The Effect of Dynamic Balance Exercises on Balance in Patients With Ankylosing Spondylitis.

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Ankylosing Spondylitis
• Intervention / Treatment: Procedure: Dynamic balance exercise with tecnobody prokin 252 balance device

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 Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Esra Karaköseli; Phone Number: +905395765952; Email: esra.karakoseli@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dynamic balance exercise with tecnobody prokin 252 balance device added to current medical treatment; 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.	Procedure: Dynamic balance exercise with tecnobody prokin 252 balance device; Dynamic balance exercise with tecnobody prokin 252 balance device
No Intervention: Group receiving current medical treatment; Participants in this group will receive only current medical treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	6 weeks after the start of rehabilitation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	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.	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.	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.	6 weeks after the start of rehabilitation

Collaborators and Investigators

• Sponsor: Hakan Alkan
• Investigators: Study Director: Hakan Alkan, Pamukkale University

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2024
• Primary Completion (Estimated): July 1, 2025
• Study Completion (Estimated): July 1, 2025

Study Registration Dates

• First Submitted: December 27, 2023
• First Submitted That Met QC Criteria: December 27, 2023
• First Posted (Actual): January 10, 2024

Study Record Updates

• Last Update Posted (Actual): January 10, 2024
• Last Update Submitted That Met QC Criteria: December 27, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Balance; Ankylosing spondylitis; Tecnobody
• Additional Relevant MeSH Terms: Infections; Joint Diseases; Musculoskeletal Diseases; Arthritis; Spinal Diseases; Bone Diseases; Spondylarthropathies; Bone Diseases, Infectious; Ankylosis; Axial Spondyloarthritis; Spondylitis; Spondylarthritis; Spondylitis, Ankylosing
• Other Study ID Numbers: PamukkaleU-Karaköseli-002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No