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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06405802
Other study ID # 2022/142
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 10, 2022
Est. completion date March 10, 2024

Study information

Verified date May 2024
Source Izmir Katip Celebi University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 50
Est. completion date March 10, 2024
Est. primary completion date January 15, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Tele-evaluation
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.

Locations

Country Name City State
Turkey Izmir Kâtip Çelebi University Vocational School of Health Services Izmir

Sponsors (3)

Lead Sponsor Collaborator
Izmir Katip Celebi University Bozyaka Training and Research Hospital, Dokuz Eylul University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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.
Primary 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.
Primary 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.
Primary 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.
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