Ankle SprainNCT02682303
Effect of Elastic Bandage on Balance in Chronic Ankle Instability
A study testing Elastic Bandage (Idealplast C®) and Pretape cramer® (non standarized tape) in people with Ankle Sprain, run by Universidad Rey Juan Carlos at 1 site in Spain.
Trial summary
Purpose: To report the immediate and prolonged (one week) effects of elastic bandage on balance control in subjects with chronic ankle instability. Material and methods: Twenty-eight individuals successfully completed the study protocol, of whom 14 were randomly assigned to the elastic bandage group (7 men, 7 women)… Read more about this study
- Who is it for?
- Ages 18 to 28 years
- Conditions the study is for
- Ankle Sprain
- What is being tested?
- Elastic Bandage (Idealplast C®) and Pretape cramer® (non standarized tape)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- 1 siteSpain
- Study dates
- Mar 2016to Aug 2016
- 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 28 years
- No healthy volunteers
- Adult
Who may be able to join
- Subjects with Chronic Ankle Instability
Who cannot join
- Neurologic disease Vestibular disease
Trial locations and contacts
1 site in 1 country.
Spain1 site
Francisco Molina Rueda. Avda. de Atenas. s/n.
Alcorcón, Madrid, 28922
About this study
Official title: Effect of Elastic Bandage on Measurements of Balance in Subjects With Chronic Ankle Instability: a Randomized Clinical Trial
Purpose: To report the immediate and prolonged (one week) effects of elastic bandage on balance control in subjects with chronic ankle instability.
Material and methods: Twenty-eight individuals successfully completed the study protocol, of whom 14 were randomly assigned to the elastic bandage group (7 men, 7 women) and 14 were assigned to the non-standardized tape group ( 9 men, 5 women). To objectively measure postural sway we used computerized dynamic posturography with Sensory Organization Test and Unilateral Stance test. We analyzed the following Sensory Organization Test parameters: the composite Sensory Organization Test score, the composite Sensory Organization Test strategy and the Sensory Organization Test condition 2 and its strategy. In addition, we studied the centre of gravity sway velocity with open eyes and close eyes during the US test.
- Conditions
- Ankle Sprain
- Being tested
- Elastic Bandage (Idealplast C®), Pretape cramer® (non standarized tape)
- Keywords
- Adhesive elastic bandaging, balance, posturography
- Medical subject headings
- Ankle Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Elastic Bandage (Idealplast C®)Device
Elastic bandage
One anchor strip is applied around the ankle with no tension applied to the tape to avoid restricting blood flow. A supporting stirrup strap is applied from the inside of the ankle, under the heel with no tension up to this point. As the tape is passed up the outside of the ankle tension is applied to the tape with the foot in slight dorsiflexion and secured to the anchor strap (black arrow).
For heel lock, a second strip is applied on the outside of the ankle, taken across the front of the ankle and just above the bony part on the inside of the ankle and back towards the heel (red arrow). Then taken around and under the heel back the way you have just come and around the front of the ankle (orange arrow). The tape then passes above the bony part of the ankle on the outside and diagonally towards the heel, across to the inside of the ankle then around the top to finish
Pretape cramer® (non standarized tape)Device
Pretape cramer® was used.
The individual is in supine position keeping the foot and ankle in a neutral position.
The strip (I) is applied with not stretch in the outside of the leg just above the ankle, and then the rest of the strip is applied on the outside of the ankle and under the heel.
This is the only intervention carried out in this group.
| Study group | Role | What they receive |
|---|---|---|
| elastic bandage | Experimental | In this study, Idealplast C® (6cm*2.5m) was used. Receives: Device: Elastic Bandage (Idealplast C®) |
| Non-standardized tape (NST) | Placebo comparator | In the NST group, Pretape Cramer® (100% cotton, 1.25cm*10m) was used. Receives: Device: Pretape cramer® (non standarized tape) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Balance using a computerized dynamic posturography test: the sensory organization test
The CDP device employed in this study was Smart Equitest® version 8.2 (NeuroCom International Inc., Clackamas, OR, USA). Posturography analysis was conducted using the SOT. This test assesses postural control through the use of external stimuli on the visual and proprioceptive system.
Participants were instructed to stand on the force-plate facing the visual surround. A safety harness was fixed to prevent injury from falls. Their bare feet position on force-plates was adjusted according to the height of the patient, as marked on the equipment. Subjects had to maintain their COG stable in 3 consecutive series of 20s duration for each of the 6 conditions in the test.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2016 (estimated)
- Study startMar 2016
- Primary completionMay 2016
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ankle SprainStudies of the same condition, open and under way.
- 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Rey Juan Carlos
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Josue Fernandez Carnero, Universidad Rey Juan Carlos
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02682303
- Sponsor's protocol ID
- 05/14
- Status last verified
- Oct 2016
- First submitted
- 28 Jan 2016
- Last updated
- 18 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Elastic Bandage on Measurements of Balance in Subjects With Chronic Ankle Instability: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT02682303
- Acronym / sponsor ID
- 05/14
- Conditions
- Ankle Sprain
- Keywords
- Adhesive elastic bandaging, balance, posturography
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Universidad Rey Juan CarlosUniversity, hospital or other
- Study start
- Mar 2016
- Primary completion
- May 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 15 Feb 2016 (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.
Purpose: To report the immediate and prolonged (one week) effects of elastic bandage on balance control in subjects with chronic ankle instability.
Material and methods: Twenty-eight individuals successfully completed the study protocol, of whom 14 were randomly assigned to the elastic bandage group (7 men, 7 women) and 14 were assigned to the non-standardized tape group ( 9 men, 5 women). To objectively measure postural sway we used computerized dynamic posturography with Sensory Organization Test and Unilateral Stance test. We analyzed the following Sensory Organization Test parameters: the composite Sensory Organization Test score, the composite Sensory Organization Test strategy and the Sensory Organization Test condition 2 and its strategy. In addition, we studied the centre of gravity sway velocity with open eyes and close eyes during the US test.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| elastic bandage | Experimental | Device: Elastic Bandage (Idealplast C®)In this study, Idealplast C® (6cm*2.5m) was used. |
| Non-standardized tape (NST) | Placebo comparator | Device: Pretape cramer® (non standarized tape)In the NST group, Pretape Cramer® (100% cotton, 1.25cm*10m) was used. |
Who may qualify
- Ages
- 18 to 28 years
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Subjects with Chronic Ankle Instability
Key exclusion criteria (1 listed)
- Neurologic disease Vestibular disease
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 |
|---|---|---|
| Elastic Bandage (Idealplast C®)Elastic bandage One anchor strip is applied around the ankle with no tension applied to the tape to avoid restricting blood flow. A supporting stirrup strap is applied from the inside of the ankle, under the heel with no tension up to this point. As the tape is passed up the outside of the ankle tension is applied to the tape with the foot in slight dorsiflexion and secured to the anchor strap (black arrow). For heel lock, a second strip is applied on the outside of the ankle, taken across the front of the ankle and just above the bony part on the inside of the ankle and back towards the heel (red arrow). Then taken around and under the heel back the way you have just come and around the front of the ankle (orange arrow). The tape then passes above the bony part of the ankle on the outside and diagonally towards the heel, across to the inside of the ankle then around the top to finish | Device | elastic bandage |
| Pretape cramer® (non standarized tape)Pretape cramer® was used. The individual is in supine position keeping the foot and ankle in a neutral position. The strip (I) is applied with not stretch in the outside of the leg just above the ankle, and then the rest of the strip is applied on the outside of the ankle and under the heel. This is the only intervention carried out in this group. | Device | Non-standardized tape (NST) |
Primary outcome
Balance using a computerized dynamic posturography test: the sensory organization test
Time frame: 7 days
The CDP device employed in this study was Smart Equitest® version 8.2 (NeuroCom International Inc., Clackamas, OR, USA). Posturography analysis was conducted using the SOT. This test assesses postural control through the use of external stimuli on the visual and proprioceptive system. Participants were instructed to stand on the force-plate facing the visual surround. A safety harness was fixed to prevent injury from falls. Their bare feet position on force-plates was adjusted according to the height of the patient, as marked on the equipment. Subjects had to maintain their COG stable in 3 consecutive series of 20s duration for each of the 6 conditions in the test.
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 Oct 2016.
- UniversityLink provided by the sponsor.
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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 Elastic Bandage (Idealplast C®) and Pretape cramer® (non standarized tape) in people with Ankle Sprain, run by Universidad Rey Juan Carlos at 1 site in Spain.
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 1 inclusion and 1 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 Oct 2016. 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 Spain. 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. Some participants in this study may receive a placebo. 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?
Balance using a computerized dynamic posturography test: the sensory organization test (time frame: 7 days). 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 Oct 2016.