Examining the Effectiveness of Combined Rehabilitation an... | NCT01511796

Studies
Examining the Effectiveness of Combined Rehabilitation and Botulinum Toxin Injection on Functional Improvement of the Upper Limb After Stroke

NCT01511796

Sponsor

Toronto Rehabilitation Institute

Status

Unknown status

Last Update Posted

Jan 19, 2012Estimated

Enrollment

38Estimated

Phase

Phase 3

Conditions

Stroke

Interventions

upper limb rehabiliation

Countries

Canada

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

Jan 2012

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Enrolling by invitation

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2012

Primary Completion Date

Apr 2013Estimated

Completion Date

Apr 2014Estimated

First Submitted Date

Jan 6, 2012

First Submission Date that Met QC Criteria

Jan 17, 2012

First Posted Date

Jan 19, 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

Jan 17, 2012

Last Update Posted Date

Jan 19, 2012Estimated

Name	Class
University of Toronto	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

The purpose of this study is to examine the effects of a combination of "Botulinum Toxin (BT) and Upper Limb (UL) rehabilitation" compared to "BT only" on UL motor function in adults with spasticity after stroke using a pre-post design. The research question is whether combination of BT and UL rehabilitation compared to BT only is more effective in improving the UL function, range of motion and pain.

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 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

38Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
upper limb rehabilitation for total of 6 months	Experimental	upper limb rehabiliation	Other: upper limb rehabiliation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
upper limb rehabiliation	Other	3 months upper rehabilation (twice a week) and then 3 more months upper limb rehabitation ( twice a week)	upper limb rehabilitation for total of 6 months

Measure	Description	Time Frame
Modified Ashworth		up tp 2013

Measure	Description	Time Frame
Goal attaiment Scale		up tp 2013

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

over 18 years of age
at least 4 months post stroke
present with UL spasticity (MAS >1 in elbow and/or spasticity of the hand, wrist or shoulder)
present with at lease a stage 3 of CMSA
able to comply with the requirements of the protocol and UL therapy programme.

Exclusion Criteria:

significant cognitive and speech impairments
other upper limb impairments such as frozen shoulder
another diagnosis which could contribute to upper limb spasticity .

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

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
Toronto Rehabiliation institute		Toronto	Ontario	M5G 2A2	Canada

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