Hemiplegia, SpasticNCT01336517
Evaluation of the Effect of an Ankle Foot Orthoses for Ambulatory Function
An observational study of Hemiplegia, Spastic, run by Kessler Foundation at 1 site in United States.
Trial summary
The main purpose of this investigation is to evaluate the effect of a lower leg brace on walking efficiency and community walking in people who have weakness in one side of the body caused after a stroke. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hemiplegia, Spastic
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2007to Dec 2008
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants with a history of hemiplegia secondary to stroke, between the ages of 18 and 75, who are greater than 6 months post and have been prescribed a custom molded AFO for assistance with gait deviations
Who may be able to join
- Between the ages of 18 and 75
- Have sustained a stroke at least 6 months prior to study enrollment
- Use a prescribed custom brace while walking
- Have no history of injury, orthopedic or other medical problem in the normal leg
- Be able to walk independently or with close supervision for 25 feet without a brace or cane
- Wear shoes sizes 5 1/2 - 11 US womens or size 6-13 US mens
Who cannot join
- Orthopedic problems or history that will interfere with walking or limit the range of motion of legs
- Neurological illness, history, or conditions that my interfere with walking except for stroke
- Psychiatric conditions or history that would interfere with the ability to walk or follow directions
- Serious lung or heart condition that could severely limit the ability to walk
Trial locations and contacts
1 site in 1 country.
United States1 site
Kessler Foundation Research Center
West Orange, New Jersey, 07052
About this study
Official title: Comprehensive Evaluations of the Effect of an Ankle Foot Orthoses for Ambulatory Function in Adults With Hemiplegia
The main purpose of this investigation is to evaluate the effect of a lower leg brace on walking efficiency and community walking in people who have weakness in one side of the body caused after a stroke. The evaluation will consist of several tests that will evaluate movement, tightness, balance and sensation in affected leg.
Read the detailed description
To comprehensively evaluate the effect of an AFO on ambulatory function and loading in hemiplegic gait. This study is addressing important questions regarding the effect of an AFO on gait and introduces technology for quantifiable objective assessment of AFO effectiveness. It will attempt to identify if AFO wear compliance increases community ambulation and walking efficiency bilaterally. Research is needed to fully understand how compliance affects mobility outcomes.
- Conditions
- Hemiplegia, Spastic
- Keywords
- Stroke, Hemiplegia, AFO, Gait
- Medical subject headings
- Hemiplegia, Stroke
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2011 (estimated)
- Study startAug 2007
- Primary completionDec 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemiplegia, SpasticStudies of the same condition, open and under way.
- More trials run by Kessler FoundationThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kessler Foundation
- Sponsor type
- University, hospital or other
- Investigators
- Karen Nolan, Ph.D., Principal investigator, Kessler Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01336517
- Sponsor's protocol ID
- E59007
- Status last verified
- Apr 2011
- First submitted
- 2 Oct 2009
- Last updated
- 18 Apr 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comprehensive Evaluations of the Effect of an Ankle Foot Orthoses for Ambulatory Function in Adults With Hemiplegia
- ClinicalTrials.gov ID
- NCT01336517
- Acronym / sponsor ID
- E59007
- Conditions
- Hemiplegia, Spastic
- Keywords
- Stroke, Hemiplegia, AFO, Gait
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Kessler FoundationUniversity, hospital or other
- Study start
- Aug 2007
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 18 Apr 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main purpose of this investigation is to evaluate the effect of a lower leg brace on walking efficiency and community walking in people who have weakness in one side of the body caused after a stroke. The evaluation will consist of several tests that will evaluate movement, tightness, balance and sensation in affected leg.
Detailed description
To comprehensively evaluate the effect of an AFO on ambulatory function and loading in hemiplegic gait. This study is addressing important questions regarding the effect of an AFO on gait and introduces technology for quantifiable objective assessment of AFO effectiveness. It will attempt to identify if AFO wear compliance increases community ambulation and walking efficiency bilaterally. Research is needed to fully understand how compliance affects mobility outcomes.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants with a history of hemiplegia secondary to stroke, between the ages of 18 and 75, who are greater than 6 months post and have been prescribed a custom molded AFO for assistance with gait deviations
Key inclusion criteria (6 listed)
- Between the ages of 18 and 75
- Have sustained a stroke at least 6 months prior to study enrollment
- Use a prescribed custom brace while walking
- Have no history of injury, orthopedic or other medical problem in the normal leg
- Be able to walk independently or with close supervision for 25 feet without a brace or cane
Key exclusion criteria (4 listed)
- Orthopedic problems or history that will interfere with walking or limit the range of motion of legs
- Neurological illness, history, or conditions that my interfere with walking except for stroke
- Psychiatric conditions or history that would interfere with the ability to walk or follow directions
- Serious lung or heart condition that could severely limit the ability to walk
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2011.
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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 Nolan, Ph.D. principal investigator
Kessler Foundation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hemiplegia, Spastic, run by Kessler Foundation 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 4 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: finished, as of the sponsor's last update on 18 Apr 2011. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
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 18 Apr 2011.