A Phase 3 interventional study of Family Mediated Exercise Therapy in Weakness and Balance, sponsored by University of Dublin, Trinity College. Status unknown at 2 sites in Ireland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2008-10-29.
Sponsored by University of Dublin, Trinity College · Phase 3, Interventional, and Treatment
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)
University of Dublin, Trinity College is the lead sponsor of 72 studies on the registry; 14 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
Participants in this group will receive routine exercise therapy following stroke
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.
Fugl Meyer (FM) Assessment
Time frame: Baseline, post intervention and 3 month follow-up
Berg Balance Scale (BBS)
Time frame: Baseline, post intervention and 3 month follow-up
Motor Assessment Scale (MAS)
Time frame: Baseline, post-intervention and 3 month follow up
Six Minute Walk Test (SMWT)
Time frame: Baseline, post-intervention and 3 month follow up
Barthel Index (BI)
Time frame: 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
Nottingham Extended Activities of Daily Living (EADL)
Time frame: Baseline, post-intervention and 3 month follow up
This study is status unknown, as verified in Apr 2008. You cannot join it, but the record below documents what was studied.
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University of Dublin, Trinity College