Cerebral PalsyPhase 2NCT01028833
Effects of Power Mobility on Young Children With Severe Motor Impairments
A Phase 2 study testing Power mobility in people with Cerebral Palsy and Arthrogryposis, run by University of Oklahoma at 1 site in United States.
Trial summary
The purpose this study is to determine the effects of power mobility on the development and function of young children of young children whose severe physical disabilities limit their exploratory behaviors and may unnecessarily restrict their cognitive, communication, and social-emotional development. Read more about this study
- Who is it for?
- Ages 14 to 30 months
- Conditions the study is for
- Cerebral Palsy, Arthrogryposis, Spinal Muscular Atrophy
- What is being tested?
- Power mobility
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2008to Dec 2012
- Phase
- Phase 2
- 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 14 to 30 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Must be between 14- and 30-months of age
- Must have clinical diagnosis of a motor impairment that prevents functional independent mobility
- Must have adequate vision and hearing to use power mobility device safely
- Must have cognitive abilities equivalent to a 12-month level or alertness and interest in the environment that suggests a trial of power mobility is warranted
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Department of Rehabilitation Sciences, Lee Mitchener Tolbert Center for Develompental Disabilities
Oklahoma City, Oklahoma, 73117
About this study
Official title: Effects of Power Mobility on the Development and Function of Young Children With Severe Motor Impairments
The purpose this study is to determine the effects of power mobility on the development and function of young children of young children whose severe physical disabilities limit their exploratory behaviors and may unnecessarily restrict their cognitive, communication, and social-emotional development.
- Conditions
- Cerebral Palsy, Arthrogryposis, Spinal Muscular Atrophy, Other Central Nervous System or Musculoskeletal Disorders
- Being tested
- Power mobility
- Keywords
- power wheelchairs, power mobility, young children
- Medical subject headings
- Cerebral Palsy, Arthrogryposis, Muscular Atrophy, Spinal, Musculoskeletal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Power mobilityOther
Project staff will use structured power mobility training program to teach the children to use the power mobility devices. Project staff will schedule 1-hour sessions with each family 3 times per week for the first month of the project and will decrease in the following manner as the child becomes proficient and develops basic wheelchair maneuvering skills: two one-hour session per week for 4 weeks; one one-hour session per week for 4 weeks; two one-hour sessions per month for 4 weeks; one one-hour session per month for the remainder of the study.
| Study group | Role | What they receive |
|---|---|---|
| Power mobility | Experimental | Intervention included provision of power wheelchair and power mobility training program. Project staff will use structured power mobility training program to teach the children to use the power mobility devices. Project staff will schedule 1-hour sessions with each family 3 times per week for the first month of the project and will decrease in the following manner as the child becomes proficient and develops basic wheelchair maneuvering skills: two one-hour session per week for 4 weeks; one one-hour session per week for 4 weeks; two one-hour sessions per month for 4 weeks; one one-hour session per month for the remainder of the study. Receives: Other: Power mobility |
| Control | No intervention | Children in the control group will not receive any additional intervention, but will continue to receive the early intervention or other services they were receiving prior to enrollment in this study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Merrill-Palmer-Revised
Measured: Entry, 6-months, and 12-months
Pediatric Evaluation of Disability Inventory
Measured: Entry, 6-months, 12-months
Secondary outcomes (7)
Child Health Status
Measured: Entry
Two-position object permanence test
Measured: Entry, 6 months, 12 months
Nonspeech Test
Measured: Entry, 6 month, 12 months
Home Observation Measure of the Environment
Measured: Entry, 6 months, 12 months
Parenting Stress Inventory
Measured: Entry, 6 months, 12 months
Center for Epidemiologic Studies Depression Scale (CES-D)
Measured: Entry, 6 months, 12 months
Hollingshead Scale
Measured: Entry
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2009 (estimated)
- Study startNov 2008
- Primary completionDec 2012
- Study completionDec 2012
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.
- More trials run by University of OklahomaThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oklahoma
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maria A. Jones, PT, PhD, Principal investigator, University of Oklahoma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01028833
- Sponsor's protocol ID
- 2480
- Status last verified
- Jan 2016
- First submitted
- 7 Dec 2009
- Last updated
- 14 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Mockler SR, McEwen IR, Jones MA. Retrospective Analysis of Predictors of Proficient Power Mobility in Young Children With Severe Motor Impairments. Arch Phys Med Rehabil. 2017 Oct;98(10):2034-2041. doi: 10.1016/j.apmr.2017.05.028. Epub 2017 Jul 5.
PubMed 28688787
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Power Mobility on the Development and Function of Young Children With Severe Motor Impairments
- ClinicalTrials.gov ID
- NCT01028833
- Acronym / sponsor ID
- 2480
- Conditions
- Cerebral Palsy, Arthrogryposis, Spinal Muscular Atrophy, Other Central Nervous System or Musculoskeletal Disorders
- Keywords
- power wheelchairs, power mobility, young children
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- University of OklahomaUniversity, hospital or other
- Study start
- Nov 2008
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 9 Dec 2009 (estimated)
- 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.
The purpose this study is to determine the effects of power mobility on the development and function of young children of young children whose severe physical disabilities limit their exploratory behaviors and may unnecessarily restrict their cognitive, communication, and social-emotional development.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Power mobility | Experimental | Other: Power mobilityIntervention included provision of power wheelchair and power mobility training program. Project staff will use structured power mobility training program to teach the children to use the power mobility devices. Project staff will schedule 1-hour sessions with each family 3 times per week for the first month of the project and will decrease in the following manner as the child becomes proficient and develops basic wheelchair maneuvering skills: two one-hour session per week for 4 weeks; one one-hour session per week for 4 weeks; two one-hour sessions per month for 4 weeks; one one-hour session per month for the remainder of the study. |
| Control | No intervention | –Children in the control group will not receive any additional intervention, but will continue to receive the early intervention or other services they were receiving prior to enrollment in this study. |
Who may qualify
- Ages
- 14 to 30 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Must be between 14- and 30-months of age
- Must have clinical diagnosis of a motor impairment that prevents functional independent mobility
- Must have adequate vision and hearing to use power mobility device safely
- Must have cognitive abilities equivalent to a 12-month level or alertness and interest in the environment that suggests a trial of power mobility is warranted
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Power mobilityProject staff will use structured power mobility training program to teach the children to use the power mobility devices. Project staff will schedule 1-hour sessions with each family 3 times per week for the first month of the project and will decrease in the following manner as the child becomes proficient and develops basic wheelchair maneuvering skills: two one-hour session per week for 4 weeks; one one-hour session per week for 4 weeks; two one-hour sessions per month for 4 weeks; one one-hour session per month for the remainder of the study. | Other | Power mobility |
Primary outcome
Merrill-Palmer-Revised
Time frame: Entry, 6-months, and 12-months
Pediatric Evaluation of Disability Inventory
Time frame: Entry, 6-months, 12-months
7 secondary outcomes
Child Health Status
Time frame: Entry
Two-position object permanence test
Time frame: Entry, 6 months, 12 months
Nonspeech Test
Time frame: Entry, 6 month, 12 months
Home Observation Measure of the Environment
Time frame: Entry, 6 months, 12 months
Parenting Stress Inventory
Time frame: Entry, 6 months, 12 months
Center for Epidemiologic Studies Depression Scale (CES-D)
Time frame: Entry, 6 months, 12 months
Hollingshead Scale
Time frame: Entry
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 14 Jan 2016.
- Derived from this study: PubMed 28688787Mockler SR, McEwen IR, Jones MA. Retrospective Analysis of Predictors of Proficient Power Mobility in Young Children With Severe Motor Impairments. Arch Phys Med Rehabil. 2017 Oct;98(10):2034-2041. doi: 10.1016/j.apmr.2017.05.028. Epub 2017 Jul 5.
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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.
Maria A. Jones, PT, PhD principal investigator
University of Oklahoma
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Power mobility in people with Cerebral Palsy and Arthrogryposis, run by University of Oklahoma at 1 site in United States.
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 4 inclusion and 0 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 14 Jan 2016. 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 United States. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Merrill-Palmer-Revised (time frame: Entry, 6-months, and 12-months). The study lists 2 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 NCT01028833, 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 14 Jan 2016; AzTrials last refreshed its copy on 7 Nov 2026.