explore whether favorable changes occur over time in range of motion and functional outcomes.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
11

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 9, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 12, 2021

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 28, 2021

Completed
4.8 years until next milestone

First Submitted

Initial submission to the registry

March 18, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 24, 2026

Completed
Last Updated

March 24, 2026

Status Verified

January 1, 2026

Enrollment Period

3 months

First QC Date

March 18, 2026

Last Update Submit

March 18, 2026

Conditions

Spastic Cerebral Palsy (sCP)

Keywords

Sensory Electrical StimulationSpastic Cerebral PalsySpasticityFunctional MobilityAnkle Range of Motion

Outcome Measures

Primary Outcomes (1)

  • Ankle Dorsiflexion Range of Motion

    Ankle dorsiflexion range of motion will be measured to evaluate change across the study intervention phases in children with spastic cerebral palsy.

    Baseline, Week 6, and Week 12

Study Arms (1)

Sensory Electrical Stimulation Plus Neurodevelopmental Treatment

EXPERIMENTAL

All participants received neurodevelopmental treatment during the first phase of the study and then continued with neurodevelopmental treatment combined with sensory-level electrical stimulation during the second phase. Outcomes were assessed at baseline, after 6 weeks of neurodevelopmental treatment, and after 6 additional weeks of combined treatment.

Device: Sensory Electrical Stimulation

Interventions

Sensory Electrical StimulationDEVICE

Sensory-level electrical stimulation was applied as an adjunct to ongoing neurodevelopmental treatment during the second phase of the study. Stimulation was delivered 3 times per week for 30 minutes per session without producing visible muscle contraction. The intervention was intended to increase sensory afferent input in children with spastic cerebral palsy.

Also known as: Sensory-Level Electrical Stimulation
Sensory Electrical Stimulation Plus Neurodevelopmental Treatment

Eligibility Criteria

Age5 Years - 15 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Children aged 5 to 15 years
  • Diagnosis of spastic cerebral palsy
  • Gross Motor Function Classification System (GMFCS) level I or II
  • Ability to understand simple verbal instructions
  • Parent or legal guardian able and willing to provide informed consent

You may not qualify if:

  • Clinically relevant sensory deficits that could affect stimulation perception or outcome assessments
  • Uncontrolled epileptic seizures
  • Severe perceptual or cognitive problems preventing cooperation
  • Significant visual or hearing impairment
  • GMFCS level III or higher
  • Botulinum toxin injection or orthopedic surgery within the previous 6 months
  • Fixed ankle contracture or severe musculoskeletal deformity limiting range of motion

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Marmara University, Faculty of Health Sciences

Istanbul, 34864, Turkey (Türkiye)

Location

Related Publications (6)

  • Satheeskumar D, Dhaneshkumar K, Rajasenthil K. Comparative study to identify the effects of transcutaneous electrical nerve stimulation combined with sensorimotor task oriented training to improve the hand function in hemiplegic cerebral palsy children. J Clin Diagnostic Res. (2018) 12(1):YC17-21. 10.7860/JCDR/2018/27015.11092

    RESULT

  • Ozer, K., Chesher, S. P., & Scheker, L. R. (2006). Neuromuscular electrical stimulation and dynamic bracing for the management of upper-extremity spasticity in children with cerebral palsy. Developmental Medicine & Child Neurology, 48(7), 559-563.

    RESULT

  • Alhusaini, A. A., Fallatah, S., Melam, G. R., & Buragadda, S. (2019). Efficacy of transcutaneous electrical nerve stimulation combined with therapeutic exercise on hand function in children with hemiplegic cerebral palsy. Somatosensory & motor research, 36(1), 49-55.

    RESULT

  • í Dali, C., Hansen, F. J., Pedersen, S. A., Skov, L., Hilden, J., Bjørnskov, I., ... & Lyskjær, U. (2002). Threshold electrical stimulation (TES) in ambulant children with CP: a randomized double-blind placebo-controlled clinical trial. Developmental medicine and child neurology, 44(6), 364-369.

    RESULT

  • de Araujo C, Gschaidmeier A, von Gunten M, Grunt S. Sensory-level electrical stimulation in children with cerebral palsy: a scoping review of current applications and outcomes. Front Pediatr. 2025 Nov 24;13:1644547. doi: 10.3389/fped.2025.1644547. PMID: 41367605; PMCID: PMC12682778.

    RESULT

  • Sah AK, Balaji GK, Agrahara S. Effects of Task-oriented Activities Based on Neurodevelopmental Therapy Principles on Trunk Control, Balance, and Gross Motor Function in Children with Spastic Diplegic Cerebral Palsy: A Single-blinded Randomized Clinical Trial. J Pediatr Neurosci. 2019 Jul-Sep;14(3):120-126. doi: 10.4103/jpn.JPN_35_19. Epub 2019 Sep 27. PMID: 31649770; PMCID: PMC6798271.

    RESULT

MeSH Terms

Conditions

Cerebral PalsyMuscle Spasticity

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMuscular DiseasesMusculoskeletal DiseasesMuscle HypertoniaNeuromuscular ManifestationsNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • VEYSEL MRV VEYSEL, PhD

    Harran University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Masking Details
No masking is used in this study. Because of the nature of the rehabilitation intervention, participants, care providers, and investigators are aware of the treatment being delivered.
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: This is a single-group, sequential repeated-measures interventional study. All participants receive neurodevelopmental treatment during the first phase and then continue with neurodevelopmental treatment combined with sensory-level electrical stimulation during the second phase. Outcomes are assessed at baseline, after the first phase, and after the second phase.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant

Study Record Dates

First Submitted

March 18, 2026

First Posted

March 24, 2026

Study Start

November 9, 2020

Primary Completion

February 12, 2021

Study Completion

May 28, 2021

Last Updated

March 24, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Individual participant data collected during the study will not be shared with other researchers because the study did not include a prespecified data-sharing plan and participant-level data are subject to privacy and confidentiality protections.

Locations

TU(1)