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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2008 by University of Dublin, Trinity College.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Foundation for Medical Research
Friends of the Royal Hospital Donnybrook
Information provided by:
University of Dublin, Trinity College
ClinicalTrials.gov Identifier:
NCT00666744
First received: April 23, 2008
Last updated: October 28, 2008
Last verified: April 2008
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomised Controlled Trial of Family Mediated Exercises (FAME) Following Stroke

Resource links provided by NLM:


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
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.
Other Name: Family mediated exercise therapy
No Intervention: 2
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
No publications provided by University of Dublin, Trinity College

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

Keywords provided by University of Dublin, Trinity College:
exercise
frequency
duration

ClinicalTrials.gov processed this record on November 27, 2014