Impact of Walking Practice on Persons With PD

The University of Texas System (UT)

Status: Terminated

Conditions: Parkinson's Disease

Treatments: Other: Individualized walking program; Other: Walking program with ankle brace; Other: Walking program with custom braces.

Study type: Interventional

Funder types: Other

Identifiers

NCT02113189

PD walking study

Details and patient eligibility

About

The purpose of this study is to investigate the impact of a specifically designed leg brace on walking endurance in individuals with Parkinson's disease.

Full description

This is a randomized, repeated measures, matched group study. There will be three groups of participants, 20 participants per group, 60 participants total. Group one (G1) will receive custom-fabricated bilateral braces and a standardized home walking/exercise program. Group two (G2) will receive an off-the shelf ankle support and standardized home walking/exercise program. Group three (G3) will receive the standardized walking/exercise program without any brace or AFO. Subjects will be randomized upon enrollment in the study. Subjects will be followed for one year during this study and outcome measures will be collected 3 times over the course of the study. Subjects will be seen every 6 months for the duration of the study for testing as well as for other visits as noted in the table below.

Enrollment: 13 patients

Sex: All

Ages: 30 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Confirmed diagnosis of Parkinson's Disease according to the UK brain bank criteria.5
2. Age between 30 and 90.
3. Ability to walk 150 feet independently over level surfaces with or without an assistive device.
4. Hoehn and Yahr stage 1-4.
5. Less than 10 full heel raises in single limb stance bilaterally.
6. Adequate insurance/funding to pay for physical therapy evaluation and AFO devices.

Exclusion criteria

1. Body mass index greater than 40.
2. Passive dorsiflexion range of motion less than approximately neutral (90 degrees)
3. Any other uncontrolled health condition for which gait training is contraindicated

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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13 participants in 3 patient groups

Walking program with ankle brace

Experimental group

Description:

This group will receive bilateral off-the-shelf ankle braces as well as a customized walking program.

Treatment:

Other: Walking program with ankle brace

Individualized walking program

Experimental group

Description:

This group will receive a customized walking program.

Treatment:

Other: Individualized walking program

Walking program with custom braces

Experimental group

Description:

This group will receive bilateral custom-fabricated ankle braces as well as a customized walking program.

Treatment:

Other: Walking program with custom braces.