Condition category
Surgery
Date applied
22/05/2015
Date assigned
27/05/2015
Last edited
27/05/2015
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
The Figure of 8 Walk (F8W) test was developed to measure both straight and curved path walking in clockwise and counterclockwise directions. Research has shown that it is a valid and reliable test in elderly people and patients with stroke. However, its validity and reliability for patients who have undergone knee replacement surgery are yet to be tested. In addition, to date the F8W test has only been validated in clinical settings under controlled conditions; i.e., with smooth floors and quiet surroundings. This is likely to differ from the environment participants will encounter in daily life and so may not accurately reflect the patient’s advanced walking performance. There is therefore a need for the F8W to be validated in both the participant’s own home environment and for patients who have undergone knee replacement surgery.

Who can participate?
Patients who have undergone knee surgery at least one year ago.

What does the study involve?
Participants will be given the opportunity to choose to have their assessments carried out by a physiotherapist in either their home or in a clinical setting. At the first visit a physiotherapist will carry out the F8W test. A second appointment will then be made between 7-21 days later. This visit will involve two separate tests, once with the same physiotherapist who attended the first appointment and a second test with a different physiotherapist. This will help us to establish the reliability of the test over time and the reliability of the test between different measuring physiotherapists.

What are the possible benefits and risks of participating?
We do not expect any particular benefits for the participants from taking part in this study. All the assessments chosen are used in clinical practice and have been used safely in the past. There are no known particular side effects of the assessments and an experienced physiotherapist will be with the participants throughout to monitor how they are doing and check they are safe. Participants may experience some pain or tiredness whilst carrying out the tests but they will be offered a rest in between each test and they may stop the test at any point should they wish to.

Where is the study run from?
Nuffield Orthopaedic Centre (UK).

When is the study starting and how long is it expected to run for?
From June to November 2015.

Who is funding the study?
NIHR Health Technology Assessment Programme - HTA (UK).

Who is the main contact?
Martha Moore
martha.moore@ouh.nhs.uk

Trial website

Contact information

Type

Public

Primary contact

Ms Martha Moore

ORCID ID

Contact details

Physiotherapy Research Unit
Windmill Road
Oxford
OX3 7LD
United Kingdom
+44 (0)1865 737526
martha.moore@ouh.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

1

Study information

Scientific title

Validity and reliability of the figure of 8 walk test: an observational crossover trial

Acronym

Fig 8

Study hypothesis

To investigate the validity and reliability of the Figure of 8 Walk Test for participants one year after knee replacement at home and in clinical settings.

Ethics approval

NHS Research and Ethics Committee South West Exeter, 21/05/2015, ref: 15/SW/0138

Study design

Observational crossover trial

Primary study design

Observational

Secondary study design

Trial setting

Home

Trial type

Other

Patient information sheet

Condition

Knee arthroplasty

Intervention

Patients who have had a knee replacement a year ago and are eligible to take part will be given the option to have their assessments at home or at the physiotherapy department at the Nuffield Orthopaedic Centre. The initial assessment will involve three physical measures tests including the figure of 8 walk test, the timed up and go and the short physical performance battery. They will also be asked to complete two short paper questionnaires, the Oxford Knee Score and an Outcome Measures Evaluation Form. At the first visit the same physiotherapy researcher will carry out the physical measures. A second appointment will then be made between 7-21 days later. This visit will involve two separate assessments, once with the same research physiotherapist who attended the initial appointment and a second assessment with a different research physiotherapist. During this appointment the initial research physiotherapist will carry out only the Figure of 8 Walk test. The participant will then be given a rest and the second research physiotherapist will carry out the Figure of 8 Walk test once more with the participant.

Intervention type

Other

Phase

Drug names

Primary outcome measures

Figure of 8 Walk test – measured at baseline and 7-21 days later at the second assessment. During the second assessment the Fig 8 will be measured twice by two different assessors. To measure the outcome we will record how long it takes to complete the test in seconds, how many steps the participant takes, whether the test was completed within the 2ft boundary and a 3-point smoothness score.

Secondary outcome measures

1. Timed up and Go – measured only at the baseline assessment. Assessed by timing how long it takes to complete the test in seconds.
2. Short Physical Performance Battery – measured only at baseline. Comprises of three different measures, assessed by time taken to complete all three.

Overall trial start date

01/06/2015

Overall trial end date

01/11/2015

Reason abandoned

Eligibility

Participant inclusion criteria

12 months post total knee replacement

Participant type

Patient

Age group

Senior

Gender

Both

Target number of participants

80

Participant exclusion criteria

1. Further surgery within 12 months
2. Rheumatoid arthritis

Recruitment start date

01/06/2015

Recruitment end date

30/09/2015

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Nuffield Orthopaedic Centre,
Oxford University Hospitals NHS Trust
OX3 7LD
United Kingdom

Sponsor information

Organisation

University of Oxford (UK)

Sponsor details

c/o NDORMS
Windmill Road
Oxford
OX3 7LD
United Kingdom

Sponsor type

University/education

Website

Funders

Funder type

Government

Funder name

NIHR Health Technology Assessment Programme - HTA (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

To be confirmed at a later date

Intention to publish date

Participant level data

Stored in repository

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes