Study of Robot-assisted Arm Therapy for Acute Stroke Patients

Kessler Foundation

Status and phase: Unknown; Phase 1

Conditions: Acute Stroke; Paresis

Treatments: Procedure: Conventional Therapy; Device: Reo Go robotic arm trainer

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00785343

R-618-08

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 65 to 84 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 2 patient groups

Conventional Treatment

Active Comparator group

Treatment:

Procedure: Conventional Therapy

Robotic and Conventional Therapy

Experimental group

Treatment:

Device: Reo Go robotic arm trainer