NCT05786118

Brief Summary

It has been reported that gait coordination changes in patients with chronic low back pain, walking slower, taking shorter steps and having asymmetrical stride lengths compared to their healthy peers. In addition to many factor cause gait dysfunction, sacroiliac joint dysfunction might be one of reason of these problems. A study examining the effects of sacroiliac joint dysfunction on gait and disability in individuals with chronic low back pain has not been found in the literature. Therefore, the aim of this study is to evaluate the gait parameters and disability of individuals with chronic low back pain and to reveal their relationship with sacroiliac joint dysfunction.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
61

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2023

Shorter than P25 for all trials

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

First Submitted

Initial submission to the registry

March 14, 2023

Completed
7 days until next milestone

Study Start

First participant enrolled

March 21, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 27, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2023

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2023

Completed
Last Updated

November 29, 2023

Status Verified

November 1, 2023

Enrollment Period

2 months

First QC Date

March 14, 2023

Last Update Submit

November 28, 2023

Conditions

Outcome Measures

Primary Outcomes (8)

  • Gate speed of time-distance gait parameters

    Gate speed will be evaluated using with gait platform. The software gives the outcome as km/h.

    1 minutes

  • Step length of time-distance gait parameters

    Step lengt will be evaluated using with gait platform. The software gives the outcome as cm and calcules for each lower extremity.

    1 minutes

  • Stride length of time-distance gait parameters

    Stride length will be evaluated using with gait platform.The software gives the outcome as cm.

    1 minutes

  • Step time of time-distance gait parameters

    Step time will be evaluated using with gait platform.The software gives the outcome as sec and calcules for each lower extremity.

    1 minutes

  • Stride time of time-distance gait parameters

    Stride time will be evaluated using with gait platform.The software gives the outcome as sec and calcules for each lower extremity.

    1 minutes

  • Cadance of time-distance gait parameters

    Cadance time will be evaluated using with gait platform.The software gives the outcome as steps/min.

    1 minutes

  • Center of Pressure path length of balance parameters

    Center of Pressure path length will be evaluated using with gait platform. The software gives the outcome as mm.

    2 minutes

  • Ellipse area of balance parameters

    Ellipse area will be evaluated using with gait platform. The software gives the outcome as mm2.

    1 minutes

Secondary Outcomes (2)

  • Oswestry Disability Index

    5 minutes

  • Numeric Pain Rating Scale

    1 minutes

Study Arms (2)

SIJ Group

Individuals with sacroiliac joint dysfunction: Participants will be grouped as positive sacroiliac joint dysfunction according to Laslett's algorithm using provocation tests to detect sacroiliac joint dysfunction.

Other: No intervention

Control Group

Individuals with no sacroiliac joint dysfunction: Individuals with sacroiliac joint dysfunction: Participants will be grouped as negative sacroiliac joint dysfunction according to Laslett's algorithm using provocation tests to detect sacroiliac joint dysfunction.

Other: No intervention

Interventions

There is no intervention in this study

Control GroupSIJ Group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Participants who directly presented to the Physical Therapy Department of Kutahya Health Sciences University Hospital during the study period with persistent low back pain, will be screened for eligibility by an independent physician (H.H.G.)

You may qualify if:

  • Volunteered to participate in the study.
  • Patients with 18-65 years
  • Low back pain for at least 3 months,
  • Reported pain severity of 2 or greater according to the numeric pain rating scale

You may not qualify if:

  • Previous spine or lower extremity surgery
  • Pregnancy
  • Severe hypermobility syndromes
  • Severe osteoporosis
  • Spondyloarthropathies
  • Spondylolisthesis
  • Systemic inflammatory diseases
  • Any neurological disorder that affects balance and gait

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kutahya Health Sciences University Evliya Celebi Hospital Physical Therapy and Rehabilitation Department

Kütahya, 43100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Gait Disorders, Neurologic

Condition Hierarchy (Ancestors)

Neurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Ismail S [isaracoglu], P.hD.

    Kutahya Health Sciences University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Target Duration
2 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

March 14, 2023

First Posted

March 27, 2023

Study Start

March 21, 2023

Primary Completion

May 30, 2023

Study Completion

September 30, 2023

Last Updated

November 29, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations