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

Harran University

Status: Completed

Conditions: Spastic Cerebral Palsy (sCP)

Treatments: Device: Sensory Electrical Stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT07491341

YOKTEZ-820221 (Other Identifier)

MU-SBF-2019-131

Details and patient eligibility

About

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.

Full 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.

Enrollment: 11 patients

Sex: All

Ages: 5 to 15 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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11 participants in 1 patient group

Sensory Electrical Stimulation Plus Neurodevelopmental Treatment

Experimental group

Description:

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.

Treatment:

Device: Sensory Electrical Stimulation