<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03792126</url>
  </required_header>
  <id_info>
    <org_study_id>ICA-CL-2017-03-011</org_study_id>
    <nct_id>NCT03792126</nct_id>
  </id_info>
  <brief_title>Implicit Learning in Stroke Study</brief_title>
  <acronym>IMPS</acronym>
  <official_title>A Pilot Cluster Randomised Controlled Trial, of an Implicit Learning Approach (ILA) Versus Standard Care, on Recovery of Mobility Following Stroke</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The Royal Bournemouth Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Southampton</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>The Royal Bournemouth Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This trial will compare an Implicit Learning Approach (ILA) to usual care, during the&#xD;
      rehabilitation of mobility post stroke.&#xD;
&#xD;
      It is a multicentre, assessor blind, cluster randomised controlled pilot trial, with embedded&#xD;
      feasibility study. It also includes a nested qualitative evaluation, designed to explore the&#xD;
      views of participants and therapists.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">March 1, 2019</start_date>
  <completion_date type="Anticipated">August 2021</completion_date>
  <primary_completion_date type="Anticipated">August 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in modified Rivermead Mobility Index Score</measure>
    <time_frame>4 weeks</time_frame>
    <description>Measure of functional mobility in people with stroke.&#xD;
Ordinal scale, measured through direct observation of function.&#xD;
Score range from 0-40, with a higher score indicating better functional mobility status.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Swedish Postural Adjustment in Stroke Scale (SwePASS)</measure>
    <time_frame>2, 4 and 6 weeks, 3 months</time_frame>
    <description>Measure of postural control in people with stroke, from lying, sitting and standing postures.&#xD;
Ordinal scale, measured through direct observation of function.&#xD;
Score range from 0-36, with a higher score indicating better postural control.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Time to achievement of Mobility Milestones</measure>
    <time_frame>2, 4 and 6 weeks, 3 months</time_frame>
    <description>Able to sit for 1 minute unsupported?&#xD;
Able to transfer from bed to chair independently?&#xD;
Able to walk 10m independently?&#xD;
Time from stroke to achieving each milestone, assessed with standardised set up.&#xD;
Earlier achievement of milestones indicated better outcome.</description>
  </other_outcome>
  <other_outcome>
    <measure>Fugl Meyer - Motor Leg Sub Section</measure>
    <time_frame>2, 4 and 6 weeks, 3 months</time_frame>
    <description>Measure of sensori-motor function in the lower limb (impairment level)&#xD;
Range 0-28, with higher score indicating better outcome.</description>
  </other_outcome>
  <other_outcome>
    <measure>Modified Rankin Score</measure>
    <time_frame>3 months</time_frame>
    <description>Measure of disability and dependence in people who have suffered a stroke.&#xD;
Score 0-6, with higher score indicating a worse outcome.</description>
  </other_outcome>
  <other_outcome>
    <measure>EuroQOL 5 D Questionnaire</measure>
    <time_frame>3 months</time_frame>
    <description>Standardised measure of health related quality of life.&#xD;
Self-administered questionnaire.&#xD;
Higher score indicates a better outcome.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Stroke</condition>
  <arm_group>
    <arm_group_label>Standard Care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Implicit Learning Approach</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Implicit Learning Approach</intervention_name>
    <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.&#xD;
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.</description>
    <arm_group_label>Implicit Learning Approach</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Clinical diagnosis of stroke, presenting with hemiplegia&#xD;
&#xD;
          -  Within 14 days of stroke onset&#xD;
&#xD;
          -  Medically stable&#xD;
&#xD;
          -  Able to...&#xD;
&#xD;
               -  tolerate daily therapy for a minimum of 30 minutes per session&#xD;
&#xD;
               -  sit for more than 5 seconds without support&#xD;
&#xD;
               -  understand and follow 1 stage commands&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Previous stroke with residual impairments&#xD;
&#xD;
          -  Other neurological diagnosis (e.g. PD, MS)&#xD;
&#xD;
          -  Clinically relevant pre-morbid disability levels&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Royal Bournemouth Hospital</name>
      <address>
        <city>Bournemouth</city>
        <state>Dorset</state>
        <zip>BH7 7DW</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Louise Johnson</last_name>
      <phone>01202 303626</phone>
      <email>louise.johnson@rbch.nhs.uk</email>
    </contact>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>January 2020</verification_date>
  <study_first_submitted>December 19, 2018</study_first_submitted>
  <study_first_submitted_qc>January 2, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 3, 2019</study_first_posted>
  <last_update_submitted>January 27, 2020</last_update_submitted>
  <last_update_submitted_qc>January 27, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">January 29, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stroke</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03792126
org study id: ICA-CL-2017-03-011
nct id: NCT03792126
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: Change in modified Rivermead Mobility Index Score
time frame: 4 weeks
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.
measure: Swedish Postural Adjustment in Stroke Scale (SwePASS)
time frame: 2, 4 and 6 weeks, 3 months
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.
measure: Time to achievement of Mobility Milestones
time frame: 2, 4 and 6 weeks, 3 months
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.
measure: Fugl Meyer - Motor Leg Sub Section
time frame: 2, 4 and 6 weeks, 3 months
description: Measure of sensori-motor function in the lower limb (impairment level)
Range 0-28, with higher score indicating better outcome.
measure: Modified Rankin Score
time frame: 3 months
description: Measure of disability and dependence in people who have suffered a stroke.
Score 0-6, with higher score indicating a worse outcome.
measure: EuroQOL 5 D Questionnaire
time frame: 3 months
description: Standardised measure of health related quality of life.
Self-administered questionnaire.
Higher score indicates a better outcome.
arm group label: Standard Care
arm group type: No Intervention
arm group label: Implicit Learning Approach
arm group type: Experimental
intervention type: Other
intervention name: Implicit Learning Approach
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.
arm group label: Implicit Learning Approach
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
status: Recruiting
contact: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Stroke
sharing ipd: No