Back to resultsEffects of Targeted Lower Extremity Joint Training on Multiple Sclerosis (MS) Gait Abnormalities
Primary Purpose
Multiple Sclerosis
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Ankle-bot
Conventional focused ankle therapy
Sponsored by
About this trial
This is an interventional treatment trial for Multiple Sclerosis focused on measuring Multiple Sclerosis, Gait, foot-drop, Ankle-Bot, Physical Therapy, Gait Abnormalities
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
- Mandell Center for Multiple Sclerosis at Mount Sinai Rehabilitation Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
No Intervention
Arm Label
Ankle-Bot Training
Conventional Therapy
Control
Arm Description
Subjects in this group receive focused ankle training using the ankle-bot device.
Subjects in this group will receive conventional focused ankle physical therapy.
Subjects in this group will not receive treatment; they will continue their usual care.
Outcomes
Primary Outcome Measures
Gait Parameters
Secondary Outcome Measures
Full Information
NCT ID
NCT00906737
First Posted
May 20, 2009
Last Updated
April 7, 2014
Sponsor
Mount Sinai Rehabilitation Hospital
1. Study Identification
Unique Protocol Identification Number
NCT00906737
Brief Title
Effects of Targeted Lower Extremity Joint Training on Multiple Sclerosis (MS) Gait Abnormalities
Official Title
Targeted Lower Extremity Joint Training Effects on MS Gait Abnormalities
Study Type
Interventional
2. Study Status
Record Verification Date
April 2014
Overall Recruitment Status
Completed
Study Start Date
April 2009 (undefined)
Primary Completion Date
April 2012 (Actual)
Study Completion Date
April 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mount Sinai Rehabilitation Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
Keywords
Multiple Sclerosis, Gait, foot-drop, Ankle-Bot, Physical Therapy, Gait Abnormalities
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
18 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ankle-Bot Training
Arm Type
Experimental
Arm Description
Subjects in this group receive focused ankle training using the ankle-bot device.
Arm Title
Conventional Therapy
Arm Type
Active Comparator
Arm Description
Subjects in this group will receive conventional focused ankle physical therapy.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Subjects in this group will not receive treatment; they will continue their usual care.
Intervention Type
Device
Intervention Name(s)
Ankle-bot
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Conventional focused ankle therapy
Intervention Description
Conventional focused ankle therapy will be performed by a physical therapist.
Primary Outcome Measure Information:
Title
Gait Parameters
Time Frame
Baseline, throughout study enrollment, and at 1 month and 3 month follow-up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Albert Lo, M.D., Ph. D.
Organizational Affiliation
Mandell Center for Multiple Sclerosis at Mount Sinai Rehabilitation Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mandell Center for Multiple Sclerosis at Mount Sinai Rehabilitation Hospital
City
Hartford
State/Province
Connecticut
ZIP/Postal Code
06112
Country
United States
12. IPD Sharing Statement
Links:
URL
http://www.saintfrancisdoctors.com/ms/
Description
Mandell Center for Multiple Sclerosis home page
Learn more about this trial
Effects of Targeted Lower Extremity Joint Training on Multiple Sclerosis (MS) Gait Abnormalities
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