NCT04531488

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2018

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 15, 2020

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 24, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 28, 2020

Completed
Last Updated

August 28, 2020

Status Verified

August 1, 2020

Enrollment Period

2.2 years

First QC Date

August 24, 2020

Last Update Submit

August 27, 2020

Conditions

Keywords

Powered mobilitySimulatorPowered Mobility Outcome Measures

Outcome Measures

Primary Outcomes (3)

  • 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.

  • 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.

  • 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.

Study Arms (2)

Powered Mobility Training Simulator

EXPERIMENTAL

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

Training with Powered Wheel Chair

ACTIVE COMPARATOR

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

Other: Training with Powered Wheel Chair

Interventions

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.

Also known as: Powered Mobility Training with Wheel Chair
Powered Mobility Training Simulator

Training with Powered Wheel Chair

Training with Powered Wheel Chair

Eligibility Criteria

Age6 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Alyn Pediatrics Rehabilitation Hospital

Jerusalem, Israel

Location

Related Publications (1)

  • Gefen N, Archambault PS, Rigbi A, Weiss PL. Pediatric powered mobility training: powered wheelchair versus simulator-based practice. Assist Technol. 2023 Sep 3;35(5):389-398. doi: 10.1080/10400435.2022.2084183. Epub 2022 Jun 23.

MeSH Terms

Conditions

Cerebral Palsy

Interventions

Wheelchairs

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Self-Help DevicesEquipment and Supplies

Study Officials

  • Naomi Gefen, M.A.

    Alyn Pediatric and Adolescent Rehabilitation Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Two groups that practiced powered mobility via different modes.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Naomi Gefen, Deputy Director General, Principal Investigator

Study Record Dates

First Submitted

August 24, 2020

First Posted

August 28, 2020

Study Start

May 1, 2018

Primary Completion

July 15, 2020

Study Completion

July 15, 2020

Last Updated

August 28, 2020

Record last verified: 2020-08

Data Sharing

IPD Sharing
Will not share

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

Locations