Disturbance; Balance, LabyrinthNCT01730859
The Effect of Ankle Taping and Balance Exercises on Postural Stability
A study testing Balance exercise and ankle taping in people with Disturbance; Balance, Labyrinth and Proprioceptive Disorders, run by Zahedan University of Medical Sciences at 1 site in Iran.
Trial summary
Both taping and balance exercises have effects on dynamic balance, so this study compared ankle taping and balance exercise on postural stability indices in healthy women. we hypothesized that both balance exercise and taping would increase stability indices but the effects of balance exercise was more greater than… Read more about this study
- Who is it for?
- Ages 19 to 22 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Disturbance; Balance, Labyrinth, Proprioceptive Disorders
- What is being tested?
- Balance exercise and ankle taping
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteIran
- Study dates
- Feb 2011to Dec 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 19 to 22 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- having no pain in ankle joint, not having sport activity in the period of this study, healthy sensory motor function in lower limb, no history of neuromuscular disease, vertigo or any uncorrected visual problems, any kind of ankle injury or lower limb surgery, taking sedative medication, cardiovascular, neurologic, and pulmonary disease, balance problems, rheumatoid disease, psychological disease, body mass index between 17 to25.
Who cannot join
- ankle pain, allergy to tape, and not completing all interventional sessions.
Trial locations and contacts
1 site in 1 country.
Iran1 site
School of rehabilitaion Sciences
Zahedan, Sistan and Baluchestan, 98167-43175
About this study
Official title: The Effect of Ankle Taping and Balance Exercises on Postural Stability Indices in Healthy Women
Both taping and balance exercises have effects on dynamic balance, so this study compared ankle taping and balance exercise on postural stability indices in healthy women. we hypothesized that both balance exercise and taping would increase stability indices but the effects of balance exercise was more greater than taping.
Read the detailed description
The ability to control the body in the space is a complex interaction between musculoskeletal and neural systems. This set is called postural control system. Postural control involves the control of body position in space for the dual purposes of postural stability and postural orientation. Balance process is divided into four-stage by Sullivan and Markos: mobility, stability, controlled mobility, and skill. Several types of exercise have been proposed to improve proprioception. Bout and Gahery stated that balance exercises improve neuromuscular relations and reduces the proprioception errors. They believe that those who have more proprioception difficulty may benefit more from exercise therapy.Taping is another technique to enhance proprioception. Improvement in proprioception leads to better function and reduction of disability. Kinesiotaping is being used to prevent injuries and to help curing the injury. It can also improve efficiency in sport, improve lymph and venous circulation, decrease edema, stimulate the mechanoreceptors and increase awareness of subject about the ankle position, reduces the pain and improves muscle performance
- Being tested
- Balance exercise and ankle taping
- Keywords
- Balance exercise, Ankle, Postural stability, Taping, Biodex
- Medical subject headings
- Somatosensory Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Balance exercise and ankle tapingOther
Also called Balance Exercises, Ankle taping
Balance Exercises: The first group performed balance exercise which last for six weeks, 3 times a week, and 40 minutes each session. Each session started by several minutes of slow walking and progressive stretching of ankle, knee and hip muscles which was gradually increased in time and repetition. After that, balance exercises were performed.
Ankle taping: In second group Ankle joint taping continued for 6 weeks and was renewed three times a week.
| Study group | Role | What they receive |
|---|---|---|
| Balance exrercise and ankle taping | Experimental | Balance Exercises:Balance exercises for 6 weeks, 3 sessions per week and each session was 40 minutes for training group.
Ankle taping: Ankle joint taping was performed for 6 weeks and was renewed three times a week. Receives: Other: Balance exercise and ankle taping |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stability Index
Biodex Balance System: It is possible to quantify the neuromuscular control performance by evaluating subject's ability in single and double leg balance on a stable or unstable surface. This system can be used to do exercises in order to increase kinesthetic abilities and improve proprioception.
Measured: 6 weeks
Secondary outcomes (1)
zone and quadrant
In balance testing which quadrant and zone are used by subjects.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2012 (estimated)
- Study startFeb 2011
- Primary completionOct 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Disturbance; Balance, LabyrinthStudies 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
- Single group
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zahedan University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Asghar Akbari, Zahedan University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01730859
- Sponsor's protocol ID
- 90-2339
- Status last verified
- Nov 2012
- First submitted
- 10 Nov 2012
- Last updated
- 22 Nov 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Lentell G, Baas B, Lopez D, McGuire L, Sarrels M, Snyder P. The contributions of proprioceptive deficits, muscle function, and anatomic laxity to functional instability of the ankle. J Orthop Sports Phys Ther. 1995 Apr;21(4):206-15. doi: 10.2519/jospt.1995.21.4.206.
PubMed 7773272
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Ankle Taping and Balance Exercises on Postural Stability Indices in Healthy Women
- ClinicalTrials.gov ID
- NCT01730859
- Acronym / sponsor ID
- 90-2339
- Keywords
- Balance exercise, Ankle, Postural stability, Taping, Biodex
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Zahedan University of Medical SciencesUniversity, hospital or other
- Study start
- Feb 2011
- Primary completion
- Oct 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 21 Nov 2012 (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.
Both taping and balance exercises have effects on dynamic balance, so this study compared ankle taping and balance exercise on postural stability indices in healthy women. we hypothesized that both balance exercise and taping would increase stability indices but the effects of balance exercise was more greater than taping.
Detailed description
The ability to control the body in the space is a complex interaction between musculoskeletal and neural systems. This set is called postural control system. Postural control involves the control of body position in space for the dual purposes of postural stability and postural orientation. Balance process is divided into four-stage by Sullivan and Markos: mobility, stability, controlled mobility, and skill. Several types of exercise have been proposed to improve proprioception. Bout and Gahery stated that balance exercises improve neuromuscular relations and reduces the proprioception errors. They believe that those who have more proprioception difficulty may benefit more from exercise therapy.Taping is another technique to enhance proprioception. Improvement in proprioception leads to better function and reduction of disability. Kinesiotaping is being used to prevent injuries and to help curing the injury. It can also improve efficiency in sport, improve lymph and venous circulation, decrease edema, stimulate the mechanoreceptors and increase awareness of subject about the ankle position, reduces the pain and improves muscle performance
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Balance exrercise and ankle taping | Experimental | Other: Balance exercise and ankle tapingBalance Exercises:Balance exercises for 6 weeks, 3 sessions per week and each session was 40 minutes for training group. Ankle taping: Ankle joint taping was performed for 6 weeks and was renewed three times a week. |
Who may qualify
- Ages
- 19 to 22 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- having no pain in ankle joint, not having sport activity in the period of this study, healthy sensory motor function in lower limb, no history of neuromuscular disease, vertigo or any uncorrected visual problems, any kind of ankle injury or lower limb surgery, taking sedative medication, cardiovascular, neurologic, and pulmonary disease, balance problems, rheumatoid disease, psychological disease, body mass index between 17 to25.
Key exclusion criteria (1 listed)
- ankle pain, allergy to tape, and not completing all interventional sessions.
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 |
|---|---|---|
| Balance exercise and ankle tapingAlso: Balance Exercises, Ankle tapingBalance Exercises: The first group performed balance exercise which last for six weeks, 3 times a week, and 40 minutes each session. Each session started by several minutes of slow walking and progressive stretching of ankle, knee and hip muscles which was gradually increased in time and repetition. After that, balance exercises were performed. Ankle taping: In second group Ankle joint taping continued for 6 weeks and was renewed three times a week. | Other | Balance exrercise and ankle taping |
Primary outcome
Stability Index
Time frame: 6 weeks
Biodex Balance System: It is possible to quantify the neuromuscular control performance by evaluating subject's ability in single and double leg balance on a stable or unstable surface. This system can be used to do exercises in order to increase kinesthetic abilities and improve proprioception.
1 secondary outcome
zone and quadrant
Time frame: 6 weeks
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 22 Nov 2012.
- Results publication: PubMed 7773272Lentell G, Baas B, Lopez D, McGuire L, Sarrels M, Snyder P. The contributions of proprioceptive deficits, muscle function, and anatomic laxity to functional instability of the ankle. J Orthop Sports Phys Ther. 1995 Apr;21(4):206-15. doi: 10.2519/jospt.1995.21.4.206.
- The Biodex Balance System SD has been designed to meet the needs of everyone looking to improve balance, increase agility, develop muscle tone and treat a wide variety of pathologies.Link provided by the sponsor.
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 Balance exercise and ankle taping in people with Disturbance; Balance, Labyrinth and Proprioceptive Disorders, run by Zahedan University of Medical Sciences at 1 site in Iran.
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 22 Nov 2012. 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 Iran. 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?
Stability Index (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01730859, which also lists 1 linked publication.
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 22 Nov 2012.