- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06405802
Comparison of Technology-assisted and Face-to-face Assessment in Patients With Low Back Pain
May 8, 2024 updated by: Muhammed Zahid Uz, Izmir Katip Celebi University
Face-to-Face and Technology-Used Balance, Mobility and Strength Assessment in Patients With Low Back Pain
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
50
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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İzmir, Turkey
- Izmir Kâtip Çelebi University Vocational School of Health Services
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion criteria
- 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
Exclusion criteria
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Tele-evulation
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.
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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.
Other Names:
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Experimental: Face-to face evulation
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.
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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.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Oswestry disability index
Time Frame: An evaluation was made once at the beginning of the research.
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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.
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An evaluation was made once at the beginning of the research.
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Timed-up and go test
Time Frame: An evaluation was made once at the beginning of the research.
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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
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An evaluation was made once at the beginning of the research.
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Single Leg Stance Test
Time Frame: An evaluation was made once at the beginning of the research.
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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
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An evaluation was made once at the beginning of the research.
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Thirty Second Chair Stand Test
Time Frame: An evaluation was made once at the beginning of the research.
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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.
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An evaluation was made once at the beginning of the research.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Muhammed Zahid Uz, Master, Izmir Katip Celebi University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 10, 2022
Primary Completion (Actual)
January 15, 2024
Study Completion (Actual)
March 10, 2024
Study Registration Dates
First Submitted
May 4, 2024
First Submitted That Met QC Criteria
May 7, 2024
First Posted (Actual)
May 8, 2024
Study Record Updates
Last Update Posted (Actual)
May 10, 2024
Last Update Submitted That Met QC Criteria
May 8, 2024
Last Verified
May 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2022/142
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
We aim to turn our research into an article and publish it in scientific journals.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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