Simulator Based Powered Mobility Training of Children With Special Needs

August 27, 2020 updated by: Naomi Gefen, Alyn Pediatric & Adolescent Rehabilitation Hospital

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Actual)

36

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Jerusalem, Israel
        • Alyn Pediatrics Rehabilitation Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 18 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Powered Mobility Training Simulator
Powered mobility simulator- the McGill Immersive Wheelchair Simulator (MiWe) was developed for adults. In a previous study the simulator was found valid for use with children. Participants were provided a laptop, joystick and the software program- MiWe- to practice at home or school
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 Names:
  • Powered Mobility Training with Wheel Chair
ACTIVE_COMPARATOR: Training with Powered Wheel Chair
Participants were provided with a powered wheelchair to practice at home or school
Other: Training with Powered Wheel Chair
Training with Powered Wheel Chair

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Powered Mobility Program- Assessing change from Baseline to End of intervention
Time Frame: This outcome measure is done at baseline and after 12 weeks of practice.
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.
Assessment of Learning Powered Mobility Use- Assessing change from Baseline to End of intervention
Time Frame: This outcome measure is done at baseline and after 12 weeks of practice.
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.
The Israel Ministry of Health Proficiency Test- Assessing change from Baseline to End of intervention
Time Frame: This outcome measure is done at baseline and after 12 weeks of practice.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alyn Pediatric & Adolescent Rehabilitation Hospital

Investigators

  • Principal Investigator: Naomi Gefen, M.A., Alyn Pediatric and Adolescent Rehabilitation Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

May 1, 2018

Primary Completion (ACTUAL)

July 15, 2020

Study Completion (ACTUAL)

July 15, 2020

Study Registration Dates

First Submitted

August 24, 2020

First Submitted That Met QC Criteria

August 27, 2020

First Posted (ACTUAL)

August 28, 2020

Study Record Updates

Last Update Posted (ACTUAL)

August 28, 2020

Last Update Submitted That Met QC Criteria

August 27, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 004-17

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

There is no plan to make individual participant data available to other researchers.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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