Recruiting
Phase 1

Robot-assisted Therapy

Sponsor:

Kessler Foundation

Code:

NCT00785343

Conditions

Acute Stroke

Paresis

Eligibility Criteria

Sex: All

Age: 65 - 70+

Healthy Volunteers: Not accepted

Interventions

Reo Go robotic arm trainer

Conventional Therapy

Study Details

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.

Conditions

Acute Stroke

Paresis

Study ID

NCT00785343

Start date

Sep, 2008

Status verified date

Dec, 2009

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 65 - 70+

Healthy Volunteers: Not accepted

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

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Conventional Treatment

experimental: Robotic and Conventional Therapy

Interventions

Reo Go robotic arm trainer

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

Conventional Therapy

Occupational therapy that is the current standard of care

Primary outcome measure

  • Fugl-Meyer Score [ Time Frame: Start and end of treatment ]

Central Contacts and Locations

Locations

Kessler Institute for Rehabilitation

Recruiting

Saddle Brook, New Jersey, United States, 07663

Contacts

Principal Investigator:

Lauren McDonagh

More Information

Sponsor

Kessler Foundation

Last update posted

Dec 24, 2009

Last verified

Dec, 2009

Keywords

  • stroke
  • acute
  • arm
  • robot
  • therapy
  • arm paresis

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Kessler Foundation on 2009-12-24.