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

NCT ID: NCT05293093

Last Updated: 2023-03-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-02
• Study Completion Date: 2023-01-16

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.

Detailed Description

Powered wheelchair training for individuals with complex movement disorders, such as severe cerebral palsy, is challenging for healthcare providers, funders, and patients: it is highly dependent on the expertise of training staff (e.g., physical and occupational therapists), time-consuming for staff and patients, and therefore costly for providers. Poor personalisation of current training protocols leads to insufficient clinical outcomes. 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.

This study focuses on the effectiveness and clinical evaluation of the Wheelchair Skills Training Program (WSTP), adapted for children with complex movement disorders. Despite the proven effectiveness of the WSTP in other wheelchair-dependent populations, it warrants cautious implementation in clinical and educational settings within our target population of children with Dyskinetic and Spastic CP (GMFCS III- V). The project contains three study objectives. In the first objective, the effectiveness of a powered-wheelchair skill training program (WSTP) tailored for children with complex movement disorders on wheelchair mobility skills will be assessed. In the second study objective, the impact of a powered-wheelchair training session on measures as stress, motivation and fatigue will be evaluated. In the third study objective, the effect on everyday participation and quality of life will be assessed.

The primary endpoint is the wheelchair mobility skill performance, assessed using the Wheelchair Skills Test (WST). This is an objective test of a set of wheelchair skills. It is proven to be a reliable and valid assessment tool and is used in a number of studies as an outcome measure for (powered) wheelchair skills capacity. The main advantage of the WST is that the tester can see how the wheelchair user carries out the skill, permitting problems due to the wheelchair or the technique used to be identified and addressed.

Although WST capacity measures have been found to be sensitive to changes due to training, other measures will also be used to identify training effects on wheelchair mobility skills as recommended. The Wheelchair Skills Test - Questionnaire (WST-Q) will be used as it allows to assess performance as well as capacity and that in subject's own setting which together with WST is recommended for a comprehensive assessment.

Secondary endpoints include measures such as heart rate variability to explore the impact of stress and fatigue on task performance. Emotion Faros 360° devices will be used. Secondary endpoints also include measures of establishing the relationship of the intervention program with the subject's perceived exertion, Intrinsic Motivation Inventory questionnaire, participation by Canadian Occupational Performance Measure (COPM), and quality of life via the CP-QoL.

Conditions

Cerebral Palsy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Wheelchair Skills Training Program intervention study

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)

Group Type: EXPERIMENTAL

Wheelchair Skills Training Program

Intervention Type: 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

Interventions

Wheelchair Skills Training Program

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

KU Leuven

OTHER

Sponsor Role: lead

Responsible Party

Elegast Monbaliu

Prof.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Elegast Monbaliu, PhD

Role: PRINCIPAL_INVESTIGATOR

KU Leuven Department of Rehabilitation Sciences, Campus Bruges

Locations

KU Leuven Department of Rehabilitation Sciences, Campus Bruges

Bruges, , Belgium

Countries

Belgium

Other Identifiers

S65462

Identifier Type: -

Identifier Source: org_study_id