Effects of Two Different Types of Ankle Foot Orthoses on Gait Outcomes in Patients With Subacute Stroke.

Summary

PURPOSE: The purpose of this study will be to identify whether patients in the subacute stage of stroke, who demonstrate foot drop, will have better gait outcomes when using a Double Adjustable AFO, or a Posterior Leaf Spring AFO. A secondary purpose will be to determine whether one week of practice significantly changes gait outcomes with either of the AFO conditions.

INCLUSION CRITERIA: Twenty participants over the age of 18, of any gender and ethnicity, diagnosed with first time unilateral stroke, 4 - 20 weeks post-stroke onset, resulting in hemiparesis with foot drop will be recruited for this study.

EXCLUSION CRITERIA:

1. Not able to receive a double adjustable AFO through their insurance
2. Unable to follow two steps commands
3. Unable to ambulate 20 feet with or without assistive device with a minimum level of assistance of contact guard assistance.
4. Cerebellar Stroke
5. Inability to ambulate prior to stroke
6. receiving chemotherapy at the time of study

OUTCOME MEASURES:

1. Six Minute walk test
2. Gait Symmetry and Gait velocity measured with GAITRite for self paced velocity walk and fast paced velocity walk.

DATA COLLECTION:

Data will be collected three times over two weeks period.

First Visit:

Demographics, Fugl-Meyer Lower Extremity Assessment of sensorimotor function, Mini Mental State Examination 6MWT and GAITRite measurements using Both types of AFO in a random order. Afterwards participant will be given one type of AFO (randomly selected) to practice walking for a week.

Second Visit: 6MWT and GAITRite measurements using the type of AFO they were practicing with. Then the other type of AFO will be given to practice walking for a week.

Third Visit: 6MWT and GAITRite measurements using the second type of AFO that they were practicing with the week prior. Patient will be asked which type of AFO they prefer to use.

Conditions

• Stroke
• CVA
• Hemiplegia
• Hemiparesis
• Foot Drop

Interventions

DEVICE

Posterior Leaf spring AFO

Posterior Leaf Spring AFO is an over the shelf polypropylene ankle foot orthosis to assist foot drop.

DEVICE

Double adjustable AFO

Double adjustable AFO is a custom AFO with double action metal upright joints

Sponsors & Collaborators

• Baylor Research Institute

  collaborator OTHER

• Texas Woman's University

  lead OTHER

Principal Investigators

• Priya Karakkattil, MS · Texas Woman's University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2016-01-31

Primary Completion

2018-04-30

Completion

2018-04-30

Countries

• United States

Study Locations