IMPS: Implicit Learning in Stroke Study

Sponsor
The Royal Bournemouth Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT03792126
Collaborator
University of Southampton (Other)
60
1
2
29
2.1

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
  • Other: Implicit Learning Approach
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Pilot Cluster Randomised Controlled Trial, of an Implicit Learning Approach (ILA) Versus Standard Care, on Recovery of Mobility Following Stroke
Actual Study Start Date :
Mar 1, 2019
Anticipated Primary Completion Date :
Aug 1, 2021
Anticipated Study Completion Date :
Aug 1, 2021

Arms and Interventions

Arm Intervention/Treatment
No Intervention: Standard Care

Experimental: Implicit Learning Approach

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.

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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

  1. 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.

  2. 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.

  3. 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.

  4. 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

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
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.
Responsible Party:
The Royal Bournemouth Hospital
ClinicalTrials.gov Identifier:
NCT03792126
Other Study ID Numbers:
  • ICA-CL-2017-03-011
First Posted:
Jan 3, 2019
Last Update Posted:
Jan 29, 2020
Last Verified:
Jan 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 29, 2020