|
ISRCTN
|
ISRCTN22274754
|
|
ClinicalTrials.gov identifier
|
|
|
Public title
|
Proprioception at the Healthy Ankle: The Effect of Taping and Dynamic Balance Exercise
|
|
Scientific title
|
|
|
Acronym
|
N/A
|
|
Serial number at source
|
N0207174694
|
|
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.
|
|
Lay summary
|
|
|
Ethics approval
|
Not provided at time of registration
|
|
Study design
|
Randomised controlled trial
|
|
Countries of recruitment
|
United Kingdom
|
|
Disease/condition/study domain
|
Musculoskeletal Diseases
|
|
Participants - inclusion criteria
|
1. Willing to consent
2. 18 to 40 years old
3. Full bilateral ankle movement
|
|
Participants - exclusion criteria
|
1. Consent not given
2. Any lower limb pathology
3. Visual acuity neurological deficit likely to affect balance
|
|
Anticipated start date
|
05/01/2006
|
|
Anticipated end date
|
01/04/2006
|
|
Status of trial
|
Completed |
|
Patient information material
|
|
|
Target number of participants
|
25 volunteers
|
|
Interventions
|
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.
|
|
Primary outcome measure(s)
|
Biodex stability system score
|
|
Secondary outcome measure(s)
|
Not provided at time of registration
|
|
Sources of funding
|
Royal Liverpool and Broadgreen University Hospitals Trust (UK), NHS R&D Support Funding - no external funding
|
|
Trial website
|
|
|
Publications
|
Part of degree and published as part of edited book
|
|
Contact name
|
Ms
Katy
Clay
|
|
Address
|
Royal Liverpool and Broadgreen University Hospitals NHS Trust
Prescot Street
|
|
City/town
|
Liverpool
|
|
Zip/Postcode
|
L78XP
|
|
Country
|
United Kingdom
|
|
Tel
|
+44 (0)1517062760
|
|
Fax
|
+44 (0)1517065840
|
|
Email
|
katy.clay@rlbuht.nhs.uk
|
|
Sponsor
|
Record Provided by the NHSTCT Register - 2006 Update - Department of Health
|
|
Address
|
The Department of Health, Richmond House, 79 Whitehall
|
|
City/town
|
London
|
|
Zip/Postcode
|
SW1A 2NL
|
|
Country
|
United Kingdom
|
|
Tel
|
+44 (0)20 7307 2622
|
|
Email
|
dhmail@doh.gsi.org.uk
|
|
Sponsor website:
|
http://www.dh.gov.uk/Home/fs/en
|
|
Date applied
|
29/09/2006
|
|
Last edited
|
10/09/2008
|
|
Date ISRCTN assigned
|
29/09/2006
|
