Bracing for Walking in Parkinson's Disease

NCT03192046 | Completed Results FDA Device

• 1 other identifier: STU 012014-059
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Gait Disorders, Neurologic; Parkinson Disease

Outcome Measures

Primary Outcomes (1)

• Change in Gait Capacity as Assessed b 6-Minute Walk Test

  The 6 Minute Walk Test (6MWT) is a test of walking (gait) endurance and walking velocity and measures the distance a subject can walk indoors on a flat, hard surface in a period of 6 minutes, using assistive devices, as necessary. The test is a reliable and valid evaluation of functional exercise capacity and is used as a sub-maximal test of aerobic capacity and endurance. The test will be used to determine participant's gait efficiency at baseline and at 6 months. While the total distance covered during six minutes (6MWTD) is often used as the standard measurement of gait capacity (i.e., the maximum distance one can achieve), the endurance (i.e., ability to maintain speed over a prolonged time) can be inferred by the gait speed trajectory (GST) during the 6MW test (6MWGST).

  Baseline and 6 months

Secondary Outcomes (2)

• Change in Step Length

  Baseline and 6 months

• Change in Temporal Spatial Gait Parameters Using the Computerized Gait Analysis System

  Baseline and 6 months

Study Arms (2)

Carbon Fiber Ankle Foot Orthosis (AFO)

EXPERIMENTAL

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)

Control Group, Walking Program Only

ACTIVE COMPARATOR

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

Other: Standardized walking/exercise program

Interventions

Carbon Fiber Ankle Foot Orthosis (AFO) DEVICE

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

Carbon Fiber Ankle Foot Orthosis (AFO)

Standardized walking/exercise program OTHER

standardized walking/exercise program without any brace or AFO

Control Group, Walking Program Only

Eligibility Criteria

• Age: 30 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Confirmed diagnosis of Parkinson's Disease according to the UK brain bank criteria.5
• Age between 30 and 85.
• 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
• Hoehn and Yahr stage 2-3.
• Less than 10 full heel raises in single limb stance bilaterally.

You may not qualify if:

• Body mass index greater than 40.
• Passive dorsiflexion range of motion less than approximately neutral (90 degrees)
• Any other uncontrolled health condition for which gait training is contraindicated
• Self-report of \> 1 fall/month
• A score of 11 or less on the Short Orientation-Memory-Concentration Test of Cognitive Impairment

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead
• American Orthotic and Prosthetic Association: collaborator

Study Sites (1)

UT Southwestern

Dallas, Texas, 75235, United States

Location

MeSH Terms

Conditions

Gait Disorders, Neurologic; Parkinson Disease

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Results Point of Contact

• Title: Staci Shearin
• Organization: UtexasSouthwestern

staci.shearin@utsouthwestern.edu

214-648-6564

Study Officials

• Staci Shearin, Masters

  UT Southwestern

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: This is a randomized, repeated measures, matched group study.

Study Record Dates

• First Submitted: June 13, 2017
• First Posted: June 19, 2017
• Study Start: September 1, 2016
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2020
• Last Updated: March 23, 2022
• Results First Posted: March 23, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)