Study of Robot-assisted Arm Therapy for Acute Stroke Patients

NCT ID: NCT00785343

Last Updated: 2009-12-24

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-09-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Acute Stroke Paresis

Keywords

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stroke acute arm robot therapy arm paresis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Conventional Treatment

Group Type ACTIVE_COMPARATOR

Conventional Therapy

Intervention Type PROCEDURE

Occupational therapy that is the current standard of care

Robotic and Conventional Therapy

Group Type EXPERIMENTAL

Reo Go robotic arm trainer

Intervention Type DEVICE

Robotic training with the Reo Go is included with conventional treatment during daily OT sessions

Interventions

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Reo Go robotic arm trainer

Robotic training with the Reo Go is included with conventional treatment during daily OT sessions

Intervention Type DEVICE

Conventional Therapy

Occupational therapy that is the current standard of care

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

65 Years

Maximum Eligible Age

84 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kessler Institute for Rehabilitation

INDUSTRY

Sponsor Role collaborator

Kessler Foundation

OTHER

Sponsor Role lead

Responsible Party

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Kessler Foundation

Principal Investigators

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Lauren McDonagh, PT

Role: PRINCIPAL_INVESTIGATOR

Kessler Rehabilitation Institute

Locations

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Kessler Institute for Rehabilitation

Saddle Brook, New Jersey, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Lauren McDonagh, PT

Role: CONTACT

Phone: 201-368-6081

Email: [email protected]

Christine Post, OT

Role: CONTACT

Phone: 201-368-6247

Email: [email protected]

Facility Contacts

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Lauren McDonagh

Role: primary

References

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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.

Reference Type BACKGROUND
PMID: 12548529 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16847784 (View on PubMed)

Other Identifiers

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R-618-08

Identifier Type: -

Identifier Source: org_study_id