Trial Outcomes & Findings for Effect of Power Wheelchairs on the Development and Function of Young Children With Severe Physical Disabilities (NCT NCT01115998)
NCT ID: NCT01115998
Last Updated: 2016-12-05
Results Overview
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.
COMPLETED
PHASE2
34 participants
Baseline and 12 months
2016-12-05
Participant Flow
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.
We used a matched pairs design and did not find matches for some of the children before they became too old for the study.
Participant milestones
| Measure |
Power Wheelchair
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.
|
Control Group
The control group did not receive power wheelchairs. They did receive early intervention services as specified on their individualized family service plans.
|
|---|---|---|
|
Overall Study
STARTED
|
17
|
17
|
|
Overall Study
COMPLETED
|
11
|
11
|
|
Overall Study
NOT COMPLETED
|
6
|
6
|
Reasons for withdrawal
| Measure |
Power Wheelchair
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.
|
Control Group
The control group did not receive power wheelchairs. They did receive early intervention services as specified on their individualized family service plans.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
6
|
6
|
Baseline Characteristics
Effect of Power Wheelchairs on the Development and Function of Young Children With Severe Physical Disabilities
Baseline characteristics by cohort
| Measure |
Power Wheelchair
n=17 Participants
|
Control Group
n=17 Participants
Children received usual early intervention services, but no power wheelchair.
|
Total
n=34 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
17 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
1.78 years
STANDARD_DEVIATION .45 • n=5 Participants
|
1.85 years
STANDARD_DEVIATION .41 • n=7 Participants
|
1.82 years
STANDARD_DEVIATION .43 • n=5 Participants
|
|
Gender
Female
|
9 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Gender
Male
|
8 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
17 participants
n=5 Participants
|
17 participants
n=7 Participants
|
34.0 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and 12 monthsPopulation: 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.
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.
Outcome measures
| Measure |
Power Wheelchair
n=11 Participants
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.
|
Control Group
n=11 Participants
The control group did not receive power wheelchairs. They did receive early intervention services as specified on their individualized family service plans.
|
|---|---|---|
|
Pediatric Evaluation of Disability Inventory
Mobility functional skills
|
14.6 Units on scale
Inter-Quartile Range 2.04 • Interval 8.6 to 17.1
|
6.4 Units on scale
Inter-Quartile Range 3.11 • Interval -2.7 to 15.5
|
|
Pediatric Evaluation of Disability Inventory
Self-care functional skills
|
8.0 Units on scale
Inter-Quartile Range 0.95 • Interval 5.7 to 11.8
|
7.9 Units on scale
Inter-Quartile Range 1.68 • Interval 1.4 to 8.5
|
|
Pediatric Evaluation of Disability Inventory
Social function functional skills
|
4.7 Units on scale
Inter-Quartile Range 1.25 • Interval 3.3 to 8.4
|
3.0 Units on scale
Inter-Quartile Range 1.93 • Interval 0.0 to 8.6
|
|
Pediatric Evaluation of Disability Inventory
Mobility caregiver assistance
|
29.2 Units on scale
Inter-Quartile Range 2.97 • Interval 17.3 to 36.8
|
14.2 Units on scale
Inter-Quartile Range 4.00 • Interval 1.8 to 28.2
|
|
Pediatric Evaluation of Disability Inventory
Self-care caregiver assistance
|
12.3 Units on scale
Inter-Quartile Range 3.60 • Interval 11.6 to 25.4
|
5.8 Units on scale
Inter-Quartile Range 3.45 • Interval 0.0 to 20.7
|
|
Pediatric Evaluation of Disability Inventory
Social function caregiver assistance
|
14.8 Units on scale
Inter-Quartile Range 3.36 • Interval 9.9 to 28.1
|
19.7 Units on scale
Inter-Quartile Range 3.96 • Interval 0.0 to 28.1
|
PRIMARY outcome
Timeframe: Baseline and 12 monthsPopulation: 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.
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.
Outcome measures
| Measure |
Power Wheelchair
n=11 Participants
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.
|
Control Group
n=11 Participants
The control group did not receive power wheelchairs. They did receive early intervention services as specified on their individualized family service plans.
|
|---|---|---|
|
Battelle Developmental Inventory (BDI)
Adaptive total
|
4.0 Units on scale
Inter-Quartile Range 1.06 • Interval 2.0 to 5.0
|
3.0 Units on scale
Inter-Quartile Range 1.05 • Interval 0.0 to 8.0
|
|
Battelle Developmental Inventory (BDI)
Cognitive total
|
4.0 Units on scale
Inter-Quartile Range 1.51 • Interval 3.0 to 12.0
|
5.0 Units on scale
Inter-Quartile Range 0.93 • Interval 2.0 to 8.0
|
|
Battelle Developmental Inventory (BDI)
Communication total
|
7.0 Units on scale
Inter-Quartile Range 1.53 • Interval 0.0 to 8.0
|
3.0 Units on scale
Inter-Quartile Range 0.98 • Interval 0.0 to 7.0
|
|
Battelle Developmental Inventory (BDI)
Motor total
|
2.0 Units on scale
Inter-Quartile Range 0.52 • Interval 2.0 to 4.0
|
3.0 Units on scale
Inter-Quartile Range 0.50 • Interval 0.0 to 3.0
|
|
Battelle Developmental Inventory (BDI)
Personal-social total
|
5.0 Units on scale
Inter-Quartile Range 0.93 • Interval 4.0 to 9.0
|
6.0 Units on scale
Inter-Quartile Range 1.18 • Interval 0.0 to 9.0
|
|
Battelle Developmental Inventory (BDI)
BDI total score
|
6.0 Units on scale
Inter-Quartile Range 0.82 • Interval 3.0 to 7.0
|
4.0 Units on scale
Inter-Quartile Range 0.73 • Interval 1.0 to 8.0
|
PRIMARY outcome
Timeframe: Baseline and 12 monthsPopulation: 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.
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.
Outcome measures
| Measure |
Power Wheelchair
n=11 Participants
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.
|
Control Group
n=11 Participants
The control group did not receive power wheelchairs. They did receive early intervention services as specified on their individualized family service plans.
|
|---|---|---|
|
Early Coping Inventory
Reactive Scale
|
6.0 Units on scale
Interval -2.0 to 12.0
|
2.0 Units on scale
Interval 0.0 to 12.0
|
|
Early Coping Inventory
Self Initiated Scale
|
7.0 Units on scale
Interval 2.0 to 16.0
|
7.0 Units on scale
Interval -1.0 to 12.0
|
Adverse Events
Power Wheelchair
Control Group
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Director of Sponsored Programs
University of Oklahoma Health Sciences Cetner
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place