Condition category
Circulatory System
Date applied
21/10/2010
Date assigned
21/10/2010
Last edited
24/09/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Paulette van Vliet

ORCID ID

Contact details

University of Birmingham
School of Health Sciences
Edgbaston
Birmingham
B15 2TT
United Kingdom
p.vanvliet@bham.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

4425

Study information

Scientific title

Acronym

Motor skill acquisition

Study hypothesis

In healthy subjects, feedback inducing an external focus of attention (about movement effects) produces more effective movements compared with feedback that induces an internal focus of attention (about body movements). It is unclear whether this extends to people with stroke.

Objective:
To examine whether feedback inducing an internal or external focus was more effective for retraining the hemiplegic arm.

Ethics approval

MREC approved (ref: 05/Q2709/126)

Study design

Multicentre non-randomised interventional phase II treatment trial

Primary study design

Interventional

Secondary study design

Non randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Topic: Stroke Research Network; Subtopic: Rehabilitation; Disease: Therapy type

Intervention

Forty-two people with stroke performed three reaching tasks in a counterbalanced, within-subject design.

Intervention type

Other

Phase

Phase II

Drug names

Primary outcome measures

Faster movements

Secondary outcome measures

1. Increased percentage time to peak deceleration
2. Increased percentage time to peak velocity

Overall trial start date

10/07/2007

Overall trial end date

25/06/2008

Reason abandoned

Eligibility

Participant inclusion criteria

1. Diagnosis of stroke of ischaemic or haemorrhagic origin
2. Score of between 25 and 60 on the Fugl-Meyer Assessment (arm section)
3. Informed written consent

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

Planned sample size: 42; UK sample size: 42

Participant exclusion criteria

1. Upper limb movement deficits attributable to non-stroke pathology
2. Severe somato-sensory disturbance (less than 1 on the Erasmus MC Modified Nottingham Sensory Assessment)
3. More than 18 months post-stroke
4. Moderate to severe receptive aphasia (less than 5 on 'receptive skills' of Sheffield Test for Acquired Language Disorders)

Recruitment start date

10/07/2007

Recruitment end date

25/06/2008

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University of Birmingham
Birmingham
B15 2TT
United Kingdom

Sponsor information

Organisation

University of Birmingham (UK)

Sponsor details

Edgbaston
Birmingham
B15 2TT
United Kingdom

Sponsor type

University/education

Website

http://www.bham.ac.uk

Funders

Funder type

Charity

Funder name

The Stroke Association (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/23796803

Publication citations

  1. Results

    Durham KF, Sackley CM, Wright CC, Wing AM, Edwards MG, van Vliet P, Attentional focus of feedback for improving performance of reach-to-grasp after stroke: a randomised crossover study., Physiotherapy, 2014, 100, 2, 108-115, doi: 10.1016/j.physio.2013.03.004.

Additional files

Editorial Notes