Information Provision During Early Gait Training Post Stroke

NCT ID: NCT02626390

Last Updated: 2015-12-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-04-30
• Study Completion Date: 2013-06-30

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.

Conditions

Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Minimal instructions/feedback and an External Focus of Attention

Intervention Type: OTHER

Explicit Learning

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

Group Type: ACTIVE_COMPARATOR

Frequent instructions/feedback and an Internal Focus of Attention

Intervention Type: OTHER

Interventions

Frequent instructions/feedback and an Internal Focus of Attention

Intervention Type: OTHER

Minimal instructions/feedback and an External Focus of Attention

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Southampton

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

7938

Identifier Type: -

Identifier Source: org_study_id