Information Provision During Early Gait Training Post Stroke

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.

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Frequent instructions/feedback and an Internal Focus of Attention

Other

Minimal instructions/feedback and an External Focus of Attention

Other

Primary outcomes

Berg Balance Scale

Time frame: 24 hours post final treatment session

Secondary outcomes

Step Test

Time frame: 24 hours post final treatment session

Sponsors and collaborators

Lead sponsor

University of Southampton

Other

Registry information

Official study title

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

Important dates

Study start: 2012
Primary completion: 2013
Study completion: 2013
First posted: Dec 10, 2015
Registry last updated: Dec 16, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed