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

• Sponsor: University of Oklahoma (Other)
• Overall Status: Completed
• CT.gov ID: NCT01115998
• Collaborator: U.S. Department of Education (U.S. Fed)
• Enrollment: 34
• Location: 1
• Arms: 2
• Duration (Months): 30
• Patients Per Site Per Month: 1.1

Study Details

Study Description

Brief 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. To compensate, power mobility has increasingly been advocated for young children with severe motor impairments. The study hypotheses were:

1. 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.

2. 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.

Condition or Disease	Intervention/Treatment	Phase
Cerebral Palsy; Child, Preschool	Other: Power wheelchair; Other: No power wheelchairs	Phase 2

Detailed Description

More extensive description is not desired.

Study Design

• Study Type: Interventional
• Actual Enrollment: 34 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Learning Early Travel Skills: Effects of Power Mobility on the Development of Young Children With Severe Motor Impairments
• Study Start Date: Jun 1, 2002
• Actual Primary Completion Date: Dec 1, 2004
• Actual Study Completion Date: Dec 1, 2004

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Power wheelchair	Other: Power wheelchair; Children used power wheelchairs for one year. They continued to receive their usual early intervention services.; Other Names: Invacare Power Tiger wheelchairs
Other: Control group	Other: No power wheelchairs; Children in the control group did not use power wheelchairs. They continued to receive their usual early intervention services.

Outcome Measures

Primary Outcome Measures

1. Pediatric Evaluation of Disability Inventory [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.

2. Battelle Developmental Inventory (BDI) [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.

3. Early Coping Inventory [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 14 Months to 30 Months
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Oklahoma Health Sciences Center	Oklahoma City	Oklahoma	United States	78104

Sponsors and Collaborators

• University of Oklahoma
• U.S. Department of Education

Investigators

• Principal Investigator: Irene R McEwen, PT, PhD, University of Oklahoma

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Irene McEwen, Principal Investigator, University of Oklahoma
• ClinicalTrials.gov Identifier: NCT01115998
• Other Study ID Numbers: 07956; USDE #R305T010757
• First Posted: May 4, 2010
• Last Update Posted: Dec 5, 2016
• Last Verified: Oct 1, 2016

• Keywords provided by Irene McEwen, Principal Investigator, University of Oklahoma: cerebral palsy; wheelchair; disabled children
• Additional relevant MeSH terms: Cerebral Palsy

Study Results

Participant Flow

Recruitment Details	Children were recruited from throughout Oklahoma between February 2002 and December 2003. They were recruited through the statewide early intervention program, parent groups, radio, and contacts with occupational and physical therapists.
Pre-assignment Detail	We used a matched pairs design and did not find matches for some of the children before they became too old for the study.

Arm/Group Title	Power Wheelchair	Control Group
Arm/Group Description	Children were provided custom-fitted Invacare Power Tiger power wheelchairs to use in their homes and communities for 12 months. Parents were primarily responsible for providing practice opportunities and instruction, with the children's early intervention therapists and research staff helping to solve any problems. Parents were asked to: (1) provide the child with daily opportunities to sit in the device with the motor turned on during play; (2) encourage the child to experiment with movement in a relatively large space and not be concerned if the child drove in circles; and (3) avoid telling the child what to do, but rather to let the child ex experiment unless frustrated or unsafe. The importance of parental supervision, as one would supervise any young child, was stressed. The children also received their usual early intervention services, as specified on their individualized family service plans.	The control group did not receive power wheelchairs. They did receive early intervention services as specified on their individualized family service plans.
Period Title: Overall Study
STARTED	17	17
COMPLETED	11	11
NOT COMPLETED	6	6

Baseline Characteristics

Arm/Group Title	Power Wheelchair	Control Group	Total
Arm/Group Description	Children received usual early intervention services, but no power wheelchair.	Total of all reporting groups
Overall Participants	17	17	34
Age (Count of Participants)
<=18 years	17 100%	17 100%	34 100%
Between 18 and 65 years	0 0%	0 0%	0 0%
>=65 years	0 0%	0 0%	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	1.78 (.45)	1.85 (.41)	1.82 (.43)
Gender (Count of Participants)
Female	9 52.9%	10 58.8%	19 55.9%
Male	8 47.1%	7 41.2%	15 44.1%
Region of Enrollment (participants) [Number]
United States	17 100%	17 100%	34.0 100%

Outcome Measures

1. Primary Outcome

Title	Pediatric Evaluation of Disability Inventory
Description	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.
Time Frame	Baseline and 12 months

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Power Wheelchair	Control Group
Arm/Group Description	Children were provided custom-fitted Invacare Power Tiger power wheelchairs to use in their homes and communities for 12 months. Parents were primarily responsible for providing practice opportunities and instruction, with the children's early intervention therapists and research staff helping to solve any problems. Parents were asked to: (1) provide the child with daily opportunities to sit in the device with the motor turned on during play; (2) encourage the child to experiment with movement in a relatively large space and not be concerned if the child drove in circles; and (3) avoid telling the child what to do, but rather to let the child ex experiment unless frustrated or unsafe. The importance of parental supervision, as one would supervise any young child, was stressed. The children also received their usual early intervention services, as specified on their individualized family service plans.	The control group did not receive power wheelchairs. They did receive early intervention services as specified on their individualized family service plans.
Measure Participants	11	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)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Power Wheelchair, Control Group
	Comments	Mobility functional skills Null hypothesis: The change scores of children in the power mobility and control groups will not differ from baseline to 12 months.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.02
	Comments	The a priori alpha level was < 0.10 and was not adjusted for multiple comparisons.
	Method	Wilcoxon Signed-Rank Test
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Power Wheelchair, Control Group
	Comments	Self-care functional skills Null hypothesis: The change scores of children in the power mobility and control groups will not differ from baseline to 12 months.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.52
	Comments	The a priori alpha level was <0.10 and was not adjusted for multiple comparisons
	Method	Wilcoxon Signed-Rank Test
	Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Power Wheelchair, Control Group
	Comments	Social function functional skills Null hypothesis: The change scores of children in the power mobility and control groups will not differ from baseline to 12 months.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.38
	Comments	The a priori alpha level was 0.10 and it was not adjusted for multiple comparisons.
	Method	Wilcoxon Signed-Rank Test
	Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Power Wheelchair, Control Group
	Comments	Mobility care giver assistance. Null hypothesis: The change scores of children in the power mobility and control groups will not differ from baseline to 12 months.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.03
	Comments	The a priori alpha level was 0.10 and it was not adjusted for multiple comparisons.
	Method	Wilcoxon Signed-Rank Test
	Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Power Wheelchair, Control Group
	Comments	Self-care caregiver assistance Null hypothesis: The change scores of children in the power mobility and control groups will not differ from baseline to 12 months.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	.006
	Comments
	Method	Wilcoxon Signed-Rank Test
	Comments	The a priori alpha level was 0.10 and it was not adjusted for multiple comparisons.

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	Power Wheelchair, Control Group
	Comments	Social function caregiver assistance Null hypothesis: The change scores of children in the power mobility and control groups will not differ from baseline to 12 months.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.45
	Comments	The a priori alpha level was <0.10 and it was not adjusted for multiple comparisons.
	Method	Wilcoxon Signed-Rank Test
	Comments

2. Primary Outcome

Title	Battelle Developmental Inventory (BDI)
Description	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.
Time Frame	Baseline and 12 months

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Power Wheelchair	Control Group
Arm/Group Description	Children were provided custom-fitted Invacare Power Tiger power wheelchairs to use in their homes and communities for 12 months. Parents were primarily responsible for providing practice opportunities and instruction, with the children's early intervention therapists and research staff helping to solve any problems. Parents were asked to: (1) provide the child with daily opportunities to sit in the device with the motor turned on during play; (2) encourage the child to experiment with movement in a relatively large space and not be concerned if the child drove in circles; and (3) avoid telling the child what to do, but rather to let the child ex experiment unless frustrated or unsafe. The importance of parental supervision, as one would supervise any young child, was stressed. The children also received their usual early intervention services, as specified on their individualized family service plans.	The control group did not receive power wheelchairs. They did receive early intervention services as specified on their individualized family service plans.
Measure Participants	11	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)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Power Wheelchair, Control Group
	Comments	Adaptive total Null hypothesis: The change scores of children in the power mobility and control groups will not differ from baseline to 12 months.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.92
	Comments	The a priori alpha level was <0.10 and it was not adjusted for multiple comparisons.
	Method	Wilcoxon Signed-Rank Test
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Power Wheelchair, Control Group
	Comments	Cognitive total Null hypothesis: The change scores of children in the power mobility and control groups will not differ from baseline to 12 months.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.38
	Comments	The a priori alpha level was <0.10 and it was not adjusted for multiple comparisons.
	Method	Wilcoxon Signed-Rank Test
	Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Power Wheelchair, Control Group
	Comments	Communication total Null hypothesis: The change scores of children in the power mobility and control groups will not differ from baseline to 12 months.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.42
	Comments	The a priori alpha level was <0.10 and it was not adjusted for multiple comparisons.
	Method	Wilcoxon Signed-Rank Test
	Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Power Wheelchair, Control Group
	Comments	Motor total Null hypothesis: The change scores of children in the power mobility and control groups will not differ from baseline to 12 months.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.57
	Comments	The a priori alpha level was <0.10 and it was not adjusted for multiple comparisons.
	Method	Wilcoxon Signed-Rank Test
	Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Power Wheelchair, Control Group
	Comments	Personal-social total Null hypothesis: The change scores of children in the power mobility and control groups will not differ from baseline to 12 months.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.69
	Comments	The a priori alpha level was <0.10 and it was not adjusted for multiple comparisons.
	Method	Wilcoxon Signed-Rank Test
	Comments

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	Power Wheelchair, Control Group
	Comments	BID total score Null hypothesis: The change scores of children in the power mobility and control groups will not differ from baseline to 12 months.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.28
	Comments	The a priori alpha level was <0.10 and it was not adjusted for multiple comparisons.
	Method	Wilcoxon Signed-Rank Test
	Comments

3. Primary Outcome

Title	Early Coping Inventory
Description	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.
Time Frame	Baseline and 12 months

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Power Wheelchair	Control Group
Arm/Group Description	Children were provided custom-fitted Invacare Power Tiger power wheelchairs to use in their homes and communities for 12 months. Parents were primarily responsible for providing practice opportunities and instruction, with the children's early intervention therapists and research staff helping to solve any problems. Parents were asked to: (1) provide the child with daily opportunities to sit in the device with the motor turned on during play; (2) encourage the child to experiment with movement in a relatively large space and not be concerned if the child drove in circles; and (3) avoid telling the child what to do, but rather to let the child ex experiment unless frustrated or unsafe. The importance of parental supervision, as one would supervise any young child, was stressed. The children also received their usual early intervention services, as specified on their individualized family service plans.	The control group did not receive power wheelchairs. They did receive early intervention services as specified on their individualized family service plans.
Measure Participants	11	11
Reactive Scale	6.0	2.0
Self Initiated Scale	7.0	7.0

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Power Wheelchair, Control Group
	Comments	Reactive scale Null hypothesis: The change scores of children in the power mobility and control groups will not differ from baseline to 12 months.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	>0.10
	Comments
	Method	Wilcoxon Signed-Rank Test
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Power Wheelchair, Control Group
	Comments	Self Initiated Scale Null hypothesis: The change scores of children in the power mobility and control groups will not differ from baseline to 12 months.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	>0.10
	Comments
	Method	Wilcoxon Signed-Rank Test
	Comments

Adverse Events

Time Frame	One year
Arm/Group Title	Power Wheelchair		Control Group
Arm/Group Description	Children were provided custom-fitted Invacare Power Tiger power wheelchairs to use in their homes and communities for 12 months. Parents were primarily responsible for providing practice opportunities and instruction, with the children's early intervention therapists and research staff helping to solve any problems. Parents were asked to: (1) provide the child with daily opportunities to sit in the device with the motor turned on during play; (2) encourage the child to experiment with movement in a relatively large space and not be concerned if the child drove in circles; and (3) avoid telling the child what to do, but rather to let the child ex experiment unless frustrated or unsafe. The importance of parental supervision, as one would supervise any young child, was stressed. The children also received their usual early intervention services, as specified on their individualized family service plans.		The control group did not receive power wheelchairs. They did receive early intervention services as specified on their individualized family service plans.
All Cause Mortality
	Power Wheelchair		Control Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Power Wheelchair		Control Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/17 (0%)		0/17 (0%)
Other (Not Including Serious) Adverse Events
	Power Wheelchair		Control Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/17 (0%)		0/17 (0%)

Limitations/Caveats

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.

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.