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

NCT06006065 | Recruiting Phase 2

• 2 other identifiers: G0C4919NS67467
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Upper extremity[MeSH]; Physiotherapy[MeSH]; Occupational therapy[MeSH]; Somatosensory discrimination therapy; Upper limb motor therapy; Randomized controlled trial[MeSH]; Child[MeSH]; Adolescent[MeSH]; Somatosensation[MeSH]; Bimanual performance; Goal performance; Robotics[MeSH]; Neuroimaging[MeSH]

Outcome Measures

Primary Outcomes (1)

• Bimanual performance/functional hand use

  The Assisting Hand Assessment (AHA) and Adolescent Assessment Hand Assessment (Ad-AHA) evaluate the spontaneous use of the more impaired upper limb during bimanual activities. For these assessments a semi-structured play session with standardized toys and materials, that require the use of both hands, is performed and video-recorded. Subsequently, 20 items are scored on a four-point Likert scale ranging from 1 ('does not do') to 4 ('effective use') and a logit-based total score in AHA unit is calculated, ranging from 0 to 100 AHA units. A highers score represents better bimanual performance. The AHA and Ad-AHA have shown to be a reliable and valid assessment for children and adolescents with unilateral cerebral palsy. Depending on the age of the participants, the AHA or Ad-AHA will be selected at each time point.

  Baseline, post-intervention (within one week) and after 6 months follow-up

Secondary Outcomes (14)

• Functional hand use

  Baseline, post-intervention (within one week) and after 6 months follow-up

• Bimanual coordination

  Baseline, post-intervention (within one week) and after 6 months follow-up

• Bimanual coordination

  Baseline, post-intervention (within one week) and after 6 months follow-up

• Proprioception - Kinarm Exoskeleton: 'Perceptual boundary task'

  Baseline, post-intervention (within one week) and after 6 months follow-up

• Proprioception - Kinarm Exoskeleton: 'Contralateral position matching task'

  Baseline, post-intervention (within one week) and after 6 months follow-up

Other Outcomes (4)

• Attentional functioning

  Baseline, post-intervention (within one week) and after 6 months follow-up

• Structural Magnetic Resonance Imaging (MRI) - semi-quantitative MRI scale

  Baseline

• Structural Magnetic Resonance Imaging (MRI) - MRI classification system

  Baseline

Study Arms (2)

Intervention group

EXPERIMENTAL

Upper limb somatosensory discrimination therapy (Sense for Kids therapy)

Behavioral: Upper limb somatosensory discrimination therapy

Active control group

ACTIVE COMPARATOR

Upper limb motor therapy

Behavioral: Upper limb motor therapy

Interventions

Upper limb somatosensory discrimination therapy BEHAVIORAL

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).

Also known as: Sense for Kids therapy

Intervention group

Upper limb motor therapy BEHAVIORAL

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.

Active control group

Eligibility Criteria

• Age: 7 Years - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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;

You may not qualify if:

• Botulinum toxin-A injections six months prior to testing;
• A history of upper limb surgery one year prior to testing;
• Severe comorbidities hindering test assessments (e.g., severe cognitive problems); and
• Inability to communicate in Dutch.

Sponsors & Collaborators

• Hilde Feys: lead
• Hasselt University: collaborator
• ETH Zurich: collaborator
• Curtin University: collaborator

Study Sites (1)

KU Leuven

Leuven, Vlaams-Brabant, 3000, Belgium

RECRUITING

Related Publications (1)

• Kleeren L, Mailleux L, McLean B, Elliott C, Dequeker G, Van Campenhout A, de Xivry JO, Verheyden G, Ortibus E, Klingels K, Feys H. Does somatosensory discrimination therapy alter sensorimotor upper limb function differently compared to motor therapy in children and adolescents with unilateral cerebral palsy: study protocol for a randomized controlled trial. Trials. 2024 Feb 26;25(1):147. doi: 10.1186/s13063-024-07967-4.

  PMID: 38409060 DERIVED

MeSH Terms

Conditions

Cerebral Palsy

Interventions

Sensation

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Nervous System Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Hilde Feys, MSc, PhD

  KU Leuven

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lize Kleeren, MSc

CONTACT

+32 16 37 79 10; lize.kleeren@kuleuven.be

Lisa Mailleux, MSc, PhD

CONTACT

+32 16 37 93 85; Lisa.mailleux@kuleuven.be

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The assessments of sensorimotor upper limb function at all three time points will be performed by a blinded assessor who is not involved in the conception of the study or the provision of therapy to the participants. Assessments that were video-recorded (Assisting Hand Assessment and Goal Attainment Scaling) will be scored afterwards by another evaluator who will be blinded to group allocation and time point of assessment. Since the robotic measurements and three-dimensional motion analysis are fully automated, these assessments will be performed by a physiotherapist not blinded to group allocation. Participants and parents will be blinded to the study hypotheses. The treating therapists will not be blinded to group allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Full professor at the Faculty of Movement and Rehabilitation Sciences; Vice rector of Diversity Policy and Student Affairs, also responsible for Sports, Health and Well-being

Model Details: Randomization will be performed by an independent person who is not involved in the selection procedure and will not have access to any additional clinical information about the participants.

Study Record Dates

• First Submitted: August 8, 2023
• First Posted: August 23, 2023
• Study Start: December 9, 2023
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: February 7, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)