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

About this trial
This is an interventional treatment trial for Stroke
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
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
NCT ID
NCT02626390
First Posted
December 7, 2015
Last Updated
December 15, 2015
Sponsor
University of Southampton
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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