StrokeNCT00776048
Validation of an Obstacle Course Used in Patients With Muscle Tightness
An observational study of Stroke and Traumatic Brain Injury, run by Kessler Foundation at 1 site in United States.
Trial summary
This study is being conducted to compare healthy patients versus patients with muscle tightness in their leg(s) after an acquired brain injury using walking trials time, a balance test, and foot pressure data. This data is obtained using foot pressure sensors, timers, and distance walked. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stroke, Traumatic Brain Injury, Multiple Sclerosis
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2007to Dec 2009
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Subjects ages > 18 years of age for this study. A total of up to 10 age matched controls and 30 clinical patients with lower extremity spasticity will be enrolled. Of the 30 clinical patients, 20 clinical patients will have received BOTOX ® injections from their clinical physician after their first visit.
Who may be able to join
- Patients > 18 years of age
- Must wear shoe size 5½ - 11 US womens or size 6 - 13 US mens
- For treatment group be a clinical patient being treated for lower extremity spasticity
Who cannot join
- Age matched controls must have no significant neurological or orthopedic disease that would effect their gait
- Clinical patients who are unable to walk for 1 minute
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Validation of a New Method to Evaluate the Effects of Chemoneurolytic Intervention on Balance and Community Ambulation in Spastic Hemiplegic Patients
This study is being conducted to compare healthy patients versus patients with muscle tightness in their leg(s) after an acquired brain injury using walking trials time, a balance test, and foot pressure data. This data is obtained using foot pressure sensors, timers, and distance walked.
Read the detailed description
This study is being conducted to demonstrate the objective utility of the use of pedobarography as a tool to differentiate normal controls from people with spastic gait as well as having utility in objectification of treatment effect on level surfaces and on a ADA based obstacle course.
- Conditions
- Stroke, Traumatic Brain Injury, Multiple Sclerosis, Spasticity, Healthy Controls
- Medical subject headings
- Stroke, Brain Injuries, Traumatic, Multiple Sclerosis, Muscle Spasticity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| ABI | Acquired brain injury with lower limb spasticity | |
| Healthy Controls | Age matched healthy controls |
What is being measured
The primary outcome is the main question the study is designed to answer.
To demonstrate the objective utility of the use of pedobarography to differentiate normal controls from people with spastic gait as well as having utility in objectification of treatment effect on level surfaces and on a ADA based obstacle course.
Measured: 4 months post acquired brain injury
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2008 (estimated)
- Study startJan 2007
- Primary completionDec 2009 (estimated)
- Study completionDec 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies 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
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kessler Foundation
- Sponsor type
- University, hospital or other
- Investigators
- Elie P Elovic, M.D., Principal investigator, Kessler Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00776048
- Sponsor's protocol ID
- E56806
- Status last verified
- Oct 2008
- First submitted
- 16 Oct 2008
- Last updated
- 24 Jun 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Validation of a New Method to Evaluate the Effects of Chemoneurolytic Intervention on Balance and Community Ambulation in Spastic Hemiplegic Patients
- ClinicalTrials.gov ID
- NCT00776048
- Acronym / sponsor ID
- E56806
- Conditions
- Stroke, Traumatic Brain Injury, Multiple Sclerosis, Spasticity, Healthy Controls
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Kessler FoundationUniversity, hospital or other
- Study start
- Jan 2007
- Primary completion
- Dec 2009 (estimated)
- Study completion
- Dec 2009 (estimated)
- First posted
- 20 Oct 2008 (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.
This study is being conducted to compare healthy patients versus patients with muscle tightness in their leg(s) after an acquired brain injury using walking trials time, a balance test, and foot pressure data. This data is obtained using foot pressure sensors, timers, and distance walked.
Detailed description
This study is being conducted to demonstrate the objective utility of the use of pedobarography as a tool to differentiate normal controls from people with spastic gait as well as having utility in objectification of treatment effect on level surfaces and on a ADA based obstacle course.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ABI | – | –Acquired brain injury with lower limb spasticity |
| Healthy Controls | – | –Age matched healthy controls |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects ages > 18 years of age for this study. A total of up to 10 age matched controls and 30 clinical patients with lower extremity spasticity will be enrolled. Of the 30 clinical patients, 20 clinical patients will have received BOTOX ® injections from their clinical physician after their first visit.
Key inclusion criteria (3 listed)
- Patients > 18 years of age
- Must wear shoe size 5½ - 11 US womens or size 6 - 13 US mens
- For treatment group be a clinical patient being treated for lower extremity spasticity
Key exclusion criteria (2 listed)
- Age matched controls must have no significant neurological or orthopedic disease that would effect their gait
- Clinical patients who are unable to walk for 1 minute
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
To demonstrate the objective utility of the use of pedobarography to differentiate normal controls from people with spastic gait as well as having utility in objectification of treatment effect on level surfaces and on a ADA based obstacle course.
Time frame: 4 months post acquired brain injury
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2010.
- KesslerMRREC Traumatic Brain Injury WebsiteLink provided by the sponsor.
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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.
Elie P Elovic, M.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 Stroke and Traumatic Brain Injury, 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 3 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 24 Jun 2010. 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?
Results are not available in the source record.
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?
To demonstrate the objective utility of the use of pedobarography to differentiate normal controls from people with spastic gait as well as having utility in objectification of treatment effect on level surfaces and on a ADA based obstacle course. (time frame: 4 months post acquired brain injury). 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 24 Jun 2010.