Effects of Targeted Lower Extremity Joint Training on Multiple Sclerosis (MS) Gait Abnormalities
Targeted Lower Extremity Joint Training Effects on MS Gait Abnormalities
1 other identifier
interventional
18
1 country
1
Brief 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 improving the gait of subjects with MS.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable multiple-sclerosis
Started Apr 2009
Typical duration for not_applicable multiple-sclerosis
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2009
CompletedFirst Submitted
Initial submission to the registry
May 20, 2009
CompletedFirst Posted
Study publicly available on registry
May 21, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2012
CompletedApril 9, 2014
April 1, 2014
3 years
May 20, 2009
April 7, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Gait Parameters
Baseline, throughout study enrollment, and at 1 month and 3 month follow-up
Study Arms (3)
Ankle-Bot Training
EXPERIMENTALSubjects in this group receive focused ankle training using the ankle-bot device.
Conventional Therapy
ACTIVE COMPARATORSubjects in this group will receive conventional focused ankle physical therapy.
Control
NO INTERVENTIONSubjects in this group will not receive treatment; they will continue their usual care.
Interventions
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 therapy will be performed by a physical therapist.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Mandell Center for Multiple Sclerosis at Mount Sinai Rehabilitation Hospital
Hartford, Connecticut, 06112, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Albert Lo, M.D., Ph. D.
Mandell Center for Multiple Sclerosis at Mount Sinai Rehabilitation Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Research Manager
Study Record Dates
First Submitted
May 20, 2009
First Posted
May 21, 2009
Study Start
April 1, 2009
Primary Completion
April 1, 2012
Study Completion
April 1, 2012
Last Updated
April 9, 2014
Record last verified: 2014-04