- ICH GCP
- Register voor klinische proeven in de VS.
- Klinische proef 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.
Studie Overzicht
Toestand
Conditie
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Geschat)
Fase
- Niet toepasbaar
Contacten en locaties
Studiecontact
- Naam: Aliha Batool, Dpt
- Telefoonnummer: 03145967336
- E-mail: alihabatool006@gmail.com
Studie Locaties
-
-
-
Islamabad, Pakistan, 44000
- Postgraduation Lab of Riphah College of Rehabilitation & Allied Health Sciences , Riphah International University. Islamabad
-
Contact:
- Aliha Batool, Dpt
- Telefoonnummer: 03145967336
- E-mail: alihabatool006@gmail.com
-
Hoofdonderzoeker:
- Huma Riaz, PhD
-
-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
Accepteert gezonde vrijwilligers
Beschrijving
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.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Enkel
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: 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.
|
|
Experimenteel: 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
|
|
Actieve vergelijker: 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
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Change in Craniovertebral angle
Tijdsspanne: 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
Tijdsspanne: 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
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Change in Neck Disability Index Score
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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.
Tijdsspanne: 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
Tijdsspanne: 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
|
Andere uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Intervention Adherence Rate
Tijdsspanne: 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.
|
Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Hoofdonderzoeker: Huma Riaz, PhD, Riphah International University, Islamabad
Publicaties en nuttige links
Algemene publicaties
- 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.
Studie record data
Bestudeer belangrijke data
Studie start (Geschat)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Andere studie-ID-nummers
- Aliha Batool
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Beschrijving IPD-plan
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .