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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00666744 |
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Date of registration:
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23/04/2008 |
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Primary sponsor: |
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Public title:
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A Randomised Controlled Trial of Family Mediated Exercises (FAME) Following Stroke
FAME |
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Scientific title:
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A Randomised Controlled Trial of Family Mediated Exercises (FAME) Following Stroke |
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Date of first enrolment:
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April 2008 |
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Target sample size:
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40 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT00666744 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
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Countries of recruitment
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Ireland
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Contacts
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Name:
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Emma K Stokes, PhD |
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Address:
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Telephone:
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00 353 1 896 2127 |
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Email:
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estokes@tcd.ie |
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Affiliation:
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Name:
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Tara Cusack, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University College Dublin |
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Name:
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Emma Stokes, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Dublin, Trinity College |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- diagnosis of first unilateral stroke
- Patients who score between 3.2 and 5.2 on the Orpington Prognostic Scale
- Patients participating in a physiotherapy programme
- Patients willing to give informed written consent
- Patients with family willing to participate in their assigned physiotherapy
intervention programme
Exclusion Criteria:
- hemiplegia of a non-vascular origin
- discharged from hospital less than two weeks following stroke
- pre-existing neurological disorder
- any lower limb orthopaedic condition that may limit exercise capacity
- aphasia
- cognitive impairment
- not willing to give written consent
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Balance
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Weakness
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Intervention(s)
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Other: Family Mediated Exercise Therapy
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Primary Outcome(s)
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Fugl Meyer (FM) Assessment
[Time Frame: Baseline, post intervention and 3 month follow-up]
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Secondary Outcome(s)
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Barthel Index (BI)
[Time Frame: Baseline, post-intervention and 3 month follow up]
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Berg Balance Scale (BBS)
[Time Frame: Baseline, post intervention and 3 month follow-up]
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Motor Assessment Scale (MAS)
[Time Frame: Baseline, post-intervention and 3 month follow up]
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Nottingham Extended Activities of Daily Living (EADL)
[Time Frame: Baseline, post-intervention and 3 month follow up]
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Re-integration into Normal Living Index (RNLI)
[Time Frame: Baseline, post-intervention and 3 month follow up]
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Six Minute Walk Test (SMWT)
[Time Frame: Baseline, post-intervention and 3 month follow up]
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Secondary ID(s)
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08/19
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Irish Heart Foundation - FAME
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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