Innovative Modalities for Restoring Upper Limb Function P... | NCT01725659

Studies
Innovative Modalities for Restoring Upper Limb Function Post Stroke

NCT01725659

Sponsor

Malcom Randall VA Medical Center

Status

Completed

Last Update Posted

Nov 14, 2012Estimated

Enrollment

35Actual

Phase

Not Applicable

Conditions

Cerebrovascular Accident

Interventions

Motor Learning
Robotics
surface FES

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

Nov 2012

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

Sep 2001

Primary Completion Date

Dec 2009Actual

Completion Date

Dec 2009Actual

First Submitted Date

Nov 9, 2012

First Submission Date that Met QC Criteria

Nov 9, 2012

First Posted Date

Nov 14, 2012Estimated

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

Nov 9, 2012

Last Update Posted Date

Nov 14, 2012Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Janis Daly, Principal Investigator, Malcom Randall VA Medical CenterPrincipal Investigator

Lead Sponsor

Malcom Randall VA Medical CenterFED

Collaborators

Not provided

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

PURPOSE. After stroke many patients are unable to engage in normal upper limb functional activities, which may restrict them from participation in meaningful life roles. For many, conventional rehabilitation does not restore upper limb function to a useful level. The purpose of this research is to investigate the benefits of three promising motor learning interventions: focused intensive, motor learning (FIML); 2) robotics and motor learning (ROB-ML); and 3) functional neuromuscular stimulation and motor learning (FNS-ML).

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

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

35Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Motor Learning	Experimental	subjects are provided with intensive motor learning training of the upper limb	Other: Motor Learning
Robotics and Motor Learning	Experimental	subject are provided with intensive motor learning and robotics training of the upper limb	Other: Motor Learning Other: Robotics
Motor learning and FES	Experimental	subjects are provided with intensive motor learning and surface FES (Functional Electrical Stimulation) of the upper limb	Other: Motor Learning Other: surface FES

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Motor Learning	Other	training of the hemiplegic upper limb with motor learning	Motor Learning Motor learning and FES Robotics and Motor Learning

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Fugl Meyer	impairment measure of coordination of the upper limb	after 12 weeks of intervention

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

>1 year post stroke no acute, uncontrolled medical condition single stroke

Exclusion Criteria:

pacemaker other neurological condition more than one stroke

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

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Louis Stokes Cleveland Department of Veterans Affairs Medical Center		Cleveland	Ohio	44118	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

Intervention Browse Module

MeSH Terms

ID	Term
D012371	Robotics

Ancestor Terms

ID	Term
D001331	Automation
D013672	Technology
D013676	Technology, Industry, and Agriculture

Browse Leaves

Not provided

Browse Branches

Not provided