N/A
Completed N=62
Evaluation of Robotic Arm Rehabilitation in Stroke Patients
Source: ClinicalTrials.gov NCT00333983 ↗Enrolled (actual)
62
Serious AEs
0.0%
Results posted
Mar 2014
Primary outcomePrimary: Upper Extremity Portion of the Fugl-Meyer Motor Performance Assessment — 3.27; 2.51; 1.82 units on a scale — p=.025
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.
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 |
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
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. Informational only — not medical advice.