Information Provision During Early Gait Training Post Stroke

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02626390
• Other study ID #: 7938
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: December 7, 2015
• Last updated: December 15, 2015
• Start date: April 2012
• Est. completion date: June 2013

Study information

• Verified date: December 2015
• Source: University of Southampton
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdon: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Stroke

Intervention

Other:
• Frequent instructions/feedback and an Internal Focus of Attention

• Minimal instructions/feedback and an External Focus of Attention

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Southampton

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Berg Balance Scale		24 hours post final treatment session	No
Secondary	Step Test		24 hours post final treatment session	No