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Study of Robot-assisted Arm Therapy for Acute Stroke Patients

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

Status
UNKNOWN
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00785343
Enrollment
40
Registered
2008-11-05
Start date
2008-09-30
Completion date
Unknown
Last updated
2009-12-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Stroke, Paresis

Keywords

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

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.

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

Sponsors

Kessler Institute for Rehabilitation
CollaboratorINDUSTRY
Kessler Foundation
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
65 Years to 84 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Fugl-Meyer ScoreStart and end of treatment

Secondary

MeasureTime frame
EMG - muscle activation and co-contraction indexStart and end of treatment

Countries

United States

Contacts

Primary ContactLauren McDonagh, PT
lmcdonagh@KESSLER-REHAB.com201-368-6081
Backup ContactChristine Post, OT
CHPost@selectmedicalcorp.com201-368-6247

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026