- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07763327
Effects of a Wearable Device ,Phone App and Exercise on Cervico-thoracic Posture in University Students.
Comparison of Wearable Device -Based , App- Based ,and Conventional Exercise Therapy for Cervico-Thoracic Postural Training in University Students.
연구 개요
상태
정황
상세 설명
Forward head posture(FHP) and thoracic kyphosis are increasingly prevalent among university students due to sustained flexed-neck postures during smartphone use, laptop-based study, and prolonged sitting. Chronic FHP alters the normal cervical lordotic curve, increases mechanical loading on cervical spine structures, and has been associated with muscular imbalance, cervicogenic pain , and headache.
Conventional postural correction exercise programs are well established, but adherence to postural correction outside of supervised sessions remains a key limitation. Students are typically unaware of their posture lapsing during daily activities such as studying, phone use and prolonged sitting and correction cues are usually absent outside the clinical or exercise setting.
Technology-assisted feedback systems have emerged as a potential solution to this adherence gap. Wearable biofeedback devices provide immediate, real-time correction cues when a threshold postural deviation is detected, theoretically reinforcing correct postural habits through continuous behavioral conditioning. App-based reminder systems, offers a scheduled, intermittent prompts rather than continuous monitoring , it is more practical and scalable given lower cost and no specialized hardware requirement.
This three arm, parallel group randomized controlled trial is designed to generate comparative evidence on the relative effectiveness of continuous biofeedback, scheduled reminders, and conventional exercise therapy alone, in order to inform evidence-based, resource-appropriate postural correction strategies for university and academic health settings.
The results of this trial are intended to directly inform clinical decision-making for physiotherapists and university wellness programs considering adoption of wearable or app-based postural correction tools. Should either technology-assisted approach demonstrate superiority over conventional exercise alone, this would support integration of low-cost, scalable postural feedback technology into standard student musculoskeletal health programs. Conversely, if outcomes are comparable across groups, this would support conventional supervised exercise as a sufficient, lower-cost first-line approach, without the added expense or complexity of technology-assisted feedback devices.
University students represent a population with high daily screen-time exposure and sedentary study behavior, making them broadly representative of the wider demographic at risk for posture-related cervical musculoskeletal strain seen in academic and early-career professional environments. Evidence generated from this population is expected to have relevance beyond the immediate study setting, informing postural health strategies applicable to similarly screen-intensive occupational and educational contexts.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Aliha Batool, Dpt
- 전화번호: 03145967336
- 이메일: alihabatool006@gmail.com
연구 장소
-
-
-
Islamabad, 파키스탄, 44000
- Postgraduation Lab of Riphah College of Rehabilitation & Allied Health Sciences , Riphah International University. Islamabad
-
연락하다:
- Aliha Batool, Dpt
- 전화번호: 03145967336
- 이메일: alihabatool006@gmail.com
-
수석 연구원:
- Huma Riaz, PhD
-
-
참여기준
자격 기준
공부할 수 있는 나이
- 성인
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- University students aged 18-30 years enrolled in a degree program at Riphah International University.
- Daily sitting duration ≥ 5 hours (academic and/or device-related activities).
- Presence of at least one observable postural deviation confirmed at baseline assessment: forward head posture (CVA < 50°), rounded shoulders (protracted shoulder distance in supine line), or thoracic kyphosis (> 40° via digital inclinometer).
- Smartphone ownership and basic digital literacy
Exclusion Criteria:
- History of spinal surgery, vertebral fracture, or major cervical/thoracic trauma within the past 12 months.
- Diagnosed neurological disorders affecting posture or motor control (e.g., Parkinson's disease, stroke, cervical dystonia).
- Structural spinal deformities requiring active medical or surgical management (e.g., scoliosis Cobb angle > 20°, Scheuermann's kyphosis).
- Current participation in physiotherapy, chiropractic treatment, or another structured posture correction program.
- Cardiovascular or pulmonary conditions contraindicating moderate-intensity exercise (e.g., uncontrolled hypertension, severe asthma).
- Skin conditions, open wounds, or allergies precluding safe use of the posture correction belt.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: Wearable Device + Exercise
Participants will receive a wearable biofeedback belt that provides real time vibration feedback upon postural deviation, in addition to the standardized cervicothoracic exercise program administered to all groups , over a 6 week intervention period
|
A wearable belt worn around the cervicothoracic region that detects postural deviation in real time and provide vibratory feedback to prompt immediate self-correction , used in conjunction with standardized exercise program.
|
|
실험적: App- based Reminder + Exercise
Participants will receive scheduled posture-check reminders via a smartphone application, in addition to the standardized cervicothoracic exercise program administered to all groups , over a 6 week intervention period.
|
A smartphone application that delivers scheduled reminders prompting participants to self-check and correct their posture throughout the day, used in conjunction with the standardized exercise program
|
|
활성 비교기: Conventional Exercise Therapy
Participants will receive the standardized cervicothoracic exercise program alone over a 6 week intervention period, without any wearable device or app based reminder.
|
A structured , supervised exercise program targeting cervicothoracic postural muscles , delivered without any wearable device or app based reminder
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Change in Craniovertebral angle
기간: baseline ,Mid treatment (4th week) , Post intervention (6th week) and follow up (12th week)
|
Degree of forward head posture measured via photogrammetry app, Calculated as angle between a horizontal line through C7 and a line to tragus of the ear.
Normal CVA is greater than 50 degrees.
|
baseline ,Mid treatment (4th week) , Post intervention (6th week) and follow up (12th week)
|
|
Thoracic Kyphosis Angle
기간: At Baseline , Mid treatment Intervention (4th week) , Post intervention (6th week) and follow up at 12 week
|
Degree of thoracic spinal curvature (T1 - T12) measured using a digital inclinometer.
Normal range 20 degree to 45 degree
|
At Baseline , Mid treatment Intervention (4th week) , Post intervention (6th week) and follow up at 12 week
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Change in Neck Disability Index Score
기간: At Baseline , Mid intervention (4th week) , Post Intervention (6th week ) and follow up at 12th week
|
10 item self report questionnaire assessing functional disability related neck pain .
Score converted to percentage ,higher score means greater disability.
Excellent test re test reliability ,ICC score of 0.91
|
At Baseline , Mid intervention (4th week) , Post Intervention (6th week ) and follow up at 12th week
|
|
Change in Neck and Upper Back Pain Intensity
기간: At Baseline , Mid intervention (4th week) , Post Intervention (6th week) and follow up at 12 week.
|
Subjective pain intensity rated on NPRS ,an 11-point scale (0 = no pain, 10 = worst pain imaginable).The test retest reliability range from 0.67 - 0.96
|
At Baseline , Mid intervention (4th week) , Post Intervention (6th week) and follow up at 12 week.
|
|
Change in Shoulder Protraction Distance
기간: At Baseline , Mid intervention (4th week) , Post Intervention (6th week) and follow up at 12 week.
|
Horizontal distance from the posterolateral acromion to a table surface, measured with participant supine (Table Top Test).
Distance greater than 2.6 cm indicates protracted shoulder posture.
|
At Baseline , Mid intervention (4th week) , Post Intervention (6th week) and follow up at 12 week.
|
|
Change in Postural Awareness Scale Score.
기간: At Baseline , Mid intervention (4th week) , Post Intervention (6th week) and follow up at 12 week
|
12-item validated self-report questionnaire assessing postural awareness and body perception, scored 12-60.
Higher scores indicate better awareness.
The test retest reliability value (ICC) is 0.75-0.83
|
At Baseline , Mid intervention (4th week) , Post Intervention (6th week) and follow up at 12 week
|
|
Change in Deep Neck Flexor Muscle Endurance
기간: At Baseline , Mid intervention (4th week) , Post Intervention (6th week) and follow up at 12 week
|
Endurance capacity of deep cervical flexor muscles (longus colli, longus capitis), measured in seconds using the Deep Neck Flexor Endurance Test.
With good Intra rater Reliability (ICC= 0.81 - 0.94)
|
At Baseline , Mid intervention (4th week) , Post Intervention (6th week) and follow up at 12 week
|
기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Intervention Adherence Rate
기간: At Baseline , Mid intervention (4th week) , Post Intervention (6th week) and follow up at 12 week.
|
Session attendance, exercise completion rate, and app/wearable device usage recorded via attendance registers, digital app logs, and wearable device session records, depending on group assignment.
|
At Baseline , Mid intervention (4th week) , Post Intervention (6th week) and follow up at 12 week.
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Huma Riaz, PhD, Riphah International University, Islamabad
간행물 및 유용한 링크
일반 간행물
- Singla D, Veqar Z. Association Between Forward Head, Rounded Shoulders, and Increased Thoracic Kyphosis: A Review of the Literature. J Chiropr Med. 2017 Sep;16(3):220-229. doi: 10.1016/j.jcm.2017.03.004. Epub 2017 Sep 28.
- Nilmart P, Sichuai A, Chedang A, Goontharo C, Janjamsai N. Internet-Based Telerehabilitation Versus in-Person Therapeutic Exercises in Young Adult Females With Chronic Neck Pain and Forward Head Posture: Randomized Controlled Trial. JMIR Rehabil Assist Technol. 2025 Jul 25;12:e74979. doi: 10.2196/74979.
- Anwar S, Zahid J, Alexe CI, Ghazi A, Mares G, Sheraz Z, Sanchez-Gomez R, Perveen W, Alexe DI, Gasibat Q. Effects of Myofascial Release Technique along with Cognitive Behavior Therapy in University Students with Chronic Neck Pain and Forward Head Posture: A Randomized Clinical Trial. Behav Sci (Basel). 2024 Mar 4;14(3):205. doi: 10.3390/bs14030205.
- Kuo YL, Huang KY, Kao CY, Tsai YJ. Sitting Posture during Prolonged Computer Typing with and without a Wearable Biofeedback Sensor. Int J Environ Res Public Health. 2021 May 19;18(10):5430. doi: 10.3390/ijerph18105430.
- Titcomb DA, Melton BF, Miyashita T, Bland HW. The Effects of Postural Education or Corrective Exercise on the Craniovertebral Angle in Young Adults with Forward Head Posture: A Randomized Controlled Trial. Int J Exerc Sci. 2023 Aug 1;16(1):954-973. doi: 10.70252/PYPQ8483. eCollection 2023.
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
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 연구와 관련된 용어
기타 연구 ID 번호
- Aliha Batool
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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. .