NCT01511796

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
38

participants targeted

Target at below P25 for phase_3 stroke

Timeline
Completed

Started Jan 2012

Shorter than P25 for phase_3 stroke

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

January 6, 2012

Completed
13 days until next milestone

First Posted

Study publicly available on registry

January 19, 2012

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2013

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2014

Completed
Last Updated

January 19, 2012

Status Verified

January 1, 2012

Enrollment Period

1.2 years

First QC Date

January 6, 2012

Last Update Submit

January 17, 2012

Conditions

Stroke

Keywords

strokeupper limb rehabilitation function

Outcome Measures

Primary Outcomes (1)

  • Modified Ashworth

    up tp 2013

Secondary Outcomes (1)

  • Goal attaiment Scale

    up tp 2013

Study Arms (1)

upper limb rehabilitation for total of 6 months

EXPERIMENTAL

upper limb rehabiliation

Other: upper limb rehabiliation

Interventions

upper limb rehabiliationOTHER

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

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Toronto Rehabiliation institute

Toronto, Ontario, M5G 2A2, Canada

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal inverstigator

Study Record Dates

First Submitted

January 6, 2012

First Posted

January 19, 2012

Study Start

January 1, 2012

Primary Completion

April 1, 2013

Study Completion

April 1, 2014

Last Updated

January 19, 2012

Record last verified: 2012-01

Locations

CA(1)