Clinical trial NCT00666744: A Randomised Controlled Trial of Family Mediated Exercises (FAME) Following Stroke
Official title: A Randomised Controlled Trial of Family Mediated Exercises (FAME) Following Stroke
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Weakness
Balance
Keywords: exercise
frequency
duration
Lead sponsor: University of Dublin, Trinity College
Sponsor class: OTHER
Collaborators: name: Foundation for Medical Research
name: Friends of the Royal Hospital Donnybrook
First posted: 2008-04-25
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

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 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

Primary outcomes:
measure: Fugl Meyer (FM) Assessment
timeFrame: Baseline, post intervention and 3 month follow-up
Secondary outcomes:
measure: Berg Balance Scale (BBS)
timeFrame: Baseline, post intervention and 3 month follow-up
measure: Motor Assessment Scale (MAS)
timeFrame: Baseline, post-intervention and 3 month follow up
measure: Six Minute Walk Test (SMWT)
timeFrame: Baseline, post-intervention and 3 month follow up
measure: Barthel Index (BI)
timeFrame: Baseline, post-intervention and 3 month follow up
measure: Re-integration into Normal Living Index (RNLI)
timeFrame: Baseline, post-intervention and 3 month follow up
measure: Nottingham Extended Activities of Daily Living (EADL)
timeFrame: Baseline, post-intervention and 3 month follow up
Other outcomes:
Locations:
city: Dublin
country: Ireland
facility: Beaumont Hospital
city: Dublin
country: Ireland
facility: MaterMisercordiae University Hospital
Study officials:
affiliation: University of Dublin, Trinity College
name: Emma Stokes, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University College Dublin
name: Tara Cusack, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Galvin R, Cusack T, Stokes E. A randomised controlled trial evaluating family mediated exercise (FAME) therapy following stroke. BMC Neurol. 2008 Jun 20;8:22. doi: 10.1186/1471-2377-8-22.