- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07602816
Comparative Effect of Virtual Reality and Core Stability Exercises in Patients With Non-specific Chronic Low Back Pain (core stability)
연구 개요
상세 설명
Non-specific low back pain (NSLBP) is a prevalent musculoskeletal disorder. (Maher et al., 2017). Globally, 60%-80% of adults' experience low back pain, with 10% developing chronic forms, of which 85% are classified as chronic nonspecific low back pain without a clear etiology. (Alsufiany et al.,2020)..Despite various treatment modalities, a significant number of individuals continue to experience pain, functional limitations, and psychological distress such as kinesiophobia.
Various strategies are employed to help improve range of motion, alleviate pain, and enhance the overall quality of life for individuals dealing with lower back pain (LBP). These strategies encompass therapeutic exercises, manual therapy techniques, educating patients on lifestyle modifications, managing medications, and utilizing modalities like cryotherapy, heat therapy, ultrasound, and electrical stimulation. (Rulewska et al., 2025). So, Physical therapies and exercises, psychological and social support, reducing strain during physical work, and lifestyle changes are commonly practiced to manage non-specific chronic low back pain (NSCLBP). (Kumari et al., 2024)
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
-
-
Giza Governorate
-
Giza, Giza Governorate, 이집트, 6892
- Rania Reda
-
-
참여기준
자격 기준
공부할 수 있는 나이
- 성인
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- Sixty-six patients with non-specific low back pain diagnosed by physician will be selected for the study from the outpatient clinic of faculty of physical therapy, October 6 university.
- Patients of both sex with age range from 20-45 years.
- Pain lasting for more than 12 weeks.
- Pain intensity score 2/10 or more on Visual Analog Scale (VAS).
- BMI ranged between 18.5 and 24.9 kg/m2.
Exclusion Criteria:
- Visual or cognitive impairments affecting VR participation.
- Pregnancy.
- specific LBP (Radiculopathy, spinal stenosis, spondylolisthesis, or recent spinal surgery.)
- neurological disorders,
- psychiatric disorders,
- physiotherapy during the last 6 months.
Exclusion Criteria:
-
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: group A: traditional physiotherapy
hot back, TENS, stretching exercise for Hamstring, Hip flexors, Back extensors and strengthening ex for back extensors and abdominal muscles each exercise.
|
hot back, TENS, stretching exercise for Hamstring, Hip flexors, Back extensors and strengthening ex for back extensors and abdominal muscles each exercise.
|
|
실험적: group B: receive traditional physiotherapy plus virtual reality.
Participants will engage in VR rehabilitation sessions, 3 sessions per week for 4 weeks using interactive balance and movement-based VR programs, the patient will performe the exercises using VR video gaming, two games were selected, one for each exercise set: Epic roller coaster and Fit x.
In addition to being enjoyable for most of the participants, both games require frequent head motions and quick direction changes which facilitate activation of the core muscles.
(Abdelraoufet al., 2020)
|
Participants will engage in VR rehabilitation sessions using interactive balance and movement-based VR programs using meta quest with android operating system and camera as a sensor technology, it includes VR headset,2 touch controllers, 2 AA batteries, silicone cover, glasses spacer, charging cable , power adapter
|
|
실험적: group C: receive traditional physiotherapy plus core stability exercise.
Traditional core exercises focused on deep trunk muscles, 3 sessions per week for 4 weeks, under therapist supervision. It includes both isotonic and isometric core ex, During the ISOM exercises, patients were instructed to hold the contraction for 8 to 15 seconds, followed by a 5-second rest between each of the 4 sets, The ISOT exercises were performed in 4 sets, with 6 to 12 repetitions in each set. Additionally, a 1-minute rest was applied between each movement. (Khaled et al., 2024). |
Traditional core exercises focused on deep trunk muscles, 3 sessions per week for 4 weeks, under therapist supervision. It includes both isotonic and isometric core ex, During the ISOM exercises, patients were instructed to hold the contraction for 8 to 15 seconds, followed by a 5-second rest between each of the 4 sets, The ISOT exercises were performed in 4 sets, with 6 to 12 repetitions in each set. Additionally, a 1-minute rest was applied between each movement. |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Oswestry Disability Index (ODI)
기간: 4 weeks
|
The questionnaire examines the level of disability in 10 everyday activities of daily living. Each item consists of 6 statements which are scored from 0 to 5. With 0 indicating the least disability and 5 the greatest then the total score is calculated as a percentage, with 0% indicating no disability and 100% indicating the highest level of disability, disability scores ranging from 0-19% indicate minimal disability, 20-39% indicate moderate disability,40-59% indicate severe disability, 60-79% indicate crippling disability, and scores ranging from 80-100% indicate people who are confined to bed. |
4 weeks
|
|
visual analogue scale (VAS)
기간: 4 weeks
|
Pain intensity Level will be measured using the VAS that consists of a 10-cm straight line with endpoints defining pain intensity. All patients will be asked to mark their pain level that corresponds to their pain intensity on the line between "0", representing "no pain", and "10", representing "the worst pain imaginable". The distance between "0" and the mark made by the patients was measured using a ruler; a higher score indicates greater pain intensity. |
4 weeks
|
|
Star excursion balance test (SEBT)
기간: 4 weeks
|
Leg length discrepancy will be measured before applying the (SEBT) for normalization of test results, SEBT will be accomplished while participants are standing on the dominant leg, and participants will be asked to reach as far as they could along a grid in the anterior, posteromedial, and posterolateral directions with the tip of the great toe of the non-stance limb.
Participant's hands held at the iliac crest during the test, If the individual touches heavily or comes to rest at the touch-down point, has to make contact with the ground with the reaching foot to maintain balance, or lifts or shifts any part of the foot of the stance limb during the trial, the trial is not considered complete.
|
4 weeks
|
|
BROM
기간: 4 weeks
|
The AROM was determined by BROM and done by calculating the difference between the angle recorded in the starting position and the angle recorded at the end position.
(Suriyaamarit et al., 2024) First step in measuring ROM is finding the reference points, which consisted of the base of the sacrum and the spinous process of thoracic spine level 12.
The base of the sacrum was located by drawing a line between the posterior superior iliac spine (PSIS) (the same level as the S2 spinous process) and counting up from the base of the sacrum.
The spinous process of thoracic spine level 12 was located by counting up six levels from the 1st reference point.
These two references were used to place the flexion/extension unit and the BROM R/L unit.
|
4 weeks
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Tampa Scale of Kinesiophobia (TSK)
기간: 4 weeks
|
is a self-report questionnaire, in its original form, the TSK is a 17 item assessment checklist.
It uses a 4-point Likert scale (Strongly Disagree-Disagree-Agree-Strongly Agree) with statements that have been later linked to the model of fear-avoidance, fear of work-related activities, fear of movement, and fear of re-injury.
The total score ranges from 17 to 68, with higher scores indicating greater levels of kinesiophobia.
(Lundberg et al., 2011) Scores above 37 suggest the presence of clinically significant kinesiophobia, while scores below 37 are considered to be within the normal range.
|
4 weeks
|
공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .