Study of Robot-assisted Arm Therapy for Acute Stroke Patients
Effectiveness of Adding Robotic Therapy to Conventional Therapy for Acute Stroke Patients With Upper Extremity Paresis
1 other identifier
interventional
40
1 country
1
Brief Summary
The purpose of this study is to compare standard occupational therapy to a combination of conventional (standard) and robotic therapy. The Reo Go device will provide robotic therapy that gives therapists a tool that could make stroke treatment faster and better by helping patients practice more accurate arm movements with help from the device.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2008
CompletedFirst Submitted
Initial submission to the registry
November 4, 2008
CompletedFirst Posted
Study publicly available on registry
November 5, 2008
CompletedDecember 24, 2009
December 1, 2009
November 4, 2008
December 23, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Fugl-Meyer Score
Start and end of treatment
Secondary Outcomes (1)
EMG - muscle activation and co-contraction index
Start and end of treatment
Study Arms (2)
Conventional Treatment
ACTIVE COMPARATORRobotic and Conventional Therapy
EXPERIMENTALInterventions
Robotic training with the Reo Go is included with conventional treatment during daily OT sessions
Occupational therapy that is the current standard of care
Eligibility Criteria
You may not qualify if:
- Previous stroke history
- Hemorrhagic stroke, cerebellar stroke, or subarachnoid hemorrhage
- Contractures in the involved upper extremity at the shoulder, elbow, or wrist
- Moderate to severe tone in the involved upper extremity
- Flaccid involved upper extremity
- Full, active isolated movement of the involved upper extremity
- Corrected visual acuity worse than 20/50 for distance
- Cognitive or other deficits that would negatively affect their ability to follow directions or track visual targets
- Unstable cardiovascular orthopedic or neurological conditions that would preclude exercise in short-duration, high work-load trials
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Kessler Foundationlead
- Kessler Institute for Rehabilitationcollaborator
Study Sites (1)
Kessler Institute for Rehabilitation
Saddle Brook, New Jersey, 07663, United States
Related Publications (2)
Lum PS, Burgar CG, Shor PC. Evidence for strength imbalances as a significant contributor to abnormal synergies in hemiparetic subjects. Muscle Nerve. 2003 Feb;27(2):211-21. doi: 10.1002/mus.10305.
PMID: 12548529BACKGROUNDPrange GB, Jannink MJ, Groothuis-Oudshoorn CG, Hermens HJ, Ijzerman MJ. Systematic review of the effect of robot-aided therapy on recovery of the hemiparetic arm after stroke. J Rehabil Res Dev. 2006 Mar-Apr;43(2):171-84. doi: 10.1682/jrrd.2005.04.0076.
PMID: 16847784BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Lauren McDonagh, PT
Kessler Rehabilitation Institute
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
November 4, 2008
First Posted
November 5, 2008
Study Start
September 1, 2008
Last Updated
December 24, 2009
Record last verified: 2009-12