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

NCT ID: NCT06198985

Last Updated: 2024-01-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-01

Study Completion Date

2025-07-01

Brief Summary

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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

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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

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Ankylosing Spondylitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Dynamic balance exercise with tecnobody prokin 252 balance device

Intervention Type PROCEDURE

Dynamic balance exercise with tecnobody prokin 252 balance device

Group receiving current medical treatment

Participants in this group will receive only current medical treatment.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Dynamic balance exercise with tecnobody prokin 252 balance device

Dynamic balance exercise with tecnobody prokin 252 balance device

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hakan Alkan

OTHER

Sponsor Role lead

Responsible Party

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Hakan Alkan

Clinical Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Hakan Alkan

Role: STUDY_DIRECTOR

Pamukkale University

Central Contacts

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Esra Karaköseli

Role: CONTACT

+905395765952

Other Identifiers

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PamukkaleU-Karaköseli-002

Identifier Type: -

Identifier Source: org_study_id

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