Sports Rehabilitation ProgramCAINCT01298856
The Effect of Hydrotherapy and Land-based Rehabilitation Program Combined With Ankle Taping in Athletes With Chronic Ankle Instability
A study testing hydrotherapy in people with Sports Rehabilitation Program and Hydrotherapy, run by Chulalongkorn University at 1 site in Thailand.
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. Read more about this study
- Who is it for?
- Ages 18 to 35 years
- Conditions the study is for
- Sports Rehabilitation Program, Hydrotherapy, Ankle Instability
- What is being tested?
- hydrotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteThailand
- Study dates
- Jun 2009to Jan 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Thammasat University
Khlong Luang, Changwat Pathum Thani, 12121
About this study
Official title: The Effect of Hydrotherapy and Land-based Rehabilitation Program Combined With Ankle Taping on Ankle Functional Ability and Re-injury Rate in Athletes With Chronic Ankle Instability
There will be a difference in ankle functional ability between athletes with chronic ankle instability in the intervention group and in the control group.
- Being tested
- hydrotherapy
- Keywords
- hydrotherapy, chronic ankle instability, ankle taping
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hydrotherapyProcedure or surgery
Also called ankle taping, land-based
hydrotherapy and ankle taping and land-based
| Study group | Role | What they receive |
|---|---|---|
| hydrotherapy | Active comparator | hydrotherapy and ankle taping and land based exercise Receives: Procedure: hydrotherapy |
| land-based | Active comparator | land-based and ankle taping program Receives: Procedure: hydrotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare the effect of ankle functional ability between the athletes with chronic ankle instability in the intervention group and the control group
Measured: 18 months
Secondary outcomes (1)
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
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2011 (estimated)
- Study startJun 2009
- Primary completionSep 2010
- Study completionJan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sports Rehabilitation ProgramStudies of the same condition, open and under way.
- More trials run by Chulalongkorn UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chulalongkorn University
- Sponsor type
- University, hospital or other
- Collaborators
- Thammasat University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01298856
- Sponsor's protocol ID
- 014/52
- Acronym
- CAI
- Status last verified
- Jan 2011
- First submitted
- 8 Jan 2011
- Last updated
- 18 Feb 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Hydrotherapy and Land-based Rehabilitation Program Combined With Ankle Taping on Ankle Functional Ability and Re-injury Rate in Athletes With Chronic Ankle Instability
- ClinicalTrials.gov ID
- NCT01298856
- Acronym / sponsor ID
- CAI / 014/52
- Keywords
- hydrotherapy, chronic ankle instability, ankle taping
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Chulalongkorn UniversityUniversity, hospital or other
- Collaborators
- Thammasat University
- Study start
- Jun 2009
- Primary completion
- Sep 2010 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 18 Feb 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
There will be a difference in ankle functional ability between athletes with chronic ankle instability in the intervention group and in the control group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| hydrotherapy | Active comparator | Procedure: hydrotherapyhydrotherapy and ankle taping and land based exercise |
| land-based | Active comparator | Procedure: hydrotherapyland-based and ankle taping program |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| hydrotherapyAlso: ankle taping, land-basedhydrotherapy and ankle taping and land-based | Procedure or surgery | hydrotherapy, land-based |
Primary outcome
To compare the effect of ankle functional ability between the athletes with chronic ankle instability in the intervention group and the control group
Time frame: 18 months
1 secondary outcome
To compare the effect of active joint position sense, single limb balance, SF-36 and re-injury rate
Time frame: 18 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing hydrotherapy in people with Sports Rehabilitation Program and Hydrotherapy, run by Chulalongkorn University at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Feb 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To compare the effect of ankle functional ability between the athletes with chronic ankle instability in the intervention group and the control group (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2011; AzTrials last refreshed its copy on 6 Nov 2026.