Cerebral PalsyNCT04531488
Simulator Based Powered Mobility Training of Children With Special Needs
A study testing Powered Mobility Training Simulator and Training with Powered Wheel Chair in people with Cerebral Palsy, run by Alyn Pediatric & Adolescent Rehabilitation Hospital at 1 site in Israel.
Trial summary
This study compared conventional powered mobility practice to simulator based practice of children with special needs aged 6-18 years. Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- Powered Mobility Training Simulator and Training with Powered Wheel Chair
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteIsrael
- Study dates
- 1 May 2018to 15 Jul 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Children with a physical disability that are not proficient powered mobility driver
- Children that can use a joystick
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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).
- Conditions
- Cerebral Palsy
- Being tested
- Powered Mobility Training Simulator, Training with Powered Wheel Chair
- Keywords
- Powered mobility, Simulator, Powered Mobility Outcome Measures
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Powered Mobility Training SimulatorProcedure or surgery
Also called Powered Mobility Training with Wheel Chair
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.
Training with Powered Wheel ChairOther
Training with Powered Wheel Chair
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Other: Training with Powered Wheel Chair |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: This outcome measure is done at baseline and after 12 weeks of practice.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2020
- Study start1 May 2018
- Primary completion15 Jul 2020
- Study completion15 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two groups that practiced powered mobility via different modes.
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alyn Pediatric & Adolescent Rehabilitation Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Naomi Gefen, Alyn Pediatric & Adolescent Rehabilitation Hospital
- Investigators
- Naomi Gefen, M.A., Principal investigator, Alyn Pediatric and Adolescent Rehabilitation Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04531488
- Sponsor's protocol ID
- 004-17
- Status last verified
- Aug 2020
- First submitted
- 24 Aug 2020
- Last updated
- 28 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to make individual participant data available to other researchers.
Publications
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.
PubMed 35737961
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Powered Mobility Training of Children With Special Needs: Conventional Versus Simulator-based Practice
- ClinicalTrials.gov ID
- NCT04531488
- Acronym / sponsor ID
- 004-17
- Conditions
- Cerebral Palsy
- Keywords
- Powered mobility, Simulator, Powered Mobility Outcome Measures
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Alyn Pediatric & Adolescent Rehabilitation HospitalUniversity, hospital or other
- Study start
- 1 May 2018 (actual)
- Primary completion
- 15 Jul 2020 (actual)
- Study completion
- 15 Jul 2020 (actual)
- First posted
- 28 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Two groups that practiced powered mobility via different modes.
| Arm | Type | Receives |
|---|---|---|
| Powered Mobility Training Simulator | Experimental | Procedure: Powered Mobility Training SimulatorPowered 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 |
| Training with Powered Wheel Chair | Active comparator | Other: Training with Powered Wheel ChairParticipants were provided with a powered wheelchair to practice at home or school |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Children with a physical disability that are not proficient powered mobility driver
- Children that can use a joystick
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Powered Mobility Training SimulatorAlso: Powered Mobility Training with Wheel ChairTwo 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. | Procedure or surgery | Powered Mobility Training Simulator |
| Training with Powered Wheel ChairTraining with Powered Wheel Chair | Other | Training with Powered Wheel Chair |
Primary outcome
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2020.
- Derived from this study: PubMed 35737961Gefen 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.
- Individual participant dataSharing planned: No. There is no plan to make individual participant data available to other researchers.
Related trials for Cerebral Palsy
Recruiting
Paired Non-invasive VNS in Adolescent Cerebral Palsy Rehabilitation
Cerebral Palsy
Recruiting
Short-Term Effects of Manual Therapy Prior to Neuromotor Therapy in Children With Cerebral Palsy
Cerebral Palsy (CP), Unilateral Spastic Cerebral Palsy
RecruitingObservational study
Study of Sagittal Pelvic Statics in the Sitting Position in Children With Cerebral Palsy
Cerebral Palsy Infantile
Recruiting
Evaluating Long-term Use of a Pediatric Robotic Exoskeleton (P.REX/Agilik) to Improve Gait in Children With Movement Disorders
Cerebral Palsy, Muscular Dystrophy
Not yet recruitingObservational study
Turkish Translation, Cross-Cultural Adaptation, Validity, and Reliability of the ABILHAND-Kids Young CP Scale
Cerebral Palsy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Naomi Gefen, M.A. principal investigator
Alyn Pediatric and Adolescent Rehabilitation Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Powered Mobility Training Simulator and Training with Powered Wheel Chair in people with Cerebral Palsy, run by Alyn Pediatric & Adolescent Rehabilitation Hospital at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04531488, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2020; AzTrials last refreshed its copy on 29 Oct 2026.