NCT06079580

Brief Summary

It is seen that patients with Lumbar Spinal Stenosis often experience balance problems. Although the relationship between muscle thickness and balance has been explained, there are insufficient studies investigating the relationship between balance problems and muscle thickness in patients with LSS. In addition, no study has been found comparing the difference in muscle thickness and cross-sectional area in LSS patients with poor and normal balance. In addition, in LSS, pain, disability and fear of falling in balance disorders are nor clear. The aim of our study is to examine the relationship between balance and biopsychosocial factors that can affect it.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
64

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 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

Study Start

First participant enrolled

September 1, 2023

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 6, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 12, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2024

Completed
Last Updated

April 25, 2024

Status Verified

April 1, 2024

Enrollment Period

4 months

First QC Date

October 6, 2023

Last Update Submit

April 24, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Static balance

    The static balance of the patients will be evaluated with the 'Single Leg Standing Balance Test'.

    First Day

Secondary Outcomes (6)

  • Dynamic balance

    First day

  • Pain Severity

    First day

  • Disability

    First day

  • Faling

    First day

  • Muscle thickness

    First day

  • +1 more secondary outcomes

Study Arms (2)

Patients with Lumbar spinal stenosis with balance disorders

According to the single-leg balance test, patients who maintain static balance for less than 10 seconds will be grouped as having impaired balance.

Patients with Lumbar spinal stenosis with normal balance

According to the single-leg balance test, patients who maintain their static balance for more than 10 seconds will be grouped as having normal balance.

Eligibility Criteria

Age45 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with Lumbar Spinal Stenosis

You may qualify if:

  • Diagnosed with L4/5 lumbar spinal stenosis by MRI,
  • Patients who can stand independently
  • Volunteering to participate in the study

You may not qualify if:

  • Patients who did not agree to participate in the study,
  • Having a history of serious neurological diseases such as Parkinson's, hemiplegia, multiple sclerosis,
  • Having undergone a surgical operation on the lumbar region within the last year,
  • Having severe joint disorders in the lower extremities,
  • Having malignancy in the spine,
  • Having had an operation on the lower extremity,
  • Having vision and/or vestibular system problems,
  • Those who do not cooperate well

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Karabuk University, Physiotherapy and Rehabilitation Application and Research Center

Karabük, Turkey (Türkiye)

Location

Related Publications (3)

  • Farrokhi MR, Haghnegahdar A, Rezaee H, Sharifi Rad MR. Spinal sagittal balance and spinopelvic parameters in patients with degenerative lumbar spinal stenosis; a comparative study. Clin Neurol Neurosurg. 2016 Dec;151:136-141. doi: 10.1016/j.clineuro.2016.10.020. Epub 2016 Oct 31.

    PMID: 27842292BACKGROUND
  • Thornes E, Robinson HS, Vollestad NK. Dynamic balance in patients with degenerative lumbar spinal stenosis; a cross-sectional study. BMC Musculoskelet Disord. 2018 Jun 15;19(1):192. doi: 10.1186/s12891-018-2111-x.

    PMID: 29902972BACKGROUND
  • Ito T, Sakai Y, Yamazaki K, Oikawa M, Morita Y. Relationship Between L4/5 Lumbar Multifidus Cross-Sectional Area Ratio and Fall Risk in Older Adults with Lumbar Spinal Stenosis: A Retrospective Study. Geriatrics (Basel). 2019 Jun 21;4(2):38. doi: 10.3390/geriatrics4020038.

    PMID: 31234297BACKGROUND

MeSH Terms

Conditions

Spinal Stenosis

Condition Hierarchy (Ancestors)

Spinal DiseasesBone DiseasesMusculoskeletal Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Study director, PT, MsC, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation

Study Record Dates

First Submitted

October 6, 2023

First Posted

October 12, 2023

Study Start

September 1, 2023

Primary Completion

December 15, 2023

Study Completion

January 15, 2024

Last Updated

April 25, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations