Clinical trial NCT04531488: Simulator Based Powered Mobility Training of Children With Special Needs
Official title: Powered Mobility Training of Children With Special Needs: Conventional Versus Simulator-based Practice
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebral Palsy
Keywords: Powered mobility
Simulator
Powered Mobility Outcome Measures
Lead sponsor: Alyn Pediatric & Adolescent Rehabilitation Hospital
Sponsor class: OTHER
First posted: 2020-08-28
Enrollment: 36
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two groups that practiced powered mobility via different modes.
Primary purpose: TREATMENT

Brief summary: This study compared conventional powered mobility practice to simulator based practice of children with special needs aged 6-18 years.

Detailed description: This study compared conventional powered mobility practice to simulator based practice of children with special needs aged 6-18 years.

The study has 3 stages: 1) Simulator validity study 2) Powered mobility outcome measures reliability and validity for children 6-18 years 3) Intervention study to compare simulator based practice and powered mobility practice.

1. Simulator validity study included 30 children aged 6-18 years, proficient powered mobility drivers. All participants had physical disabilities- CP or Neuromuscular conditions.
2. This stage included the first 30 children from the intervention study. Data for the study was based on the first evaluation out of the two evaluations in the study.
3. This stage included 36 children aged 6-18 years in need of powered mobility practice to become a proficient driver. The particpants were divided into two groups- experimental (simulator based practice) and control group (standard powered wheelchair practice).

Eligibility criteria: Inclusion Criteria:

* Children with a physical disability that are not proficient powered mobility driver
* Children that can use a joystick

Exclusion Criteria:

* Children with visual accuracy limitations that cannot be corrected with glasses or contact lens;
* Children who have a severe intellectual and developmental disability as defined by the Israel Ministry of Welfare's index for intellectual and developmental disabilities and reported by parents; Children that have a unstable medical conditions that prevent them from participating in powered mobility training (e.g., epilepsy)
* Children that can operate a powered wheelchair via switches or a scanning device.

Primary outcomes:
measure: Powered Mobility Program- Assessing change from Baseline to End of intervention
timeFrame: This outcome measure is done at baseline and after 12 weeks of practice.
measure: Assessment of Learning Powered Mobility Use- Assessing change from Baseline to End of intervention
timeFrame: This outcome measure is done at baseline and after 12 weeks of practice.
measure: The Israel Ministry of Health Proficiency Test- Assessing change from Baseline to End of intervention
timeFrame: This outcome measure is done at baseline and after 12 weeks of practice.
Secondary outcomes:
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Alyn Pediatrics Rehabilitation Hospital
Study officials:
affiliation: Alyn Pediatric and Adolescent Rehabilitation Hospital
name: Naomi Gefen, M.A.
role: PRINCIPAL_INVESTIGATOR
References: