NCT06198985

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2024

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 27, 2023

Completed
5 days until next milestone

Study Start

First participant enrolled

January 1, 2024

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 10, 2024

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2025

Completed
Last Updated

January 10, 2024

Status Verified

December 1, 2023

Enrollment Period

1.5 years

First QC Date

December 27, 2023

Last Update Submit

December 27, 2023

Conditions

Keywords

TecnobodyAnkylosing spondylitisBalance

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (8)

  • ASQoL

    a day before rehabilitation

  • ASQoL

    6 weeks after the start of rehabilitation

  • Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)

    a day before rehabilitation

  • Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)

    6 weeks after the start of rehabilitation

  • Bath Ankylosing Spondylitis Functional Index (BASFI)

    a day before rehabilitation

  • +3 more secondary outcomes

Study Arms (2)

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.

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.

Interventions

Dynamic balance exercise with tecnobody prokin 252 balance device

Dynamic balance exercise with tecnobody prokin 252 balance device added to current medical treatment

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Spondylitis, Ankylosing

Condition Hierarchy (Ancestors)

Axial SpondyloarthritisSpondylarthropathiesSpondylarthritisSpondylitisSpinal DiseasesBone DiseasesMusculoskeletal DiseasesAnkylosisJoint DiseasesArthritis

Study Officials

  • Hakan Alkan

    Pamukkale University

    STUDY DIRECTOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

December 27, 2023

First Posted

January 10, 2024

Study Start

January 1, 2024

Primary Completion

July 1, 2025

Study Completion

July 1, 2025

Last Updated

January 10, 2024

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share