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Short-term Effect of Patellar Taping and Electromyographic Biofeedback Strength Training on Quadriceps Strength

Primary Purpose

Patello Femoral Syndrome

Status
Completed
Phase
Not Applicable
Locations
Saudi Arabia
Study Type
Interventional
Intervention
EMG-BF guided patellar taping
sham patellar taping without EMG-BF guided stimulation; maximum voluntary isometric contraction exercise
Sponsored by
Majmaah University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Patello Femoral Syndrome focused on measuring Patello-femoral pain syndrome, pain, strength, Maximum voluntary Isometric contraction (MVIC).

Eligibility Criteria

25 Years - 40 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • knee pain for at least eight weeks that was aggravated by activities such as descending and ascending stairs, squatting, and running.
  • knee pain with a positive J sign (lateral tilt of patella)
  • more symptomatic and mal align knee included in case of bilateral involvement and a sign of patellar malalignment on the radiograph.

Exclusion Criteria:

  • History of knee fracture
  • Patella dislocation
  • knee deformity (e.g., genu varum)
  • Knee Flexion contracture
  • Ligament/meniscal injuries,
  • NSAID or intra-articular injection, or knee Osteo arthritis.

Sites / Locations

  • Rehabilitation center, Majmaah University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Experimental(Group A): EMG-BF guided patellar taping

Control group (Group B): sham patellar taping without EMG-BF guided stimulation.

Arm Description

The experimental group (Group A): EMG-BF guided patellar taping Maximum voluntary isometric contraction exercise at 60, and 90 degrees angle for six weeks.

Control group (Group B): sham patellar taping without EMG-BF guided stimulation; maximum voluntary isometric contraction exercise at angles of 60, and 90 degrees for six weeks.

Outcomes

Primary Outcome Measures

Quadriceps muscle strength
Knee extensors (Maximal Voluntary Isometric Contraction) strength (STN) test at 60, and 90 degrees angles
Pain intensity
investigated for their current intensity of pain on a Visual analogue scale 0 to 10 scale.
Knee function
Knee function will be assessed using the validated Kujala Anterior Knee Pain scale

Secondary Outcome Measures

Full Information

First Posted
December 12, 2021
Last Updated
November 13, 2022
Sponsor
Majmaah University
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1. Study Identification

Unique Protocol Identification Number
NCT05168332
Brief Title
Short-term Effect of Patellar Taping and Electromyographic Biofeedback Strength Training on Quadriceps Strength
Official Title
Short-term Effect of Patellar Taping and Electromyographic Biofeedback Strength Training on Quadriceps Strength and Functional Performance in Female With Patellofemoral Pain Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
December 5, 2021 (Actual)
Primary Completion Date
June 26, 2022 (Actual)
Study Completion Date
September 25, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Majmaah University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Patellofemoral pain syndrome is one of the most common young adult female complaints, caused by changes in the patellofemoral joint's physical and biomechanical properties. This study compared the Short-term effects of patellar taping and electromyographic-biofeedback (EMG-BF) guided maximum voluntary isometric contraction of quadriceps muscle strengthening at 900 or 600 knee angles on quadriceps strength and functional performance in a female patient with patello-femoral pain syndrome (PFPS)
Detailed Description
Quadriceps muscle strength Pain intensity Knee function

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Patello Femoral Syndrome
Keywords
Patello-femoral pain syndrome, pain, strength, Maximum voluntary Isometric contraction (MVIC).

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Experimental group Control group
Masking
Participant
Masking Description
single (participant)
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental(Group A): EMG-BF guided patellar taping
Arm Type
Experimental
Arm Description
The experimental group (Group A): EMG-BF guided patellar taping Maximum voluntary isometric contraction exercise at 60, and 90 degrees angle for six weeks.
Arm Title
Control group (Group B): sham patellar taping without EMG-BF guided stimulation.
Arm Type
Sham Comparator
Arm Description
Control group (Group B): sham patellar taping without EMG-BF guided stimulation; maximum voluntary isometric contraction exercise at angles of 60, and 90 degrees for six weeks.
Intervention Type
Behavioral
Intervention Name(s)
EMG-BF guided patellar taping
Intervention Description
EMG-BF guided patellar taping Maximum voluntary isometric contraction exercise at 60, and 90 degrees angle.
Intervention Type
Behavioral
Intervention Name(s)
sham patellar taping without EMG-BF guided stimulation; maximum voluntary isometric contraction exercise
Intervention Description
sham patellar taping without EMG-BF guided stimulation; maximum voluntary isometric contraction exercise
Primary Outcome Measure Information:
Title
Quadriceps muscle strength
Description
Knee extensors (Maximal Voluntary Isometric Contraction) strength (STN) test at 60, and 90 degrees angles
Time Frame
6 weeks
Title
Pain intensity
Description
investigated for their current intensity of pain on a Visual analogue scale 0 to 10 scale.
Time Frame
6 weeks
Title
Knee function
Description
Knee function will be assessed using the validated Kujala Anterior Knee Pain scale
Time Frame
6 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: knee pain for at least eight weeks that was aggravated by activities such as descending and ascending stairs, squatting, and running. knee pain with a positive J sign (lateral tilt of patella) more symptomatic and mal align knee included in case of bilateral involvement and a sign of patellar malalignment on the radiograph. Exclusion Criteria: History of knee fracture Patella dislocation knee deformity (e.g., genu varum) Knee Flexion contracture Ligament/meniscal injuries, NSAID or intra-articular injection, or knee Osteo arthritis.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shahnaz Hasan, PhD
Organizational Affiliation
Associate Professor, Majmaah University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rehabilitation center, Majmaah University
City
Al Majma'ah
State/Province
Al Riyadh
ZIP/Postal Code
11952
Country
Saudi Arabia

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Short-term Effect of Patellar Taping and Electromyographic Biofeedback Strength Training on Quadriceps Strength

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