Biomechanical and Functional Effects of Adding Sensory-Threshold Electrical Stimulation to Neurod… (NCT07491341) | Clinical Trial Compass
CompletedNot Applicable
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
Turkey (Türkiye)11 participantsStarted 2020-11-09
Plain-language 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.
Who can participate
Age range
5 Years – 15 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.