A Randomised Controlled Trial of Family Mediated Exercises (FAME) Following Stroke
Recruitment status was Recruiting
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 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|
- Fugl Meyer (FM) Assessment [ Time Frame: Baseline, post intervention and 3 month follow-up ] [ Designated as safety issue: No ]
- 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 ]
|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)|
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
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)
Please refer to this study by its ClinicalTrials.gov identifier: NCT00666744
|Contact: Emma K Stokes, PhD||00 353 1 896 firstname.lastname@example.org|
|Contact: Rose Galvin, BSc||00 353 1 896 email@example.com|
|Contact: Julie Shanahan, BSc 00 353 1 809 2535 firstname.lastname@example.org|
|Sub-Investigator: Julie Shanahan, BSc|
|MaterMisercordiae University Hospital||Recruiting|
|Contact: Orla Friel, BSc 00 353 1 8034273 email@example.com|
|Sub-Investigator: Orla Friel, BSc|
|Principal Investigator:||Emma Stokes, PhD||University of Dublin, Trinity College|
|Principal Investigator:||Tara Cusack, PhD||University College Dublin|