N/A N=62 Randomized Treatment

Evaluation of Robotic Arm Rehabilitation in Stroke Patients

Stroke

Bottom Line

View on ClinicalTrials.gov: NCT00333983 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Mar 2014

Primary outcome: Primary: Upper Extremity Portion of the Fugl-Meyer Motor Performance Assessment — 3.27; 2.51; 1.82 units on a scale — p=.025

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Robotic Upper Extremity Neurorehabilitation (Device); Traditional Upper Extremity Exercise Group (Other)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: US Department of Veterans Affairs
Primary completion: Apr 2010

Outcome Measures

Outcome	Result	p-value
PRIMARY Upper Extremity Portion of the Fugl-Meyer Motor Performance Assessment	3.27; 2.51; 1.82	.025 sig

Summary

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.

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00333983). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.