Implicit Learning in Stroke Study

NCT03792126 | Completed Results

• 1 other identifier: ICA-CL-2017-03-011
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke

Outcome Measures

Primary Outcomes (1)

• 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.

  12 weeks

Secondary Outcomes (1)

• Swedish Postural Adjustment in Stroke Scale (SwePASS)

  Week 0, 2 and 12

Other Outcomes (3)

• Fugl Meyer - Motor Leg Sub Section

  Week 0, week 2 and week 12

• Modified Rankin Score

  Week 0, Week 12

• EuroQOL 5 D Questionnaire Index Score

  3 months

Study Arms (2)

Standard Care

NO INTERVENTION

Standard care, as per usual working practice for the stroke unit. Control stroke units will have minimal contact with the research team, other than for data collection. They will be aware of the broad aims of the study, but not the specific detail of the intervention.

Implicit Learning Approach

EXPERIMENTAL

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, which have been developed by an international expert group (using Delhi methodology). 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. Other therapy interventions, such as upper limb rehabilitation, will be provided as usual.

Other: Implicit Learning Approach

Interventions

Implicit Learning Approach OTHER

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.

Implicit Learning Approach

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Previous stroke with residual impairments
• Other neurological diagnosis (e.g. Parkinsons Disease, Multiple Sclerosis)
• Clinically relevant pre-morbid disability levels

Sponsors & Collaborators

• The Royal Bournemouth Hospital: lead
• University of Southampton: collaborator

Study Sites (1)

Royal Bournemouth Hospital

Bournemouth, Dorset, BH7 7DW, United Kingdom

Location

Related Publications (3)

• Johnson L, Mardo J, Demain S. Understanding implementation of a complex intervention in a stroke rehabilitation research trial: A qualitative evaluation using Normalisation Process Theory. PLoS One. 2023 Sep 8;18(9):e0282612. doi: 10.1371/journal.pone.0282612. eCollection 2023.

  PMID: 37682841 DERIVED

• 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.

  PMID: 36306569 DERIVED

• 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.

  PMID: 31687935 DERIVED

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Louise Johnson
• Organization: University Hospitals Dorset NHS Foundation Trust

Louise.Johnson@uhd.nhs.uk

0300 019 4473

Study Officials

• Louise Johnson

  University Hospitals Dorset

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2018
• First Posted: January 3, 2019
• Study Start: March 1, 2019
• Primary Completion: January 24, 2022
• Study Completion: January 24, 2022
• Last Updated: December 13, 2024
• Results First Posted: December 13, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR, ANALYTIC CODE
• Time Frame: Following final paper publication and for the duration of the archiving period (10 years)
• Access Criteria: Will be assessed upon request.

Locations

GB (1)