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Search / Trial NCT06006065

Upper Limb Somatosensory Discrimination Therapy and Dose-matched Motor Therapy in Children and Adolescents With Unilateral Cerebral Palsy

Launched by HILDE FEYS · Aug 16, 2023

Trial Information

Current as of July 23, 2025

Recruiting

Keywords

Upper Extremity[Me Sh] Physiotherapy[Me Sh] Occupational Therapy[Me Sh] Somatosensory Discrimination Therapy Upper Limb Motor Therapy Randomized Controlled Trial[Me Sh] Child[Me Sh] Adolescent[Me Sh] Somatosensation[Me Sh] Bimanual Performance Goal Performance Robotics[Me Sh] Neuroimaging[Me Sh]

ClinConnect Summary

This clinical trial is focused on comparing two types of therapy for children and teenagers aged 7 to 15 who have spastic unilateral cerebral palsy, a condition that affects movement on one side of the body. The researchers want to see how an 8-week program of upper limb somatosensory discrimination therapy, which helps improve the sense of touch and awareness of body position, compares to a similar amount of motor therapy that focuses on movement skills. They hope to find out if one therapy leads to better long-term improvement in using both hands together and in feeling sensations in the affected arm.

To participate in this trial, children should have a confirmed diagnosis of spastic unilateral cerebral palsy and be able to grasp and hold objects with some ability. However, those who have had certain recent treatments or surgeries, or have serious other health issues, won't be eligible. Children who join the study can expect evaluations of their movement and touch abilities before and after the therapy, as well as a follow-up six months later to check on their progress. This research aims to help improve therapy options for kids with this condition.

Gender

ALL

Eligibility 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.

About Hilde Feys

Hilde Feys is a dedicated clinical trial sponsor with a strong commitment to advancing medical research and improving patient outcomes. With extensive experience in overseeing clinical studies, Hilde Feys focuses on innovative methodologies and rigorous adherence to regulatory standards. The organization is known for fostering collaboration among multidisciplinary teams, ensuring that trials are conducted ethically and efficiently. By prioritizing patient safety and leveraging cutting-edge technologies, Hilde Feys aims to contribute significantly to the development of new therapies and enhance the overall landscape of healthcare.

Locations

Leuven, Vlaams Brabant, Belgium

Patients applied

0 patients applied

Trial Officials

Hilde Feys, MSc, PhD

Principal Investigator

KU Leuven

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported