Effect of Robot-assisted Training on Foot Drop in Multiple Sclerosis
This study has suspended participant recruitment.
Information provided by:
Department of Veterans Affairs
First received: March 27, 2009
Last updated: January 20, 2011
Last verified: January 2011
The primary aim of this study is to:
- Collect pilot data on the effect of task-specific lower extremity training using the Anklebot on subjects with Multiple Sclerosis (MS) and who have foot drop;
- Collect pilot data on the use of combination therapy on improving gait in subjects with MS. This therapy will use both Anklebot training and robot-assisted gait training.
Hypothesis: Both trainings will result in improved walking performance, but the combination therapy will result in greater gains than ankle training alone.
MS (Multiple Sclerosis)
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Effect of Robot-assisted Training on Foot Drop in Multiple Sclerosis|
Resource links provided by NLM:
U.S. FDA Resources
Further study details as provided by Department of Veterans Affairs:
Primary Outcome Measures:
- Ankle accuracy and stiffness [ Time Frame: At inclusion, after 8 sessions, after 16 sessions ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Gait assessments (e.g., 6-Minute Walk, Timed 25-Foot Walk) [ Time Frame: At inclusion, after every 4 sessions ] [ Designated as safety issue: No ]
- Functional assessments (EDSS, MS Functional Composite) [ Time Frame: At inclusion, after 8 sessions, after 16 sessions ] [ Designated as safety issue: No ]
|Study Start Date:||February 2009|
|Estimated Study Completion Date:||January 2010|
|Estimated Primary Completion Date:||December 2009 (Final data collection date for primary outcome measure)|
Focused Ankle Training
The Anklebot is a robotic device that is worn via a leather boot and knee brace (Fig.1). As the participant goes through a series of ankle-training "games," the Anklebot can assist ankle movement throughout 3 planes.
The Anklebot is a robotic device that is worn via a leather boot and knee brace (Fig.1). As the participant goes through a series of ankle-training "games," the Anklebot can assist ankle movement throughout 3 planes.Device: Lokomat
The Lokomat is a motor driven exoskeleton device that employs a body weight support suspension system and treadmill. Attached to the lower limbs, the Lokomat moves the subject's legs over a treadmill through position controlled trajectories that mimic normal human gait patterns.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00872053
|United States, Rhode Island|
|Providence VA Medical Center|
|Providence, Rhode Island, United States, 02908-4799|
Sponsors and Collaborators
|Principal Investigator:||Albert Lo, MD PhD||Providence VA Medical Center|