- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07693634
Tele-rehabilitation for Recreational Athletes With Patellofemoral Pain Syndrome
Usability and Effectiveness of Tele-rehabilitation Interventions on Pain, Range of Motion and Quality of Life in Recreational Athletes With Patellofemoral Pain Syndrome: A Randomized Clinical Trial
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Detailní popis
Background:
Patellofemoral Pain Syndrome (PFPS) is one of the most common causes of anterior knee pain in recreational athletes, often resulting from overuse, muscle weakness, and abnormal patellar tracking. It causes pain during activities such as running, squatting, stair climbing, and jumping, leading to reduced physical performance and quality of life. Exercise-based physiotherapy is the recommended treatment; however, regular attendance at rehabilitation clinics may be limited by time, travel, cost, and accessibility .Tele-rehabilitation has emerged as an effective alternative by delivering supervised exercise programs through digital platforms, allowing patients to receive treatment remotely. Previous studies have demonstrated that tele-rehabilitation can reduce pain and improve function in various musculoskeletal conditions while enhancing accessibility and patient satisfaction. However, evidence regarding its usability and effectiveness in recreational athletes with PFPS remains limited. Therefore, this study aims to evaluate the effects of tele-rehabilitation on pain, knee range of motion, quality of life, and user satisfaction in recreational athletes with PFPS, providing evidence for its use as a practical alternative to conventional physiotherapy.
Objectives: The objective of this study is to evaluate the usability and effectiveness of tele-rehabilitation in recreational athletes with Patellofemoral Pain Syndrome (PFPS). Specifically, the study aims to determine the effect of tele-rehabilitation on pain intensity, knee range of motion, and quality of life, and to compare these outcomes with those of conventional physiotherapy. Pain intensity will be assessed using the Numerical Pain Rating Scale (NPRS), knee range of motion will be measured with a universal goniometer, quality of life and knee-related function will be evaluated using the Knee Injury and Osteoarthritis Outcome Score (KOOS), and the usability and patient satisfaction of the tele-rehabilitation platform will be assessed using the Telehealth Usability Questionnaire (TUQ).
Study Design: Randomized, parallel-group, assessor-blind clinical trial.
Setting: The University of Faisalabad ( Amin Campus and Saleem Campus)and The University of Agriculture , Faisalabad, Punjab, Pakistan.
Sample Size: Twenty-six participants (13 per group). Sample size calculated based on effect sizes from previous similar studies (Nilmart et al., 2024b) , with 10% allowance for attrition (n=2).
Eligibility Criteria :Eligible participants should be recreational athletes aged 18-35 years, both males and females. Participants must have experienced anterior or retro-patellar knee pain for at least one month, with a pain intensity of 3-6 on the Numerical Pain Rating Scale (NPRS), aggravated by activities such as squatting, stair climbing or descending, prolonged sitting, or knee flexion. A positive Patellar Apprehension Test, the ability to access a smartphone and the internet for tele-rehabilitation, and eligibility confirmed using the Kujala Anterior Knee Pain Questionnaire will also be required. Participants will be excluded if they have knee meniscal, ligamentous, or tendon injuries, knee effusion, patellar dislocation or subluxation, fractures, recent knee surgery, neuromuscular, metabolic, or rheumatologic disorders, or if they are unwilling or unable to provide informed consent.
Intervention Protocol:
Participants are randomly allocated into two groups: a conventional physiotherapy group (Group A) and a tele-rehabilitation group (Group B). Both groups follow the same standardized, evidence-based exercise program for 4 weeks, with two supervised sessions per week. The exercise protocol include stretching, strengthening, functional, and balance exercises, with the only difference being the mode of delivery.
Group A (Conventional Physiotherapy): Participants attend face-to-face physiotherapy sessions in the outpatient department under the direct supervision of a physiotherapist. The therapist will instruct, supervise, and progressively modify the exercises throughout the intervention period.
Group B (Tele-rehabilitation): Participants perform the same exercise program remotely using the Physitrack® mobile application. During the initial session, the physiotherapist install the application, educate participants on its use, and prescribe individualized exercises. Participants receive instructional videos, exercise reminders, and weekly progress updates through the application. The physiotherapist monitor adherence remotely, provide weekly telephone or video-call consultations, and adjust the exercise program according to each participant's progress.
The intervention should delivere in two phases. Weeks 1-2 focus on flexibility and early strengthening exercises, including hamstring, quadriceps, iliotibial band, and gastrocnemius stretching (2 sets of 30-second holds), quadriceps setting, seated knee extension, side-lying hip abduction (2 sets of 10 repetitions), and mini-squats (0-45° knee flexion; 2 sets of 10 repetitions). Weeks 3-4 emphasize progressive strengthening and neuromuscular control through side-lying hip abduction, prone hip extension, squats (45-60°), lunges (45°) (2 sets of 10-12 repetitions), and balance exercises including single-leg stance and single-leg heel raises (3 sets of 8-10 repetitions). Outcome measures would be recorded at baseline and at the completion of the 4-week intervention.
Outcome Measures:
Outcome measures would be assessed at two time points: pre-intervention (baseline, before the commencement of the 4-week rehabilitation program) and post-intervention (at the completion of the 4-week intervention). Pain intensity will be evaluated using the Numerical Pain Rating Scale (NPRS), an 11-point scale ranging from 0 (no pain) to 10 (worst imaginable pain). Knee range of motion (ROM), specifically knee flexion, will be measured in degrees using a universal goniometer. Quality of life and knee-related function will be assessed using the Knee Injury and Osteoarthritis Outcome Score (KOOS), which evaluates pain, symptoms, activities of daily living, sport and recreation function, and knee-related quality of life. The usability and patient satisfaction of the tele-rehabilitation intervention will be assessed only in the tele-rehabilitation group after completion of the intervention using the Telehealth Usability Questionnaire (TUQ), which measures ease of use, usefulness, interface quality, reliability, satisfaction, and future acceptance of the tele-rehabilitation platform.
Statistical Analysis: Intention-to-treat analysis will be used. Normality of data will be assessed by Shapiro-Wilk test. Within-group comparisons will use paired t-test for normally distributed data or Wilcoxon signed-rank test for non-normal data. Between-group comparisons will use independent t-test or Mann-Whitney U test. Significance level set at p ≤ 0.05. Results will be presented in graphical and tabular form using SPSS version (latest available).
Expected Outcomes:
It is expected that both the conventional physiotherapy and tele-rehabilitation groups will demonstrate improvements following the 4-week intervention. However, participants receiving tele-rehabilitation are anticipated to achieve clinically significant reductions in pain intensity, improved knee range of motion, and enhanced quality of life comparable to those receiving conventional physiotherapy. Additionally, the tele-rehabilitation group is expected to report high usability and patient satisfaction on the Telehealth Usability Questionnaire (TUQ), indicating that the digital rehabilitation platform is feasible, user-friendly, and acceptable for recreational athletes with Patellofemoral Pain Syndrome (PFPS). The findings are expected to support tele-rehabilitation as an effective and accessible alternative to conventional physiotherapy, particularly for individuals with limited access to in-person rehabilitation services.
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: Dr. Noreen Kiran Assit Professor
- Telefonní číslo: +923451438143
- E-mail: noreenkiran.DPT@tuf.edu.pk
Studijní záloha kontaktů
- Jméno: Dr. Muhammad Ateeb Research Associate, PhD Public Health
- Telefonní číslo: +923357333383
- E-mail: mateeb.oric@tuf.edu.pk
Studijní místa
-
-
Punjan
-
Faisalābad, Punjan, Pákistán, 38000
- Nábor
- Department of Rehabilitation Sciences, The University of Faisalabad
-
Kontakt:
- Anbreena Rasool, MS-NMPT
- Telefonní číslo: +92 345 7936825
- E-mail: anbreenarasool.DPT@tuf.edu.pk
-
Vrchní vyšetřovatel:
- Dr. Noreen Kiran
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
Přijímá zdravé dobrovolníky
Popis
Inclusion Criteria:
- Recreational athletes
- age between 18 and 35
- Males and females
- Unilateral Anterior knee pain between 3 to 6 on NPRS and retro patellar pain brought on by squatting, knee flexion, climbing, descending stairs, and extended sitting
- At least one month of knee pain
- Positive Apprehension test
- Can access the internet and smart phone
- Kujala questionnaire scale
Exclusion Criteria:
- Knee meniscus, ligament, and tendon injuries
- Knee effusion
- Dislocation of the patella, subluxation, and fractures
- Recent Surgery or fracture of the affected knee
- Neuromuscular, metabolic, and rheumatologic disorders.
- Who does not sign the consent form?
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Singl
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Aktivní komparátor: Conventional Physical Therapy Group
Participants will receive standard face-to-face physiotherapy under the direct supervision of a licensed physiotherapist.
It consists of an individualized exercise program including stretching, strengthening, functional, and balance exercises.
The physiotherapist will monitor participants' performance, ensure correct exercise execution, provide feedback, and modify the treatment program according to each participant's progress throughout the period.
|
Participants will receive supervised face-to-face physiotherapy for 4 weeks (2 sessions/week).
The program will include stretching (hamstrings, quadriceps, IT band, gastrocnemius), strengthening exercises (quadriceps and hip muscles), functional exercises (mini-squats, squats, lunges), and balance training (single-leg stance and heel raises).
Exercises will be progressed according to participant tolerance under the supervision of a physiotherapist.
|
|
Experimentální: Tele-rehabilitation Group
Participants will receive a structured tele-rehabilitation program delivered through a secure digital platform under the remote supervision of a licensed physiotherapist.
The intervention will consist of individualized therapeutic exercises designed to improve pain, knee function, and overall physical performance.
Participants will receive exercise instructions, educational guidance, and regular remote follow-up to monitor adherence, provide feedback, and adjust the rehabilitation program based on their progress.
This approach enables continuous physiotherapist support and personalized rehabilitation while allowing participants to complete their treatment remotely.
|
Participants will receive a 4-week tele-rehabilitation program (2 sessions/week) delivered through the Physitrack® mobile application.
The intervention will include the same standardized stretching, strengthening, functional, and balance exercises as the conventional physiotherapy group.
Participants will receive individualized exercise prescriptions, instructional videos, automated reminders, and remote monitoring through the application.
A physiotherapist will provide weekly telephone or video-call follow-up, monitor adherence, and progress the exercise program based on the participant's performance.
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Pain Intensity
Časové okno: Base line and week 4
|
Measured by NPRS ( Numerical Pain Rating Scale)
|
Base line and week 4
|
|
Range of Motion
Časové okno: Baseline and week 4
|
ROM of Flexion of affected knee by Universal Goniometer
|
Baseline and week 4
|
|
Quality of Life in Recreational Athletes
Časové okno: Baseline and week 4
|
Quality of Life is assessed through KOOS (Knee Injury and Osteoarthritis Outcome Score)
|
Baseline and week 4
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Telehealth Usability
Časové okno: week 4
|
It is measured by Telehealth Usability Questionnaire
|
week 4
|
Spolupracovníci a vyšetřovatelé
Sponzor
Vyšetřovatelé
- Studijní židle: Dr Muhammad Ateeb Research Associate, PhD Public Health, Research Associate , The University of Faisalabad, Faisalabad 38000, Pakistan
Publikace a užitečné odkazy
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
- Nemoci pohybového aparátu
- Onemocnění kloubů
- Syndrom patelofemorální bolesti
- Správa zdravotnických služeb
- Poskytování zdravotní péče
- Terapeutika
- Péče o pacienty
- Zdravotní služby
- Zdravotnická zařízení pracovní síla a služby
- Rehabilitace
- Následná péče
- Kontinuita péče o pacienty
- Telemedicína
- Řízení péče o pacienty
- Telerehabilitace
Další identifikační čísla studie
- TUF/EIRB/270/26
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .
Klinické studie na Syndrom patelofemorální bolesti
-
Istanbul University - CerrahpasaNáborPatellofemoral Pain, PFPTurecko (Türkiye)
-
Beijing Sport UniversityZatím nenabírámePatellofemoral Pain, PFP
-
Beijing Sport UniversityZatím nenabíráme
-
Pamukkale UniversityZatím nenabírámePatellofemoral Pain, PFPTurecko (Türkiye)
-
Beijing Sport UniversityDokončenoPatellofemoral Pain, PFPČína
-
University of North Carolina, Chapel HillCanadian Institutes of Health Research (CIHR)DokončenoSyndrom patelofemorální bolesti | Patelofemorální bolest (PFPS) | Patelofemorální bolest | Patellofemoral Pain, PFPSpojené státy
-
Cairo UniversityNáborSyndrom patelofemorální bolesti | Patelofemorální bolest (PFPS) | Syndrom bolesti předního kolena | Patelofemorální porucha | PFPS | Patellofemoral Pain, PFP | Syndrom patelofemorální bolestiLibanon
-
Cardiff Metropolitan UniversityDokončenoPatellofemoral Pain, PFPSpojené království
-
Zeyi ZhangDokončenoZranění související s běháním | Mediální tibiální stresový syndrom | Chronická Achillova tendinopatie | Patellofemoral Pain, PFPČína
-
Ankara Medipol UniversityGazi UniversityDokončeno
Klinické studie na Conventional Physical Therapy
-
Ming-Yuan ChihDokončeno
-
Centre Hospitalier Universitaire de BesanconNáborJuvenilní idiopatická artritidaFrancie
-
University of Health Sciences LahoreAktivní, ne nábor
-
Inonu UniversityDokončenoMrtvice | Snímky motoru | Výcvik pozorování akcí | Odstupňované snímky motoruTurecko (Türkiye)
-
Northeastern UniversitySociety for Pediatric Psychology; APA: American Psychological AssociationNáborPorucha autistického spektra (ASD)Spojené státy
-
The First Affiliated Hospital of Guangzhou Medical...Neznámý
-
Istanbul Kültür UniversityMarmara University; Istanbul University - Cerrahpasa (IUC)DokončenoFyzická aktivita | Parkinsonova choroba | Zůstatek | Padající | KineziofobieKrocan
-
The University of Hong KongNáborDemence | Zátěž pečovatele | Kognitivní porucha, mírná | Demence, mírnáHongkong
-
NHS Greater Glasgow and ClydeUniversity of Glasgow; Roche Diagnostics GmbHNáborKardiomyopatie | Genetická predispozice | Kardiomyopatie, primárníSpojené království