CClinicalTrials.gg
Status unknownNCT04481022Updated Sep 3, 2020

Developmental of Clinical Prediction Rule for Females Responding to Proximal Control Exercises

An interventional study of proximal control exercises in Patellofemoral Pain Syndrome Clinical Prediction Rule, sponsored by Cairo University. Status unknown. Open to female participants aged 18 Years to 35 Years. Per ClinicalTrials.gov, last updated 2020-09-03.

Sponsored by Cairo University · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Sep 2020), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Not applicable
Ages
18 Years to 35 Years
Sex
Female
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Study summary

the aim of study is to investigate the effect of body mass index (BMI), age, duration of symptoms, pain severity and knee angle valgus on patient̕̕s response to proximal control exercises.

Read the detailed description

Patellofemoral pain syndrome (PFPS) is recognized as one of the most common lower-extremity disorders encountered by orthopaedic physical therapists. Females were 2.23 times more likely to develop PFPS than males. Various authors have suggested that hip weakness may be an impairment associated with PFPS, because poor hip control may lead to abnormal lower extremity or patellofemoral motions. Clinical prediction rules (CPRs) are tools designed to improve decision making in clinical practice by assisting practitioners in making a particular diagnosis, establishing a prognosis, or matching patients to optimal interventions.

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Conditions studied

  • Patellofemoral Pain Syndrome Clinical Prediction Rule

Keywords

  • clinical predicton rule
  • proximal control exercises
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In context

Patellofemoral Pain Syndrome

295 studies on the registry are indexed under Patellofemoral Pain Syndrome; 75 are open to participants now.

This study's planned enrollment of 60 is above the median of 45 across 242 interventional studies indexed under Patellofemoral Pain Syndrome.

Browse Patellofemoral Pain Syndrome studies →

Lead sponsor

Cairo University is the lead sponsor of 4,780 studies on the registry; 1,427 are open to participants now.

Of its 36 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 35 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

  • Age 18 to 35 years.
  • Anterior or retropatellar knee pain of non-traumatic origin that was greater than six weeks duration and provoked by at least two predefined activities (prolonged sitting or kneeling, squatting, jogging or running, hopping, jumping, or stair walking).
  • Pain on palpation of the patellar facets, or with step down from a 15 cm step, or double leg squat.

Exclusion criteria

Exclusion Criteria:

  1. Concomitant injury or pathology of other knee structures.
  2. Previous knee surgery.
  3. patellofemoral instability (history of sublaxation or dislocation; positive apprehension test).
  4. knee joint effusion.
  5. Osgood-Schlatter's.
  6. hip or lumbar spine pain (local or referred).
  7. physiotherapy within previous year; prior foot orthoses treatment or use of anti inflammatories or corticosteroids.
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
60 participants (estimated)

Study arms

  • Other
    group will receive proximal control exercises

    Other: proximal control exercises

Interventions

  • Otherproximal control exercises

    study investigates the effectiveness of proximal control exercises for patients with PFPS in improving pain and function. The findings of this systematic review are consistent with previous evidence reporting effectiveness of exercise for PFPS. In particular, there is consistent moderate to high quality evidence (three RCT, one CCT, three cohort studies, and one case series) that proximal interventions provide relief of pain and improved function in the short term, whereas the knee programs have variable effectiveness. Physical therapists should consider using proximal interventions for early stage treatment for PFPS (Peters et al., 2013). After 4 weeks of a combined knee and hip strengthening exercise program, sedentary females with PFPS had a greater reduction in pain during stair descent compared to the group who performed knee strengthening exercises only. Both groups also showed significant improvement in function and pain during stair ascent (Fakuda et al., 2010).

06

What researchers measure

Primary outcomes

  1. level of pain

    visual analogue scale 100-mm horizontal line anchored by word descriptors at each end by no the left and worst imaginable pain on the right

    Time frame: baseline

  2. functional status

    Kujala questionnaire is a 13-items knee specific self-report questionnaire. It documents response to six activities thought to be associated specifically with anterior knee pain syndrome (walking, running, jumping, climbing stairs, squatting, and sitting for prolonged periods with knees bent), as well as symptoms such as limp, inability to bear weight through the affected limb, swelling, abnormal patellar movement, muscle atrophy and limitation of knee flexion. This questionnaire was used to ssess the individual's functional status and PFPS experienced during specific functional tasks.

    Time frame: baseline

  3. Dynamic knee valgus 2d frontal plane projection angle

    2D frontal plane projection angle (FPPA) analysis to measure dynamic knee valgus. for 2D FPPA analysis, the centers of each of hip, knee and ankle joints will be determined using a standard tape measure, markers will be placed at the midpoint of the ankle malleoli for the center of the ankle joint, midpoint of the femoral condyles to approximate the center of the knee joint, and on the proximal thigh at the midpoint of the line from the anterior superior iliac spine to the knee joint center.

    Time frame: baseline

Secondary outcomes

  1. isometric muscle power of hip abductor and external rotation

    Hand held dynamometer will be used to asses isomteric hip abductor and isometric hip external rotator power

    Time frame: baseline

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Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • Robinson RL, Nee RJ. Analysis of hip strength in females seeking physical therapy treatment for unilateral patellofemoral pain syndrome. J Orthop Sports Phys Ther. 2007 May;37(5):232-8. doi: 10.2519/jospt.2007.2439. PubMed 17549951 ↗
  • Earl JE, Hoch AZ. A proximal strengthening program improves pain, function, and biomechanics in women with patellofemoral pain syndrome. Am J Sports Med. 2011 Jan;39(1):154-63. doi: 10.1177/0363546510379967. Epub 2010 Oct 7. PubMed 20929936 ↗
  • Lesher JD, Sutlive TG, Miller GA, Chine NJ, Garber MB, Wainner RS. Development of a clinical prediction rule for classifying patients with patellofemoral pain syndrome who respond to patellar taping. J Orthop Sports Phys Ther. 2006 Nov;36(11):854-66. doi: 10.2519/jospt.2006.2208. PubMed 17154139 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 3, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04481022
Lead sponsor
Cairo University
Responsible party
Khaled Alaa Eldin (Mr, Cairo University) — Principal investigator
First posted
Jul 22, 2020
Start date
Sep 3, 2020 (estimated)
Primary completion
Apr 30, 2021 (estimated)
Completion
Aug 30, 2021 (estimated)
Last update
Sep 3, 2020

Study contacts

khaled AlaaEldin Fetouh, Master
Contact
drkhaled929292@yahoo.com
01090737464 ext. 20
Ahmed Mohamed El Melhat, dr
Contact
ahmed.elmelhat@cu.edu.eg
01112595022 ext. 20

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Sep 2020. You cannot join it, but the record below documents what was studied.

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