Clinical trial NCT06198985: The Effect of Dynamic Balance Exercises on Balance in Patients With Ankylosing Spondylitis.
Official title: The Effect of Dynamic Balance Exercises Added to Current Medical Treatment on Balance in Patients With Ankylosing Spondylitis.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Ankylosing Spondylitis
Keywords: Tecnobody
Ankylosing spondylitis
Balance
Lead sponsor: Pamukkale University
Sponsor class: OTHER
First posted: 2024-01-10
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

All participants will be evaluated with the following evaluation parameters before the treatment and at the end of 6 weeks.

Eligibility criteria: 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

Primary outcomes:
measure: Dynamic balance measurements
timeFrame: a day before rehabilitation
measure: Dynamic balance measurements
timeFrame: 6 weeks after the start of rehabilitation
Secondary outcomes:
measure: ASQoL
timeFrame: a day before rehabilitation
measure: ASQoL
timeFrame: 6 weeks after the start of rehabilitation
measure: Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
timeFrame: a day before rehabilitation
measure: Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
timeFrame: 6 weeks after the start of rehabilitation
measure: Bath Ankylosing Spondylitis Functional Index (BASFI)
timeFrame: a day before rehabilitation
measure: Bath Ankylosing Spondylitis Functional Index (BASFI)
timeFrame: 6 weeks after the start of rehabilitation
measure: Bath Ankylosing Spondylitis Metrology Index (BASMI)
timeFrame: a day before rehabilitation
measure: Bath Ankylosing Spondylitis Metrology Index (BASMI)
timeFrame: 6 weeks after the start of rehabilitation
Other outcomes:
Locations:
Study officials:
affiliation: Pamukkale University
name: Hakan Alkan
role: STUDY_DIRECTOR
References: