Study of Robot-assisted Arm Therapy for Acute Stroke Patients

Acute Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00785343
• Other study ID #: R-618-08
• Status: Recruiting
• Phase: Phase 1
• First received: November 4, 2008
• Last updated: December 23, 2009
• Start date: September 2008

Study information

• Verified date: December 2009
• Source: Kessler Foundation
• Contact: Lauren McDonagh, PT
• Phone: 201-368-6081
• Email: lmcdonagh[@]KESSLER-REHAB.com
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years to 84 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Stroke
• Muscle Weakness
• Paresis
• Stroke

Intervention

Device:
• Reo Go robotic arm trainer
Robotic training with the Reo Go is included with conventional treatment during daily OT sessions

Procedure:
• Conventional Therapy
Occupational therapy that is the current standard of care

Locations

Country	Name	City	State
United States	Kessler Institute for Rehabilitation	Saddle Brook	New Jersey

Sponsors (2)

Lead Sponsor	Collaborator
Kessler Foundation	Kessler Institute for Rehabilitation

Country where clinical trial is conducted

United States, 

References & 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. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fugl-Meyer Score		Start and end of treatment	No
Secondary	EMG - muscle activation and co-contraction index		Start and end of treatment	No