Trial Outcomes & Findings for Orthotics in Ambulatory Cerebral Palsy (NCT NCT01527162)

Results Overview

Daily walking activity will be measured with the StepWatch accelerometer documenting average strides/day.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

11 participants

Primary outcome timeframe

average of 5 days of second week of intervention

Results posted on

2021-06-16

Participant Flow

Participant milestones

Participant milestones
Measure	SAFO Worn First, Then Not Worn Child wears their prescribed SAFO for 14 days by random assignment and then not worn	SAFO NOT Worn First, Then Worn Child does not wear their prescirbed SAFO for 14 days by random assignment, then worn
Overall Study NOT COMPLETED	0	0
Overall Study STARTED	6	5
Overall Study COMPLETED	6	5

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Orthotics in Ambulatory Cerebral Palsy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Participants n=11 Participants We used a randomized cross-over design with eleven children with bilateral 9 CP, mean age 4.3 years. Subjects were randomized to their current SAFO worn or SAFO not worn for 2 weeks and then crossed over.
Age, Categorical <=18 years	11 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	4.3 years n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants
Region of Enrollment United States	11 participants n=5 Participants

PRIMARY outcome

Timeframe: average of 5 days of second week of intervention

Daily walking activity will be measured with the StepWatch accelerometer documenting average strides/day.

Outcome measures

Outcome measures
Measure	SAFO Worn n=11 Participants Child wears their prescribed SAFO for 14 days SAFO worn: Child wears their prescribed SAFO for 14 days by random assignment SAFO not worn: Child does not wear their prescirbed SAFO for 14 days by random assignment	SAFO Not Worn n=11 Participants Child does not wear the prescribed SAFO for 14 days
Walking Activity Levels	4660 average total strides/day Standard Deviation 1421	4897 average total strides/day Standard Deviation 1438

SECONDARY outcome

Timeframe: previous 7 day reference

Physical activity will be by parental report of Physical Activities Scale for Kids performance version (ASKp) survey- total score. Scale ranges from 0 to 100 with higher scores representing more physical activity. A score of 100 on this criterion referenced evalutive measure is consistent with physical activity like that of a typically developing 5 year old.

Outcome measures

Outcome measures
Measure	SAFO Worn n=11 Participants Child wears their prescribed SAFO for 14 days SAFO worn: Child wears their prescribed SAFO for 14 days by random assignment SAFO not worn: Child does not wear their prescirbed SAFO for 14 days by random assignment	SAFO Not Worn n=11 Participants Child does not wear the prescribed SAFO for 14 days
Physical Activity Scale for Kids - Performance Version (ASKp)	51.08 units on a scale Standard Deviation 11.64	49.45 units on a scale Standard Deviation 14.2

SECONDARY outcome

Timeframe: previous 7 day reference

Participation in habits of daily life will be by parental report of the Life Habits questionnaire(Life-H for children) by the weighted total score on a scale of 0 to 9, with a higher score representing more participation in habits of daily life.

Outcome measures

Outcome measures
Measure	SAFO Worn n=11 Participants Child wears their prescribed SAFO for 14 days SAFO worn: Child wears their prescribed SAFO for 14 days by random assignment SAFO not worn: Child does not wear their prescirbed SAFO for 14 days by random assignment	SAFO Not Worn n=11 Participants Child does not wear the prescribed SAFO for 14 days
Assessment of Life Habits for Children (LIFE-H)	5.71 units on a scale Standard Deviation 2.0	5.11 units on a scale Standard Deviation 2.2

Adverse Events

SAFO Worn

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

SAFO Not Worn

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

Kristie Bjornson, PhD, PT

Seattle Children's Research Institute

Phone: 206 884-2066

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place