Parkinson's DiseaseNCT01798927
Effect of Lower Extremity Ankle Foot Orthoses in Parkinson's Disease
A study testing Ankle foot orthosis 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 ankle foot orthosis (AFO, hinged, with Tamarack joint and adjustable check strap) on the spatial and temporal gait parameters, electromyography (EMG) and walking endurance, in select individuals living with Parkinson's disease. Read more about this study
- Who is it for?
- Ages 50 to 75 years
- Conditions the study is for
- Parkinson's Disease
- What is being tested?
- Ankle foot orthosis
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2012to Jul 2013
- 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 50 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Confirmed diagnosis of Parkinson's Disease
- Between the ages of 50 and 75
- Ability to walk 150 feet independently over level surfaces with or without an assistive device
- Stable medication usage for the duration of the study (10 weeks)
- Obvious gait dysfunction (Observational Gait Analysis)
- Score of greater than 22 on the Short Orientation-Memory-Concentration Test
Who cannot join
- Body mass index of greater than 35
- Dorsiflexion range of motion less than 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
UT Southwestern Medical Center, School of Health Professions
Dallas, Texas, 75390
About this study
Official title: Investigation of Lower Extremity Orthoses on Gait in Persons With Parkinson's Disease: a Case Series.
The purpose of this study is to investigate the impact of a specifically designed ankle foot orthosis (AFO, hinged, with Tamarack joint and adjustable check strap) on the spatial and temporal gait parameters, electromyography (EMG) and walking endurance, in select individuals living with Parkinson's disease.
Read the detailed description
This study will be 10 weeks long. Following fitting with unilateral or bilateral custom-fabricated AFOs the subject will participate in 4 gait training sessions which will be at weeks 1, 2, and 7. Each training session will be 45-60 minutes in duration. Various outcome measures will be completed at the following times: time of consent (T1), treatment 1 at time of brace delivery (T2), week 5 (T3), and week 10 (T4). Subjects will be closely monitored throughout the 10 week study and will be unenrolled by self-request or the following medical reasons: 1. New diagnosis with direct consequences affecting gait training, 2. Inability to tolerate the study AFO(s).
- Conditions
- Parkinson's Disease
- Being tested
- Ankle foot orthosis
- Keywords
- Parkinson's disease, ankle foot orthosis (AFO), gait
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ankle foot orthosisDevice
Also called Tamarack with check strap
Participants will receive a Tamarack ankle foot orthosis with a check strap for gait training as well as a home walking program.
| Study group | Role | What they receive |
|---|---|---|
| Ankle foot orthosis fitting | Other | All participants will receive ankle foot orthosis or orthoses. Outcomes will be compared to pre-bracing findings. Receives: Device: Ankle foot orthosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Step Length by Means of Computerized Gait Analysis From Initial to Final Testing
Participants will be asked to walk on a 12-16 foot long vinyl pad placed on the floor. The mat will record and analyze step length.
Measured: Done at time of enrollment in the study, i.e. baseline and 10 weeks post enrollment
Secondary outcomes (1)
Number of Participants With a Change in Electromyography of Key Lower Extremity Muscles From Initial to Final Testing
Surface electromyography will be done on key muscles in the lower extremity (quads, anterior tibialis, gastrocnemius) during computerized gait assessment. Changes in EMG activity include things such as increases in amplitude or timing that might indicate increases in strength or motor learning as a result of wearing the ankle foot orthosis.
Measured: Done at time of enrollment in the study, i.e. baseline and week 10 post enrollment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2013 (estimated)
- Study startDec 2012
- Primary completionJul 2013
- Study completionJul 2013
Why it stopped: Modifications are being made to protocol
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 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
- NCT01798927
- Sponsor's protocol ID
- PD AFO
- Status last verified
- Jul 2015
- First submitted
- 11 Feb 2013
- Last updated
- 3 Aug 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Lower Extremity Orthoses on Gait in Persons With Parkinson's Disease: a Case Series.
- ClinicalTrials.gov ID
- NCT01798927
- Acronym / sponsor ID
- PD AFO
- Conditions
- Parkinson's Disease
- Keywords
- Parkinson's disease, ankle foot orthosis (AFO), gait
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Modifications are being made to protocol
- Enrolment
- 4 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Study start
- Dec 2012
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 26 Feb 2013 (estimated)
- Results
- Posted 3 Aug 2015
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 ankle foot orthosis (AFO, hinged, with Tamarack joint and adjustable check strap) on the spatial and temporal gait parameters, electromyography (EMG) and walking endurance, in select individuals living with Parkinson's disease.
Detailed description
This study will be 10 weeks long. Following fitting with unilateral or bilateral custom-fabricated AFOs the subject will participate in 4 gait training sessions which will be at weeks 1, 2, and 7. Each training session will be 45-60 minutes in duration. Various outcome measures will be completed at the following times: time of consent (T1), treatment 1 at time of brace delivery (T2), week 5 (T3), and week 10 (T4). Subjects will be closely monitored throughout the 10 week study and will be unenrolled by self-request or the following medical reasons: 1. New diagnosis with direct consequences affecting gait training, 2. Inability to tolerate the study AFO(s).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ankle foot orthosis fitting | Other | Device: Ankle foot orthosisAll participants will receive ankle foot orthosis or orthoses. Outcomes will be compared to pre-bracing findings. |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Confirmed diagnosis of Parkinson's Disease
- Between the ages of 50 and 75
- Ability to walk 150 feet independently over level surfaces with or without an assistive device
- Stable medication usage for the duration of the study (10 weeks)
- Obvious gait dysfunction (Observational Gait Analysis)
Key exclusion criteria (3 listed)
- Body mass index of greater than 35
- Dorsiflexion range of motion less than 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 |
|---|---|---|
| Ankle foot orthosisAlso: Tamarack with check strapParticipants will receive a Tamarack ankle foot orthosis with a check strap for gait training as well as a home walking program. | Device | Ankle foot orthosis fitting |
Primary outcome
Change in Step Length by Means of Computerized Gait Analysis From Initial to Final Testing
Time frame: Done at time of enrollment in the study, i.e. baseline and 10 weeks post enrollment
Participants will be asked to walk on a 12-16 foot long vinyl pad placed on the floor. The mat will record and analyze step length.
1 secondary outcome
Number of Participants With a Change in Electromyography of Key Lower Extremity Muscles From Initial to Final Testing
Time frame: Done at time of enrollment in the study, i.e. baseline and week 10 post enrollment.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2015.
- 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 Ankle foot orthosis 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 3 Aug 2015. 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 3 Aug 2015). 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 Step Length by Means of Computerized Gait Analysis From Initial to Final Testing (time frame: Done at time of enrollment in the study, i.e. baseline and 10 weeks post enrollment). 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 3 Aug 2015.