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Study of Robot-assisted Arm Therapy for Acute Stroke Patients

Primary Purpose

Acute Stroke, Paresis

Status

Unknown status

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Reo Go robotic arm trainer

Conventional Therapy

About this trial

This is an interventional treatment trial for Acute Stroke focused on measuring stroke, acute, arm, robot, therapy, arm paresis

Eligibility Criteria

65 Years - 84 Years (Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Kessler Institute for RehabilitationRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Conventional Treatment

Robotic and Conventional Therapy

Arm Description

Outcomes

Primary Outcome Measures

Fugl-Meyer Score

Secondary Outcome Measures

EMG - muscle activation and co-contraction index

Full Information

NCT ID

NCT00785343

First Posted

November 4, 2008

Last Updated

December 23, 2009

Sponsor

Kessler Foundation

Collaborators

Kessler Institute for Rehabilitation

1. Study Identification

Unique Protocol Identification Number

NCT00785343

Brief Title

Study of Robot-assisted Arm Therapy for Acute Stroke Patients

Official Title

Effectiveness of Adding Robotic Therapy to Conventional Therapy for Acute Stroke Patients With Upper Extremity Paresis

Study Type

Interventional

2. Study Status

Record Verification Date

December 2009

Overall Recruitment Status

Unknown status

Study Start Date

September 2008 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Kessler Foundation

Collaborators

Kessler Institute for Rehabilitation

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acute Stroke, Paresis

Keywords

stroke, acute, arm, robot, therapy, arm paresis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Conventional Treatment

Arm Type

Active Comparator

Arm Title

Robotic and Conventional Therapy

Arm Type

Experimental

Intervention Type

Device

Intervention Name(s)

Reo Go robotic arm trainer

Intervention Description

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

Intervention Type

Procedure

Intervention Name(s)

Conventional Therapy

Intervention Description

Occupational therapy that is the current standard of care

Primary Outcome Measure Information:

Title

Fugl-Meyer Score

Time Frame

Start and end of treatment

Secondary Outcome Measure Information:

Title

EMG - muscle activation and co-contraction index

Time Frame

Start and end of treatment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

65 Years

Maximum Age & Unit of Time

84 Years

Accepts Healthy Volunteers

Eligibility 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Lauren McDonagh, PT

Phone

201-368-6081

lmcdonagh@KESSLER-REHAB.com

First Name & Middle Initial & Last Name or Official Title & Degree

Christine Post, OT

Phone

201-368-6247

CHPost@selectmedicalcorp.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Lauren McDonagh, PT

Organizational Affiliation

Kessler Rehabilitation Institute

Official's Role

Principal Investigator

Facility Information:

Facility Name

Kessler Institute for Rehabilitation

City

Saddle Brook

State/Province

New Jersey

ZIP/Postal Code

07663

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Lauren McDonagh

Phone

201-368-6081

lmcdonagh@KESSLER-REHAB.com

First Name & Middle Initial & Last Name & Degree

Lauren McDonagh

First Name & Middle Initial & Last Name & Degree

Christine Post

First Name & Middle Initial & Last Name & Degree

Antoinette Gentile

12. IPD Sharing Statement

Citations:

PubMed Identifier

12548529

Citation

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.

Results Reference

background

PubMed Identifier

16847784

Citation

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.

Results Reference

background

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Study of Robot-assisted Arm Therapy for Acute Stroke Patients

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