Simulator Based Powered Mobility Training of Children With Special Needs

Cerebral Palsy Clinical Trial

Official title:

Powered Mobility Training of Children With Special Needs: Conventional Versus Simulator-based Practice

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04531488
• Other study ID #: 004-17
• Status: Completed
• Phase: N/A
• Start date: May 1, 2018
• Est. completion date: July 15, 2020

Study information

• Verified date: August 2020
• Source: Alyn Pediatric & Adolescent Rehabilitation Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: July 15, 2020
• Est. primary completion date: July 15, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cerebral Palsy

Intervention

Procedure:
• Powered Mobility Training Simulator
Two groups of participants- 18 in each- were provided with either a simulator or powered wheelchair. Both groups were tested at baseline for powered mobility level. Both groups the practiced at home or school for 12 weeks, 4 times a week for at least 20 minutes. Both groups returned and underwent another evaluation to assess powered mobility level after 12 weeks of practice.

Other:
• Training with Powered Wheel Chair
Training with Powered Wheel Chair

Locations

Country	Name	City	State
Israel	Alyn Pediatrics Rehabilitation Hospital	Jerusalem

Sponsors (1)

Lead Sponsor	Collaborator
Alyn Pediatric & Adolescent Rehabilitation Hospital

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Powered Mobility Program- Assessing change from Baseline to End of intervention	This is an evaluation that has up to 34 items that assess the driving skills of powered wheelchair users. Each skill can receive a score of 0-5. The higher the score the better. The total sum of all skills is divided by the number of skills tested and an average score ranging from 0-5 is recorded.	This outcome measure is done at baseline and after 12 weeks of practice.
Primary	Assessment of Learning Powered Mobility Use- Assessing change from Baseline to End of intervention	This is an evaluation that has 8 levels of 5 skills. It assess the level of powered mobility driving in areas that the PMP does not- cognitive, emotional, social. Each of the 5 skills receives a score of 1-8. The sum of all skills scores is divided by 5. The score can be between 1-8. A higher score is better.	This outcome measure is done at baseline and after 12 weeks of practice.
Primary	The Israel Ministry of Health Proficiency Test- Assessing change from Baseline to End of intervention	This is an evaluation that assess 7 powered mobility skills. The driver needs to succeed 4/5 times each skill in order to pass test. Each of the 7 skills receives a score of 1,3,5. The sum of all skills is divided by 7 and the average score is recorded 1-5. The higher the score the better.	This outcome measure is done at baseline and after 12 weeks of practice.