IMPS: Implicit Learning in Stroke Study
Study Details
Study Description
Brief Summary
This trial will compare an Implicit Learning Approach (ILA) to usual care, during the rehabilitation of mobility post stroke.
It is a multicentre, assessor blind, cluster randomised controlled pilot trial, with embedded feasibility study. It also includes a nested qualitative evaluation, designed to explore the views of participants and therapists.
Condition or Disease | Intervention/Treatment | Phase |
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N/A |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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No Intervention: Standard Care
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Experimental: Implicit Learning Approach
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Other: Implicit Learning Approach
All mobility focussed rehabilitation sessions will utilise the Implicit Learning Approach (ILA), as usual care. This includes rehabilitation (delivered by a physiotherapist, occupational therapist or therapy assistant) that focusses on sitting, sit to stand, standing, stepping, transfers and walking. The content of therapy will be based on the treatment guidelines and intervention manual - and primarily involves changing the quantity and focus of attention of instructions and feedback.
As this is a clinically grounded, pragmatic trial, therapists will have freedom to tailor the specific content of each treatment session to patient need, whilst remaining true to the ILA.
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Outcome Measures
Primary Outcome Measures
- Change in modified Rivermead Mobility Index Score [4 weeks]
Measure of functional mobility in people with stroke. Ordinal scale, measured through direct observation of function. Score range from 0-40, with a higher score indicating better functional mobility status.
Secondary Outcome Measures
- Swedish Postural Adjustment in Stroke Scale (SwePASS) [2, 4 and 6 weeks, 3 months]
Measure of postural control in people with stroke, from lying, sitting and standing postures. Ordinal scale, measured through direct observation of function. Score range from 0-36, with a higher score indicating better postural control.
Other Outcome Measures
- Time to achievement of Mobility Milestones [2, 4 and 6 weeks, 3 months]
Able to sit for 1 minute unsupported? Able to transfer from bed to chair independently? Able to walk 10m independently? Time from stroke to achieving each milestone, assessed with standardised set up. Earlier achievement of milestones indicated better outcome.
- Fugl Meyer - Motor Leg Sub Section [2, 4 and 6 weeks, 3 months]
Measure of sensori-motor function in the lower limb (impairment level) Range 0-28, with higher score indicating better outcome.
- Modified Rankin Score [3 months]
Measure of disability and dependence in people who have suffered a stroke. Score 0-6, with higher score indicating a worse outcome.
- EuroQOL 5 D Questionnaire [3 months]
Standardised measure of health related quality of life. Self-administered questionnaire. Higher score indicates a better outcome.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Clinical diagnosis of stroke, presenting with hemiplegia
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Within 14 days of stroke onset
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Medically stable
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Able to...
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tolerate daily therapy for a minimum of 30 minutes per session
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sit for more than 5 seconds without support
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understand and follow 1 stage commands
Exclusion Criteria:
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Previous stroke with residual impairments
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Other neurological diagnosis (e.g. PD, MS)
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Clinically relevant pre-morbid disability levels
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Royal Bournemouth Hospital | Bournemouth | Dorset | United Kingdom | BH7 7DW |
Sponsors and Collaborators
- The Royal Bournemouth Hospital
- University of Southampton
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- ICA-CL-2017-03-011