Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12611000290998
Ethics application status
Approved
Date submitted
17/03/2011
Date registered
21/03/2011
Date last updated
21/03/2011
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of cryotherapy on force reproduction of the ankle
Scientific title
The effect of cryotherapy applied on the ankle of young adults on isometric force reproduction - a cross over randomised controlled trial
Secondary ID [1] 259789 0
Nil
Universal Trial Number (UTN)
U1111-1119-9887
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
The effect of cryotherapy on proprioception of the ankle when applied on the plantar surface and dorsum of the foot in healthy young adults 261376 0
Condition category
Condition code
Physical Medicine / Rehabilitation 259531 259531 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Cryotherapy will be applied to the plantar surface and dorsum of the foot for 20 minutes and reapplied for another 10 minutes after a interval of approximately 15 minutes. There will be a washout interval of at least 48 hours between the two evaluation moments for both groups (group A: cryotherapy -washout - no cryotherapy; group B: no cryotherapy - washout - cryotherapy). The cryotherapy will be applied by immersing the plantar surface of the foot on iced water (about 2cm deep) and keeping the toes out of the water and applying ice packs on the dorsum of the foot.
Intervention code [1] 264226 0
Rehabilitation
Comparator / control treatment
no treatment
Control group
Active

Outcomes
Primary outcome [1] 262339 0
Capacity to reproduce (replicate) force of 20% and 50% of maximum isometric plantar flexion. The participant will be asked to sit on a chair and place the foot on a flat apparatus that will be attached to a load cell that can register force. The participant will be asked to perform a maximum voluntary isometric dorsiflexion (MVID) and the result of this MVID will be used to calculate the 20% and 50%. The capacity to reproduce force will be calculated after 10 test trials for each percentage. Up to 4 familiarisation trials will be allowed prior to the 10 test trials
Timepoint [1] 262339 0
After cryotherapy application (while temperature is still low)
Secondary outcome [1] 273571 0
Nil
Timepoint [1] 273571 0
Nil

Eligibility
Key inclusion criteria
Healthy volunteers
Minimum age
18 Years
Maximum age
40 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Injury on lower limbs for the 6 weeks prior to data collection
Skin alergic reaction to cryotherapy
Raynaud's phenomenon
Diabetes mellitus
Skin rash

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
One of the researchers, not involved in enrolling participants, will be responsible for the randomisation process will prepare sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
computerised sequence generation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Nil
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
4/04/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment outside Australia
Country [1] 3303 0
Brazil
State/province [1] 3303 0
SANTA CATARINA

Funding & Sponsors
Funding source category [1] 264673 0
University
Name [1] 264673 0
Santa Catarina State University - UDESC
Country [1] 264673 0
Brazil
Primary sponsor type
Individual
Name
Marcos Amaral de Noronha
Address
Rua Pascoal Simone, 358 - Coqueiros, Florianopolis - SC, CEP 88080-350
Country
Brazil
Secondary sponsor category [1] 263807 0
None
Name [1] 263807 0
Address [1] 263807 0
Country [1] 263807 0
Other collaborator category [1] 251876 0
Individual
Name [1] 251876 0
Daniela Pacheco dos Santos
Address [1] 251876 0
Rua Pascoal Simone, 358 - Coqueiros, Florianopolis - SC, CEP 88080-350
Country [1] 251876 0
Brazil
Other collaborator category [2] 251877 0
Individual
Name [2] 251877 0
Guilherme Nunes
Address [2] 251877 0
Rua Pascoal Simone, 358 - Coqueiros, Florianopolis - SC, CEP 88080-350
Country [2] 251877 0
Brazil
Other collaborator category [3] 251878 0
Other Collaborative groups
Name [3] 251878 0
AQUATIC BIOMECHANICS LABORATORY
Address [3] 251878 0
Rua Pascoal Simone, 358 - Coqueiros, Florianopolis - SC, CEP 88080-350
Country [3] 251878 0
Brazil

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 266677 0
Comite de Etica em Pesquisa em Seres Humanos da UDESC (Research Ethics Committee in Humans - UDESC)
Ethics committee address [1] 266677 0
Av. Madre Benvenuta, 2007 - Itacorubi - 88.035-001 - Florianopolis - SC
Ethics committee country [1] 266677 0
Brazil
Date submitted for ethics approval [1] 266677 0
03/11/2010
Approval date [1] 266677 0
26/11/2010
Ethics approval number [1] 266677 0
231/2010

Summary
Brief summary
The purpose of the study is to evaluate whether cryotherapy, applied on the foot, can alter the capacity to reproduce a predetermened plantar flexion force. It is possible that cryotherapy will significantly decreased the capacity to feel force on the ankle.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32348 0
Address 32348 0
Country 32348 0
Phone 32348 0
Fax 32348 0
Email 32348 0
Contact person for public queries
Name 15595 0
MARCOS AMARAL DE NORONHA
Address 15595 0
Rua Pascoal Simone, 358 - Coqueiros, Florianopolis - SC, CEP 88080-350
Country 15595 0
Brazil
Phone 15595 0
+55 48 33218600
Fax 15595 0
Email 15595 0
[email protected]
Contact person for scientific queries
Name 6523 0
MARCOS AMARAL DE NORONHA
Address 6523 0
Rua Pascoal Simone, 358 - Coqueiros, Florianopolis - SC, CEP 88080-350
Country 6523 0
Brazil
Phone 6523 0
+55 48 33218600
Fax 6523 0
Email 6523 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.