Clinical trial NCT05293093: Effectiveness of the Wheelchair Skills Training Program in People With Complex Movement Disorders
Official title: Clinical Evaluation and Effectiveness of the Adapted Wheelchair Skills Training Program in People With Complex Movement Disorders
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebral Palsy
Lead sponsor: KU Leuven
Sponsor class: OTHER
First posted: 2022-03-24
Enrollment: 12
Sex: ALL
Minimum age (years): 6
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 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).
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change from Baseline Wheelchair mobility skill performance at Post-Intervention assessed by the Wheelchair Skills Test (WST).
timeFrame: 4-week Wheelchair Skills Training Program intervention period (starting from the end of the baseline period)
measure: Change from Post-Intervention Wheelchair mobility skill performance after a 4-week retention period assessed by the Wheelchair Skills Test (WST).
timeFrame: 4-week retention period (starting from the end of the intervention period)
Secondary outcomes:
measure: Monitoring of Heart Rate Variability measured by the eMotion Faros 360° Heart rate variability Sensor during the experiments.
timeFrame: 11-13 weeks (starting from the beginning of the baseline period until the end of the retention period)
measure: Change in Baseline Participation goals assessed by the Canadian Occupational Performance Measure assessment tool at Post-intervention
timeFrame: 4-week intervention period (starting from the end of the baseline period)
measure: Change in Post-intervention Participation goals assessed by the Canadian Occupational Performance Measure assessment tool after a 4-week retention period
timeFrame: 4-week retention period (starting from the end of the intervention period)
measure: Change from Baseline Quality of Life assessed by the Cerebral Palsy Quality of Life Questionnaire for Children (CP QOL-Child) at Post-intervention
timeFrame: 4-week intervention period (starting from the end of the baseline period)
measure: Change from Baseline Quality of Life assessed by the Cerebral Palsy Quality of Life Questionnaire for Adolescents (CP QOL-Teen) at Post-intervention
timeFrame: 4-week intervention period (starting from the end of the baseline period)
measure: Change from Post-intervention Quality of Life assessed by the Cerebral Palsy Quality of Life Questionnaire for Children (CP QOL-Child) after a 4-week retention period
timeFrame: 4-week retention period (starting from the end of the intervention period)
measure: Change from Post-intervention Quality of Life assessed by the Cerebral Palsy Quality of Life Questionnaire for Adolescents (CP QOL-Teen) after a 4-week retention period
timeFrame: 4-week retention period (starting from the end of the intervention period)
measure: Change in Baseline Motivation assessed by the Intrinsic Motivation Inventory questionnaire at Post-intervention
timeFrame: 4-week intervention period (starting from the end of the baseline period)
measure: Change from Baseline Wheelchair mobility skill performance at Post-Intervention assessed by the Wheelchair Skills Test-Questionnaire (WST-Q).
timeFrame: 4-week intervention period (starting from the end of the baseline period)
measure: Change from Post-Intervention Wheelchair mobility skill performance after a 4-week retention period assessed by the Wheelchair Skills Test-Questionnaire (WST-Q).
timeFrame: 4-week retention period (starting from the end of the intervention period)
Other outcomes:
Locations:
city: Bruges
country: Belgium
facility: KU Leuven Department of Rehabilitation Sciences, Campus Bruges
Study officials:
affiliation: KU Leuven Department of Rehabilitation Sciences, Campus Bruges
name: Elegast Monbaliu, PhD
role: PRINCIPAL_INVESTIGATOR
References: