NCT06006065

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

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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Hilde Feys · Academic / Other
• Sex: All
• Age: 7 Years – 15 Years
• Healthy volunteers: Not accepted

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.

Detailed description

BACKGROUND: Although cerebral palsy has primarily been defined as a motor disorder, research has shown that up to 90% of children and adolescents with unilateral cerebral palsy also present with somatosensory deficits in the upper limb. Despite the fact that somatosensation has shown to be crucial for coordinated movements and even motor learning, therapy programs designated to improve somatosensory deficits is scarce. Nevertheless, previous studies provided a neurological basis for somatosensory interventions in individuals with unilateral cerebral palsy, showing that the somatosensory system is disorganized and potentially treatment responsive. Hence, a clinical reasoning framework for somatosensory interventions was recently developed. Somatosensory discrimination therapy, also known as Sense for Kids therapy, was one of the recommended approaches. This therapy was found to improve tactile perception in chronic stroke patients. Also in children and adolescents with unilateral cerebral palsy, a first study reported promising results to improve functional hand use as well as somatosensory function. Yet, the full clinical potential and long-term effects of this therapy still remain to be explored. AIM: The aim of this study is to investigate the effects of Sense for Kids therapy compared to an equal dose of motor therapy on upper limb sensorimotor outcomes in children and adolescents with unilateral cerebral palsy. Additionally the potential role of clinical and neurological baseline characteristics on treatment response will be explored, including the anatomical characterization of the brain lesion, age and baseline somatosensory function. METHODS/DESIGN: A randomized, controlled, and evaluator-blinded randomized controlled trial will be carried out in 50 children and adolescents with spastic unilateral cerebral palsy aged between 7 and 15 years old. To determine the number of required participants, a sample size calculation was performed for the primary research objective, being better bimanual performance at 6 months follow-up for children and adolescents that received Sense for Kids therapy compared to upper limb motor therapy. An effect size of 0.9 was calculated based on the results of earlier studies on intensive upper limb therapy in children with unilateral cerebral palsy. Combined with an alpha-level of 0.05 and a statistical power of 0.80, this results in a required sample size of 21 children and adolescents in each group to detect a difference equal or larger than the smallest detectable difference between groups. This number will be increased to 25 participants per group to account for inevitable dropouts and to maximize the study sample for prediction purposes. Participants will be randomized to the intervention or active control group through randomization by minimization with an allocation ratio of 1:1. Participants will be stratified based on age (2 levels: \<11 years and ≥11 years), manual ability (3 Manual Ability Classification Scale: I, II and III) and tactile impairment (2 levels: mild or moderate-severe). The probability will be set at 80% to diminish allocation prediction. Participants in both groups will receive three session of 45 minutes upper limb therapy per week for a period of 8 weeks, resulting in a total therapy intensity of 18 hours. The intervention group will receive Sense for Kids therapy, which consists of component-based training and occupation-based training. During the component-based training participants will perform graded and structured practice of tactile object recognition, texture discrimination and proprioception. During the occupation-based practice, participants will repetitively perform self-chosen activities of daily living while attention is denoted to somatosensory aspects necessary for successful task completion (e.g., position of the upper limb, texture of materials, localization of materials based on touch). Participants in the control group will receive an equal amount of motor training, consisting of unimanual motor tasks and bimanual goal directed training of self-chosen activities. Outcomes will be assessed at three different points in time, being within two weeks prior to therapy commencement (baseline), within one week following therapy completion (post-intervention) and 6 months after the therapy has ended (follow-up). Outcome assessments include qualitative and quantitative measures of upper limb sensorimotor function. The primary outcome measure is the Assisting Hand Assessment and is used to score the (spontaneous) use of the more impaired hand during bimanual activities. The medical imaging protocol, which will be only acquired at baseline, includes structural Magnetic Resonance Imaging and diffusion weighted images. The time effects of the intervention on upper limb sensorimotor outcomes will be objectified using linear and/or generalized mixed models. Behavioral and neurological variables will further be included in the model as covariates to study their predictive value on the therapy response.

Conditions

• Cerebral Palsy, Spastic
• Hemiplegic Cerebral Palsy

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-12-09
• Primary completion: 2024-12-01
• Completion: 2024-12-01
• First posted: 2023-08-23
• Last updated: 2024-02-07

Locations

1 site across 1 country: Belgium