Impact of Tensor Fascia Lata Stretch on Vastus Medialis O... | NCT06736756

Studies
Impact of Tensor Fascia Lata Stretch on Vastus Medialis Obliqus Activity

NCT06736756

Sponsor

Ahram Canadian University

Status

Recruiting

Last Update Posted

Dec 17, 2024Actual

Enrollment

37Estimated

Phase

Not provided

Conditions

Patellofemoral Pain Syndrome

Interventions

Stretch Exercise

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2024

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 30, 2024Actual

Primary Completion Date

Dec 2024Estimated

Completion Date

Apr 2025Estimated

First Submitted Date

Dec 7, 2024

First Submission Date that Met QC Criteria

Dec 14, 2024

First Posted Date

Dec 17, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 14, 2024

Last Update Posted Date

Dec 17, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Tasneem Khaled Fouad Abdelghany, Teaching Assistant Orthopedic department, Ahram Canadian UniversityPrincipal Investigator

Lead Sponsor

Ahram Canadian UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Patellofemoral pain syndrome (PFPS) is one of the most typical causes of anterior knee pain in adolescents and young adults under the age of 50.It is believed that imbalanced action between quadriceps components, is the most contributing cause of PFPS.Investigating exercises that increase VMO muscle activation and enhance the ratio between VMO and VL have been a standardized target in literature.

Detailed Description

Participants will have the assessed limb ready by shaving the hair on thigh and using alcohol swabs to clean the area from any residues.

For the VMO, a surface EMG electrode will be placed 4 cm superior and 4 cm medial to the supromedial boarder of patella at approximately 55 degrees to the long axis of the femur. As for the VL, the electrode will be placed 10 cm superior and 6-8 cm lateral to the superior lateral boarder of the patella and orientated 15 degrees to the vertical. All electrodes are self-adhesive (Figure 8) and will be connected to EMG sensors that will be attached and secured by double-sided tape.Each participant will perform three consecutive squats with 5 seconds interval break between each repetition. The squat depth will be kept at 50 degrees knee flexion. Mean muscle activity from three squat repetitions of VMO and VL is recorded and VMO:VL ratio is calculated. Afterward, each participant will perform the TFL stretch and repeat the three squats again.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

37Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Stretch Exercise	Other	To stretch Tensor fascia lata muscle,each participant starts with side lying position with the tested limb upmost. The lower limb (non-tested) is kept in hip and knee flexion to ensure stability. The tested limb is then taken into hip extension and adduction with knee extended. The exercise is held for 60 seconds and repeated 5 times with 10 seconds break intervals.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
VMO muscle activity	VMO muscle activity during squat is assessed by EMG device	During the procedure

Secondary Outcomes

Measure	Description	Time Frame
VMO to VL ratio	Ratio between VMO and VL activity during squat	Immediately after the procedure

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Both genders.
Body mass index (BMI) ranges from 18.5 to 29.9.
Age ranges between 18 and 30 years old.
Experience nontraumatic anterior knee pain.
Pain with any two activities, including running, jumping, squatting, kneeling, stair ascent/descent or prolonged sitting.
Having at least one positive PFPS clinical tests including, patellofemoral compression, patellofemoral gliding or resistive quadriceps setting

Exclusion Criteria:

Coexisting pathology around the knee, including patellar subluxation or dislocation.
Previous knee surgery.
Suspicion of patellar tendinopathy, with strong consideration of pain localised to the patellar tendon.
Patients didn't receive physiotherapy treatment or use of non-steroidal anti-inflammatory drugs for knee pain in the previous 3 months.
Any neurological or rheumatic disorders
Pain intensity more than 5 (based on visual analogue scale)
Hip and ankle pathology.
BMI more than 30%.
Pregnancy.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

30 Years

Standard Ages

Adult

Study Population

patients referred from orthopedic surgeon with diagnosis of PFPS

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Tasneem Abdelghany, Bachelor	Contact	01015507353		tasnim.khaled@acu.edu.eg

Overall Officials

Name	Affiliation	Role
Enas Fawzy, Professor	Cairo University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Tasneem Khaled	Recruiting	Cairo			Egypt

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D046788	Patellofemoral Pain Syndrome

Ancestor Terms

ID	Term
D007592	Joint Diseases
D009140	Musculoskeletal Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D059385	Plyometric Exercise

Ancestor Terms

ID	Term
D005081	Exercise Therapy
D012046	Rehabilitation
D000359	Aftercare
D003266	Continuity of Patient Care

Browse Leaves

Not provided

Browse Branches

Not provided