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Implicit Learning in Stroke Study (IMPS)

Primary Purpose

Stroke

Status
Unknown status
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Implicit Learning Approach
Sponsored by
The Royal Bournemouth Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Royal Bournemouth HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Standard Care

Implicit Learning Approach

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
December 19, 2018
Last Updated
January 27, 2020
Sponsor
The Royal Bournemouth Hospital
Collaborators
University of Southampton
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1. Study Identification

Unique Protocol Identification Number
NCT03792126
Brief Title
Implicit Learning in Stroke Study
Acronym
IMPS
Official Title
A Pilot Cluster Randomised Controlled Trial, of an Implicit Learning Approach (ILA) Versus Standard Care, on Recovery of Mobility Following Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Unknown status
Study Start Date
March 1, 2019 (Actual)
Primary Completion Date
August 2021 (Anticipated)
Study Completion Date
August 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Royal Bournemouth Hospital
Collaborators
University of Southampton

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Standard Care
Arm Type
No Intervention
Arm Title
Implicit Learning Approach
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Implicit Learning Approach
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in modified Rivermead Mobility Index Score
Description
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.
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Swedish Postural Adjustment in Stroke Scale (SwePASS)
Description
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.
Time Frame
2, 4 and 6 weeks, 3 months
Other Pre-specified Outcome Measures:
Title
Time to achievement of Mobility Milestones
Description
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.
Time Frame
2, 4 and 6 weeks, 3 months
Title
Fugl Meyer - Motor Leg Sub Section
Description
Measure of sensori-motor function in the lower limb (impairment level) Range 0-28, with higher score indicating better outcome.
Time Frame
2, 4 and 6 weeks, 3 months
Title
Modified Rankin Score
Description
Measure of disability and dependence in people who have suffered a stroke. Score 0-6, with higher score indicating a worse outcome.
Time Frame
3 months
Title
EuroQOL 5 D Questionnaire
Description
Standardised measure of health related quality of life. Self-administered questionnaire. Higher score indicates a better outcome.
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Royal Bournemouth Hospital
City
Bournemouth
State/Province
Dorset
ZIP/Postal Code
BH7 7DW
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Louise Johnson
Phone
01202 303626
Email
louise.johnson@rbch.nhs.uk

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
36306569
Citation
Johnson L, Burridge J, Ewings S, Westcott E, Gayton M, Demain S. Principles into Practice: An Observational Study of Physiotherapists use of Motor Learning Principles in Stroke Rehabilitation. Physiotherapy. 2023 Mar;118:20-30. doi: 10.1016/j.physio.2022.06.002. Epub 2022 Jun 20.
Results Reference
derived
PubMed Identifier
31687935
Citation
Johnson L, Burridge J, Demain S, Ewings S. Comparing the Impact of an Implicit Learning Approach With Standard Care on Recovery of Mobility Following Stroke: Protocol for a Pilot Cluster Randomized Controlled Trial. JMIR Res Protoc. 2019 Nov 5;8(11):e14222. doi: 10.2196/14222.
Results Reference
derived

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Implicit Learning in Stroke Study

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