NCT07491341

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 11 (actual)
• Sponsor: Harran University · Academic / Other
• Sex: All
• Age: 5 Years – 15 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Spastic Cerebral Palsy (sCP)

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2020-11-09
• Primary completion: 2021-02-12
• Completion: 2021-05-28
• First posted: 2026-03-24
• Last updated: 2026-03-24

Locations

1 site across 1 country: Turkey (Türkiye)