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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01298856
Other study ID # 014/52
Secondary ID
Status Completed
Phase N/A
First received January 8, 2011
Last updated February 16, 2011
Start date June 2009
Est. completion date January 2011

Study information

Verified date January 2011
Source Chulalongkorn University
Contact n/a
Is FDA regulated No
Health authority Thailand : Thammasat University Ethics Committee for Human Research
Study type Interventional

Clinical Trial Summary

There will be a difference in ankle functional ability between athletes with chronic ankle instability in the intervention group and in the control group.


Recruitment information / eligibility

Status Completed
Enrollment 50
Est. completion date January 2011
Est. primary completion date September 2010
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 35 Years
Eligibility Inclusion Criteria:

- recurrent ankle sprain in one year

- sustain at least one repeated injury or have the experience of ankle instability feelings or "giving way"

- not undergoing formal or informal rehabilitation for the unstable ankle in the last three months

- have residual symptoms after recurrent sprain of the ankle

Exclusion Criteria:

- have the history of fracture or surgical procedures in the lower extremity

- have the history of neurological disorders affecting the lower extremities vestibular dysfunction or balance disorder

- allergic to the zinc oxide compound in the adhesive tape

Study Design

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

Procedure:
hydrotherapy
hydrotherapy and ankle taping and land-based

Locations

Country Name City State
Thailand Thammasat University Khlong Luang Pathum Thani

Sponsors (2)

Lead Sponsor Collaborator
Chulalongkorn University Thammasat University

Country where clinical trial is conducted

Thailand, 

Outcome

Type Measure Description Time frame Safety issue
Primary To compare the effect of ankle functional ability between the athletes with chronic ankle instability in the intervention group and the control group 18 months No
Secondary To compare the effect of active joint position sense, single limb balance, SF-36 and re-injury rate Parameters
active joint position sense in ankle plantarflexion 30 degree and ankle inversion 15 degree
single limb balance in standard deviation and Range
SF-36 in 8 Items of questionnairs
18 months No
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