Down Syndrome
Conditions
Keywords
Down syndrome, Gait, Motor Development, Orthoses
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALTreadmill Training
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.
DEVICESupramalleolar Orthoses
In addition to treadmill training the infants receive Supramalleolar orthoses. They wear the orthoses for 8 hours a day, 5 days a week.
Sponsors
University of Michigan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Months to 36 Months
Healthy volunteers
No
Inclusion criteria
* Trisomy 21 * Able to pull to stand but not walk
Exclusion criteria
* Additional developmental diagnoses * Uncorrected vision or hearing impairments * Previous orthotic intervention * Previous treadmill intervention
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pattern of Gross Motor Development | monthly; starting when child can pull to stand and ending when the test determined that the child was walking. | Age in months at walking development as indicated by the Gross Motor Function Measure, a standardized test of gross motor development. |
Countries
United States
Participant flow
Recruitment details
Recruitment in Winter 2007 for in home intervention.
Pre-assignment details
Subjects were excluded if they previously had worn foot orthoses
Participants by arm
| Arm | Count |
|---|---|
| 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. | 10 |
| 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. | 12 |
| Total | 22 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 0 | 5 |
Baseline characteristics
| Characteristic | Treadmill Training and Orthotic Use | Treadmill Training Only | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 12 Participants | 10 Participants | 22 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 12 years STANDARD_DEVIATION 2 | 12 years STANDARD_DEVIATION 2 | 12 years STANDARD_DEVIATION 2 |
| Region of Enrollment United States | 12 participants | 10 participants | 22 participants |
| Sex: Female, Male Female | 5 Participants | 4 Participants | 9 Participants |
| Sex: Female, Male Male | 7 Participants | 6 Participants | 13 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 10 | 0 / 12 |
| other Total, other adverse events | 0 / 10 | 0 / 12 |
| serious Total, serious adverse events | 0 / 10 | 0 / 12 |
Outcome results
Primary
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.
Population: analysis was on protocol
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treadmill Training Only | Pattern of Gross Motor Development | 28.2 months | Standard Deviation 8.3 |
| Treadmill Training and Orthotic Use | Pattern of Gross Motor Development | 28.3 months | Standard Deviation 5.9 |