Information Provision During Early Gait Training Post Stroke

NCT02626390 | Completed Phase 1

• 1 other identifier: 7938
• Study Type: interventional
• Target: 18
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• Berg Balance Scale

  24 hours post final treatment session

Secondary Outcomes (1)

• Step Test

  24 hours post final treatment session

Study Arms (2)

Implicit Learning

EXPERIMENTAL

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

Explicit Learning

ACTIVE COMPARATOR

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

Interventions

Frequent instructions/feedback and an Internal Focus of Attention OTHER

Explicit Learning

Minimal instructions/feedback and an External Focus of Attention OTHER

Implicit Learning

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Southampton: lead

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 7, 2015
• First Posted: December 10, 2015
• Study Start: April 1, 2012
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: December 16, 2015

Record last verified: 2015-12

Data Sharing

• IPD Sharing: Will not share