MS (Multiple Sclerosis)
Conditions
Keywords
robot, treadmill, foot drop, rehabilitation, gait
Brief summary
The primary aim of this study is to: 1. 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; 2. 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.
Interventions
DEVICEAnklebot
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.
DEVICELokomat
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.
Sponsors
US Department of Veterans Affairs
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Clinical diagnosis of MS by McDonald criteria (McDonald, Compston et al. 2001). EDSS level between 3.5-5.5, who report ambulation problems. * Presence of unilateral foot drop that is clinically apparent to the PI or PI designate. * Must be able to ambulate 25 feet without an assisting device.
Exclusion criteria
* Cardiovascular: recent MI \< 4 wk, uncontrolled HTN \>190/110 mmHg. * History of uncontrolled diabetes. * Symptoms of orthostasis when standing up. * Circulatory problems, history of vascular claudication or pitting edema. * Unable to fully understand instructions in order to use the equipment or the process of the study. * Body weight over 150 kg. * Lower extremity injuries that limit range of motion or function. * Joint problems (hip or leg) that limit range of motion or cause pain with movement despite treatment. * Unstable fractures. * Pressure sores with any skin breakdown in areas in contact with the body harness or Lokomat apparatus. * Chronic and ongoing alcohol or drug abuse. * Pre-morbid, ongoing depression or psychosis. * Ongoing physical therapy. * Pregnancy (self-reported) * PI's determination of inability to complete the test protocol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Ankle accuracy and stiffness | At inclusion, after 8 sessions, after 16 sessions |
Secondary
| Measure | Time frame |
|---|---|
| Gait assessments (e.g., 6-Minute Walk, Timed 25-Foot Walk) | At inclusion, after every 4 sessions |
| Functional assessments (EDSS, MS Functional Composite) | At inclusion, after 8 sessions, after 16 sessions |
Countries
United States
Outcome results
None listed