- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00785343
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
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
HYPOTHESES
- Motor function will be significantly greater for the patients in the robotic training group as measured by standard clinical evaluations.
- Functional independence gains will be similar for both groups because the robotic therapy is not task-specific for activities of daily living (ADL).
- Robotic training will reduce pain and spasticity more effectively than conventional therapy alone, due to increased number of movements performed during the robotic training.
- Muscle activation patterns for patients receiving robotic training will show decreased agonist/antagonist co-contraction and less erratic muscle activation.
- Robotic training patients will demonstrate significantly greater ROM, movement accuracy and higher movement speed during exercises performed as part of robotic training. For robotic exercises performed only as part of the robotic assessment, these improvements will be significantly less than those for practiced movements.
Study Type
Enrollment (Anticipated)
Phase
- Phase 1
Contacts and Locations
Study Contact
- Name: Lauren McDonagh, PT
- Phone Number: 201-368-6081
- Email: lmcdonagh@KESSLER-REHAB.com
Study Contact Backup
- Name: Christine Post, OT
- Phone Number: 201-368-6247
- Email: CHPost@selectmedicalcorp.com
Study Locations
-
-
New Jersey
-
Saddle Brook, New Jersey, United States, 07663
- Recruiting
- Kessler Institute for Rehabilitation
-
Contact:
- Lauren McDonagh
- Phone Number: 201-368-6081
- Email: lmcdonagh@KESSLER-REHAB.com
-
Principal Investigator:
- Lauren McDonagh
-
Sub-Investigator:
- Christine Post
-
Sub-Investigator:
- Antoinette Gentile
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion criteria Right hemisphere, unilateral ischemic stroke with onset of less than 15 days that results in arm weakness Right-handed 65-84 years of age Manual Muscle Test score of at least 2/5 Must be able to follow 2-3 step commands Head, neck, and trunk control to maintain an upright posture for a minimum of 45 minutes Some synergistic movement at shoulder Active shoulder flexion and/or abduction greater then 30 degrees Active elbow flexion of 45 degrees or more
Exclusion criteria
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: Conventional Treatment
|
Occupational therapy that is the current standard of care
|
EXPERIMENTAL: Robotic and Conventional Therapy
|
Robotic training with the Reo Go is included with conventional treatment during daily OT sessions
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Fugl-Meyer Score
Time Frame: Start and end of treatment
|
Start and end of treatment
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
EMG - muscle activation and co-contraction index
Time Frame: Start and end of treatment
|
Start and end of treatment
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Lauren McDonagh, PT, Kessler Rehabilitation Institute
Publications and helpful links
General Publications
- 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.
- Prange 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.
Study record dates
Study Major Dates
Study Start
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- R-618-08
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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