Balance Clinical Trial
Official title:
A Randomised Controlled Trial of Family Mediated Exercises (FAME) Following Stroke
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.
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)
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
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