An interventional study of Treadmill Training and Supramalleolar Orthoses in Down Syndrome, sponsored by University of Michigan. Completed at 1 site in United States. Open to participants aged 6 Months to 36 Months. Per ClinicalTrials.gov, last updated 2017-12-04.
Sponsored by University of Michigan · Not applicable, Interventional, and Treatment
This study determines the effect of orthotic use in combination with treadmill training on the development of gross motor skills and walking onset in infants with Down syndrome.
The goal of this study is to determine if orthotic use impacts the development of walking and upright play skills over and above the impact that treadmill training alone has. Infants with Down syndrome who can pull to stand but not walk will be recruited and assigned to a group that receives treadmill training and orthoses or just treadmill training. The infants are followed monthly until they have one month of walking experience. During the monthly visits, the infants' gross motor development is tested and their upright play behavior is observed. At the end of the study each infants gait is evaluated. We believe that the orthoses will lead to a decreased age at walking onset, an improvement in gait patterns, and an improvement in upright play ability.
432 studies on the registry are indexed under Down Syndrome; 100 are open to participants now.
This study's enrollment of 22 is below the median of 36 across 283 interventional studies indexed under Down Syndrome.
Browse Down Syndrome studies →University of Michigan is the lead sponsor of 1,475 studies on the registry; 196 are open to participants now.
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Exclusion Criteria:
Treadmill Training in infants with Down syndrome only
Behavioral: Treadmill Training
Treadmill Training and supramalleolar orthoses use for infants with Down syndrome
Behavioral: Treadmill Training · Device: Supramalleolar Orthoses
Parents hold their infants on an infant treadmill for 8 minutes a day, 5 days a week. The treadmill speed is set at 0.2 m/s.
In addition to treadmill training the infants receive Supramalleolar orthoses. They wear the orthoses for 8 hours a day, 5 days a week.
Also known as: Orthoses, Orthotics
Pattern of Gross Motor Development
Age in months at walking development as indicated by the Gross Motor Function Measure, a standardized test of gross motor development.
Time frame: monthly; starting when child can pull to stand and ending when the test determined that the child was walking.
Recruitment in Winter 2007 for in home intervention.
| Milestone | Treadmill Training Only | Treadmill Training and Orthotic Use |
|---|---|---|
| Started | 10 | 12 |
| Completed | 10 | 7 |
| Not completed | 0 | 5 |
| Withdrew: Withdrawal by subject | 0 | 5 |
Age in months at walking development as indicated by the Gross Motor Function Measure, a standardized test of gross motor development.
| months | Treadmill Training Only | Treadmill Training and Orthotic Use |
|---|---|---|
| Pattern of Gross Motor Development | 28.2 ± 8.3 | 28.3 ± 5.9 |
Non-serious events are listed at a 1% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Treadmill Training Only | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) |
| Treadmill Training and Orthotic Use | 0/12 (0%) | 0/12 (0%) | 0/12 (0%) |
| Age, Categorical(Participants) | Treadmill Training Only | Treadmill Training and Orthotic Use | Total |
|---|---|---|---|
| <=18 years | 10 | 12 | 22 |
| Between 18 and 65 years | 0 | 0 | 0 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(years) | Treadmill Training Only | Treadmill Training and Orthotic Use | Total |
|---|---|---|---|
| Mean | 12 ± 2 | 12 ± 2 | 12 ± 2 |
| Sex: Female, Male(Participants) | Treadmill Training Only | Treadmill Training and Orthotic Use | Total |
|---|---|---|---|
| Female | 4 | 5 | 9 |
| Male | 6 | 7 | 13 |
| Region of Enrollment(participants) | Treadmill Training Only | Treadmill Training and Orthotic Use | Total |
|---|---|---|---|
| United States | 10 | 12 | 22 |
This study is completed, as verified in Oct 2017. You cannot join it, but the record below documents what was studied.
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