A Randomised Controlled Trial of Family Mediated Exercises (FAME) Following Stroke (FAME)

October 28, 2008 updated by: University of Dublin, Trinity College
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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)

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Ireland
      • Dublin, Ireland
        • Recruiting
        • Beaumont Hospital
        • Contact:
        • Sub-Investigator:
          • Julie Shanahan, BSc
      • Dublin, Ireland
        • Recruiting
        • MaterMisercordiae University Hospital
        • Contact:
        • Sub-Investigator:
          • Orla Friel, BSc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
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.
No Intervention: 2
Participants in this group will receive routine exercise therapy following stroke

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Fugl Meyer (FM) Assessment
Time Frame: Baseline, post intervention and 3 month follow-up
Baseline, post intervention and 3 month follow-up

Secondary Outcome Measures

Outcome Measure
Time Frame
Berg Balance Scale (BBS)
Time Frame: Baseline, post intervention and 3 month follow-up
Baseline, post intervention and 3 month follow-up
Motor Assessment Scale (MAS)
Time Frame: Baseline, post-intervention and 3 month follow up
Baseline, post-intervention and 3 month follow up
Six Minute Walk Test (SMWT)
Time Frame: Baseline, post-intervention and 3 month follow up
Baseline, post-intervention and 3 month follow up
Barthel Index (BI)
Time Frame: Baseline, post-intervention and 3 month follow up
Baseline, post-intervention and 3 month follow up
Re-integration into Normal Living Index (RNLI)
Time Frame: Baseline, post-intervention and 3 month follow up
Baseline, post-intervention and 3 month follow up
Nottingham Extended Activities of Daily Living (EADL)
Time Frame: Baseline, post-intervention and 3 month follow up
Baseline, post-intervention and 3 month follow up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Dublin, Trinity College

Collaborators

Foundation for Medical Research
Friends of the Royal Hospital Donnybrook

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2008

Primary Completion (Anticipated)

March 1, 2009

Study Completion (Anticipated)

March 1, 2009

Study Registration Dates

First Submitted

April 23, 2008

First Submitted That Met QC Criteria

April 23, 2008

First Posted (Estimate)

April 25, 2008

Study Record Updates

Last Update Posted (Estimate)

October 29, 2008

Last Update Submitted That Met QC Criteria

October 28, 2008

Last Verified

April 1, 2008

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 08/19
  • Irish Heart Foundation - FAME

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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