Implicit Learning in Stroke Study

Stroke Clinical Trial

— IMPS  

Official title:

A Pilot Cluster Randomised Controlled Trial, of an Implicit Learning Approach (ILA) Versus Standard Care, on Recovery of Mobility Following Stroke

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03792126
• Other study ID #: ICA-CL-2017-03-011
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2019
• Est. completion date: August 2021

Study information

• Verified date: January 2020
• Source: The Royal Bournemouth Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: August 2021
• Est. primary completion date: August 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Clinical diagnosis of stroke, presenting with hemiplegia

• Within 14 days of stroke onset

• Medically stable

• Able to...

• tolerate daily therapy for a minimum of 30 minutes per session

• sit for more than 5 seconds without support

• understand and follow 1 stage commands

Exclusion Criteria:

• Previous stroke with residual impairments

• Other neurological diagnosis (e.g. PD, MS)

• Clinically relevant pre-morbid disability levels

Related Conditions & MeSH terms

• Stroke

Intervention

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.

Locations

Country	Name	City	State
United Kingdom	Royal Bournemouth Hospital	Bournemouth	Dorset

Sponsors (2)

Lead Sponsor	Collaborator
The Royal Bournemouth Hospital	University of Southampton

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Time to achievement of Mobility Milestones	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.	2, 4 and 6 weeks, 3 months
Other	Fugl Meyer - Motor Leg Sub Section	Measure of sensori-motor function in the lower limb (impairment level); Range 0-28, with higher score indicating better outcome.	2, 4 and 6 weeks, 3 months
Other	Modified Rankin Score	Measure of disability and dependence in people who have suffered a stroke.; Score 0-6, with higher score indicating a worse outcome.	3 months
Other	EuroQOL 5 D Questionnaire	Standardised measure of health related quality of life.; Self-administered questionnaire.; Higher score indicates a better outcome.	3 months
Primary	Change in modified Rivermead Mobility Index Score	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.	4 weeks
Secondary	Swedish Postural Adjustment in Stroke Scale (SwePASS)	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.	2, 4 and 6 weeks, 3 months