Effect of Robot-assisted Training on Foot Drop in Multiple Sclerosis
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|ClinicalTrials.gov Identifier: NCT00872053|
Recruitment Status : Completed
First Posted : March 31, 2009
Last Update Posted : September 20, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|MS (Multiple Sclerosis)||Device: Anklebot Device: Lokomat||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||18 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Effect of Robot-assisted Training on Foot Drop in Multiple Sclerosis|
|Study Start Date :||February 2009|
|Actual Primary Completion Date :||December 2009|
|Actual Study Completion Date :||January 2010|
Experimental: Arm 1
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.
Experimental: Arm 2
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.
- Ankle accuracy and stiffness [ Time Frame: At inclusion, after 8 sessions, after 16 sessions ]
- Gait assessments (e.g., 6-Minute Walk, Timed 25-Foot Walk) [ Time Frame: At inclusion, after every 4 sessions ]
- Functional assessments (EDSS, MS Functional Composite) [ Time Frame: At inclusion, after 8 sessions, after 16 sessions ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00872053
|United States, Rhode Island|
|Providence VA Medical Center|
|Providence, Rhode Island, United States, 02908-4799|
|Principal Investigator:||Albert Lo, MD PhD||Providence VA Medical Center|