Effect on Shoulder Training Using Rehabilitation Robot fo... | NCT01117194

Studies
Effect on Shoulder Training Using Rehabilitation Robot for Stroke Patients

NCT01117194

Sponsor

National Taiwan University Hospital

Status

Unknown status

Last Update Posted

Dec 21, 2012Estimated

Enrollment

12Estimated

Phase

Phase 1

Conditions

Stroke

Interventions

Rehabilitation Robot for Upper Limb Dysfunction (NTUH Model One)

Countries

Taiwan

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

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2010

Primary Completion Date

Feb 2013Estimated

Completion Date

Feb 2013Estimated

First Submitted Date

Jan 18, 2010

First Submission Date that Met QC Criteria

May 4, 2010

First Posted Date

May 5, 2010Estimated

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

Dec 20, 2012

Last Update Posted Date

Dec 21, 2012Estimated

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

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 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

12Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
shoulder training, rehabilitation robot	Experimental		Device: Rehabilitation Robot for Upper Limb Dysfunction (NTUH Model One)
control group	No Intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Rehabilitation Robot for Upper Limb Dysfunction (NTUH Model One)	Device	Use an intelligent robot to assist upper limb rehabilitation.	shoulder training, rehabilitation robot

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Barthel index,		1 year
Modified Asworth Scale		1 year
STREAM and PASS scales		1 year

Secondary Outcomes

Measure	Description	Time Frame
shoulder range of motion, VAS		1 year

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

stroke (1-3 months)
Brunnstrom Stage II-III
single, unilateral

Exclusion Criteria:

aphasic
shoulder impairment
severe osteoporosis

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

50 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Wen-Shiang Chen	Contact	+886-2-2123456	67087	wenshiang@gmail.com

Overall Officials

Name	Affiliation	Role
Wen-Shiang Chen, MD, PhD	Dpt. Physical Medicine and Rehabilitation, NTUH Taipei, Taiwan	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Dpt. Physical Medicine and Rehabilitation, NTUH	Recruiting	Taipei		100	Taiwan

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