Status:
COMPLETED
Restoration of Walking in Multiple Sclerosis Using Treadmill Training.
Lead Sponsor:
US Department of Veterans Affairs
Conditions:
Multiple Sclerosis
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The primary purpose of this study is to collect preliminary and pilot data to begin to determine whether the use of body weight support treadmill therapy (BWSTT) with and without driven-gait-orthotics...
Detailed Description
Gait impairment is a major cause of ongoing disability in patients with multiple sclerosis (MS). New treadmills that provide body weight support and even robotic assistance to the lower limbs have rec...
Eligibility Criteria
Inclusion
- Clinical diagnosis of MS by McDonald criteria. EDSS level between 4-6.5.
Exclusion
- Cardiovascular: recent MI \< 4 wk, uncontrolled HTN \>190/110 mmHg, Uncontrolled diabetes (blood glucose 2X above the upper limit of normal or non-fasting blood drain).
- Symptomatic fall in blood pressure (\>30mm Hg), when upright in the body support apparatus, despite medical therapy.
- Circulatory problems, history of vascular claudication or pitting edema.
- Cognitive impairment MMSE \< 21.
- Body weight over 150 kg (structural limits of the Lokomat).
- 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 DGO apparatus.
- Chronic and ongoing alcohol or drug abuse.
- Pre-morbid, ongoing depression or psychosis.
Key Trial Info
Start Date :
September 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2007
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00156676
Start Date
September 1 2004
End Date
September 1 2007
Last Update
September 20 2013
Active Locations (1)
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1
Providence VA Medical Center
Providence, Rhode Island, United States, 02908-4799