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

Balance Clinical Trial

— FAME  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00666744
• Other study ID #: 08/19
• Secondary ID: Irish Heart Foun
• Status: Recruiting
• Phase: Phase 3
• First received: April 23, 2008
• Last updated: October 28, 2008
• Start date: April 2008
• Est. completion date: March 2009

Study information

• Verified date: April 2008
• Source: University of Dublin, Trinity College
• Contact: Emma K Stokes, PhD
• Phone: 00 353 1 896 2127
• Email: estokes[@]tcd.ie
• Is FDA regulated: No
• Health authority: Ireland: Medical Ethics Research Committee
• Study type: Interventional

Clinical Trial Summary

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.

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)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: March 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Balance
• Weakness

Intervention

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.

Locations

Country	Name	City	State
Ireland	Beaumont Hospital	Dublin
Ireland	MaterMisercordiae University Hospital	Dublin

Sponsors (3)

Lead Sponsor	Collaborator
University of Dublin, Trinity College	Foundation for Medical Research, Friends of the Royal Hospital Donnybrook

Country where clinical trial is conducted

Ireland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fugl Meyer (FM) Assessment		Baseline, post intervention and 3 month follow-up	No
Secondary	Berg Balance Scale (BBS)		Baseline, post intervention and 3 month follow-up	No
Secondary	Motor Assessment Scale (MAS)		Baseline, post-intervention and 3 month follow up	No
Secondary	Six Minute Walk Test (SMWT)		Baseline, post-intervention and 3 month follow up	No
Secondary	Barthel Index (BI)		Baseline, post-intervention and 3 month follow up	No
Secondary	Re-integration into Normal Living Index (RNLI)		Baseline, post-intervention and 3 month follow up	No
Secondary	Nottingham Extended Activities of Daily Living (EADL)		Baseline, post-intervention and 3 month follow up	No

External Links

•   Family- mediated exercise intervention post stroke