Bracing for Walking in Parkinson's Disease


Original post, click here

Verified June 2017 by Staci Shearin, University of Texas Southwestern Medical Center

Sponsor:

Collaborator:

American Orthotic and Prosthetic Association

Information provided by (Responsible Party):

Staci Shearin, University of Texas Southwestern Medical Center

ClinicalTrials.gov Identifier:

NCT03192046

First received: June 13, 2017

Last updated: June 14, 2017

Last verified: June 2017

Parkinson disease (PD) is a progressive neurological disease that results in characteristic gait dysfunction. Gait problems include decreased velocity, decreased stride length, difficulty with initiation of gait, postural stability problems and alteration in joint kinematics.1 In this typically older patient population, these gait deviations affect their participation in household and community activities. The standard of care is currently focused on therapeutic exercise and cueing of various types (visual, auditory, verbal). Current interventions have not been demonstrated to markedly improve gait kinematics, so there is a need to identify interventions that could improve gait performance in this population. Lower extremity bracing is a common and well-established intervention for gait dysfunction with other populations, including stroke and brain injury. The braces allow for improved stability, sensory feedback, and consistent tactile cues to allow patients to have the best gait mechanics with each step. It is reasonable to hypothesize that appropriate bracing may have the potential to improve gait function and kinematics in PD since these patient often have gastroc-soleus weakness. Data from our early pilot studies indicates that bracing individuals with PD can positively impact their mobility. This includes improvements in velocity, step length, and dynamic balance. Additional data supported an upward trend in quality of life.

Gait Disorders, Neurologic
Parkinson Disease
Device: Carbon Fiber Ankle Foot Orthosis (AFO)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

This is a randomized, repeated measures, matched group study.

Masking: No masking
Primary Purpose: Treatment

Official Title: Impact of Carbon Fiber AFOs on Gait and Resulting Changes in Quality of Life Across Time in Persons With PD

Primary Outcome Measures:

Secondary Outcome Measures:

  • Change in Four Square Step test [ Time Frame: Initial and 6 months ]

    Balance while stepping in different directions will be assessed using this test.

  • Change in Computerized Gait Analysis [ Time Frame: Initial and 6 months ]

    Gait will be evaluated using the Observational Gait Analysis system during over ground walking

  • Change in Three-Dimensional gait analysis [ Time Frame: Initial and 6 months ]

    Subjects will be outfitted with small retro-reflective markers secured to anatomical locations with easily removable tape

Estimated Enrollment: 16
Actual Study Start Date: September 2016
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Experimental: Carbon Fiber Ankle Foot Orthosis (AFO)

For the bracing group, the participants will wear custom fabricated carbon fiber braces in addition to participating in a daily walking program and 7 visits of PT.

Device: Carbon Fiber Ankle Foot Orthosis (AFO)

Custom AFOs in conjunction with a walking program, working up to walking 30 minutes 6 days a week.

Active Comparator: Control Group, Walking Program Only

The participants in this group will be prescribed a daily home walking walking program and 7 visits of PT.

Device: Carbon Fiber Ankle Foot Orthosis (AFO)

Custom AFOs in conjunction with a walking program, working up to walking 30 minutes 6 days a week.

This is a randomized, repeated measures, matched group study. There will be two groups of participants, 8 participants per group, 35 participants total from time of initial enrollment in this study. Group one (G1) will receive bilateral custom braces and a standardized home walking/exercise program. Group two will receive the standardized walking/exercise program without any brace or AFO. Subjects will be randomized upon enrollment in the study. At the time of consent, random drawing from concealed envelopes with red, blue or green chips will be done to determine group assignment. Subjects will be recruited through the Clinical Center for Movement Disorders at UT Southwestern Medical Center where patients with PD receive routine evaluation and follow-up. Subjects will be followed for 6 months during this study and outcome measures will be collected 3 times over the course of the study. Subjects will be seen every 3 months for the duration of the study for testing as well as for other visits as noted in the table below. Participants will not need to have insurance benefits for initial physical therapy evaluation and for ankle braces. All subsequent visits to the Crowley gait lab for assessments and brace adjustment will be provided at no cost to the participants.

Ages Eligible for Study:   30 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Confirmed diagnosis of Parkinson’s Disease according to the UK brain bank criteria.5
  2. Age between 30 and 85.
  3. Measurable decrement in gait velocity (between 35 and 15 percent below age-predicted norms for self-selected walking velocity) as measured by the 6 MWT
  4. Hoehn and Yahr stage 2-3.
  5. Less than 10 full heel raises in single limb stance bilaterally.

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
  4. Self-report of > 1 fall/month
  5. A score of 11 or less on the Short Orientation-Memory-Concentration Test of Cognitive Impairment

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03192046

UT Southwestern
Dallas, Texas, United States, 75235
Contact: Staci Shearin, Masters         

University of Texas Southwestern Medical Center

American Orthotic and Prosthetic Association

Principal Investigator: Staci Shearin, Masters UT Southwestern

Responsible Party: Staci Shearin, Assistant Professor, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT03192046     History of Changes
Other Study ID Numbers: Parkinson’s Disease AFO
Study First Received: June 13, 2017
Last Updated: June 14, 2017
Individual Participant Data  
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:

Parkinson Disease
Nervous System Diseases
Gait Disorders, Neurologic
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Neurologic Manifestations
Signs and Symptoms
Carbon fiber
Anti-Infective Agents, Local
Anti-Infective Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents

ClinicalTrials.gov processed this record on June 19, 2017