A randomised trial of an occupational therapy and physiotherapy intervention to enhance mobility and activity in a nursing or residential home setting after stroke

ISRCTN ISRCTN79859980
DOI https://doi.org/10.1186/ISRCTN79859980
Protocol serial number 554/1474
Sponsor University of Birmingham (UK)
Funder The Health Foundation (UK) - reference number 554/1474
Submission date
13/02/2006
Registration date
18/04/2006
Last edited
03/09/2009
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Catherine Sackley
Scientific

School of Health Sciences
52 Pritchatt's Road
University of Birmingham
Edgbaston
Birmingham
B15 2TT
United Kingdom

Phone +44 (0)121 414 4198
Email c.m.sackley@bham.ac.uk

Study information

Primary study designInterventional
Study designCluster, randomised controlled trial
Secondary study designRandomised controlled trial
Scientific title
Study acronymRICH-T
Study objectivesDoes a rehabilitation intervention targeting mobility and self-care independence reduce deterioration in independence and immobility-related complications?
Ethics approval(s)The Applied and Qualitative Research Ethics Committee, Oxfordshire National Health Service (NHS) gave ethical approval for the study on 04/02/2003. Site-specific assessment approval was also granted in both the South and East Birmingham Local Research Ethics Committees, reference number: A02.072 REC 2003/247L
Health condition(s) or problem(s) studiedStroke and other vascular diseases
InterventionAn evidence-based occupational therapy and physiotherapy intervention, including individual treatments, group treatments and staff education versus usual care
Intervention typeOther
Primary outcome measure(s)

Independence and mobility measured by the Barthel ADL Index and the Rivermead mobility index

Key secondary outcome measure(s)

1. Emotional distress - hospital anxiety and depression scale or the stroke aphasia depression scale (if unable to communicate verbally or in writing)
2. Mobility - timed up and go
3. Bone density - lunar achilles express ultrasonometer
4. Strength - hand grip dynamometer
5. Health economics - EuroQol
6. Complication events such as pressure sores, falls and fear of falling were also recorded

Completion date31/05/2006

Eligibility

Participant type(s)Patient
Age groupAdult
SexAll
Target sample size at registration250
Key inclusion criteriaReduced self-care independence, as indicated by a Barthel activities of daily living (ADL) index score between 5 and 15 inclusively
Key exclusion criteriaEnd of life stage of illness (e.g. life expectancy <1 year)
Date of first enrolment01/05/2004
Date of final enrolment31/05/2006

Locations

Countries of recruitment

  • United Kingdom
  • England

Study participating centre

School of Health Sciences
Birmingham
B15 2TT
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/09/2009 Yes No
Study website Study website 11/11/2025 11/11/2025 No Yes