A Randomised Controlled Trial of Family Mediated Exercises (FAME) Following Stroke
NCT ID: NCT00666744
Last Updated: 2008-10-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
40 participants
INTERVENTIONAL
2008-04-30
2009-03-31
Brief Summary
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Detailed Description
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Training will be provided to the nominated family member (s)/friends of participants in the 'intervention' group on a weekly basis by the research physiotherapist (R1). Family members/friends will be requested to keep an exercise diary on a daily basis to document completion of exercises. The trial will continue for eight weeks with an expectation that at least 1200 additional minutes of FAME therapy will be delivered over this time period. Each FAME session is expected to last 35-40 minutes.
Exercises will include repetitive sit to stand exercises with an emphasis on improving symmetry, weight bearing exercises during standing, bridging, straight leg raises, quadriceps strengthening exercises, active/active assisted range of movement exercises for the lower limb and walking. Outcome will be assessed by a blinded outcome assessor (R2) on entry to the study, at eight weeks (post-intervention) and again three months post-intervention (follow-up)
In addition, a semi-structured interview will be carried out with a random sample of the participants and their family member (s)/friends to gain a more qualitative insight into the impact of the programme on those involved. This interview will be completed by a person unknown to the participant. (R3)
Conditions
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Keywords
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
SINGLE
Study Groups
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1
Exercise Intervention - additional lower limb exercises will be completed by the person with stroke with the assistance of his/her family for 35 minutes daily for a period of 8 weeks.
Family Mediated Exercise Therapy
35 minutes of lower limb exercises to be completed by the person with stroke on a daily basis with the assistance of their family for a period of 8 weeks.
2
Participants in this group will receive routine exercise therapy following stroke
No interventions assigned to this group
Interventions
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Family Mediated Exercise Therapy
35 minutes of lower limb exercises to be completed by the person with stroke on a daily basis with the assistance of their family for a period of 8 weeks.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Foundation for Medical Research
OTHER
Friends of the Royal Hospital Donnybrook
UNKNOWN
University of Dublin, Trinity College
OTHER
Responsible Party
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University of Dublin, Trinity College
Principal Investigators
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Emma Stokes, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Dublin, Trinity College
Tara Cusack, PhD
Role: PRINCIPAL_INVESTIGATOR
University College Dublin
Locations
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Beaumont Hospital
Dublin, , Ireland
MaterMisercordiae University Hospital
Dublin, , Ireland
Countries
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Central Contacts
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Facility Contacts
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Julie Shanahan, BSc
Role: primary
Orla Friel, BSc
Role: primary
References
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Galvin R, Cusack T, Stokes E. A randomised controlled trial evaluating family mediated exercise (FAME) therapy following stroke. BMC Neurol. 2008 Jun 20;8:22. doi: 10.1186/1471-2377-8-22.
Other Identifiers
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Irish Heart Foundation - FAME
Identifier Type: -
Identifier Source: secondary_id
08/19
Identifier Type: -
Identifier Source: org_study_id