Robotic Upper-Limb Neurorehabilitation in Chronic Stroke... | NCT00037934

Studies
Robotic Upper-Limb Neurorehabilitation in Chronic Stroke Patient

NCT00037934

Sponsor

US Department of Veterans Affairs

Status

Completed

Last Update Posted

Oct 7, 2011Estimated

Enrollment

30Actual

Phase

Phase 2

Conditions

Stroke

Interventions

Upper extremity robot
Traditional Supervised Upper Extremity Exercises

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2002

Primary Completion Date

Sep 2004Actual

Completion Date

Dec 2004Actual

First Submitted Date

May 24, 2002

First Submission Date that Met QC Criteria

May 24, 2002

First Posted Date

May 27, 2002Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 6, 2011

Last Update Posted Date

Oct 7, 2011Estimated

Name	Class
Massachusetts Institute of Technology	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

We have established the feasibility and effectiveness of robot-aided rehabilitation in stroke patients using a robot for neurological rehabilitation designed and built by MIT. Results of a pilot study of 20 patients were promising and showed that robot therapy is safe, tolerated by patients and produces a significant, measurable benefit. We propose to test that the robotic upper extremity trainer is an acceptable cost effective adjunct to standard occupational therapy for patients with dysfunction of the shoulder and elbow due to hemiparetic stroke in a VA rehabilitation program.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	Robot exercise group	Device: Upper extremity robot
2	Active Comparator	Traditional exercise group	Device: Upper extremity robot Other: Traditional Supervised Upper Extremity Exercises

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Upper extremity robot	Device	Robotic upper extremity neuro-rehabilitation	1 2

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Upper limb Motor Status Score, Wolf Motor Function Test, Motor Power Assessment, and Fugl-Meyer Upper Extremity Motor Performance Test		The Primary Outcome measures were performed at baseline, after completion of 18 sessions of intervention and at 3 months follow-up.

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Chronic Stroke
Manual Muscle Score of Grade 3 or lower in at least one muscle of the affected arm

Exclusion Criteria:

Acute Stroke
Contracture or orthopedic problems limiting the movement of the affected arm
Visual deficit such that the participant cannot see the test pattern on the robot trainer
Serious complicating medical illness
Botox treatment to the involved arm within three months of enrollment

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Christopher Bever, MD	VA Maryland Health Care System, Baltimore	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
VA Maryland Health Care System, Baltimore		Baltimore	Maryland	21201	United States

Condition Browse Module

MeSH Terms

ID	Term
D020521	Stroke

Ancestor Terms

ID	Term
D002561	Cerebrovascular Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided