NCT06405802

Brief Summary

Although the concepts of telemedicine and tele-rehabilitation have been frequently emphasized in recent years, the evaluation part remains inadequate. There is no study investigating remote technology-based balance, mobility and strength assessments in patients with low back pain. Therefore, the aim of the study is; It is the examination of face-to-face and technology-based remote balance, mobility and strength assessment in patients with low back pain.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable low-back-pain

Timeline
Completed

Started Aug 2022

Typical duration for not_applicable low-back-pain

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

August 10, 2022

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 10, 2024

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 4, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 8, 2024

Completed
Last Updated

May 10, 2024

Status Verified

May 1, 2024

Enrollment Period

1.4 years

First QC Date

May 4, 2024

Last Update Submit

May 8, 2024

Conditions

Keywords

tele-evaluationLow Back PainFace to face evaluation

Outcome Measures

Primary Outcomes (4)

  • Oswestry disability index

    The Oswestry Disability Questionnaire is a self-assessment tool that allows patients to assess the various constraints encountered during their daily activities. Utilizing a comprehensive scoring system ranging from 0 to 100, higher scores on the questionnaire indicate a heightened level of disability.

    An evaluation was made once at the beginning of the research.

  • Timed-up and go test

    Simmonds et al. (1998) researched to ascertain the reliability of this test in swiftly and practically demonstrating functional status among patients with low back pain. The assessment involves the patient transitioning from seated to standing, traversing a 3-meter-long path, executing a turn, and returning to a seated posture. The duration of this performance is meticulously recorded

    An evaluation was made once at the beginning of the research.

  • Single Leg Stance Test

    This examination, focused on assessing balance and static standing capacity, also offers insights into individuals' susceptibility to falls. During the evaluation process, participants were instructed to elevate their foot on their unaffected side and sustain this position for as long as possible. The termination of the test was determined by either contact of the free leg with the ground or a notable increase in arm oscillations

    An evaluation was made once at the beginning of the research.

  • Thirty Second Chair Stand Test

    The Thirty Second Chair Stand Test is a validated and reliable assessment modality to gauge lower extremity strength (7). During the administration of this test, participants were tasked with repeatedly rising from and sitting back down on a chair within a 30-second timeframe, with the total number of repetitions recorded. A chair with a standardized sitting height of 43 cm was utilized for the assessments, and for safety precautions, it was positioned against a wall.

    An evaluation was made once at the beginning of the research.

Study Arms (2)

Tele-evulation

EXPERIMENTAL

Face-to-face tests will be recorded by video and re-evaluation will be made over the video by another person who has not performed the tests. During technology-based remote evaluations, the evaluator will monitor the tests simultaneously via video. During technology-based remote evaluations, video recording will be made and a re-evaluation will be made over the video by another person who has not performed the tests.

Other: Tele-evaluation

Face-to face evulation

EXPERIMENTAL

Face-to-face applications were carried out with individuals with low back pain who came to Bozyaka Training and Research Hospital and volunteered to participate in the study.

Other: Tele-evaluation

Interventions

Evaluations will be carried out in two different environments: face-to-face in the clinic and remotely using technology. Face-to-face applications and remote evaluations using technology will be repeated once. Face-to-face applications will be made to individuals with low back pain who come to Bozyaka Training and Research Hospital and volunteer to participate in the study. Then, patients will be video-called at home, asked to perform the tests twice as taught, and recorded as a video.

Also known as: Face to face evaluation
Face-to face evulationTele-evulation

Eligibility Criteria

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

You may qualify if:

  • Those over the age of 18
  • People who can read and write
  • Patients who have not undergone surgery
  • Those whose body mass index is less than 30 m2/kg
  • Volunteering to participate in the study

You may not qualify if:

  • Patients who underwent surgery due to disc herniation
  • Having any spinal pathology
  • Having an uncontrolled neurological and metabolic disease
  • Having a spinal deformity such as scoliosis or kyphosis
  • Those with serious orthopedic, vascular, neurological or psychiatric problems that affect balance

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Izmir Kâtip Çelebi University Vocational School of Health Services

Izmir, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Muhammed Zahid Uz, Master

    Izmir Katip Çelebi University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

May 4, 2024

First Posted

May 8, 2024

Study Start

August 10, 2022

Primary Completion

January 15, 2024

Study Completion

March 10, 2024

Last Updated

May 10, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

We aim to turn our research into an article and publish it in scientific journals.

Locations