Multiple SclerosisNCT00906737
Effects of Targeted Lower Extremity Joint Training on Multiple Sclerosis (MS) Gait Abnormalities
A study testing Ankle-bot and Conventional focused ankle therapy in people with Multiple Sclerosis, run by Mount Sinai Rehabilitation Hospital at 1 site in United States.
Trial summary
This study is being done to test the possible benefits of task-specific focused ankle training using the Ankle-Bot on subjects with Multiple Sclerosis who have "foot-drop." The study also compares the effectiveness of task-specific focused ankle training using the Ankle-Bot with conventional focused ankle therapy in… Read more about this study
- Who is it for?
- Ages 25 to 65 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Ankle-bot and Conventional focused ankle therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2009to Apr 2012
- Phase
- Interventional
- 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 25 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical Diagnosis of MS
- EDSS level between 3.5 - 6.0
- Unilateral foot-drop
- Able to ambulate 25 ft. with no more than a unilateral assistive device
Who cannot join
- Lower extremity injuries that limit range of motion or function
- Unable to demonstrate an understanding of the process of the study and/or fully understand instructions in order to safely participate in the study and use study equipment
- Unable to fit safely and properly into the Ankle-Bot device
Trial locations and contacts
1 site in 1 country.
United States1 site
Mandell Center for Multiple Sclerosis at Mount Sinai Rehabilitation Hospital
Hartford, Connecticut, 06112
About this study
Official title: Targeted Lower Extremity Joint Training Effects on MS Gait Abnormalities
This study is being done to test the possible benefits of task-specific focused ankle training using the Ankle-Bot on subjects with Multiple Sclerosis who have "foot-drop." The study also compares the effectiveness of task-specific focused ankle training using the Ankle-Bot with conventional focused ankle therapy in improving the gait of subjects with MS.
- Conditions
- Multiple Sclerosis
- Being tested
- Ankle-bot, Conventional focused ankle therapy
- Keywords
- Multiple Sclerosis, Gait, foot-drop, Ankle-Bot, Physical Therapy, Gait Abnormalities
- Medical subject headings
- Multiple Sclerosis, Peroneal Neuropathies, Mobility Limitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ankle-botDevice
The Ankle-bot is a piece of robotic therapy equipment for the ankle. In this study, it will be used to guide and assist the subject into ankle flexion, extension, inversion and eversion.
Conventional focused ankle therapyOther
Conventional focused ankle therapy will be performed by a physical therapist.
| Study group | Role | What they receive |
|---|---|---|
| Ankle-Bot Training | Experimental | Subjects in this group receive focused ankle training using the ankle-bot device. Receives: Device: Ankle-bot |
| Conventional Therapy | Active comparator | Subjects in this group will receive conventional focused ankle physical therapy. Receives: Other: Conventional focused ankle therapy |
| Control | No intervention | Subjects in this group will not receive treatment; they will continue their usual care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gait Parameters
Measured: Baseline, throughout study enrollment, and at 1 month and 3 month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2009 (estimated)
- Study startApr 2009
- Primary completionApr 2012
- Study completionApr 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mount Sinai Rehabilitation Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jennifer Fawcett, Mount Sinai Rehabilitation Hospital
- Investigators
- Albert Lo, M.D., Ph. D., Principal investigator, Mandell Center for Multiple Sclerosis at Mount Sinai Rehabilitation Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00906737
- Sponsor's protocol ID
- AL0002
- Status last verified
- Apr 2014
- First submitted
- 20 May 2009
- Last updated
- 9 Apr 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Targeted Lower Extremity Joint Training Effects on MS Gait Abnormalities
- ClinicalTrials.gov ID
- NCT00906737
- Acronym / sponsor ID
- AL0002
- Conditions
- Multiple Sclerosis
- Keywords
- Multiple Sclerosis, Gait, foot-drop, Ankle-Bot, Physical Therapy, Gait Abnormalities
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Mount Sinai Rehabilitation HospitalUniversity, hospital or other
- Study start
- Apr 2009
- Primary completion
- Apr 2012 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 21 May 2009 (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 done to test the possible benefits of task-specific focused ankle training using the Ankle-Bot on subjects with Multiple Sclerosis who have "foot-drop." The study also compares the effectiveness of task-specific focused ankle training using the Ankle-Bot with conventional focused ankle therapy in improving the gait of subjects with MS.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Ankle-Bot Training | Experimental | Device: Ankle-botSubjects in this group receive focused ankle training using the ankle-bot device. |
| Conventional Therapy | Active comparator | Other: Conventional focused ankle therapySubjects in this group will receive conventional focused ankle physical therapy. |
| Control | No intervention | –Subjects in this group will not receive treatment; they will continue their usual care. |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Clinical Diagnosis of MS
- EDSS level between 3.5 - 6.0
- Unilateral foot-drop
- Able to ambulate 25 ft. with no more than a unilateral assistive device
Key exclusion criteria (3 listed)
- Lower extremity injuries that limit range of motion or function
- Unable to demonstrate an understanding of the process of the study and/or fully understand instructions in order to safely participate in the study and use study equipment
- Unable to fit safely and properly into the Ankle-Bot device
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-botThe Ankle-bot is a piece of robotic therapy equipment for the ankle. In this study, it will be used to guide and assist the subject into ankle flexion, extension, inversion and eversion. | Device | Ankle-Bot Training |
| Conventional focused ankle therapyConventional focused ankle therapy will be performed by a physical therapist. | Other | Conventional Therapy |
Primary outcome
Gait Parameters
Time frame: Baseline, throughout study enrollment, and at 1 month and 3 month follow-up
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 9 Apr 2014.
- Mandell Center for Multiple Sclerosis home pageLink 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.
Albert Lo, M.D., Ph. D. principal investigator
Mandell Center for Multiple Sclerosis at Mount Sinai Rehabilitation Hospital
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-bot and Conventional focused ankle therapy in people with Multiple Sclerosis, run by Mount Sinai Rehabilitation Hospital 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 4 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: finished, as of the sponsor's last update on 9 Apr 2014. 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.
What does the primary outcome measure?
Gait Parameters (time frame: Baseline, throughout study enrollment, and at 1 month and 3 month follow-up). 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 9 Apr 2014; AzTrials last refreshed its copy on 6 Nov 2026.