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Information Provision During Early Gait Training Post Stroke

Primary Purpose

Stroke

Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Frequent instructions/feedback and an Internal Focus of Attention
Minimal instructions/feedback and an External Focus of Attention
Sponsored by
University of Southampton
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:

  • Patients receiving rehabilitation for their first episode of stroke which resulted in hemiplegia
  • Able to give informed consent to take part in the study.
  • Currently receiving physiotherapy for the re-education of gait (at minimum is able to stand, weight bear and take one step with assistance of one person).

Exclusion Criteria:

  • Patients with a history of:

    • any other neurological conditions including previous stroke
    • any pre-stroke musculoskeletal condition that either: i. limited walking to less than 100 metres and/or ii. resulted in a noticeable gait abnormality and/or iii. required use of a bilateral walking aid (e.g. 2 walking sticks or a walking frame)
  • Patients with marked receptive dysphasia (not able to follow 3-stage commands) - confirmed through liaison with multi-disciplinary team, including Speech and Language Therapists where necessary

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Implicit Learning

    Explicit Learning

    Arm Description

    Physiotherapy delivered based on implicit treatment guidance - achieved primarily by reducing the frequency of verbal coaching statements and promoting an external focus of attention.

    Physiotherapy delivered based on explicit treatment guidance - achieved primarily by giving frequent verbal coaching statements and promoting an internal focus of attention.

    Outcomes

    Primary Outcome Measures

    Berg Balance Scale

    Secondary Outcome Measures

    Step Test

    Full Information

    First Posted
    December 7, 2015
    Last Updated
    December 15, 2015
    Sponsor
    University of Southampton
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02626390
    Brief Title
    Information Provision During Early Gait Training Post Stroke
    Official Title
    How do Different Styles of Information Provision Affect Learning During Early Gait Training Post Stroke? A Feasibility Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    April 2012 (undefined)
    Primary Completion Date
    June 2013 (Actual)
    Study Completion Date
    June 2013 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University of Southampton

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    This study examined the feasibility of using implicit and explicit learning approaches during gait rehabilitation in the early phase following stroke. It was a double blind trial (participants and assessors) using a matched pairs design. Participants were recruited from an acute stroke unit, and were randomised to receive gait rehabilitation over three consecutive days using either an implicit or explicit approach. Guidelines for each were developed empirically, including differences in the amount, timing, and attentional focus of therapists' verbal communication. Sessions were recorded and their content analysed to establish concordance with the guidance. Clinical measures were taken at baseline and 24 hours post intervention using the Berg Balance Scale and the Step Test. Therapists were able to adhere to the guidance. Both approaches were found to be acceptable to both patients and therapists. The findings will be used to design an appropriately powered RCT.

    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
    Phase 1, Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    18 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Implicit Learning
    Arm Type
    Experimental
    Arm Description
    Physiotherapy delivered based on implicit treatment guidance - achieved primarily by reducing the frequency of verbal coaching statements and promoting an external focus of attention.
    Arm Title
    Explicit Learning
    Arm Type
    Active Comparator
    Arm Description
    Physiotherapy delivered based on explicit treatment guidance - achieved primarily by giving frequent verbal coaching statements and promoting an internal focus of attention.
    Intervention Type
    Other
    Intervention Name(s)
    Frequent instructions/feedback and an Internal Focus of Attention
    Intervention Type
    Other
    Intervention Name(s)
    Minimal instructions/feedback and an External Focus of Attention
    Primary Outcome Measure Information:
    Title
    Berg Balance Scale
    Time Frame
    24 hours post final treatment session
    Secondary Outcome Measure Information:
    Title
    Step Test
    Time Frame
    24 hours post final treatment session

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients receiving rehabilitation for their first episode of stroke which resulted in hemiplegia Able to give informed consent to take part in the study. Currently receiving physiotherapy for the re-education of gait (at minimum is able to stand, weight bear and take one step with assistance of one person). Exclusion Criteria: Patients with a history of: any other neurological conditions including previous stroke any pre-stroke musculoskeletal condition that either: i. limited walking to less than 100 metres and/or ii. resulted in a noticeable gait abnormality and/or iii. required use of a bilateral walking aid (e.g. 2 walking sticks or a walking frame) Patients with marked receptive dysphasia (not able to follow 3-stage commands) - confirmed through liaison with multi-disciplinary team, including Speech and Language Therapists where necessary

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Information Provision During Early Gait Training Post Stroke

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