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

NCT06006065 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2024-02-07

No results posted yet for this study

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.

Conditions

  • Cerebral Palsy, Spastic
  • Hemiplegic Cerebral Palsy

Interventions

BEHAVIORAL

Upper limb somatosensory discrimination therapy

Participants will receive three 45 minute sessions of upper limb somatosensory discrimination therapy per week for a period of 8 weeks. Each session includes 30 minutes of component-based training, including graded practice of three components of somatosensation (i.e., tactile object recognition, texture discrimination and proprioception). Next, 15 minutes of occupation-based practice will be completed to enhance transfer to a functional context. This includes repetitive and structured practice of self-chosen activities of daily living, while attention is designated to the somatosensory aspects necessary for successful task completion (e.g., identification of button based on touch).

BEHAVIORAL

Upper limb motor therapy

Participants in the control group will receive an equal amount of motor training, including 30 minutes of unimanual motor tasks and 15 minutes of bimanual goal directed training. The unimanual motor tasks will be selected based on the main difficulties of the child (e.g., grip strength, supination). Bimanual goal directed training includes whole task practice of self-chosen activities of daily living. All therapy sessions will be performed under supervision of a trained physical and/or occupational therapist. Therapy adherence and progression will be closely monitored by the therapist.

Sponsors & Collaborators

  • Hasselt University

    collaborator OTHER
  • ETH Zurich

    collaborator OTHER
  • Curtin University

    collaborator OTHER
  • Hilde Feys

    lead OTHER

Principal Investigators

  • Hilde Feys, MSc, PhD · KU Leuven

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
7 Years
Max Age
15 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-12-09
Primary Completion
2024-12-31
Completion
2024-12-31

Countries

  • Belgium

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06006065 on ClinicalTrials.gov