Trial Outcomes & Findings for Gait in Children With Down Syndrome While Wearing Orthoses (NCT NCT01598350)

NCT ID: NCT01598350

Last Updated: 2013-12-30

Results Overview

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

6 participants

Primary outcome timeframe

60 minutes

Results posted on

2013-12-30

Participant Flow

Subjects were recruited from local elementary schools from November 2009 until January 2009

Participant milestones

Participant milestones
Measure
Orthotic
Orthotic Use Supramalleolar Orthoses (Cascade) : Walk wearing supramalleolar orthoses - three trial
Overall Study
STARTED
6
Overall Study
COMPLETED
6
Overall Study
NOT COMPLETED
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Gait in Children With Down Syndrome While Wearing Orthoses

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Orthotic
n=6 Participants
Orthotic Use Supramalleolar Orthoses (Cascade) : Walk wearing supramalleolar orthoses - three trial
Age, Categorical
<=18 years
6 Participants
n=5 Participants
Age, Categorical
Between 18 and 65 years
0 Participants
n=5 Participants
Age, Categorical
>=65 years
0 Participants
n=5 Participants
Age Continuous
4.5 years
STANDARD_DEVIATION .71 • n=5 Participants
Sex: Female, Male
Female
2 Participants
n=5 Participants
Sex: Female, Male
Male
4 Participants
n=5 Participants
Region of Enrollment
United States
6 participants
n=5 Participants

PRIMARY outcome

Timeframe: 60 minutes

Outcome measures

Outcome measures
Measure
Orthotic
n=6 Participants
Orthotic Use Supramalleolar Orthoses (Cascade) : Walk wearing supramalleolar orthoses - three trial
Step Width
10.4 cm
Standard Deviation 2.8

Adverse Events

Orthotic

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

Julia Looper, PT PhD

University of Puget Sound

Phone: 253 879 2895

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place