Information Provision During Early Gait Training Post Stroke

How do Different Styles of Information Provision Affect Learning During Early Gait Training Post Stroke? A Feasibility Study

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.

Study Overview

• Status: Completed
• Conditions: Stroke
• Intervention / Treatment: Other: Minimal instructions/feedback and an External Focus of Attention; Other: Frequent instructions/feedback and an Internal Focus of Attention

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Phase 2; Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Implicit Learning; Physiotherapy delivered based on implicit treatment guidance - achieved primarily by reducing the frequency of verbal coaching statements and promoting an external focus of attention.	Other: Minimal instructions/feedback and an External Focus of Attention
Active Comparator: Explicit Learning; Physiotherapy delivered based on explicit treatment guidance - achieved primarily by giving frequent verbal coaching statements and promoting an internal focus of attention.	Other: Frequent instructions/feedback and an Internal Focus of Attention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Berg Balance Scale	24 hours post final treatment session

Secondary Outcome Measures

Outcome Measure	Time Frame
Step Test	24 hours post final treatment session

Collaborators and Investigators

• Sponsor: University of Southampton

Study record dates

Study Major Dates

• Study Start: April 1, 2012
• Primary Completion (Actual): June 1, 2013
• Study Completion (Actual): June 1, 2013

Study Registration Dates

• First Submitted: December 7, 2015
• First Submitted That Met QC Criteria: December 9, 2015
• First Posted (Estimate): December 10, 2015

Study Record Updates

• Last Update Posted (Estimate): December 16, 2015
• Last Update Submitted That Met QC Criteria: December 15, 2015
• Last Verified: December 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: 7938

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO