Spastic Cerebral Palsy (sCP)
Conditions
Keywords
Sensory Electrical Stimulation, Spastic Cerebral Palsy, Spasticity, Functional Mobility, Ankle Range of Motion
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.
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.
Interventions
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.
Sponsors
Harran University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Masking description
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.
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
5 Years to 15 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ankle Dorsiflexion Range of Motion | Baseline, Week 6, and Week 12 | Ankle dorsiflexion range of motion will be measured to evaluate change across the study intervention phases in children with spastic cerebral palsy. |
Countries
Turkey (Türkiye)
Contacts
PRINCIPAL_INVESTIGATORVEYSEL MRV VEYSEL, PhD
Harran University
Outcome results
None listed