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Trials / Completed

CompletedNCT05293093

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

Clinical Evaluation and Effectiveness of the Adapted Wheelchair Skills Training Program in People With Complex Movement Disorders

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
12 (actual)
Sponsor
KU Leuven · Academic / Other
Sex
All
Age
6 Years – 21 Years
Healthy volunteers
Not accepted

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

Interventions

TypeNameDescription
OTHERWheelchair Skills Training Programa 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

Timeline

Start date
2022-03-02
Primary completion
2023-01-16
Completion
2023-01-16
First posted
2022-03-24
Last updated
2023-03-02

Locations

1 site across 1 country: Belgium

Source: ClinicalTrials.gov record NCT05293093. Inclusion in this directory is not an endorsement.

Effectiveness of the Wheelchair Skills Training Program in People With Complex Movement Disorders (NCT05293093) · Clinical Trials Directory