Status:
TERMINATED
Lokomat Training Effects on MS Gait Abnormalities
Lead Sponsor:
US Department of Veterans Affairs
Conditions:
Multiple Sclerosis
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
PHASE2
Brief Summary
Multiple sclerosis is a degenerative disease that affects more than 400,000 people in the US alone. MS is in fact the most common disabling neurological disorder in young adults. Symptoms of the disea...
Eligibility Criteria
Inclusion
- Diagnosis of MS by McDonald criteria
- Ability to clearly understand written and oral direction in English
- Self-reported gait problem
- One or more falls in the past 6 months
- The ability to walk 25 feet with no more than a cane for assistance (The subject must be comfortable using a cane)
- Age 18-70
- Written informed consent to participate in the study
- Approval from subject's primary care physician for physical activity
Exclusion
- No relapse within the last 3 months
- No more than two relapses within the past 12 months
- Recent myocardial infarction
- Uncontrolled hypertension or diabetes
- Symptomatic fall in blood pressure when standing
- Vascular claudication or pitting edema
- Cognitive impairments that limit comprehension of protocol instructions (assessed by Comprehension Test of Consent Form)
- Body weight over 150 kg
- FES-I \< 25
- 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
- Unstable fractures
- Pressure sores with any skin breakdown in areas in contact with the body harness or the robot-driven gait orthotic apparatus
- Currently enrolled in an alcohol or drug treatment program
- A complicating medical condition that would prevent completion of the trial
- Enrolled in or planning to enroll in another interventional research trial using procedures proposed to enhance or limit the function of the upper or lower extremities (such as adjuvant rehabilitation or Botox injections) during the 24 weeks of participation
- A difference of more than 2cm between subjects' right and left leg lengths
- Unable to be properly fit into the harness or Lokomat device
- Hypertonicity or spasticity that it interferes with a proper fit into the Lokomat
- Pregnancy at enrollment, as determined by a home pregnancy test kit at screening visit
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2008
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00766272
Start Date
June 1 2008
End Date
June 1 2008
Last Update
September 23 2013
Active Locations (1)
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1
Providence VA Medical Center
Providence, Rhode Island, United States, 02908-4799