Trial Outcomes & Findings for Treadmill Training and Orthotic Use in Infants With Down Syndrome (NCT NCT00825175)
NCT ID: NCT00825175
Last Updated: 2017-12-04
Results Overview
Age in months at walking development as indicated by the Gross Motor Function Measure, a standardized test of gross motor development.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
22 participants
Primary outcome timeframe
monthly; starting when child can pull to stand and ending when the test determined that the child was walking.
Results posted on
2017-12-04
Participant Flow
Recruitment in Winter 2007 for in home intervention.
Subjects were excluded if they previously had worn foot orthoses
Participant milestones
| Measure |
Treadmill Training Only
This group received treadmill training in home for 8 min per day/ 5 days per week. Training started when the children pulled to stand and ended when they could take 3 independent steps.
|
Treadmill Training and Orthotic Use
This group received treadmill training from the time they could pull to stand until they could take 3 independent steps. They also work supramalleolar foot orthoses for 8 hours a day during that time frame.
|
|---|---|---|
|
Overall Study
STARTED
|
10
|
12
|
|
Overall Study
COMPLETED
|
10
|
7
|
|
Overall Study
NOT COMPLETED
|
0
|
5
|
Reasons for withdrawal
| Measure |
Treadmill Training Only
This group received treadmill training in home for 8 min per day/ 5 days per week. Training started when the children pulled to stand and ended when they could take 3 independent steps.
|
Treadmill Training and Orthotic Use
This group received treadmill training from the time they could pull to stand until they could take 3 independent steps. They also work supramalleolar foot orthoses for 8 hours a day during that time frame.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
5
|
Baseline Characteristics
Treadmill Training and Orthotic Use in Infants With Down Syndrome
Baseline characteristics by cohort
| Measure |
Treadmill Training Only
n=10 Participants
This group received treadmill training in home for 8 min per day/ 5 days per week. Training started when the children pulled to stand and ended when they could take 3 independent steps.
|
Treadmill Training and Orthotic Use
n=12 Participants
This group received treadmill training from the time they could pull to stand until they could take 3 independent steps. They also work supramalleolar foot orthoses for 8 hours a day during that time frame.
|
Total
n=22 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
10 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
22 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
|
12 years
STANDARD_DEVIATION 2 • n=5 Participants
|
12 years
STANDARD_DEVIATION 2 • n=7 Participants
|
12 years
STANDARD_DEVIATION 2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=5 Participants
|
12 participants
n=7 Participants
|
22 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: monthly; starting when child can pull to stand and ending when the test determined that the child was walking.Population: analysis was on protocol
Age in months at walking development as indicated by the Gross Motor Function Measure, a standardized test of gross motor development.
Outcome measures
| Measure |
Treadmill Training Only
n=10 Participants
This group received treadmill training in home for 8 min per day/ 5 days per week. Training started when the children pulled to stand and ended when they could take 3 independent steps.
|
Treadmill Training and Orthotic Use
n=7 Participants
This group received treadmill training from the time they could pull to stand until they could take 3 independent steps. They also work supramalleolar foot orthoses for 8 hours a day during that time frame.
|
|---|---|---|
|
Pattern of Gross Motor Development
|
28.2 months
Standard Deviation 8.3
|
28.3 months
Standard Deviation 5.9
|
Adverse Events
Treadmill Training Only
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Treadmill Training and Orthotic Use
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place