Chronic Ankle InstabilityNCT05455957
The Effect of Neuromuscular and Vestibulo-Ocular Training on Balance,Isokinetic Strength and Proprioception in Chronic Ankle Instability
A study testing exercise in people with Chronic Ankle Instability, run by Yeditepe University at 1 site in Turkey (Türkiye).
Trial summary
The aim of the study is to compare the effects of neromuscular exercise combined with vestibulo-ocular reflex training on balance,isokinetic muscle strength and proprioception in subjects with ankle instability.The aim of the study is to compare the effects of neromuscular exercise combined with vestibulo-ocular… Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Ankle Instability
- What is being tested?
- exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Mar 2021to 4 Feb 2022
- 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 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Being 18-30 years old
- At least 2 lateral sprains to the same ankle in the past
- At least 1 episode of "giving way" that had occurred within the past 6 months
- The presence of residual symptoms during functional activities and had to be free from symptoms of any other previous injury to the lower extremity.
- No other injuries to the lower limbs
Who cannot join
- Having a bilateral ankle instability
- Having a history of ankle fracture
- Having a history of fracture or surgery to the involved lower extremity
- Having a history of balance and vestibular disorders
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Neuromuscular and Vestibulo-Ocular Reflex Training Program on Balance, Isokinetic Muscle Strength and Proprioception in Subjects With Chronic Ankle Instability
The aim of the study is to compare the effects of neromuscular exercise combined with vestibulo-ocular reflex training on balance,isokinetic muscle strength and proprioception in subjects with ankle instability.The aim of the study is to compare the effects of neromuscular exercise combined with vestibulo-ocular reflex training on balance and isokinetic muscle strength in subjects with ankle instability.
Hypotheses of the study; H0: Vestibulo-ocular reflex training protocol, which is given in addition to the neuromuscular exercise program, has an effect on isokinetic ankle muscle strength and balance in individuals with ankle instability.
H1: Vestibulo-ocular reflex training protocol, which is given in addition to the neuromuscular exercise program, has no effect on isokinetic ankle muscle strength and balance in individuals with ankle instability.
Read the detailed description
The aim of the study is to compare the effects of neromuscular exercise combined with vestibulo-ocular reflex training on balance,isokinetic muscle strength and proprioception in subjects with ankle instability. This study was conducted in Sportomed Athlete Health and Orthopedic Rehabilitation clinic in February 2020, September 2022.A total of 20 participants aged 18-30 were included in the study on a voluntary basis..Participants were randomly seperated to 2 groups. Demographic information and informed consent forms were filled into all subjects who volunteered to participate in the study and in accordance with the research criteria. After the evaluation, the subjects in the first group were included in the vestibulo-ocular exercise program in addition to the neuromuscular exercise programs with the same physiotherapist. Subjects in the second group were included in neuromuscular training programs. The trainings were applied three days a week for four weeks and each training session lasted approximately 60 minutes. Functional limitations of the participants before and after the treatment were evaluated with the Foot and Ankle Ability Measure Daily Living Subscale (FAAM-ADL) and Sports Subscale (FAAM-S). Dynamic balance evaluation with star excursion balance test, proprioception evaluation by measuring joint position sense with goniometer, and ankle evertor and inverter concentric muscle strength were evaluated using isokinetic dynamometer at angular velocities of 60/s, 120/s and 180/s, and the results were recorded.
- Conditions
- Chronic Ankle Instability
- Being tested
- exercise
- Keywords
- ankle instability, balance, neuromuscular,vestibulo-ocular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
exerciseOther
neuromuscular and vestibulo-ocular training
| Study group | Role | What they receive |
|---|---|---|
| Neuromuscular Training | Experimental | The neuromuscular exercise training group includes single-leg stance, single leg hop and strength exercise.Each training session took approximately 60 minutes and 3 times a week for 4 weeks.The neuromuscular group included supervised, strength, balance and hop stabilization exercises on the different surfaces that focus on the restoring of static and dynamic balance. Both groups completed strength exercises in the same way. Strength exercises include ;4-way ankle theraband exercises,foot intrinsic strengthening (toe curl, doming),heel raises exercise,squat, lunge activities.Balance exercises include single-leg stance single leg hop and unticipated hop to stabilization activities. Receives: Other: exercise |
| Vestibulo-Ocular Reflex Training | Experimental | The vestibulo ocular reflex training group includes head and gaze stability exercises in addition to single le stance,single leg hop and strength exercise.Each training session took approximately 60 minutes and 3 times a week for 4 weeks.In the vestibulo- ocular exercise program, individuals tried to maintain their balance with head and eye movements in addition to balance and hop stabilization activities. Both groups completed strength exercises in the same way. Strength exercises include ;4-way ankle theraband exercises,foot intrinsic strengthening (toe curl, doming),heel raises exercise,squat, lunge activities.Balance exercises include single-leg stance single leg hop and unticipated hop to stabilization activities. Receives: Other: exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
balance,isokinetic muscle strength,proprioception
Dynamic balance evaluation with star excursion balance test recorded in centimeters.
Measured: 1 hours
isokinetic muscle strength
ankle evertor- inverter concentric muscle strength by using isokinetic dynamometer at angular velocities of 60 degree/s, 120 degree /s and 180 degree/s were recorded.
Measured: 1 hours
proprioception
Proprioception was evaluated by measuring joint position sense with a goniometer, and deviations in proprioception were recorded as degrees.
Measured: 1 hours
Secondary outcomes (2)
weight
kilogram
Measured: 1 hours
height
meter
Measured: 1 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2022
- Study start10 Mar 2021
- Primary completion16 Sep 2021
- Study completion4 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Ankle InstabilityStudies 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
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yeditepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05455957
- Sponsor's protocol ID
- YeditepeU1
- Status last verified
- Jun 2022
- First submitted
- 10 Jun 2022
- Last updated
- 13 Jul 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Neuromuscular and Vestibulo-Ocular Reflex Training Program on Balance, Isokinetic Muscle Strength and Proprioception in Subjects With Chronic Ankle Instability
- ClinicalTrials.gov ID
- NCT05455957
- Acronym / sponsor ID
- YeditepeU1
- Conditions
- Chronic Ankle Instability
- Keywords
- ankle instability, balance, neuromuscular,vestibulo-ocular
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Yeditepe UniversityUniversity, hospital or other
- Study start
- 10 Mar 2021 (actual)
- Primary completion
- 16 Sep 2021 (actual)
- Study completion
- 4 Feb 2022 (actual)
- First posted
- 13 Jul 2022 (actual)
- 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.
The aim of the study is to compare the effects of neromuscular exercise combined with vestibulo-ocular reflex training on balance,isokinetic muscle strength and proprioception in subjects with ankle instability.The aim of the study is to compare the effects of neromuscular exercise combined with vestibulo-ocular reflex training on balance and isokinetic muscle strength in subjects with ankle instability.
Hypotheses of the study; H0: Vestibulo-ocular reflex training protocol, which is given in addition to the neuromuscular exercise program, has an effect on isokinetic ankle muscle strength and balance in individuals with ankle instability.
H1: Vestibulo-ocular reflex training protocol, which is given in addition to the neuromuscular exercise program, has no effect on isokinetic ankle muscle strength and balance in individuals with ankle instability.
Detailed description
The aim of the study is to compare the effects of neromuscular exercise combined with vestibulo-ocular reflex training on balance,isokinetic muscle strength and proprioception in subjects with ankle instability. This study was conducted in Sportomed Athlete Health and Orthopedic Rehabilitation clinic in February 2020, September 2022.A total of 20 participants aged 18-30 were included in the study on a voluntary basis..Participants were randomly seperated to 2 groups. Demographic information and informed consent forms were filled into all subjects who volunteered to participate in the study and in accordance with the research criteria. After the evaluation, the subjects in the first group were included in the vestibulo-ocular exercise program in addition to the neuromuscular exercise programs with the same physiotherapist. Subjects in the second group were included in neuromuscular training programs. The trainings were applied three days a week for four weeks and each training session lasted approximately 60 minutes. Functional limitations of the participants before and after the treatment were evaluated with the Foot and Ankle Ability Measure Daily Living Subscale (FAAM-ADL) and Sports Subscale (FAAM-S). Dynamic balance evaluation with star excursion balance test, proprioception evaluation by measuring joint position sense with goniometer, and ankle evertor and inverter concentric muscle strength were evaluated using isokinetic dynamometer at angular velocities of 60/s, 120/s and 180/s, and the results were recorded.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Neuromuscular Training | Experimental | Other: exerciseThe neuromuscular exercise training group includes single-leg stance, single leg hop and strength exercise.Each training session took approximately 60 minutes and 3 times a week for 4 weeks.The neuromuscular group included supervised, strength, balance and hop stabilization exercises on the different surfaces that focus on the restoring of static and dynamic balance. Both groups completed strength exercises in the same way. Strength exercises include ;4-way ankle theraband exercises,foot intrinsic strengthening (toe curl, doming),heel raises exercise,squat, lunge activities.Balance exercises include single-leg stance single leg hop and unticipated hop to stabilization activities. |
| Vestibulo-Ocular Reflex Training | Experimental | Other: exerciseThe vestibulo ocular reflex training group includes head and gaze stability exercises in addition to single le stance,single leg hop and strength exercise.Each training session took approximately 60 minutes and 3 times a week for 4 weeks.In the vestibulo- ocular exercise program, individuals tried to maintain their balance with head and eye movements in addition to balance and hop stabilization activities. Both groups completed strength exercises in the same way. Strength exercises include ;4-way ankle theraband exercises,foot intrinsic strengthening (toe curl, doming),heel raises exercise,squat, lunge activities.Balance exercises include single-leg stance single leg hop and unticipated hop to stabilization activities. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Being 18-30 years old
- At least 2 lateral sprains to the same ankle in the past
- At least 1 episode of "giving way" that had occurred within the past 6 months
- The presence of residual symptoms during functional activities and had to be free from symptoms of any other previous injury to the lower extremity.
- No other injuries to the lower limbs
Key exclusion criteria (4 listed)
- Having a bilateral ankle instability
- Having a history of ankle fracture
- Having a history of fracture or surgery to the involved lower extremity
- Having a history of balance and vestibular disorders
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 |
|---|---|---|
| exerciseneuromuscular and vestibulo-ocular training | Other | Neuromuscular Training, Vestibulo-Ocular Reflex Training |
Primary outcome
balance,isokinetic muscle strength,proprioception
Time frame: 1 hours
Dynamic balance evaluation with star excursion balance test recorded in centimeters.
isokinetic muscle strength
Time frame: 1 hours
ankle evertor- inverter concentric muscle strength by using isokinetic dynamometer at angular velocities of 60 degree/s, 120 degree /s and 180 degree/s were recorded.
proprioception
Time frame: 1 hours
Proprioception was evaluated by measuring joint position sense with a goniometer, and deviations in proprioception were recorded as degrees.
2 secondary outcomes
weight
Time frame: 1 hours
height
Time frame: 1 hours
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 13 Jul 2022.
- Individual participant dataSharing planned: Undecided
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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 exercise in people with Chronic Ankle Instability, run by Yeditepe University at 1 site in Turkey (Türkiye).
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 5 inclusion and 4 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 13 Jul 2022. 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 Turkey (Türkiye). 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?
balance,isokinetic muscle strength,proprioception (time frame: 1 hours). The study lists 3 primary outcomes in all. 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 13 Jul 2022.