A multi-centre randomised controlled trial of rehabilitation aimed at improving outdoor mobility for people after stroke: study protocol for a randomised controlled trial.
BACKGROUND
Up to 42% of all stroke patients do not get out of the house as much as they would like. This can impede a person's quality of life. This study is testing the clinical effectiveness and cost effectiveness of a new outdoor mobility rehabilitation intervention by comparing it to usual care.


METHODS
This is a multi-centre parallel group individually randomised, controlled trial. At least 506 participants will be recruited through 15 primary and secondary care settings and will be eligible if they are over 18 years of age, have had a stroke and wish to get out of the house more often. Participants are being randomly allocated to either the intervention group or the control group. Intervention group participants receive up to 12 rehabilitation outdoor mobility sessions over up to four months. The main component of the intervention is repeated practice of outdoor mobility with a therapist. Control group participants are receiving the usual intervention for outdoor mobility limitations: verbal advice and provision of leaflets provided over one session.Outcome measures are being collected using postal questionnaires, travel calendars and by independent assessors. The primary outcome measure is the Social Function domain of the SF36v2 quality of life assessment six months after recruitment. The secondary outcome measures include: functional ability, mobility, the number of journeys (monthly travel diaries), satisfaction with outdoor mobility, mood, health-related quality of life, resource use of health and social care. Carer mood information is also being collected.The mean Social Function score of the SF-36v2 will be compared between treatment arms using a multiple membership form of mixed effects multiple regression analysis adjusting for centre (as a fixed effect), age and baseline Social Function score as covariates and therapist as a multiple membership random effect. Regression coefficients and 95% confidence intervals will be presented.


CONCLUSIONS
This study protocol describes a pragmatic randomised controlled trial that will hopefully provide robust evidence of the benefit of outdoor mobility interventions after stroke for clinicians working in the community. The results will be available towards the end of 2012.


BACKGROUND
ISRCTN58683841.
Division of Rehabilitation and Aging, University of Nottingham, Nottingham, UK. pip.logan@nottingham.ac.uk.
Pip A
PA
Logan
Mat P
MP
Leighton
Marion F
MF
Walker
Sarah
S
Armstrong
John R F
JR
Gladman
Tracey H
TH
Sach
Shirley
S
Smith
Ossie
O
Newell
Tony
T
Avery
Hywel
H
Williams
James
J
Scott
Kathleen
K
O'Neil
Annie
A
McCluskey
Simon
S
Leach
David
D
Barer
Claire
C
Ritchie
Ailie
A
Turton
Jane
J
Bisiker
David
D
Smithard
Tess
T
Baird
Paul
P
Guyler
Therese
T
Jackson
Ingrid
I
Watmough
Maggie
M
Webster
Janet
J
Ivey
D000203:Activities of Daily Living; D002985:Clinical Protocols; D006801:Humans; D017063:Outcome Assessment, Health Care; D011788:Quality of Life; D018401:Sample Size; D020521:Stroke / Q000523:psychology; D000071939:Stroke Rehabilitation