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Evaluation of Robotic Arm Rehabilitation in Stroke Patients

US Department of Veterans Affairs (VA) logo

US Department of Veterans Affairs (VA)

Status

Completed

Conditions

Stroke

Treatments

Device: Robotic Upper Extremity Neurorehabilitation
Other: Traditional Upper Extremity Exercise Group

Study type

Interventional

Funder types

Other U.S. Federal agency

Identifiers

NCT00333983
B3833-R

Details and patient eligibility

About

The purpose of this study is to compare 2 training programs using robotic exercise devices to supervised arm exercises in stroke patients with chronic stable deficits.

Full description

A robotic exercise device has been developed(MIT-MANUS)capable of providing therapy to the arm for patients with weakness due to stroke. The randomized trial will compare conventional care, planar robot intervention and an intervention of planar and vertical robot training among patients with chronic, stable deficits. We will evaluate motor outcomes, effectiveness, cost, patient satisfaction and quality of life. The study will determine the efficacy of upper extremity robot therapy compared to supervised self-administered exercise therapy in patients with deficits due to stroke.

Enrollment

62 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Subjects must have a clinically, defined, unilateral, hemiparetic stroke with radiologic exclusion of other diagnoses
  • Stroke onset greater than six months before randomization for ischemic stroke patients and one year before randomization for hemorrhagic stroke patients
  • A grade 3 or lower in Manual Muscle Test in the hemiparetic elbow flexion and shoulder abduction

Exclusion criteria

  • Subjects unable to give informed consent
  • Serious complicating medical illness
  • Contracture or orthopedic problems limiting the range of joint movement in the study arm
  • Visual loss
  • Stroke occurred within 6 months for ischemic stroke patients, one year for hemorrhagic patients
  • Botox treatment within 3 months of enrollment

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

62 participants in 2 patient groups

Arm 1
Experimental group
Description:
Robot Exercise Group
Treatment:
Device: Robotic Upper Extremity Neurorehabilitation
Arm 2
Active Comparator group
Description:
Traditional Upper Extremity Exercise Group
Treatment:
Other: Traditional Upper Extremity Exercise Group

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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