Biomechanical and Functional Effects of Adding Sensory-Threshold Electrical Stimulation to Neurodevelopmental Therapy in Children With Spastic Cerebral Palsy: A Single-Arm Repeated-Measures Study

The Effect of Subthreshold Electrical Stimulation on Spasticity and Functionality in Patients With Spastic Cerebral Palsy

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.

Study Overview

• Status: Completed
• Conditions: Spastic Cerebral Palsy (sCP)
• Intervention / Treatment: Device: Sensory Electrical Stimulation

Detailed Description

This study is a single-arm, sequential, repeated-measures investigation conducted in children with spastic cerebral palsy. The purpose is to examine biomechanical and functional changes associated with adding sensory-level electrical stimulation to an individualized neurodevelopmental treatment program.

All participants complete a 12-week rehabilitation program with assessments at three time points: baseline (week 0), after Phase 1 (week 6), and after Phase 2 (week 12). During Phase 1, participants receive individualized neurodevelopmental treatment as routine care, 2 days per week for 60 minutes per session. During Phase 2, sensory-level electrical stimulation is added as an adjunct to the ongoing neurodevelopmental treatment and is delivered 3 times per week for 30 minutes per session. Sensory-level stimulation is applied without eliciting visible muscle contraction and is intended to increase sensory afferent input.

The primary outcome is ankle dorsiflexion range of motion. Secondary outcomes include inversion and eversion range of motion, spasticity measures, muscle mechanical properties, and functional outcomes including mobility and independence in daily activities. Assessments are performed at all three study visits to evaluate change over time across the intervention phases.

The study is designed to explore feasibility and preliminary clinical change patterns associated with this combined rehabilitation approach. Because the study does not include a concurrent control group, the findings are intended to provide preliminary evidence to inform future randomized controlled trials.

• Study Type: Interventional
• Enrollment (Actual): 11
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey (Türkiye)
  • Istanbul, Turkey (Türkiye), 34864
    • Marmara University, Faculty of Health Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Sensory Electrical Stimulation Plus Neurodevelopmental Treatment; 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; 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.; Other Names: Sensory-Level Electrical Stimulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Harran University
• Investigators: Principal Investigator: VEYSEL MRV VEYSEL, PhD, Harran University

Publications and helpful links

General Publications

• 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
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 9, 2020
• Primary Completion (Actual): February 12, 2021
• Study Completion (Actual): May 28, 2021

Study Registration Dates

• First Submitted: March 18, 2026
• First Submitted That Met QC Criteria: March 18, 2026
• First Posted (Actual): March 24, 2026

Study Record Updates

• Last Update Posted (Actual): March 24, 2026
• Last Update Submitted That Met QC Criteria: March 18, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Functional Mobility; Spasticity; Spastic Cerebral Palsy; Sensory Electrical Stimulation; Ankle Range of Motion
• Additional Relevant MeSH Terms: Neurologic Manifestations; Musculoskeletal Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Muscular Diseases; Muscle Hypertonia; Neuromuscular Manifestations; Brain Damage, Chronic; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Muscle Spasticity; Cerebral Palsy
• Other Study ID Numbers: MU-SBF-2019-131; YOKTEZ-820221 (Other Identifier: YÖK Tez Merkezi)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No