CClinicalTrials.gg
Status unknownNCT00785343Updated Dec 24, 2009

Study of Robot-assisted Arm Therapy for Acute Stroke Patients

A Phase 1 interventional study of Reo Go robotic arm trainer and Conventional Therapy in Acute Stroke and Paresis, sponsored by Kessler Foundation. Status unknown at 1 site in United States. Open to participants aged 65 Years to 84 Years. Per ClinicalTrials.gov, last updated 2009-12-24.

Sponsored by Kessler Foundation · Phase 1, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Dec 2009), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 1
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
65 Years to 84 Years
Sex
All
01

Study 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.

Read the 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.
02

Conditions studied

  • Acute Stroke
  • Paresis

Keywords

  • stroke
  • acute
  • arm
  • robot
  • therapy
  • arm paresis
03

In context

Muscle Weakness

601 studies on the registry are indexed under Muscle Weakness; 99 are open to participants now.

This study's planned enrollment of 40 is below the median of 46 across 444 interventional studies indexed under Muscle Weakness.

Browse Muscle Weakness studies →

Lead sponsor

Kessler Foundation is the lead sponsor of 170 studies on the registry; 58 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
65 Years to 84 Years
Sexes eligible
All
Accepts healthy volunteers
No

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
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
40 participants (estimated)

Study arms

  • Active comparator
    Conventional Treatment

    Procedure: Conventional Therapy

  • Experimental
    Robotic and Conventional Therapy

    Device: Reo Go robotic arm trainer

Interventions

  • DeviceReo Go robotic arm trainer

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

  • ProcedureConventional Therapy

    Occupational therapy that is the current standard of care

06

What researchers measure

Primary outcomes

  1. Fugl-Meyer Score

    Time frame: Start and end of treatment

Secondary outcomes

  1. EMG - muscle activation and co-contraction index

    Time frame: Start and end of treatment

07

Study locations

1 of 1 sites recruiting
  • Kessler Institute for Rehabilitation
    Saddle Brook, New Jersey 07663, United States
    • Lauren McDonagh · Contact · lmcdonagh@KESSLER-REHAB.com · 201-368-6081
    • Lauren McDonagh · Principal investigator
    • Christine Post · Sub investigator
    • Antoinette Gentile · Sub investigator
    Recruiting
08

References and documents

Publications

  • 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. PubMed 12548529 ↗
  • 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. PubMed 16847784 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 24, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00785343
Lead sponsor
Kessler Foundation
Collaborators
Kessler Institute for Rehabilitation
First posted
Nov 5, 2008
Start date
Sep 2008
Last update
Dec 24, 2009

Study contacts

Lauren McDonagh, PT
Contact
lmcdonagh@KESSLER-REHAB.com
201-368-6081
Christine Post, OT
Contact
CHPost@selectmedicalcorp.com
201-368-6247
Lauren McDonagh, PT
principal investigator · Kessler Rehabilitation Institute

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Dec 2009. You cannot join it, but the record below documents what was studied.

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