Study of Robot-assisted Arm Therapy for Acute Stroke Patients

Phase 1

• Conditions: Acute Stroke; Paresis
• Interventions: Procedure: Conventional Therapy; Device: Reo Go robotic arm trainer

• Registration Number: NCT00785343
• Lead Sponsor: Kessler Foundation

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.

Study Timeline

• Study Start: 2008-09
• Study First Submitted: 2008-11-04
• Study First Submitted QC: 2008-11-04
• Study First Posted: 2008-11-05
• Status Verified: 2009-12
• Last Update Submitted: 2009-12-23
• Last Update Posted: 2009-12-24

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Conventional Treatment	Conventional Therapy	-
Robotic and Conventional Therapy	Reo Go robotic arm trainer	-

Primary Outcome Measures

Name	Time	Method
Fugl-Meyer Score	Start and end of treatment

Secondary Outcome Measures

Name	Time	Method
EMG - muscle activation and co-contraction index	Start and end of treatment

Trial Locations

Locations (1)

Kessler Institute for Rehabilitation; 🇺🇸 Saddle Brook, New Jersey, United States