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A cluster randomised controlled trial of an occupational therapy intervention for residents with stroke living in UK care-homes

A cluster randomised controlled trial of an occupational therapy intervention for residents with stroke living in UK care-homes

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN00757750
Enrollment
840
Registered
2009-10-21
Start date
2010-01-01
Completion date
Unknown
Last updated
2016-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stroke rehabilitation Circulatory System Stroke, not specified as haemorrhage or infarction

Interventions

This is a pragmatic phase III cluster randomised controlled trial with independent assessment. Randomisation will be conducted by the Clinical Trials Unit (CTU) and only revealed to the treating occup
feeding, dressing, toileting, bathing, transferring and mobilising. The frequency and duration will be dependent on the resident and therapist's agreed goals and will be around 8 hours per resident ov

Sponsors

University of Birmingham (UK)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Adult men and women living in a care home with a history of stroke or transient ischaemic attack (TIA)

Exclusion criteria

Exclusion criteria: Active end of life care plan

Design outcomes

Primary

MeasureTime frame
Independence in activities of daily living, assessed using the Barthel Activity of Daily Living Index, a commonly used measure (toileting, dressing, feeding, continence, mobility and grooming) containing 10 items and scored from 0-20 (with 20 being more independent) All primary and secondary outcome measures will be assessed at baseline (0 months), after the intervention (3 months) and at follow-up (6 and 12 months).

Secondary

MeasureTime frame
1. Rivermead Mobility Index (RMI), a 15 item measure of functional mobility (scored 0-15, 15 being more mobile) 2. Mood, assessed by a 15-item Geriatric Depression Scale (GDS15), and informant version 3. Adverse events 4. Staff attitude 5. Health utility will be estimated using the Euroqol EQ-5D All primary and secondary outcome measures will be assessed at baseline (0 months), after the intervention (3 months) and at follow-up (6 and 12 months). In addition, the Mini-Mental State Examination (MMSE) will be used at baseline to determine the level of a resident's cognitive impairment; not as an exclusion criterion.

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 26, 2026