A Randomised Controlled Trial of Family Mediated Exercises (FAME) Following Stroke - Full Text View

Sponsors and Collaborators:	University of Dublin, Trinity College Foundation for Medical Research Friends of the Royal Hospital Donnybrook
Information provided by:	University of Dublin, Trinity College
ClinicalTrials.gov Identifier:	NCT00666744

Purpose

The aim of the study is to evaluate the functional recovery in two groups of primary stroke patients presenting with moderate/severe disability over a six month period through the implementation of a randomised controlled trial. The first group or the experimental group will receive routine therapy and additional lower limb exercise therapy in the form of family assisted exercises. The second group or the control group will receive routine therapy with no additional formal input from their family members. A secondary aim of the project is to evaluate the impact of the FAME programme on the person with stroke and the individual (s) assisting in the delivery of exercises.

Condition	Intervention	Phase
Weakness Balance	Other: Family Mediated Exercise Therapy	Phase III

MedlinePlus related topics: Exercise and Physical Fitness

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Single Group Assignment, Efficacy Study
Official Title:	A Randomised Controlled Trial of Family Mediated Exercises (FAME) Following Stroke

Further study details as provided by University of Dublin, Trinity College:

Primary Outcome Measures:

Fugl Meyer (FM) Assessment [ Time Frame: Baseline, post intervention and 3 month follow-up ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Berg Balance Scale (BBS) [ Time Frame: Baseline, post intervention and 3 month follow-up ] [ Designated as safety issue: No ]
Motor Assessment Scale (MAS) [ Time Frame: Baseline, post-intervention and 3 month follow up ] [ Designated as safety issue: No ]
Six Minute Walk Test (SMWT) [ Time Frame: Baseline, post-intervention and 3 month follow up ] [ Designated as safety issue: No ]
Barthel Index (BI) [ Time Frame: Baseline, post-intervention and 3 month follow up ] [ Designated as safety issue: No ]
Re-integration into Normal Living Index (RNLI) [ Time Frame: Baseline, post-intervention and 3 month follow up ] [ Designated as safety issue: No ]
Nottingham Extended Activities of Daily Living (EADL) [ Time Frame: Baseline, post-intervention and 3 month follow up ] [ Designated as safety issue: No ]

Estimated Enrollment:	40
Study Start Date:	April 2008
Estimated Study Completion Date:	March 2009
Estimated Primary Completion Date:	March 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental 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.	Other: 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: No Intervention Participants in this group will receive routine exercise therapy following stroke

Detailed Description:

Participants with primary stroke eligible for inclusion to the study at 2 weeks post stroke will be randomised into either a 'control' group that will receive routine therapy or an 'experimental' group that will receive routine therapy AND additional 'family mediated exercise therapy.

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)

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00666744

Contacts

Contact: Emma K Stokes, PhD	00 353 1 896 2127	estokes@tcd.ie
Contact: Rose Galvin, BSc	00 353 1 896 3613	rgalvin@tcd.ie

Locations

Ireland
Beaumont Hospital	Recruiting
Dublin, Ireland
Contact: Julie Shanahan, BSc 00 353 1 809 2535 julieshanahan@beaumont.ie
Sub-Investigator: Julie Shanahan, BSc
MaterMisercordiae University Hospital	Recruiting
Dublin, Ireland
Contact: Orla Friel, BSc 00 353 1 8034273 physiorehab@mater.ie
Sub-Investigator: Orla Friel, BSc

Sponsors and Collaborators

University of Dublin, Trinity College

Foundation for Medical Research

Friends of the Royal Hospital Donnybrook

Investigators

Principal Investigator:	Emma Stokes, PhD	University of Dublin, Trinity College
Principal Investigator:	Tara Cusack, PhD	University College Dublin

More Information

Additional Information:

Family- mediated exercise intervention post stroke This link exits the ClinicalTrials.gov site

No publications provided by University of Dublin, Trinity College

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

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.

Responsible Party:	University of Dublin, Trinity College ( Dr. Emma Stokes )
Study ID Numbers:	08/19, Irish Heart Foundation - FAME
Study First Received:	April 23, 2008
Last Updated:	October 28, 2008
ClinicalTrials.gov Identifier:	NCT00666744 History of Changes
Health Authority:	Ireland: Medical Ethics Research Committee

Keywords provided by University of Dublin, Trinity College:

exercise
frequency
duration

Study placed in the following topic categories:

Cerebral Infarction
Asthenia
Stroke

ClinicalTrials.gov processed this record on May 07, 2009