NCT04483648

Brief Summary

The aim of this study is to investigate the effectiveness of cervical stabilization exercises on cervical positioning error in spondyloarthritis patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
39

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2019

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

July 21, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 23, 2020

Completed
Last Updated

February 3, 2023

Status Verified

February 1, 2023

Enrollment Period

4 months

First QC Date

July 21, 2020

Last Update Submit

February 2, 2023

Conditions

Keywords

ArthritisExerciseProprioception

Outcome Measures

Primary Outcomes (1)

  • Change in Cervical Proprioception Accuracy

    Cervical position error method was used to determine the cervical proprioception accuracy. Cervical position error was evaluated in flexion, extension, rotation and lateral flexion directions and was calculated using a special formula. The results were analyzed as angles.

    At baseline and six weeks later

Study Arms (2)

Exercise Group

EXPERIMENTAL

A progressive home-based cervical stabilization exercise program was delivered by sending messages and video instructions via a freeware and cross-platform messaging service (WhatsApp Messenger) in a weekly basis.

Other: Exercise

Control Group

NO INTERVENTION

Patients in control group did not receive any exercise intervention.

Interventions

Home exercises were performed three times in a week for six weeks. Home exercises included range of motion exercises, coordination exercises and strengthening exercises. Repeats and durations of the exercises increased every week to provide progression.

Exercise Group

Eligibility Criteria

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

You may qualify if:

  • Being diagnosed as axial spondyloarthritis according to ASAS criteria
  • Being able to understand and follow the exercise commands
  • Willingness to participate in the study

You may not qualify if:

  • Trauma history related to cervical region
  • A completed ankylosis in cervical region
  • Surgery history related to cervical region
  • Any vestibular disorders
  • Upper extremity involvement other than axial spondyloarthritis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Izmir Katip Celebi University

Izmir, Turkey (Türkiye)

Location

Related Publications (7)

  • Sieper J, Braun J, Dougados M, Baeten D. Axial spondyloarthritis. Nat Rev Dis Primers. 2015 Jul 9;1:15013. doi: 10.1038/nrdp.2015.13.

    PMID: 27188328BACKGROUND
  • Swinkels A, Dolan P. Spinal position sense and disease progression in ankylosing spondylitis: a longitudinal study. Spine (Phila Pa 1976). 2004 Jun 1;29(11):1240-5. doi: 10.1097/00007632-200406010-00014.

    PMID: 15167664BACKGROUND
  • Roijezon U, Clark NC, Treleaven J. Proprioception in musculoskeletal rehabilitation. Part 1: Basic science and principles of assessment and clinical interventions. Man Ther. 2015 Jun;20(3):368-77. doi: 10.1016/j.math.2015.01.008. Epub 2015 Jan 29.

    PMID: 25703454BACKGROUND
  • Armstrong B, McNair P, Taylor D. Head and neck position sense. Sports Med. 2008;38(2):101-17. doi: 10.2165/00007256-200838020-00002.

    PMID: 18201114BACKGROUND
  • Treleaven J. Sensorimotor disturbances in neck disorders affecting postural stability, head and eye movement control--Part 2: case studies. Man Ther. 2008 Jun;13(3):266-75. doi: 10.1016/j.math.2007.11.002. Epub 2008 Jan 3.

    PMID: 18180194BACKGROUND
  • Alahmari K, Reddy RS, Silvian P, Ahmad I, Nagaraj V, Mahtab M. Intra- and inter-rater reliability of neutral head position and target head position tests in patients with and without neck pain. Braz J Phys Ther. 2017 Jul-Aug;21(4):259-267. doi: 10.1016/j.bjpt.2017.05.003. Epub 2017 May 19.

    PMID: 28558952BACKGROUND
  • Jull G, Falla D, Treleaven J, Hodges P, Vicenzino B. Retraining cervical joint position sense: the effect of two exercise regimes. J Orthop Res. 2007 Mar;25(3):404-12. doi: 10.1002/jor.20220.

    PMID: 17143898BACKGROUND

MeSH Terms

Conditions

SpondylarthritisArthritisMotor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

SpondylitisSpinal DiseasesBone DiseasesMusculoskeletal DiseasesJoint DiseasesBehavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Deniz Bayraktar, PT, PhD

    Izmir Katip Celebi University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

July 21, 2020

First Posted

July 23, 2020

Study Start

September 1, 2019

Primary Completion

December 31, 2019

Study Completion

December 31, 2019

Last Updated

February 3, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will share

Data will be sent upon a reasonable request.

Time Frame
December 2022 to December 2042
Access Criteria
Data will be sent for academical purposes (for conducting a meta-analysis or systematic review)

Locations