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Simulator Based Powered Mobility Training of Children With Special Needs

Primary Purpose

Cerebral Palsy

Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Powered Mobility Training Simulator
Training with Powered Wheel Chair
Sponsored by
Alyn Pediatric & Adolescent Rehabilitation Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cerebral Palsy focused on measuring Powered mobility, Simulator, Powered Mobility Outcome Measures

Eligibility Criteria

6 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Alyn Pediatrics Rehabilitation Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Powered Mobility Training Simulator

Training with Powered Wheel Chair

Arm Description

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

Participants were provided with a powered wheelchair to practice at home or school

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
August 24, 2020
Last Updated
August 27, 2020
Sponsor
Alyn Pediatric & Adolescent Rehabilitation Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04531488
Brief Title
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

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
May 1, 2018 (Actual)
Primary Completion Date
July 15, 2020 (Actual)
Study Completion Date
July 15, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Alyn Pediatric & Adolescent Rehabilitation Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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. Simulator validity study included 30 children aged 6-18 years, proficient powered mobility drivers. All participants had physical disabilities- CP or Neuromuscular conditions. 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. 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy
Keywords
Powered mobility, Simulator, Powered Mobility Outcome Measures

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Two groups that practiced powered mobility via different modes.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Powered Mobility Training Simulator
Arm Type
Experimental
Arm Description
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
Arm Title
Training with Powered Wheel Chair
Arm Type
Active Comparator
Arm Description
Participants were provided with a powered wheelchair to practice at home or school
Intervention Type
Procedure
Intervention Name(s)
Powered Mobility Training Simulator
Other Intervention Name(s)
Powered Mobility Training with Wheel Chair
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Training with Powered Wheel Chair
Intervention Description
Training with Powered Wheel Chair
Primary Outcome Measure Information:
Title
Powered Mobility Program- Assessing change from Baseline to End of intervention
Description
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.
Time Frame
This outcome measure is done at baseline and after 12 weeks of practice.
Title
Assessment of Learning Powered Mobility Use- Assessing change from Baseline to End of intervention
Description
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.
Time Frame
This outcome measure is done at baseline and after 12 weeks of practice.
Title
The Israel Ministry of Health Proficiency Test- Assessing change from Baseline to End of intervention
Description
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.
Time Frame
This outcome measure is done at baseline and after 12 weeks of practice.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Naomi Gefen, M.A.
Organizational Affiliation
Alyn Pediatric and Adolescent Rehabilitation Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Alyn Pediatrics Rehabilitation Hospital
City
Jerusalem
Country
Israel

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
There is no plan to make individual participant data available to other researchers.

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Simulator Based Powered Mobility Training of Children With Special Needs

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