Therapy for improving upper limb function in children with unilateral cerebral palsy
The Effectiveness of an Intensive Upper Limb Therapy Program Focused on Somatosensation in Children and Adolescents With Unilateral Cerebral Palsy
This study is testing if an 8-week therapy that helps kids with unilateral cerebral palsy better sense and use their hands can improve their arm function more than regular motor therapy.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 7 Years to 15 Years |
| Sex | All |
| Sponsor | KU Leuven Academic / other |
| Locations | 1 site (Leuven, Vlaams-Brabant) |
| Trial ID | NCT06006065 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effects of an 8-week upper limb somatosensory discrimination therapy, known as Sense for Kids therapy, compared to an equal dose of motor therapy in children and adolescents aged 7 to 15 with spastic unilateral cerebral palsy. The study is randomized, controlled, and evaluator-blinded, focusing on sensorimotor outcomes and the potential impact of clinical and neurological characteristics on treatment response. Researchers aim to determine if the somatosensory therapy leads to better long-term improvements in bimanual performance compared to traditional motor therapy. The trial will also assess the retention of these benefits at a 6-month follow-up.
Who should consider this trial
Good fit: Ideal candidates are children and adolescents aged 7 to 15 with predominantly spastic unilateral cerebral palsy and confirmed tactile function impairments.
Not a fit: Patients who have had recent botulinum toxin-A injections, upper limb surgery, severe comorbidities, or cannot communicate in Dutch may not benefit from this study.
Why it matters
Potential benefit: If successful, this therapy could significantly enhance upper limb function and sensory perception in children with unilateral cerebral palsy.
How similar studies have performed: Previous studies have shown promising results for somatosensory interventions in similar populations, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Congenital or acquired, predominantly spastic unilateral cerebral palsy; 2. Aged 7 to 15 years; 3. Minimal ability to actively grasp and hold an object (modified House Functional Classification System ≥4); 4. Having a confirmed impairment in tactile function as objectified using a clinical assessment battery containing assessments of tactile registration and tactile perception; and 5. Sufficient cooperation to comprehend and complete the test and therapy procedures; Exclusion Criteria: 1. Botulinum toxin-A injections six months prior to testing; 2. A history of upper limb surgery one year prior to testing; 3. Severe comorbidities hindering test assessments (e.g., severe cognitive problems); and 4. Inability to communicate in Dutch.
Where this trial is running
Leuven, Vlaams-Brabant
- KU Leuven — Leuven, Vlaams-Brabant, Belgium (Recruiting)
Study contacts
- Principal investigator: Hilde Feys, MSc, PhD — KU Leuven
- Study coordinator: Lize Kleeren, MSc
- Email: lize.kleeren@kuleuven.be
- Phone: +32 16 37 79 10
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.