Effectiveness of the Wheelchair Skills Training Program in People With Complex Movement Disorders

NCT05293093 | Completed

• 1 other identifier: S65462
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

The overall goal of this project is to increase independent mobility in populations with complex movement disorders, such as severe cerebral palsy, by adapting The Wheelchair Skills Training Program (WSTP) to the needs and capabilities of this population. The primary objective is to evaluate the clinical effectiveness of an adapted Wheelchair Skills Training Program tailored for children with complex movement disorders and its impact on wheelchair mobility skills. Secondary objectives are to evaluate the clinical effectiveness of an adapted Wheelchair Skills Training Program tailored for children with complex movement disorders, and its impact on stress, fatigue, and symptoms of the movement disorder, and to evaluate the clinical effectiveness of an adapted Wheelchair Skills Training Program tailored for children with complex movement disorders, and its impact on participation. The investigators hypothesize an improvement in wheelchair skill capacity and performance post-intervention compared to pre-intervention. In addition, the investigators hypothesize that the levels of stress and fatigue are in the general low to moderate throughout the training sessions. However, the investigators also expect that higher levels of (perceived) stress and fatigue negatively impact task performance and provoke the symptoms of the movement disorder. The investigators hypothesize that participation will improve post-intervention compared to pre-intervention.

Conditions

Cerebral Palsy

Outcome Measures

Primary Outcomes (2)

• Change from Baseline Wheelchair mobility skill performance at Post-Intervention assessed by the Wheelchair Skills Test (WST).

  The change from Baseline Wheelchair mobility skill performance at Post-Intervention will be assessed using the Wheelchair Skills Test (WST). This is an objective test of a set of wheelchair skill tasks, where wheelchair mobility skill performance is scored as a percentage between 0-100% (higher scores indicate a better wheelchair mobility skill performance).

  4-week Wheelchair Skills Training Program intervention period (starting from the end of the baseline period)

• Change from Post-Intervention Wheelchair mobility skill performance after a 4-week retention period assessed by the Wheelchair Skills Test (WST).

  The change from Post-Intervention Wheelchair mobility skill performance after a 4-week retention period will be assessed using the Wheelchair Skills Test (WST). This is an objective test of a set of wheelchair skill tasks, where wheelchair mobility skill performance is scored as a percentage between 0-100% (higher scores indicate a better wheelchair mobility skill performance).

  4-week retention period (starting from the end of the intervention period)

Secondary Outcomes (10)

• Monitoring of Heart Rate Variability measured by the eMotion Faros 360° Heart rate variability Sensor during the experiments.

  11-13 weeks (starting from the beginning of the baseline period until the end of the retention period)

• Change in Baseline Participation goals assessed by the Canadian Occupational Performance Measure assessment tool at Post-intervention

  4-week intervention period (starting from the end of the baseline period)

• Change in Post-intervention Participation goals assessed by the Canadian Occupational Performance Measure assessment tool after a 4-week retention period

  4-week retention period (starting from the end of the intervention period)

• Change from Baseline Quality of Life assessed by the Cerebral Palsy Quality of Life Questionnaire for Children (CP QOL-Child) at Post-intervention

  4-week intervention period (starting from the end of the baseline period)

• Change from Baseline Quality of Life assessed by the Cerebral Palsy Quality of Life Questionnaire for Adolescents (CP QOL-Teen) at Post-intervention

  4-week intervention period (starting from the end of the baseline period)

Study Arms (1)

Wheelchair Skills Training Program intervention study

EXPERIMENTAL

A one-group pretest-posttest design study will be conducted, consisting of three phases (3- or 5-week baseline phase, 4-week training phase, 4-week retention phase)

Other: Wheelchair Skills Training Program

Interventions

Wheelchair Skills Training Program OTHER

a standardized training method for users of manual and powered wheelchairs and it combines evidence on motor-skills learning with evidence on how to perform specific wheelchair skills. A recent systematic review and meta-analysis provided evidence that WSTP is a safe and effective intervention that has a clinically meaningful effect on powered wheelchair skill capacity, in particular for new wheelchair users. The WSTP has shown to be effective in several wheelchair-dependent populations and promising to be used in people with complex movement disorders. Yet, adaptation to the specific needs and capabilities of individuals with complex movement disorders is necessary as it has not been assessed in this population. During the 4-week training phase, the participants will receive 3 training sessions per week of 45 minutes, including exercises as described in the Wheelchair Skill Training Program Version 5.1.2

Wheelchair Skills Training Program intervention study

Eligibility Criteria

• Age: 6 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• clinical diagnosis of Cerebral Palsy
• classified as level III-V on the Gross Motor Function Classification System
• classified as level III-V on the Manual Ability Classification System
• must be able to understand mobility training instructions
• must be currently using a powered wheelchair

You may not qualify if:

• underwent surgery of neurological nature less than 12 months prior to the start of the study
• known diagnosis of autism spectrum disorder
• history of traumatic brain injury since diagnosis of cerebral palsy
• history of epilepsy

Sponsors & Collaborators

• KU Leuven: lead

Study Sites (1)

KU Leuven Department of Rehabilitation Sciences, Campus Bruges

Bruges, 8200, Belgium

Location

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

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

Study Officials

• Elegast Monbaliu, PhD

  KU Leuven Department of Rehabilitation Sciences, Campus Bruges

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Model Details: A one-group pretest-posttest design study will be conducted, consisting of three phases (3- or 5-week baseline phase, 4-week training phase, 4-week retention phase) and four wheelchair skill capacity assessment points (T0: baseline; T1: pre-intervention; T2: post-intervention; T3: retention).

Study Record Dates

• First Submitted: March 2, 2022
• First Posted: March 24, 2022
• Study Start: March 2, 2022
• Primary Completion: January 16, 2023
• Study Completion: January 16, 2023
• Last Updated: March 2, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)