Robot Assisted Upper Limb Neuro-Rehabilitation | NCT00011583

Studies
Robot Assisted Upper Limb Neuro-Rehabilitation

NCT00011583

Sponsor

US Department of Veterans Affairs

Status

Completed

Last Update Posted

Mar 11, 2008Estimated

Enrollment

60Estimated

Phase

Phase 2

Conditions

Acute Stroke

Interventions

Robot-assisted therapy
Traditional therapy

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

Mar 2008

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

Jan 2000

Primary Completion Date

Dec 2003Actual

Completion Date

Dec 2003Actual

First Submitted Date

Feb 22, 2001

First Submission Date that Met QC Criteria

Feb 23, 2001

First Posted Date

Feb 26, 2001Estimated

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

Mar 10, 2008

Last Update Posted Date

Mar 11, 2008Estimated

Description Module

Brief Summary

Our long term objectives are to understand the mechanisms of motor impairment following neurologic injury and to develop interventions to improve motor recovery. A series of complementary, overlapping clinical trials and development activities will validate and optimize the use of robot-assisted upper limb therapy for neuro rehabilitation.

We have developed a robotic system that assists or resists elbow and shoulder movements in three dimensional space. In addition to unilateral exercise modes, a novel bimanual mode enables hemiparetic subjects to practice mirror image upper limb exercises.

Detailed Description

Randomized controlled clinical trial of the Mirror Image Movement Enabler (MIME) robotic device for shoulder and elbow neurorehabilitation in subacute stroke patients. MIME incorporates a PUMA 560 robot that applies forces to the paretic limb during unilateral and bilateral movements in three dimensions. Robot-assisted treatment (bilateral, unilateral, and combined bilateral and unilateral) was compared with conventional therapy.

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

60Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	1 hour/day of mechanically-assisted upper limb therapy	Device: Robot-assisted therapy
2	Active Comparator	1 hour/day of upper limb therapy that includes exposure to, but no manipulation by the robot	Device: Traditional therapy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Robot-assisted therapy	Device	1 hour/day of mechanically-assisted upper limb therapy	1

Measure	Description	Time Frame
Fugl-Meyer score		end of training, 6-month follow-up

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Stroke patients

Exclusion Criteria:

Unable to follow instructions; medically unstable.

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
Charles Burgar, MD	Central Texas Veterans Health Care System	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Central Texas Veterans Health Care System		Temple	Texas	76504	United States

Condition Browse Module

MeSH Terms

ID	Term
D020521	Stroke
D006429	Hemiplegia

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