Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE1/PHASE2
10 participants
INTERVENTIONAL
2008-09-30
2008-09-30
Brief Summary
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One of the key limitations of the Lokomat is a lack of robot-assisted training for the ankle joint. The Anklebot, an MIT-developed rehabilitation robot for the ankle, has the potential to address this. The device can move throughout three planes and train ankle flexion, extension, inversion and eversion; however, therapy with the Anklebot alone does not train the knee or hip.
We plan to test whether subject foot drop and overall gait benefit more from Anklebot therapy alone or a combination of Anklebot and Lokomat.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Arm 1
Anklebot
Anklebot
The Ankle-Bot (Wheeler et al., 2004) is a stand-alone robot assisted device that is worn via a leather boot and knee brace (Fig.1). The Ankle-Bot can assist ankle movement throughout 3 planes. The percentage of force generated by the Ankle-Bot can be adjusted from no help, 0% assistance to 100% assistance. The device is low impedance and a subject can easily over come the forces generated by the Ankle-Bot. The Ankle-Bot will guide and assist the subject into ankle flexion, extension, inversion and eversion.
Arm 2
Body-weight supported treadmill training
Lokomat
The Lokomat is a motor driven exoskeleton device that employs a body weight support suspension system and treadmill .
Arm 3
Combination therapy (Anklebot and BWSTT)
Anklebot
The Ankle-Bot (Wheeler et al., 2004) is a stand-alone robot assisted device that is worn via a leather boot and knee brace (Fig.1). The Ankle-Bot can assist ankle movement throughout 3 planes. The percentage of force generated by the Ankle-Bot can be adjusted from no help, 0% assistance to 100% assistance. The device is low impedance and a subject can easily over come the forces generated by the Ankle-Bot. The Ankle-Bot will guide and assist the subject into ankle flexion, extension, inversion and eversion.
Lokomat
The Lokomat is a motor driven exoskeleton device that employs a body weight support suspension system and treadmill .
Interventions
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Anklebot
The Ankle-Bot (Wheeler et al., 2004) is a stand-alone robot assisted device that is worn via a leather boot and knee brace (Fig.1). The Ankle-Bot can assist ankle movement throughout 3 planes. The percentage of force generated by the Ankle-Bot can be adjusted from no help, 0% assistance to 100% assistance. The device is low impedance and a subject can easily over come the forces generated by the Ankle-Bot. The Ankle-Bot will guide and assist the subject into ankle flexion, extension, inversion and eversion.
Lokomat
The Lokomat is a motor driven exoskeleton device that employs a body weight support suspension system and treadmill .
Eligibility Criteria
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Inclusion Criteria
2. Men and women between the ages 18-75 years.
3. Presence of unilateral foot drop that is clinically apparent to the PI or PI designate.
4. Must be able to ambulate 25 feet without an assisting device
Exclusion Criteria
2. Symptoms of orthostasis when standing up.
3. Circulatory problems, history of vascular claudication or pitting edema.
4. Unable to fully understand instructions in order to use the equipment or the process of the study.
5. Body weight over 150 kg.
6. Lower extremity injuries that limit range of motion or function.
7. Joint problems (hip or leg) that limit range of motion or cause pain with movement despite treatment.
8. Unstable fractures.
9. Pressure sores with any skin breakdown in areas in contact with the body harness or Lokomat apparatus.
10. Chronic and ongoing alcohol or drug abuse.
11. Pre-morbid, ongoing depression or psychosis.
12. Ongoing physical therapy.
18 Years
75 Years
ALL
No
Sponsors
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US Department of Veterans Affairs
FED
Responsible Party
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Principal Investigators
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Albert Lo, MD PhD
Role: PRINCIPAL_INVESTIGATOR
Providence VA Medical Center
Locations
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Providence VA Medical Center
Providence, Rhode Island, United States
Countries
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Other Identifiers
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LO-0002
Identifier Type: -
Identifier Source: org_study_id