Ankylosing SpondylitisNCT06198985
The Effect of Dynamic Balance Exercises on Balance in Patients With Ankylosing Spondylitis.
A study testing Dynamic balance exercise with tecnobody prokin 252 balance device in people with Ankylosing Spondylitis, run by Hakan Alkan.
Trial summary
The aim of the study is to investigate the effect of dynamic balance exercises added to current medical treatment on balance in patients with ankylosing spondylitis. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Ankylosing Spondylitis
- What is being tested?
- Dynamic balance exercise with tecnobody prokin 252 balance device
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2024to 1 Jul 2025
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants aged 18 to 65 years with a clinical diagnosis of ankylosing spondylitis according to ASAS criteria
- To have the ability to give written informed consent
- Having the ability to understand procedures
Who cannot join
- Visual and vestibular system diseases that may affect balance
- Neurological or orthopedic diseases that may affect balance (Parkinson's disease, history of stroke, presence of knee or hip prosthesis, previous fracture sequelae, foot problems, etc.)
- Individuals with severe mental and sensory problems
- History of balance exercise and/or spine surgery in the last 6 months
- Pregnancy or breastfeeding
- Over 150 kg
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Effect of Dynamic Balance Exercises Added to Current Medical Treatment on Balance in Patients With Ankylosing Spondylitis.
The aim of the study is to investigate the effect of dynamic balance exercises added to current medical treatment on balance in patients with ankylosing spondylitis.
Read the detailed description
The study was planned as a randomized controlled study. Forty participants with a clinically confirmed diagnosis of AS according to ASAS criteria will be recruited from the PAU Department of Physical Medicine and Rehabilitation (PMR). These participants who meet the inclusion and exclusion criteria will be randomly divided into 2 groups.
The trial will be carried out at Pamukkale University Department of Physical Medicine and Rehabilitation between January 2024 and July 2025. The local ethics committee approved the study. All participants will be informed about the purpose and content of the study and will sign written consent to participate in the study.
Participant's age, gender, body mass index, education, occupation, medications, duration of diagnosis, comorbidity, functional status and pain will be questioned and recorded.
Group1: Group receiving dynamic balance exercise with tecnobody prokin 252 balance device added to current medical treatment (Intervention group) The first group will be given dynamic balance exercises with the tecnobody prokin 252 device and participants will continue their current medical treatment. These dynamic balance exercises will be performed in 3 days a week for 6 weeks. Each exercise will last 30 minutes. It will take 18 sessions in total. These exercises include 14 balance exercise movements performed on tecnobody prokin 252 balance device (manufactured in Italy).
Group 2: Group receiving current medical treatment (control group) Participants in this group will receive only current medical treatment. Care will be taken not to change the medical treatments of the participants during the study.
All participants will be evaluated with the following evaluation parameters before the treatment and at the end of 6 weeks.
- Conditions
- Ankylosing Spondylitis
- Being tested
- Dynamic balance exercise with tecnobody prokin 252 balance device
- Keywords
- Tecnobody, Ankylosing spondylitis, Balance
- Medical subject headings
- Spondylitis, Ankylosing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dynamic balance exercise with tecnobody prokin 252 balance deviceProcedure or surgery
Dynamic balance exercise with tecnobody prokin 252 balance device
| Study group | Role | What they receive |
|---|---|---|
| Dynamic balance exercise with tecnobody prokin 252 balance device added to current medical treatment | Experimental | Dynamic balance exercises: The treatment will be performed in 3 days a week for 6 weeks. Each exercise will last 30 minutes. It will take 18 sessions in total. These exercises include 14 balance exercise movements performed on tecnobody prokin 252 balance device. Receives: Procedure: Dynamic balance exercise with tecnobody prokin 252 balance device |
| Group receiving current medical treatment | No intervention | Participants in this group will receive only current medical treatment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dynamic balance measurements
The TecnoBody Prokin 252 system was used to assess balance in the standing position for all participants. This equipment provides data on average track error and stability index.
Measured: a day before rehabilitation
Dynamic balance measurements
The TecnoBody Prokin 252 system was used to assess balance in the standing position for all participants. This equipment provides data on average track error and stability index.
Measured: 6 weeks after the start of rehabilitation
Secondary outcomes (8)
ASQoL
A disease-specific, patient-completed outcome measure for patients with AS. The scale consists of 18 questions with two answers as 0 'no' and 1 'yes' for each item. The total score ranges from 0-18, with a high score indicating good quality of life.
Measured: a day before rehabilitation
ASQoL
A disease-specific, patient-completed outcome measure for patients with AS. The scale consists of 18 questions with two answers as 0 'no' and 1 'yes' for each item. The total score ranges from 0-18, with a high score indicating good quality of life.
Measured: 6 weeks after the start of rehabilitation
Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
It consists of 6 VAS measures of fatigue, spinal and peripheral joint pain, tenderness and morning stiffness. Morning stiffness is measured in terms of both severity and duration. The mean score for the two questions on morning stiffness is calculated and summed with the scores for the other questions. The BASDAI score is obtained by converting the total value into a 0-10 scale. Below four is considered inactive disease and four and above is considered active disease.
Measured: a day before rehabilitation
Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
It consists of 6 VAS measures of fatigue, spinal and peripheral joint pain, tenderness and morning stiffness. Morning stiffness is measured in terms of both severity and duration. The mean score for the two questions on morning stiffness is calculated and summed with the scores for the other questions. The BASDAI score is obtained by converting the total value into a 0-10 scale. Below four is considered inactive disease and four and above is considered active disease.
Measured: 6 weeks after the start of rehabilitation
Bath Ankylosing Spondylitis Functional Index (BASFI)
It is a quick, easy-to-administer functional index consisting of ten items developed to assess the functional status of patients. The total BASFI score is evaluated between 0-10.
Measured: a day before rehabilitation
Bath Ankylosing Spondylitis Functional Index (BASFI)
It is a quick, easy-to-administer functional index consisting of ten items developed to assess the functional status of patients. The total BASFI score is evaluated between 0-10.
Measured: 6 weeks after the start of rehabilitation
Bath Ankylosing Spondylitis Metrology Index (BASMI)
It is used to measure the level of spinal mobility of patients. The higher the BASMI score, the more severe the patient's limitation of movement.
Measured: a day before rehabilitation
Bath Ankylosing Spondylitis Metrology Index (BASMI)
It is used to measure the level of spinal mobility of patients. The higher the BASMI score, the more severe the patient's limitation of movement.
Measured: 6 weeks after the start of rehabilitation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2024
- Study start1 Jan 2024 (estimated)
- Primary completion1 Jul 2025 (estimated)
- Study completion1 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ankylosing SpondylitisStudies 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
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hakan Alkan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Hakan Alkan, Pamukkale University
- Investigators
- Hakan Alkan, Study director, Pamukkale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06198985
- Sponsor's protocol ID
- PamukkaleU-Karaköseli-002
- Status last verified
- Dec 2023
- First submitted
- 27 Dec 2023
- Last updated
- 10 Jan 2024
- Results posted
- 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 10 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Dynamic Balance Exercises Added to Current Medical Treatment on Balance in Patients With Ankylosing Spondylitis.
- ClinicalTrials.gov ID
- NCT06198985
- Acronym / sponsor ID
- PamukkaleU-Karaköseli-002
- Conditions
- Ankylosing Spondylitis
- Keywords
- Tecnobody, Ankylosing spondylitis, Balance
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Hakan AlkanUniversity, hospital or other
- Study start
- 1 Jan 2024 (estimated)
- Primary completion
- 1 Jul 2025 (estimated)
- Study completion
- 1 Jul 2025 (estimated)
- First posted
- 10 Jan 2024 (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 investigate the effect of dynamic balance exercises added to current medical treatment on balance in patients with ankylosing spondylitis.
Detailed description
The study was planned as a randomized controlled study. Forty participants with a clinically confirmed diagnosis of AS according to ASAS criteria will be recruited from the PAU Department of Physical Medicine and Rehabilitation (PMR). These participants who meet the inclusion and exclusion criteria will be randomly divided into 2 groups.
The trial will be carried out at Pamukkale University Department of Physical Medicine and Rehabilitation between January 2024 and July 2025. The local ethics committee approved the study. All participants will be informed about the purpose and content of the study and will sign written consent to participate in the study.
Participant's age, gender, body mass index, education, occupation, medications, duration of diagnosis, comorbidity, functional status and pain will be questioned and recorded.
Group1: Group receiving dynamic balance exercise with tecnobody prokin 252 balance device added to current medical treatment (Intervention group) The first group will be given dynamic balance exercises with the tecnobody prokin 252 device and participants will continue their current medical treatment. These dynamic balance exercises will be performed in 3 days a week for 6 weeks. Each exercise will last 30 minutes. It will take 18 sessions in total. These exercises include 14 balance exercise movements performed on tecnobody prokin 252 balance device (manufactured in Italy).
Group 2: Group receiving current medical treatment (control group) Participants in this group will receive only current medical treatment. Care will be taken not to change the medical treatments of the participants during the study.
All participants will be evaluated with the following evaluation parameters before the treatment and at the end of 6 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dynamic balance exercise with tecnobody prokin 252 balance device added to current medical treatment | Experimental | Procedure: Dynamic balance exercise with tecnobody prokin 252 balance deviceDynamic balance exercises: The treatment will be performed in 3 days a week for 6 weeks. Each exercise will last 30 minutes. It will take 18 sessions in total. These exercises include 14 balance exercise movements performed on tecnobody prokin 252 balance device. |
| Group receiving current medical treatment | No intervention | –Participants in this group will receive only current medical treatment. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Participants aged 18 to 65 years with a clinical diagnosis of ankylosing spondylitis according to ASAS criteria
- To have the ability to give written informed consent
- Having the ability to understand procedures
Key exclusion criteria (6 listed)
- Visual and vestibular system diseases that may affect balance
- Neurological or orthopedic diseases that may affect balance (Parkinson's disease, history of stroke, presence of knee or hip prosthesis, previous fracture sequelae, foot problems, etc.)
- Individuals with severe mental and sensory problems
- History of balance exercise and/or spine surgery in the last 6 months
- Pregnancy or breastfeeding
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 |
|---|---|---|
| Dynamic balance exercise with tecnobody prokin 252 balance deviceDynamic balance exercise with tecnobody prokin 252 balance device | Procedure or surgery | Dynamic balance exercise with tecnobody prokin 252 balance device added to current medical treatment |
Primary outcome
Dynamic balance measurements
Time frame: a day before rehabilitation
The TecnoBody Prokin 252 system was used to assess balance in the standing position for all participants. This equipment provides data on average track error and stability index.
Dynamic balance measurements
Time frame: 6 weeks after the start of rehabilitation
The TecnoBody Prokin 252 system was used to assess balance in the standing position for all participants. This equipment provides data on average track error and stability index.
8 secondary outcomes
ASQoL
Time frame: a day before rehabilitation
ASQoL
Time frame: 6 weeks after the start of rehabilitation
Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
Time frame: a day before rehabilitation
Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
Time frame: 6 weeks after the start of rehabilitation
Bath Ankylosing Spondylitis Functional Index (BASFI)
Time frame: a day before rehabilitation
Bath Ankylosing Spondylitis Functional Index (BASFI)
Time frame: 6 weeks after the start of rehabilitation
Bath Ankylosing Spondylitis Metrology Index (BASMI)
Time frame: a day before rehabilitation
Bath Ankylosing Spondylitis Metrology Index (BASMI)
Time frame: 6 weeks after the start of rehabilitation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2024.
- 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.
Hakan Alkan study director
Pamukkale University
Questions about this trial
What is this clinical trial studying?
A study testing Dynamic balance exercise with tecnobody prokin 252 balance device in people with Ankylosing Spondylitis, run by Hakan Alkan.
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 6 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 10 Jan 2024. 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?
Contact Esra Karaköseli (+905395765952, esra.karakoseli@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dynamic balance measurements (time frame: a day before rehabilitation). The study lists 2 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 10 Jan 2024.