- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07921212
Effects of Telerehabilitation Versus Supervised Rehabilitation Protocol on Pain, Range of Motion and Functional Recovery in Patients With Patellofemoral Pain Syndrome.
This study aims to compare the effects of telerehabilitation and supervised rehabilitation protocols on pain, range of motion (ROM), and functional recovery in patients with Patellofemoral Pain Syndrome (PFPS). The findings will help determine the effectiveness of remote rehabilitation compared to conventional supervised physiotherapy in improving clinical outcomes among PFPS patients.
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Detailní popis
Patellofemoral Pain Syndrome (PFPS) is one of the most common musculoskeletal conditions affecting the knee, particularly among physically active individuals and young adults. It is characterized by anterior knee pain that is aggravated during activities such as stair climbing, squatting, running, prolonged sitting, and other weight-bearing tasks. PFPS can lead to reduced physical function, limitations in daily activities, decreased participation in sports, and a lower quality of life. Rehabilitation programs focusing on pain reduction, restoration of range of motion, muscle strengthening, and functional recovery are considered essential components of management.
Recent advances in digital healthcare have increased the use of telerehabilitation as an alternative method for delivering physiotherapy services. Telerehabilitation offers remote access to exercise programs and clinical guidance, making rehabilitation more accessible and convenient for patients. Several studies have reported positive outcomes of both supervised rehabilitation and telerehabilitation in managing musculoskeletal disorders. However, evidence directly comparing the effects of telerehabilitation and supervised rehabilitation for improving pain, range of motion, and functional recovery in individuals with PFPS remains limited and inconsistent.
There is a need for further research to determine whether telerehabilitation can provide outcomes comparable to conventional supervised rehabilitation in patients with PFPS. Addressing this gap may help clinicians make evidence-based decisions regarding rehabilitation delivery methods and improve access to effective treatment for individuals experiencing patellofemoral pain.
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: Vaneeza Jamshaid, DPT
- Telefonní číslo: 03064542445
- E-mail: malikawanvaneeza22@gmail.com
Studijní záloha kontaktů
- Jméno: Iqra Abdul Ghafoor, PPDPT
- Telefonní číslo: 0321-6414266
- E-mail: Iqra.ghafoor@riphah.edu.pk
Studijní místa
-
-
Punjab Province
-
Lahore, Punjab Province, Pákistán, 54000
- Nábor
- Riphah International University
-
Kontakt:
- Vaneeza Jamshaid, DPT
- Telefonní číslo: 03064542445
- E-mail: malikawanvaneeza22@gmail.com
-
Kontakt:
- Iqra abdul ghafoor, PPDPT
- Telefonní číslo: 032116414266
- E-mail: Iqra.ghafoor@riphah.edu.pk
-
Vrchní vyšetřovatel:
- Vaneeza M Jamshaid, DPT
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
Inclusion Criteria:
-
• Participants aged 18-60 years
- Anterior knee pain for at least 6 months.
- Presence of retro-patellar or peri-patellar pain lasting more than 6 weeks.
- Diagnosis of PFPS based on:
Kujala score < 100). Participants were included with PFPS when Kujala (AKPS) score < 85 indicating limitation function limitation in PFPS.
Positive Clarke's Test
• Pain during patellar compression or patellar facet palpation
Exclusion Criteria:
-
• History of knee injury/trauma or lower extremity joint replacement.
- Systemic diseases: diabetes or rheumatoid arthritis.
- Synovitis of the knee, degenerative osteoarthritis of the knee, and history of prior chronic knee pain. Having referred pain coming from the lumbar spine, hips, ankles or feet.
- Athletes or individuals with high physical activity (based on GPAQ).
- Neurological disorders
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Dvojnásobek
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Experimentální: Group A
Participants receive a structured 6-week telerehabilitation exercise program delivered remotely under live, real-time video call supervision by a licensed physical therapist (3 sessions per week, total 18 sessions, for 40 mins. Baseline Protocol (Pre-Exercise):5-10 minutes warm-up walk.10-15 minutes self-applied moist hot pack over anterior knee. Self-stretching exercises for Hamstrings, Quadriceps, Gastrocnemius-Soleus, and Iliotibial band (3 repetitions of 30-second holds each).Pain-free active knee range of motion (flexion and extension) exercises. Exercise Progression Protocol: Week 1 (Muscle Activation & Pain Relief). Week 2 (Subacute Phase - Closed Kinetic Chain & Hip Stability)Week 3 (Intermediate Phase - Dynamic Stability),Week 4 (Advanced Phase - Eccentric Control),Week 5 (Functional Integration),Week 6 (High-Level Function & Discharge Prep): Full depth controlled squats , Stair negotiation drills, Unassisted single-leg squats, and Multi-planar step agility drills. |
The telerehabilitation intervention consists of a structured rehabilitation program delivered remotely through virtual communication platforms. The program includes therapeutic exercises, stretching, strengthening, and functional training designed to reduce pain, improve knee range of motion, and enhance functional recovery in patients with Patellofemoral Pain Syndrome. Participants will receive regular guidance, monitoring, and progression of exercises through remote sessions. Participants receive a structured 6-week telerehabilitation exercise program delivered remotely under live, real-time video call supervision by a licensed physical therapist (3 sessions per week, total 18 sessions, for 40 mins. Baseline Protocol 5-10 minutes warm-up walk.10-15 minutes self-applied moist hot pack over anterior knee. Self-stretching exercises for Hamstrings, Quadriceps, Gastrocnemius-Soleus, and Iliotibial band (3 repetitions of 30-second holds each).Pain-free active knee range of motion exercises
Ostatní jména:
|
|
Experimentální: Group B
Participants receive face-to-face, in-clinic supervised physical therapy delivered directly by a licensed physical therapist (3 sessions per week ,40 min,total 18 sessions). Baseline Protocol (Pre-Exercise): 5-10 minutes warm-up walk. 10-15 minutes hot pack surrounding patella). Therapist-assisted passive/active-assisted stretching for Hamstrings, Quadriceps, Gastrocnemius-Soleus, and Iliotibial band (3 repetitions of 20-second holds each). Pain-free active and active-assisted knee range of motion (flexion and extension) exercises. Exercise Progression Protocol: Identical exercise progression framework as the Telerehabilitation group (Weeks 1 to 6 covering SLR, hip abduction, clamshells, squats, lunges, step-ups, step-downs, and single-leg balance), performed in-clinic under direct hands-on physical supervision and guidance. |
Participants receive face-to-face, in-clinic supervised physical therapy delivered directly by a licensed physical therapist (3 sessions per week ,40 min,total 18 sessions). Baseline Protocol (Pre-Exercise): 5-10 minutes warm-up walk. 10-15 minutes hot pack surrounding patella). Therapist-assisted passive/active-assisted stretching for Hamstrings, Quadriceps, Gastrocnemius-Soleus, and Iliotibial band (3 repetitions of 20-second holds each). Pain-free active and active-assisted knee range of motion (flexion and extension) exercises. Exercise Progression Protocol: Identical exercise progression framework as the Telerehabilitation group (Weeks 1 to 6 covering SLR, hip abduction, clamshells, squats, lunges, step-ups, step-downs, and single-leg balance), performed in-clinic under direct hands-on physical supervision and guidance.
Ostatní jména:
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Numeric Pain Rating Scale
Časové okno: The NPRS Scale will be assessed at baseline (pre-intervention) and after completion of the rehabilitation program. The total intervention duration will be 6 weeks, with sessions conducted 3 times per week.
|
The NPRS was utilized to assess the patient's pain level. Patients were asked to rate the intensity of their current pain level on an 11-point scale ranging from 0 (no pain) to 10 (the worst discomfort possible). |
The NPRS Scale will be assessed at baseline (pre-intervention) and after completion of the rehabilitation program. The total intervention duration will be 6 weeks, with sessions conducted 3 times per week.
|
|
Anterior Knee Pain Scale/ Kujala Score
Časové okno: The Kujala Score will be assessed at baseline (pre-intervention) and after completion of the rehabilitation program. The total intervention duration will be 6 weeks, with sessions conducted 3 times per week.
|
The Kujala score was originally designed to assess symptoms and functional disability in patients with Patellofemoral dysfunction. The grading system consists of 13 questions about functional features, such as limping, support, walking, stair descending and climbing, squatting, running, jumping, prolonged sitting with knees flexed, pain, swelling, kneecap movement, thigh atrophy, and flexion deficit. The maximum score is 100, and a higher number indicates a better result. |
The Kujala Score will be assessed at baseline (pre-intervention) and after completion of the rehabilitation program. The total intervention duration will be 6 weeks, with sessions conducted 3 times per week.
|
|
Universal Goniometer for ROM
Časové okno: The ROM will be assessed at baseline (pre-intervention) and after completion of the rehabilitation program. The total intervention duration will be 6 weeks, with sessions conducted 3 times per week.
|
The universal goniometer is the most often used clinical equipment for measuring ROM. Goniometer demonstrates good intra-rater and inter-rater reliability when used consistently with proper technique. The whole range of joint mobility can be measured in degrees by aligning the goniometer's fixed and moveable arms to specific bony landmarks on either side of the joint, and a universal goniometer is used to measure joint range of motion (ROM). |
The ROM will be assessed at baseline (pre-intervention) and after completion of the rehabilitation program. The total intervention duration will be 6 weeks, with sessions conducted 3 times per week.
|
Spolupracovníci a vyšetřovatelé
Sponzor
Spolupracovníci
Vyšetřovatelé
- Vrchní vyšetřovatel: Vaneeza Jamshaid, DPT, Riphah International University
Publikace a užitečné odkazy
Obecné publikace
- Nilmart P, Vongsirinavarat M, Khawsuwan P, Chumthong K, Tadein R, Komalasari DR. Impact of telehealth-based therapeutic exercise on pain, functional performance and dynamic knee valgus in young adult females with patellofemoral pain: a randomised controlled trial. BMJ Open Sport Exerc Med. 2024 Dec 18;10(4):e001939. doi: 10.1136/bmjsem-2024-001939. eCollection 2024.
- Lee JH, Shin KH, Lee GB, Son S, Jang KM. Comparison of Functional Outcomes between Supervised Rehabilitation and Telerehabilitation in Female Patients with Patellofemoral Pain Syndrome during the COVID-19 Pandemic. Int J Environ Res Public Health. 2023 Jan 26;20(3):2233. doi: 10.3390/ijerph20032233.
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
- Vaneeza Jamshaid RIU
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 .