Trial Outcomes & Findings for Effect of Lower Extremity Ankle Foot Orthoses in Parkinson's Disease (NCT NCT01798927)

Results Overview

Participants will be asked to walk on a 12-16 foot long vinyl pad placed on the floor. The mat will record and analyze step length.

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

4 participants

Primary outcome timeframe

Done at time of enrollment in the study, i.e. baseline and 10 weeks post enrollment

Results posted on

2015-08-03

Participant Flow

Participant milestones

Participant milestones
Measure	Ankle Foot Orthosis Fitting All participants will receive ankle foot orthosis or orthoses. Outcomes will be compared to pre-bracing findings. Ankle foot orthosis: Participants will receive a Tamarack ankle foot orthosis with a check strap for gait training as well as a home walking program.
Overall Study STARTED	4
Overall Study COMPLETED	3
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Ankle Foot Orthosis Fitting All participants will receive ankle foot orthosis or orthoses. Outcomes will be compared to pre-bracing findings. Ankle foot orthosis: Participants will receive a Tamarack ankle foot orthosis with a check strap for gait training as well as a home walking program.
Overall Study Withdrawal by Subject	1

Baseline Characteristics

Effect of Lower Extremity Ankle Foot Orthoses in Parkinson's Disease

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Ankle Foot Orthosis Fitting n=4 Participants All participants will receive ankle foot orthosis or orthoses. Outcomes will be compared to pre-bracing findings. Ankle foot orthosis: Participants will receive a Tamarack ankle foot orthosis with a check strap for gait training as well as a home walking program.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	2 Participants n=5 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants
Age, Continuous	68 years STANDARD_DEVIATION 5.22 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants
Region of Enrollment United States	4 participants n=5 Participants

PRIMARY outcome

Timeframe: Done at time of enrollment in the study, i.e. baseline and 10 weeks post enrollment

Population: step length was analyzed from the GAITRite

Participants will be asked to walk on a 12-16 foot long vinyl pad placed on the floor. The mat will record and analyze step length.

Outcome measures

Outcome measures
Measure	Ankle Foot Orthosis Fitting n=3 Participants All participants will receive ankle foot orthosis or orthoses. Outcomes will be compared to pre-bracing findings. Ankle foot orthosis: Participants will receive a Tamarack ankle foot orthosis with a check strap for gait training as well as a home walking program.
Change in Step Length by Means of Computerized Gait Analysis From Initial to Final Testing	6.7 cm Standard Deviation 2.77

SECONDARY outcome

Timeframe: Done at time of enrollment in the study, i.e. baseline and week 10 post enrollment.

Population: EMG data was analyzed from 3 of the 4 participants

Surface electromyography will be done on key muscles in the lower extremity (quads, anterior tibialis, gastrocnemius) during computerized gait assessment. Changes in EMG activity include things such as increases in amplitude or timing that might indicate increases in strength or motor learning as a result of wearing the ankle foot orthosis.

Outcome measures

Outcome measures
Measure	Ankle Foot Orthosis Fitting n=3 Participants All participants will receive ankle foot orthosis or orthoses. Outcomes will be compared to pre-bracing findings. Ankle foot orthosis: Participants will receive a Tamarack ankle foot orthosis with a check strap for gait training as well as a home walking program.
Number of Participants With a Change in Electromyography of Key Lower Extremity Muscles From Initial to Final Testing	0 participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Done at time of enrollment in the study, i.e. baseline and week 10 post enrollment

Population: data from 3 of the 4 participants was analyzed

Each participant will be asked to walk at a self-selected velocity on level surfaces for 6 minutes. They will be allowed to use assistive devices if necessary.

Outcome measures

Outcome measures
Measure	Ankle Foot Orthosis Fitting n=3 Participants All participants will receive ankle foot orthosis or orthoses. Outcomes will be compared to pre-bracing findings. Ankle foot orthosis: Participants will receive a Tamarack ankle foot orthosis with a check strap for gait training as well as a home walking program.
Change in Walking Endurance by Use of 6-Minute Walk Test From Initial to Final Testing	.2 meters Standard Deviation 0

Adverse Events

Ankle Foot Orthosis Fitting

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

Karen McCain, PT, DPT, NCS

UT Southwestern Medical Center

Phone: 214-648-1559

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place