NCT02113189

Brief Summary

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2014

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

April 10, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 14, 2014

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
2.5 years until next milestone

Results Posted

Study results publicly available

March 22, 2019

Completed
Last Updated

March 22, 2019

Status Verified

March 1, 2019

Enrollment Period

2.5 years

First QC Date

April 10, 2014

Results QC Date

December 21, 2017

Last Update Submit

March 20, 2019

Conditions

Parkinson's Disease

Keywords

gaitParkinson's disease

Outcome Measures

Primary Outcomes (1)

  • Change in Distance Walked on 6-Minute Walk Test (6MWT)

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

    6MWT will be done at initial testing and 12 months

Secondary Outcomes (1)

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

    Testing will be done at initial testing and 12 months

Other Outcomes (1)

  • Change in Daily Activity as Measured by Steps Per Day

    Total steps per day will be measured at the start of the study and a week prior to testing at 6 months, and 12 months

Study Arms (3)

Walking program with ankle brace

EXPERIMENTAL

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

Other: Walking program with ankle brace

Individualized walking program

EXPERIMENTAL

This group will receive a customized walking program.

Other: Individualized walking program

Walking program with custom braces

EXPERIMENTAL

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

Other: Walking program with custom braces.

Interventions

Walking program with ankle braceOTHER

Walking program will include instructions on walking activities at home such as time of walking. Walking will be done with the bilateral ankle braces on.

Walking program with ankle brace
Individualized walking programOTHER

Walking program will include instructions on walking activities at home such as time of walking

Individualized walking program
Walking program with custom braces.OTHER

Walking program will include instructions on walking activities at home such as time of walking. Walking will be done with custom-fabricated ankle braces on.

Walking program with custom braces

Eligibility Criteria

Age30 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (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 90.
  • Ability to walk 150 feet independently over level surfaces with or without an assistive device.
  • Hoehn and Yahr stage 1-4.
  • Less than 10 full heel raises in single limb stance bilaterally.
  • Adequate insurance/funding to pay for physical therapy evaluation and AFO devices.

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Texas Southwestern Medical Center David M. Crowley Research and Rehabilitation Laboratory

Dallas, Texas, 75390, United States

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Results Point of Contact

Title
Karen McCain, PT, DPT, NCS
Organization
University of Texas Southwestern Medical Center
karen.mccain@utsouthwestern.edu
2146481559

Study Officials

  • Karen J McCain, DPT

    UTSW Medical Center

    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
Associate Professor

Study Record Dates

First Submitted

April 10, 2014

First Posted

April 14, 2014

Study Start

April 1, 2014

Primary Completion

October 1, 2016

Study Completion

October 1, 2016

Last Updated

March 22, 2019

Results First Posted

March 22, 2019

Record last verified: 2019-03

Locations

US(1)