OsteoarthritisNCT03361449
Effect of Flamingo Exercises on Balance
A study testing Flamingo exercise and training with kinesthetic ability trainer in people with Osteoarthritis and Gait Disorders, Neurologic, run by Ufuk University.
Trial summary
The aim of this study is to determine the effect of flamingo exercise on balance in patients with balance impairment due to senil osteoarthritis Read more about this study
- Who is it for?
- Ages 65 to 95 yearsHealthy volunteers can take part
- Conditions the study is for
- Osteoarthritis, Gait Disorders, Neurologic
- What is being tested?
- Flamingo exercise and training with kinesthetic ability trainer
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 25 Apr 2018to 30 May 2018
- 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 65 to 95 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Older than 65 years old
- osteoarthritis diagnosis
- Balance impairment (Berg balance scale 21-40 points)
Who cannot join
- Severe neurological deficit
- Defect of vision
- Vitamin B12 deficiency
- Sedative drug use
About this study
Official title: Effect of Flamingo Exercises on Balance in Patients With Balance Impairment Due to Senile Osteoarthritis
The aim of this study is to determine the effect of flamingo exercise on balance in patients with balance impairment due to senil osteoarthritis
Read the detailed description
Changes in the sensory, neurological, and musculoskeletal systems in older adults affect several motor tasks,including postural balance. Also osteoarthritis contribute to this process. Older people can gain balance disorders. The flamingo balance exercise is a full lower body workout utilizing many major muscle groups. Therefore investigators aimed to determine the effect of flamingo exercise combined with kinesthetic ability trainer or alone in patients with balance impairment due to osteoarthritis
- Conditions
- Osteoarthritis, Gait Disorders, Neurologic
- Being tested
- Flamingo exercise, training with kinesthetic ability trainer
- Medical subject headings
- Osteoarthritis, Gait Disorders, Neurologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Flamingo exerciseOther
Flamingo exercise
training with kinesthetic ability trainerOther
training with kinesthetic ability trainer
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Active comparator | training with kinesthetic ability trainer. Receives: Other: training with kinesthetic ability trainer |
| Group 2 | Active comparator | Flamingo exercise Receives: Other: Flamingo exercise |
| Group 3 | Active comparator | training with kinesthetic ability trainer and Flamingo exercise Receives: Other: Flamingo exercise; Other: training with kinesthetic ability trainer |
What is being measured
The primary outcome is the main question the study is designed to answer.
kinesthetic ability trainer static score
kinesthetic ability trainer static score
Measured: 4 weeks
kinesthetic ability trainer static dynamic score
kinesthetic ability trainer static dynamic score
Measured: 4 weeks
Berg Balance Scale
a scale for balance
Measured: 4 weeks
Timed up and Go test
for balance and gait
Measured: 4 weeks
activity specific balance scale.
for balance
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2017
- Study start25 Apr 2018 (estimated)
- Primary completion30 May 2018 (estimated)
- Study completion30 May 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoarthritisStudies 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
- Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ufuk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ASLIHAN UZUNKULAOGLU, Ufuk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03361449
- Sponsor's protocol ID
- 30112015-7
- Status last verified
- Apr 2018
- First submitted
- 28 Nov 2017
- Last updated
- 12 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Flamingo Exercises on Balance in Patients With Balance Impairment Due to Senile Osteoarthritis
- ClinicalTrials.gov ID
- NCT03361449
- Acronym / sponsor ID
- 30112015-7
- Conditions
- Osteoarthritis, Gait Disorders, Neurologic
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Ufuk UniversityUniversity, hospital or other
- Study start
- 25 Apr 2018 (estimated)
- Primary completion
- 30 May 2018 (estimated)
- Study completion
- 30 May 2018 (estimated)
- First posted
- 4 Dec 2017 (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 this study is to determine the effect of flamingo exercise on balance in patients with balance impairment due to senil osteoarthritis
Detailed description
Changes in the sensory, neurological, and musculoskeletal systems in older adults affect several motor tasks,including postural balance. Also osteoarthritis contribute to this process. Older people can gain balance disorders. The flamingo balance exercise is a full lower body workout utilizing many major muscle groups. Therefore investigators aimed to determine the effect of flamingo exercise combined with kinesthetic ability trainer or alone in patients with balance impairment due to osteoarthritis
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Active comparator | Other: training with kinesthetic ability trainertraining with kinesthetic ability trainer. |
| Group 2 | Active comparator | Other: Flamingo exerciseFlamingo exercise |
| Group 3 | Active comparator | Other: Flamingo exercise, Other: training with kinesthetic ability trainertraining with kinesthetic ability trainer and Flamingo exercise |
Who may qualify
- Ages
- 65 to 95 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Older than 65 years old
- osteoarthritis diagnosis
- Balance impairment (Berg balance scale 21-40 points)
Key exclusion criteria (4 listed)
- Severe neurological deficit
- Defect of vision
- Vitamin B12 deficiency
- Sedative drug use
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 |
|---|---|---|
| Flamingo exerciseFlamingo exercise | Other | Group 2, Group 3 |
| training with kinesthetic ability trainertraining with kinesthetic ability trainer | Other | Group 1, Group 3 |
Primary outcome
kinesthetic ability trainer static score
Time frame: 4 weeks
kinesthetic ability trainer static score
kinesthetic ability trainer static dynamic score
Time frame: 4 weeks
kinesthetic ability trainer static dynamic score
Berg Balance Scale
Time frame: 4 weeks
a scale for balance
Timed up and Go test
Time frame: 4 weeks
for balance and gait
activity specific balance scale.
Time frame: 4 weeks
for balance
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2018.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Flamingo exercise and training with kinesthetic ability trainer in people with Osteoarthritis and Gait Disorders, Neurologic, run by Ufuk University.
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 3 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: status not confirmed, as of the sponsor's last update on 12 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
kinesthetic ability trainer static score (time frame: 4 weeks). The study lists 5 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 12 Apr 2018.