Effect of Robot-assisted Training on Foot Drop in Multiple Sclerosis
|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|
|Primary Completion Date :||December 2009|
|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 ]
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|