The Effect of Dynamic Balance Exercises Added to Current Medical Treatment on Balance in Patients With Ankylosing Spondylitis.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Hakan Alkan
- Enrollment
- 40
- Primary Endpoint
- Dynamic balance measurements
Study Overview
Brief 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.
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Bath Ankylosing Spondylitis Metrology Index (BASMI)(6 weeks after the start of rehabilitation)
- ASQoL(6 weeks after the start of rehabilitation)
- Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)(6 weeks after the start of rehabilitation)
- Bath Ankylosing Spondylitis Functional Index (BASFI)(6 weeks after the start of rehabilitation)
Investigators
Hakan Alkan
Clinical Professor
Pamukkale University