Parkinson's DiseaseNCT02113189
Impact of Walking Practice on Persons With PD
A study testing Walking program with ankle brace, Individualized walking program and Walking program with custom braces. in people with Parkinson's Disease, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 90 years
- Conditions the study is for
- Parkinson's Disease
- What is being tested?
- Walking program with ankle brace, Individualized walking program and Walking program with custom braces.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2014to Oct 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas Southwestern Medical Center David M. Crowley Research and Rehabilitation Laboratory
Dallas, Texas, 75390
About this study
Official title: The Long Term Impact of Walking Practice on Functional Mobility and Quality of Life in Persons With Parkinson's Disease
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.
Read the detailed 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.
- Conditions
- Parkinson's Disease
- Being tested
- Walking program with ankle brace, Individualized walking program, Walking program with custom braces.
- Keywords
- gait, Parkinson's disease
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
Individualized walking programOther
Walking program will include instructions on walking activities at home such as time of walking
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.
| Study group | Role | What they receive |
|---|---|---|
| Walking program with ankle brace | Experimental | This group will receive bilateral off-the-shelf ankle braces as well as a customized walking program. Receives: Other: Walking program with ankle brace |
| Individualized walking program | Experimental | This group will receive a customized walking program. Receives: 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. Receives: Other: Walking program with custom braces. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Participants will be asked to walk on a 12-16 foot long vinyl pad placed on the floor. The mat will record and analyze temporal and spatial parameters.
Measured: Testing will be done at initial testing and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2014 (estimated)
- Study startApr 2014
- Primary completionOct 2016
- Study completionOct 2016
Why it stopped: Inadequate funding to continue the study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
- More trials run by University of Texas Southwestern Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Karen McCain, University of Texas Southwestern Medical Center
- Investigators
- Karen J McCain, DPT, Principal investigator, UTSW Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02113189
- Sponsor's protocol ID
- PD walking study
- Status last verified
- Mar 2019
- First submitted
- 10 Apr 2014
- Last updated
- 22 Mar 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Long Term Impact of Walking Practice on Functional Mobility and Quality of Life in Persons With Parkinson's Disease
- ClinicalTrials.gov ID
- NCT02113189
- Acronym / sponsor ID
- PD walking study
- Conditions
- Parkinson's Disease
- Keywords
- gait, Parkinson's disease
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Inadequate funding to continue the study
- Enrolment
- 13 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- Oct 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 14 Apr 2014 (estimated)
- Results
- Posted 22 Mar 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Walking program with ankle brace | Experimental | Other: Walking program with ankle braceThis group will receive bilateral off-the-shelf ankle braces as well as a customized walking program. |
| Individualized walking program | Experimental | Other: Individualized walking programThis group will receive a customized walking program. |
| Walking program with custom braces | Experimental | Other: Walking program with custom braces.This group will receive bilateral custom-fabricated ankle braces as well as a customized walking program. |
Who may qualify
- Ages
- 30 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Walking program with ankle braceWalking program will include instructions on walking activities at home such as time of walking. Walking will be done with the bilateral ankle braces on. | Other | Walking program with ankle brace |
| Individualized walking programWalking program will include instructions on walking activities at home such as time of walking | Other | Individualized walking program |
| Walking program with custom braces.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. | Other | Walking program with custom braces |
Primary outcome
Change in Distance Walked on 6-Minute Walk Test (6MWT)
Time frame: 6MWT will be done at initial testing and 12 months
Each participant walks at a self-selected velocity on level surfaces for 6 minutes. They will be allowed to use assistive devices if necessary.
1 secondary outcome
Change in Temporal Spatial Gait Parameters Using the Computerized Gait Analysis System
Time frame: Testing will be done at initial testing and 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karen J McCain, DPT principal investigator
UTSW Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Walking program with ankle brace, Individualized walking program and Walking program with custom braces. in people with Parkinson's Disease, run by University of Texas Southwestern Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 22 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Mar 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Distance Walked on 6-Minute Walk Test (6MWT) (time frame: 6MWT will be done at initial testing and 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2019.