- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg 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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiekontakt
- Navn: Vaneeza Jamshaid, DPT
- Telefonnummer: 03064542445
- E-mail: malikawanvaneeza22@gmail.com
Undersøgelse Kontakt Backup
- Navn: Iqra Abdul Ghafoor, PPDPT
- Telefonnummer: 0321-6414266
- E-mail: Iqra.ghafoor@riphah.edu.pk
Studiesteder
-
-
Punjab Province
-
Lahore, Punjab Province, Pakistan, 54000
- Rekruttering
- Riphah International University
-
Kontakt:
- Vaneeza Jamshaid, DPT
- Telefonnummer: 03064542445
- E-mail: malikawanvaneeza22@gmail.com
-
Kontakt:
- Iqra abdul ghafoor, PPDPT
- Telefonnummer: 032116414266
- E-mail: Iqra.ghafoor@riphah.edu.pk
-
Ledende efterforsker:
- Vaneeza M Jamshaid, DPT
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: 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
Andre navne:
|
|
Eksperimentel: 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.
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Numeric Pain Rating Scale
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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.
|
Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Vaneeza Jamshaid, DPT, Riphah International University
Publikationer og nyttige links
Generelle publikationer
- 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.
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
- Muskuloskeletale sygdomme
- Ledsygdomme
- Patellofemoralt smertesyndrom
- Sundhedstjenester Administration
- Levering af sundhedsvæsenet
- Terapeutik
- Patientpleje
- Sundhedstjenester
- Sundhedsfaciliteter Arbejdsstyrke og tjenester
- Rehabilitering
- Efterpleje
- Kontinuitet i patientpleje
- Telemedicin
- Patientplejestyring
- Telerehabilitation
Andre undersøgelses-id-numre
- Vaneeza Jamshaid RIU
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .