Information Provision During Early Gait Training Post Stroke

Phase 1

Completed

• Conditions: Stroke
• Interventions: Other: Minimal instructions/feedback and an External Focus of Attention; Other: Frequent instructions/feedback and an Internal Focus of Attention

• Registration Number: NCT02626390
• Lead Sponsor: University of Southampton

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-04
• Primary Completion: 2013-06
• Study Completion: 2013-06
• Status Verified: 2015-12
• Study First Submitted: 2015-12-07
• Study First Submitted QC: 2015-12-09
• Study First Posted: 2015-12-10
• Last Update Submitted: 2015-12-15
• Last Update Posted: 2015-12-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Implicit Learning	Minimal instructions/feedback and an External Focus of Attention	Physiotherapy delivered based on implicit treatment guidance - achieved primarily by reducing the frequency of verbal coaching statements and promoting an external focus of attention.
Explicit Learning	Frequent instructions/feedback and an Internal 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.

Primary Outcome Measures

Name	Time	Method
Berg Balance Scale	24 hours post final treatment session

Secondary Outcome Measures

Name	Time	Method
Step Test	24 hours post final treatment session