Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsors and Collaborators: |
University of Dublin, Trinity College Foundation for Medical Research Friends of the Royal Hospital Donnybrook |
---|---|
Information provided by: | University of Dublin, Trinity College |
ClinicalTrials.gov Identifier: | NCT00666744 |
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.
Condition | Intervention | Phase |
---|---|---|
Weakness Balance |
Other: Family Mediated Exercise Therapy |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Single Group Assignment, Efficacy Study |
Official Title: | A Randomised Controlled Trial of Family Mediated Exercises (FAME) Following Stroke |
Estimated Enrollment: | 40 |
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) |
Arms | Assigned Interventions |
---|---|
1: Experimental
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.
|
2: No Intervention
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)
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Emma K Stokes, PhD | 00 353 1 896 2127 | estokes@tcd.ie |
Contact: Rose Galvin, BSc | 00 353 1 896 3613 | rgalvin@tcd.ie |
Ireland | |
Beaumont Hospital | Recruiting |
Dublin, Ireland | |
Contact: Julie Shanahan, BSc 00 353 1 809 2535 julieshanahan@beaumont.ie | |
Sub-Investigator: Julie Shanahan, BSc | |
MaterMisercordiae University Hospital | Recruiting |
Dublin, Ireland | |
Contact: Orla Friel, BSc 00 353 1 8034273 physiorehab@mater.ie | |
Sub-Investigator: Orla Friel, BSc |
Principal Investigator: | Emma Stokes, PhD | University of Dublin, Trinity College |
Principal Investigator: | Tara Cusack, PhD | University College Dublin |
Responsible Party: | University of Dublin, Trinity College ( Dr. Emma Stokes ) |
Study ID Numbers: | 08/19, Irish Heart Foundation - FAME |
Study First Received: | April 23, 2008 |
Last Updated: | October 28, 2008 |
ClinicalTrials.gov Identifier: | NCT00666744 History of Changes |
Health Authority: | Ireland: Medical Ethics Research Committee |
exercise frequency duration |
Cerebral Infarction Asthenia Stroke |