Evaluation of Robotic Arm Rehabilitation in Stroke Patients

Stroke Clinical Trial

Official title:

Evaluation of Robotic Arm Rehabilitation in Stroke Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00333983
• Other study ID #: B3833-R
• Status: Completed
• Phase: N/A
• First received: June 2, 2006
• Last updated: February 3, 2014
• Start date: June 2006
• Est. completion date: February 2011

Study information

• Verified date: February 2014
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: February 2011
• Est. primary completion date: April 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Stroke

Intervention

Device:
• Robotic Upper Extremity Neurorehabilitation
Upper extremity exercise using a planar robot Upper extremity exercise using a planar and vertical robot

Other:
• Traditional Upper Extremity Exercise Group
Upper extremity stretching, skateboard reaching activities, and arm ergometer

Locations

Country	Name	City	State
United States	VA Maryland Health Care System, Baltimore	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

References & Publications (1)

Conroy SS, Whitall J, Dipietro L, Jones-Lush LM, Zhan M, Finley MA, Wittenberg GF, Krebs HI, Bever CT. Effect of gravity on robot-assisted motor training after chronic stroke: a randomized trial. Arch Phys Med Rehabil. 2011 Nov;92(11):1754-61. doi: 10.101 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Upper Extremity Portion of the Fugl-Meyer Motor Performance Assessment	The Fugl-Meyer Assessment (FMA) is a stroke-specific, performance-based impairment index. It is designed to assess motor functioning, balance, sensation and joint functioning in patients with post-stroke hemiplegia (Fugl-Meyer, Jaasko, Leyman, Olsson, & Steglind, 1975; Gladstone, Danells, & Black, 2002).; Sections can be administered separately and the upper extremity motor portion of this measure was used as our primary outcome. Assessment items included movement, coordination, and reflex action of the shoulder, elbow, forearm, wrist, and hand. These items were scored on the basis of ability to complete using a 3-point ordinal scale where 0=cannot perform, 1=performs partially and 2=performs fully.; The total possible score for the upper extremity is 66 with a minimum range of 0 and maximum of 66. A higher score indicates a better outcome.	Baseline to Final Training (6 weeks)	No