Effect of Robot-assisted Training on Foot Drop in Multiple Sclerosis
Phase 1
Completed
- Conditions
- MS (Multiple Sclerosis)
- Registration Number
- NCT00872053
- Lead Sponsor
- US Department of Veterans Affairs
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 18
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Ankle accuracy and stiffness At inclusion, after 8 sessions, after 16 sessions
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
Providence VA Medical Center
🇺🇸Providence, Rhode Island, United States
Providence VA Medical Center🇺🇸Providence, Rhode Island, United States