Effect of Robot-assisted Training on Foot Drop in Multiple Sclerosis
Effect of Robot-assisted Training on Foot Drop in Multiple Sclerosis
What it found
We found no results in the registry or in papers.
This trial finished 16 years ago. We found no results in the registry or in any paper that cites it.
What was tested
Treatment tested
- Anklebot
- Lokomat
What it measured
Main measures
Ankle accuracy and stiffness
At inclusion, after 8 sessions, after 16 sessions
Other measures (2)
Gait assessments (e.g., 6-Minute Walk, Timed 25-Foot Walk)
At inclusion, after every 4 sessions
Disability progressionWalking and mobilityFunctional assessments (EDSS, MS Functional Composite)
At inclusion, after 8 sessions, after 16 sessions
Disability progression
Who could take part
MS (type not specified) · 18 to 75 · EDSS 3.5 to 5.5
Show the full criteria
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
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
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.
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History
Started
Feb 2009
Main results due
Dec 2009
Finished
Jan 2010