The Effectiveness of an Intensive Upper Limb Therapy Program Focused on Somatosensation in Children and Adolescents With Unilateral Cerebral Palsy

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

A randomized, controlled, and evaluator-blinded trial will be carried out to investigate the effects of 8 weeks of upper limb somatosensory discrimination therapy compared to an equal dose of motor therapy on sensorimotor outcomes in children and adolescents with spastic unilateral cerebral palsy aged 7 to 15 years old. Additionally, the potential role of clinical and neurological baseline characteristics on treatment response will be explored, including the extent of the brain lesion, age and baseline somatosensory function. The researchers primarily expect that the bimanual performance will improve equally in children and adolescents from both intervention groups, as measured immediately after the intervention has ended. The researchers hypothesize, however, that there will be a better retention effect in children and adolescents that received somatosensory discrimination therapy, resulting in differences between both groups in bimanual performance as measured at 6-months follow-up. The researchers further expect larger improvements in somatosensory function for children and adolescents in the somatosensory discrimination group and this both immediately after the intervention and at 6-month follow-up.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 7
Maximum Age: 15
Healthy Volunteers: f
View:

• Congenital or acquired, predominantly spastic unilateral cerebral palsy;

• Aged 7 to 15 years;

• Minimal ability to actively grasp and hold an object (modified House Functional Classification System ≥4);

• Having a confirmed impairment in tactile function as objectified using a clinical assessment battery containing assessments of tactile registration and tactile perception; and

• Sufficient cooperation to comprehend and complete the test and therapy procedures;

Locations
Other Locations
Belgium
KU Leuven
RECRUITING
Leuven
Contact Information
Primary
Lize Kleeren, MSc
lize.kleeren@kuleuven.be
+32 16 37 79 10
Backup
Lisa Mailleux, MSc, PhD
Lisa.mailleux@kuleuven.be
+32 16 37 93 85
Time Frame
Start Date: 2023-12-09
Estimated Completion Date: 2024-12
Participants
Target number of participants: 50
Treatments
Experimental: Intervention group
Upper limb somatosensory discrimination therapy (Sense for Kids therapy)
Active_comparator: Active control group
Upper limb motor therapy
Related Therapeutic Areas
Sponsors
Collaborators: Hasselt University, Curtin University, ETH Zurich
Leads: Hilde Feys

This content was sourced from clinicaltrials.gov