Condition category
Musculoskeletal Diseases
Date applied
29/09/2006
Date assigned
29/09/2006
Last edited
10/09/2008
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

Ms Katy Clay

ORCID ID

Contact details

Royal Liverpool and Broadgreen University Hospitals NHS Trust
Prescot Street
Liverpool
L78XP
United Kingdom
+44 (0)1517062760
katy.clay@rlbuht.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0207174694

Study information

Scientific title

Acronym

Study hypothesis

The principle aim of this study is to determine whether ankle taping improves dynamic ankle proprioception in healthy subjects using the Biodex stability system.

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Not Specified

Patient information sheet

Condition

Musculoskeletal Diseases

Intervention

The proposed study will be a repeated measures design. The participants will be tested as both members of control and test groups.
The participants will be consented to the study and randomly allocated to either control or test trial. After initial one-off testing they will then return at a later date and be tested as a member of the other group. Blinding the participants is not possible as both subject and assessor will be aware of the use of tape. Testing will take place on the dominant leg.
The Biodex stability system is a computerised force platform. It challenges an individual to maintain balance whilst standing on a moveable platform that tilts in all planes. The difficulty of the test is controlled electronically. Visual feedback is provided via a computer screen and a report is generated. Testing within the study will take place at two levels (one easy and one hard). Each test at each level will last for twenty seconds with two practice tests to negate learning effects.

For the test group:
Initially ankle joint range of movement will be measured and Biodex testing will take place. The dominant ankle will then be taped, followed by further measurement of ankle range of movement and Biodex testing. The participants will then undergo twenty minutes of balance exercise followed by a final measurement of ankle joint range of movement and Biodex testing.

For the control group:
Initially ankle joint range of movement will be measured and Biodex testing will take place. The participants will then rest for twenty minutes followed by further measurement of ankle range of movement and Biodex testing. The participants will then undergo twenty minutes of balance exercise followed by a final measurement of ankle joint range of movement and Biodex testing.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Biodex stability system score

Secondary outcome measures

Not provided at time of registration

Overall trial start date

05/01/2006

Overall trial end date

01/04/2006

Reason abandoned

Eligibility

Participant inclusion criteria

1. Willing to consent
2. 18 to 40 years old
3. Full bilateral ankle movement

Participant type

Patient

Age group

Adult

Gender

Not Specified

Target number of participants

25 volunteers

Participant exclusion criteria

1. Consent not given
2. Any lower limb pathology
3. Visual acuity neurological deficit likely to affect balance

Recruitment start date

05/01/2006

Recruitment end date

01/04/2006

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Royal Liverpool and Broadgreen University Hospitals NHS Trust
Liverpool
L78XP
United Kingdom

Sponsor information

Organisation

Record Provided by the NHSTCT Register - 2006 Update - Department of Health

Sponsor details

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk

Sponsor type

Government

Website

http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

Funder name

Royal Liverpool and Broadgreen University Hospitals Trust (UK), NHS R&D Support Funding - no external funding

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

Part of degree and published as part of edited book

Publication citations

Additional files

Editorial Notes