Ignite Creation Date:
2024-05-06 @ 8:20 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06347406
Status:
RECRUITING
Last Update Posted:
2024-04-04
First Post:
2024-03-29
Brief Title:
Effects of Combined Physiotherapy Management and Education
Sponsor:
Fakulti Sains Kesihatan
Organization:
Fakulti Sains Kesihatan
Study Overview
Official Title:
Effects of Combined Physiotherapy Management and Education on Physiological Functions and Quality of Life Among Individuals With Patellofemoral Pain
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This observational study aims to determine the effects of combined physiotherapy programs and education in patellofemoral pain syndrome The main questions it aims to answer are
Are there any effects of combined physiotherapy program among individuals with PFPS on
i Pain ii Muscle functions strength muscle bulk flexibility iii Knee muscle functional performance anteromedial lunge step-down bilateral squat and balance and reach iv Kinesiophobia v Quality of life Participants will be
Measure for the anthropometrics data including body weight height and BMI
Answer the Numerical Pain Rating scale
Abswe Malay version of KOOS-PF and TAMPA scale
Once they finished with the questionnaire the participants will be stationed into station 1 HDD station 2 Realtime Ultrasound and station 3 Dartfish Motion Analysis Treatment they will receive
Blood flow restrictions cuff with physiotherapy exercises
Patient education Researcher will compare Blood flow exercises combined with physiotherapy exercises and education Group A with Physiotherapy exercises Group B to see if there is an effect on i Pain ii Muscle Functions strength muscle bulk flexibility iii Functional performance anteromedial lunge step-down bilateral squat balance and reach iv Kinesiophobia v Quality of life
Are there any effects of combined physiotherapy program among individuals with PFPS on
i Pain ii Muscle functions strength muscle bulk flexibility iii Knee muscle functional performance anteromedial lunge step-down bilateral squat and balance and reach iv Kinesiophobia v Quality of life Participants will be
Measure for the anthropometrics data including body weight height and BMI
Answer the Numerical Pain Rating scale
Abswe Malay version of KOOS-PF and TAMPA scale
Once they finished with the questionnaire the participants will be stationed into station 1 HDD station 2 Realtime Ultrasound and station 3 Dartfish Motion Analysis Treatment they will receive
Blood flow restrictions cuff with physiotherapy exercises
Patient education Researcher will compare Blood flow exercises combined with physiotherapy exercises and education Group A with Physiotherapy exercises Group B to see if there is an effect on i Pain ii Muscle Functions strength muscle bulk flexibility iii Functional performance anteromedial lunge step-down bilateral squat balance and reach iv Kinesiophobia v Quality of life
Detailed Description:
The participants who volunteered will be screened for inclusion and exclusion criteria Prior to the assessments and examinations the physiotherapist in charge will explain the study and will get consent from the participants This study will follow the Consort RCT 2010 guidelines
Then the participants will go into randomization sequence before they go into the interventions The participants will go into block randomization The participants will be blocks into color Blue for Experimental group Red for control group This study will be double blinded The blinded person will be the accessors and the participants
Then they will complete the demographic questionnaire which will include questions on personal data health status medical illness past medical history simple questions on their pain site of pain with the assistance by the researchers to read the questions as most of the participants is illiterate
Then the participants will be measure for the anthropometric data including body weight height and BMI
The participants will answer the Numerical Pain Rating scale KOOS-PF Malay version and TAMPA scale Then they will proceed with station 1 HHD which measure strength station 2 Real time ultrasound which measure muscle bulk and then station 3 Dartfish motion analysis for knee functional performance test anteromedial lunge step-down single-leg press bilateral squat and balance and reach using the Dartfish software
Station 1 HDD will be conducted by a physiotherapist who specially trained to do the HDD The physiotherapist will then measure the Quadriceps and Hamstrings These were the procedures that the physiotherapist needs to do
1 Quadriceps Procedure Allow for free hanging of the leg at a 90-degree angle Place the HDD just proximal to the lateral and medial maleolis Instruct the individual to reach full knee extension effort in 1-2 seconds and then sustain it for an additional 2-3 seconds Ascertain that the subjects leg is fully stretched away from their body
2 Hamstrings Procedure In a prone position the knee was flexed to 15 and 90 of flexion as determined by ocular judgement The examiner positioned the HHD at the subjects heel and gradually increased the force applied to the calcaneal for 1-2 seconds The individual will be instructed to resist the applied forceIn a prone position the knee was flexed to 15 and 90 of flexion as determined by ocular judgement The examiner positioned the HHD at the subjects heel and gradually increased the force applied to the calcaneal for 1-2 seconds The individual will be instructed to resist the applied force In a prone position the knee was flexed to 15 and 90 of flexion as determined by ocular judgement The examiner positioned the HHD at the subjects heel and gradually increased the force applied to the calcaneal for 1-2 seconds The individual will be instructed to resist the applied force
After the participant completed with the station 1 then heshe will be proceeded with Station 2 Real time ultrasound
Procedure To prevent hip external rotation when supine a strap was attached around both participants feet A 38 mm 13e18Hz linear transducer was placed above each pen-marked spot to get ultrasonic readings HDI3000 by Advanced Technology Laboratories California The photographs were taken by a technician or a physiotherapist which one is available who had received training in real-time ultrasonography Gain was increased until muscle borders appeared on the screen and the picture depth was adjusted until the femur was visible in the screens central Each muscle namely the vastus medialis VM the vastus lateralis VL the vastus intermedius VI the rectus femoris RF and the vastus medialis VM semimembranousus SM semitendinosus ST and Biceps Femoris BF Iliotibial band ITB tenssofacialate TFL and gastrocnemius GSN will be photographed three times To minimize muscular stiffness the transducer head was adequately covered in ultrasonic gel
Once completed with the station 2 then the participant will proceed with station 3 Knee Muscle performance Test with Dartfish motion software This station will be conducted by a physiotherapist who trained in Dartfish motion analysis software
Procedure
The participant is dressed in compression shorts and shirt that fit tightly to the body The lower extremity model that utilizes four markers placed in various locations from the acromion joint greater trochanteric medial tuberosity of femur down to the lateral malleolus After the marker is install on the participant body they are requiring to perform these movements
Anteromedial lunge left and right The subject is positioned behind a starting line The subject lunges forward with the uninvolved limb so that the front leg bends to 90 degrees and crosses the midline The patient must keep his or her balance and maintain an upright trunk posture The participant is then instructed to perform as many lunges in 30 seconds lunges that do not meet the 80 level are not recorded The lunge is not included in the count if the subject deviates from the path of motion or takes an extra step
Step-down left and right The step-down is a unilateral test done from an 8-inch 2032-centimeter high platform Participant take a step forward and lower themselves to the ground Only the heel of the down leg brushes the floor before returning to full knee extension This is considered one repeat This to allow to calculate the time take to complete one cycle and speed Refer to Appendix E The trunk hip knee and ankle ROM is calculate when the both foot touches the step and when the test foot starting to go down to the ground Both limbs are put to the test
Bilateral squat The participant begin by standing with their legs fully extended shoulders shoulder-width apart and their weight evenly distributed on both limbs Participant lower their bodies to a 90 degrees knee position before returning to full extension A complete cycle of straight standing to 90 degrees of knee flexion and back to straight standing constitutes one repeat speed and time of this cycle will be calculate
Balance and reach to measure distance Behind a start line the subject begins the test The participant extends one leg straight forward until the heel contacts the floor with the rear test leg bearing most of the body weight The unaffected limb is put to the test first Measurement between the starting point to end point will be calculated
Once they completed the questionnaire and assessment then the participant will proceed with the interventions
The participant will need to strap proximal parts of the lower limb with 40 of subjects RECOVER FUN AIR CUFF WITH PUMP The timer will be set up to 10 minutes during the intervention for the participants to release the pressure of the cuff The participants will rest on the chair for 5 minutes The participants will need to perform physiotherapy exercises with the cuff on
Education booklet will be designed to educate the participants about the PFPS advice and importance of exercises
The contain of this booklet consist of
1 What is PFPS
2 What causes PFPS
3 What are the symptoms of PFPS
4 Pain gate theory
5 Importance of treatment
6 Exercises
7 Frequently asked questions
Follow up Participants will need to come in for intervention for three times a week for 12 weeks
Then the participants will go into randomization sequence before they go into the interventions The participants will go into block randomization The participants will be blocks into color Blue for Experimental group Red for control group This study will be double blinded The blinded person will be the accessors and the participants
Then they will complete the demographic questionnaire which will include questions on personal data health status medical illness past medical history simple questions on their pain site of pain with the assistance by the researchers to read the questions as most of the participants is illiterate
Then the participants will be measure for the anthropometric data including body weight height and BMI
The participants will answer the Numerical Pain Rating scale KOOS-PF Malay version and TAMPA scale Then they will proceed with station 1 HHD which measure strength station 2 Real time ultrasound which measure muscle bulk and then station 3 Dartfish motion analysis for knee functional performance test anteromedial lunge step-down single-leg press bilateral squat and balance and reach using the Dartfish software
Station 1 HDD will be conducted by a physiotherapist who specially trained to do the HDD The physiotherapist will then measure the Quadriceps and Hamstrings These were the procedures that the physiotherapist needs to do
1 Quadriceps Procedure Allow for free hanging of the leg at a 90-degree angle Place the HDD just proximal to the lateral and medial maleolis Instruct the individual to reach full knee extension effort in 1-2 seconds and then sustain it for an additional 2-3 seconds Ascertain that the subjects leg is fully stretched away from their body
2 Hamstrings Procedure In a prone position the knee was flexed to 15 and 90 of flexion as determined by ocular judgement The examiner positioned the HHD at the subjects heel and gradually increased the force applied to the calcaneal for 1-2 seconds The individual will be instructed to resist the applied forceIn a prone position the knee was flexed to 15 and 90 of flexion as determined by ocular judgement The examiner positioned the HHD at the subjects heel and gradually increased the force applied to the calcaneal for 1-2 seconds The individual will be instructed to resist the applied force In a prone position the knee was flexed to 15 and 90 of flexion as determined by ocular judgement The examiner positioned the HHD at the subjects heel and gradually increased the force applied to the calcaneal for 1-2 seconds The individual will be instructed to resist the applied force
After the participant completed with the station 1 then heshe will be proceeded with Station 2 Real time ultrasound
Procedure To prevent hip external rotation when supine a strap was attached around both participants feet A 38 mm 13e18Hz linear transducer was placed above each pen-marked spot to get ultrasonic readings HDI3000 by Advanced Technology Laboratories California The photographs were taken by a technician or a physiotherapist which one is available who had received training in real-time ultrasonography Gain was increased until muscle borders appeared on the screen and the picture depth was adjusted until the femur was visible in the screens central Each muscle namely the vastus medialis VM the vastus lateralis VL the vastus intermedius VI the rectus femoris RF and the vastus medialis VM semimembranousus SM semitendinosus ST and Biceps Femoris BF Iliotibial band ITB tenssofacialate TFL and gastrocnemius GSN will be photographed three times To minimize muscular stiffness the transducer head was adequately covered in ultrasonic gel
Once completed with the station 2 then the participant will proceed with station 3 Knee Muscle performance Test with Dartfish motion software This station will be conducted by a physiotherapist who trained in Dartfish motion analysis software
Procedure
The participant is dressed in compression shorts and shirt that fit tightly to the body The lower extremity model that utilizes four markers placed in various locations from the acromion joint greater trochanteric medial tuberosity of femur down to the lateral malleolus After the marker is install on the participant body they are requiring to perform these movements
Anteromedial lunge left and right The subject is positioned behind a starting line The subject lunges forward with the uninvolved limb so that the front leg bends to 90 degrees and crosses the midline The patient must keep his or her balance and maintain an upright trunk posture The participant is then instructed to perform as many lunges in 30 seconds lunges that do not meet the 80 level are not recorded The lunge is not included in the count if the subject deviates from the path of motion or takes an extra step
Step-down left and right The step-down is a unilateral test done from an 8-inch 2032-centimeter high platform Participant take a step forward and lower themselves to the ground Only the heel of the down leg brushes the floor before returning to full knee extension This is considered one repeat This to allow to calculate the time take to complete one cycle and speed Refer to Appendix E The trunk hip knee and ankle ROM is calculate when the both foot touches the step and when the test foot starting to go down to the ground Both limbs are put to the test
Bilateral squat The participant begin by standing with their legs fully extended shoulders shoulder-width apart and their weight evenly distributed on both limbs Participant lower their bodies to a 90 degrees knee position before returning to full extension A complete cycle of straight standing to 90 degrees of knee flexion and back to straight standing constitutes one repeat speed and time of this cycle will be calculate
Balance and reach to measure distance Behind a start line the subject begins the test The participant extends one leg straight forward until the heel contacts the floor with the rear test leg bearing most of the body weight The unaffected limb is put to the test first Measurement between the starting point to end point will be calculated
Once they completed the questionnaire and assessment then the participant will proceed with the interventions
The participant will need to strap proximal parts of the lower limb with 40 of subjects RECOVER FUN AIR CUFF WITH PUMP The timer will be set up to 10 minutes during the intervention for the participants to release the pressure of the cuff The participants will rest on the chair for 5 minutes The participants will need to perform physiotherapy exercises with the cuff on
Education booklet will be designed to educate the participants about the PFPS advice and importance of exercises
The contain of this booklet consist of
1 What is PFPS
2 What causes PFPS
3 What are the symptoms of PFPS
4 Pain gate theory
5 Importance of treatment
6 Exercises
7 Frequently asked questions
Follow up Participants will need to come in for intervention for three times a week for 12 weeks
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None