Cerebral PalsyPhase 2NCT01115998

Effect of Power Wheelchairs on the Development and Function of Young Children With Severe Physical Disabilities

A Phase 2 study testing Power wheelchair and No power wheelchairs in people with Cerebral Palsy and Child, Preschool, run by University of Oklahoma at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Self-produced locomotion often is limited in children with cerebral palsy and other conditions that cause severe motor impairments. As a result, these children may be at risk for secondary impairments in spatial cognition, communication, social development, and other domains influenced by independent mobility. Read more about this study

Who is it for?: Ages 14 to 30 months
Conditions the study is for: Cerebral Palsy, Child, Preschool
What is being tested?: Power wheelchair and No power wheelchairs
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 34 participants
Where: 1 siteUnited States
Study dates: Jun 2002to Dec 2004
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

Age 14 to 30 months
Motor impairment that prevents functional independent mobility
Vision and hearing adequate to use a power mobility device safely.
Cognitive abilities assessed to be at least 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

University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 78104

Other trials in United States

About this study

Official title: Learning Early Travel Skills: Effects of Power Mobility on the Development of Young Children With Severe Motor Impairments

Children with severe disabilities that prevent independent locomotion who learn to use power mobility devices when they are 14- to 30-months-of-age will have greater communication, social, and cognitive development over a 12-month period, and will demonstrate more competent coping skills than children with the same characteristics who do not use power mobility.
Parents of children who use power mobility will view it as a positive influence on their children's lives, and will perceive their children's development to be more mature than the parents of children who do not use power mobility will perceive their children's development.

Read the detailed description

More extensive description is not desired.

Conditions: Cerebral Palsy, Child, Preschool
Being tested: Power wheelchair, No power wheelchairs
Keywords: cerebral palsy, wheelchair, disabled children
Medical subject headings: Cerebral Palsy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Power wheelchairOther
Also called Invacare Power Tiger wheelchairs
Children used power wheelchairs for one year. They continued to receive their usual early intervention services.
No power wheelchairsOther
Children in the control group did not use power wheelchairs. They continued to receive their usual early intervention services.

Study groups in NCT01115998
Study group	Role	What they receive
Power wheelchair	Experimental	Not described Receives: Other: Power wheelchair
Control group	Other	Not described Receives: Other: No power wheelchairs

What is being measured

The primary outcome is the main question the study is designed to answer.

Pediatric Evaluation of Disability Inventory
Items measure mobility, self-care, and social function using a 2-point scale (0 = unable or limited ability; 1 = capable in most situations). Items measure caregiver assistance on a 6-point scale (0 = total assistance; 5 = independent). We used the change in scaled scores in each area and total scores for analyses. Worst possible scaled score is 0 and the best possible score is 100.
Measured: Baseline and 12 months
Battelle Developmental Inventory (BDI)
Items measure adaptive, cognitive, communication, motor, and personal-social development using 3-point ordinal scales (0 = does not complete; 1 = partially completes; 2 = completes item). We used change in age equivalent scores for each area and the total scores for analyses. The worst possible scores are 0 months age equivalent and the best possible scores are 95 months age equivalent.
Measured: Baseline and 12 months
Early Coping Inventory
We used the reactive and self-initiated behavior scales. We used change in raw scores for analyses. The worst possible raw score for each scale is 16 and the best possible score is 80.
Measured: Baseline and 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2002Dec 2004

First posted4 May 2010 (estimated)
Study startJun 2002
Primary completionDec 2004
Study completionDec 2004

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 34 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01115998
Sponsor's protocol ID: 07956
Other IDs: USDE #R305T010757
Status last verified: Oct 2016
First submitted: 19 Mar 2009
Last updated: 5 Dec 2016
Results posted: Yes, on ClinicalTrials.gov
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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Cerebral Palsy trials

Study at a glance

From the registry record, last updated by the sponsor on 5 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Learning Early Travel Skills: Effects of Power Mobility on the Development of Young Children With Severe Motor Impairments
ClinicalTrials.gov ID: NCT01115998
Acronym / sponsor ID: 07956
Conditions: Cerebral Palsy, Child, Preschool
Keywords: cerebral palsy, wheelchair, disabled children
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 34 participants (actual)
Lead sponsor: University of OklahomaUniversity, hospital or other
Collaborators: U.S. Department of Education
Study start: Jun 2002
Primary completion: Dec 2004 (actual)
Study completion: Dec 2004 (actual)
First posted: 4 May 2010 (estimated)
Results: Posted 4 May 2010

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Children with severe disabilities that prevent independent locomotion who learn to use power mobility devices when they are 14- to 30-months-of-age will have greater communication, social, and cognitive development over a 12-month period, and will demonstrate more competent coping skills than children with the same characteristics who do not use power mobility.
Parents of children who use power mobility will view it as a positive influence on their children's lives, and will perceive their children's development to be more mature than the parents of children who do not use power mobility will perceive their children's development.

Detailed description

More extensive description is not desired.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Power wheelchair	Experimental	Other: Power wheelchair
Control group	Other	Other: No power wheelchairs

Who may qualify

Ages: 14 to 30 months
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (4 listed)

Age 14 to 30 months
Motor impairment that prevents functional independent mobility
Vision and hearing adequate to use a power mobility device safely.
Cognitive abilities assessed to be at least 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 wheelchairAlso: Invacare Power Tiger wheelchairsChildren used power wheelchairs for one year. They continued to receive their usual early intervention services.	Other	Power wheelchair
No power wheelchairsChildren in the control group did not use power wheelchairs. They continued to receive their usual early intervention services.	Other	Control group

Primary outcome

Pediatric Evaluation of Disability Inventory
Time frame: Baseline and 12 months
Items measure mobility, self-care, and social function using a 2-point scale (0 = unable or limited ability; 1 = capable in most situations). Items measure caregiver assistance on a 6-point scale (0 = total assistance; 5 = independent). We used the change in scaled scores in each area and total scores for analyses. Worst possible scaled score is 0 and the best possible score is 100.
Battelle Developmental Inventory (BDI)
Time frame: Baseline and 12 months
Items measure adaptive, cognitive, communication, motor, and personal-social development using 3-point ordinal scales (0 = does not complete; 1 = partially completes; 2 = completes item). We used change in age equivalent scores for each area and the total scores for analyses. The worst possible scores are 0 months age equivalent and the best possible scores are 95 months age equivalent.
Early Coping Inventory
Time frame: Baseline and 12 months
We used the reactive and self-initiated behavior scales. We used change in raw scores for analyses. The worst possible raw score for each scale is 16 and the best possible score is 80.

Results and safety

Results posted to the registry on 4 May 2010, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Power Wheelchair	17	11
Control Group	17	11

Primary outcome: Pediatric Evaluation of Disability Inventory

Time frame: Baseline and 12 months. Median (Inter-Quartile Range). Unit: Units on scale

Measure	Power Wheelchair n = 11	Control Group n = 11
Mobility functional skills	14.6 (2.04)	6.4 (3.11)
Self-care functional skills	8.0 (0.95)	7.9 (1.68)
Social function functional skills	4.7 (1.25)	3.0 (1.93)
Mobility caregiver assistance	29.2 (2.97)	14.2 (4.00)
Self-care caregiver assistance	12.3 (3.60)	5.8 (3.45)
Social function caregiver assistance	14.8 (3.36)	19.7 (3.96)

Power Wheelchair vs Control Group: p = 0.02, Wilcoxon Signed-Rank Test
Power Wheelchair vs Control Group: p = 0.52, Wilcoxon Signed-Rank Test
Power Wheelchair vs Control Group: p = 0.38, Wilcoxon Signed-Rank Test

Population analysed: We did a per protocol analysis for 22 children who completed the study and an intention to treat (ITT) analysis for the 28 children for whom we had complete data at 12 months. The overall results of the ITT analysis did not differ from the per protocol analysis.

Primary outcome: Battelle Developmental Inventory (BDI)

Time frame: Baseline and 12 months. Median (Inter-Quartile Range). Unit: Units on scale

Measure	Power Wheelchair n = 11	Control Group n = 11
Adaptive total	4.0 (1.06)	3.0 (1.05)
Cognitive total	4.0 (1.51)	5.0 (0.93)
Communication total	7.0 (1.53)	3.0 (0.98)
Motor total	2.0 (0.52)	3.0 (0.50)
Personal-social total	5.0 (0.93)	6.0 (1.18)
BDI total score	6.0 (0.82)	4.0 (0.73)

Power Wheelchair vs Control Group: p = 0.92, Wilcoxon Signed-Rank Test
Power Wheelchair vs Control Group: p = 0.38, Wilcoxon Signed-Rank Test
Power Wheelchair vs Control Group: p = 0.42, Wilcoxon Signed-Rank Test

Primary outcome: Early Coping Inventory

Time frame: Baseline and 12 months. Median (Inter-Quartile Range). Unit: Units on scale

Measure	Power Wheelchair n = 11	Control Group n = 11
Reactive Scale	6.0 (-2.0 to 12.0)	2.0 (0 to 12.0)
Self Initiated Scale	7.0 (2.0 to 16.0)	7.0 (-1.0 to 12.0)

Power Wheelchair vs Control Group: p >0.10, Wilcoxon Signed-Rank Test
Power Wheelchair vs Control Group: p >0.10, Wilcoxon Signed-Rank Test

Adverse events

Time frame: One year. Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Power Wheelchair	0 of 17 (0%)	0 of 17 (0%)	Not reported
Control Group	0 of 17 (0%)	0 of 17 (0%)	Not reported

Limitations and caveats (from the sponsor): Small sample limited power; matched pairs design limited sample size and analyses; not all children were independent using power wheelchair in 1 year; cognitive measure probably unresponsive to changes in children with physical limitations.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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.

Irene R McEwen, 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 wheelchair and No power wheelchairs in people with Cerebral Palsy and Child, Preschool, 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 5 Dec 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?

Yes. Results are posted in the registry (first posted 4 May 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Pediatric Evaluation of Disability Inventory (time frame: Baseline and 12 months). 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 NCT01115998, 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 5 Dec 2016.