Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202301535060049 Date of Approval: 30/01/2023
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title THE EFFECT OF SENSORY MOTOR TRAINING IN TREATMENT OF PATELLOFEMORAL PAIN SYNDROME
Official scientific title THE EFFECT OF SENSORY MOTOR TRAINING IN TREATMENT OF PATELLOFEMORAL PAIN SYNDROME
Brief summary describing the background and objectives of the trial PFPS is described as anterior or retropatellar knee pain in the absence of other pathology. Clinically, the case represents diffuse anterior or retropatellar knee pain intensified by activities such as prolonged sitting, stair climbing, and squatting. It is also known by such terms as anterior knee pain, patellar sublaxation, or patellofemoral dysfunction. The purpose is to examine the effect of sensory motor training on plantar pressure, dynamic balance, function and hip abductors, extensors, lateral rotators, and knee extensor strength in patients with PFPS.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Musculoskeletal Diseases
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 09/07/2022
Actual trial start date 09/07/2022
Anticipated date of last follow up 20/10/2022
Actual Last follow-up date 20/10/2022
Anticipated target sample size (number of participants) 48
Actual target sample size (number of participants) 48
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group sensory motor training and conventional physical therapy program 2 times per week 6 weeks Conventional physical therapy program will be consisted of: Hip abductors strengthening exercise, Hip external rotator strengthening exercise, Hip extension strengthenig exercise, Knee extension strengthening exercise, Iliotibial band stretch, Hamstring stretch, and Calf stretch. Sensory motor training will be consisted of: Sensory motor training alone was modified and supplemented by the training program. •Changes in posture in the static (weeks 1–2), dynamic (weeks 3–4), and functional (weeks 5–6) stages; base of support; and center of gravity will be induced in a closed kinetic chain state with bare feet. Each movement was repeated ten times or maintained for 30 s in three sets. A break of 30 s will be provided after each movement. 24
Control Group Conventional physical therapy program 2 times per week 6 weeks Conventional physical therapy program will be consisted of: Hip abductors strengthening exercise, Hip external rotator strengthening exercise, Hip extension strengthenig exercise, Knee extension strengthening exercise, Iliotibial band stretch, Hamstring stretch, and Calf stretch. 24 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1) Diagnosed as unilateral PFPS with pronated foot. 2) Their age will be ranged from 18-25 years old including both genders (male & female). 3) Insidious onset of peripatellar or retropatellar knee pain of more than 6 weeks duration. 4) Pain elicited by two of the following four tests: (I) Isometric muscle contraction with slight bent knee, (II) palpation of the patellofemoral joint line, (III) patellar compression against the femoral bone (IV) active resisted knee extension. 5) No knee injuries or surgeries in the last three months or even apparent deformities, no history of foot orthoses in the previous 5 years. 6) Their BMI will be ≤ 25 kg/m2. The participants who will not be able to fulfill the inclusion criteria will be excluded from the study. Adult: 19 Year-44 Year 18 Year(s) 25 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 12/04/2022 Cairo University Faculty of physical therapy research ethical committee
Ethics Committee Address
Street address City Postal code Country
El-Tahrir st. - in front of Ben El- Sarayat Traffic, Ad Doqi, Giza District, Giza Governorate Giza 11432 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome plantar pressure after 6 weeks
Secondary Outcome static balance, dynamic balance, function, and hip abductors, extensors, lateral rotators, and knee extensors strength after 6 weeks
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
faculty of physical therapy Delta University for science and technology International Coastal Rd, Al Hafir WA Al Amal, Belqas, Dakahlia Governorate Dakahlia 7730103 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
the principal investigator International Coastal Rd, Al Hafir WA Al Amal, Belqas, Dakahlia Governorate Dakahlia 7730103 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Mostafa Elshafey Delta University Dakahlia 33155 Egypt Individual
COLLABORATORS
Name Street address City Postal code Country
MOHAMED SHAWKI ABDELSALAM Cairo University Cairo 33155 Egypt
Dina Sayed Abd Allah Cairo University Cairo 33155 Egypt
MOHAMED AHMED BEHIRY Delta University Dakahlia 33155 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mohamed Shawki Abdelsalam m.shawki@pt.cu.edu.eg 00201287232366 El-Tahrir st. - in front of Ben El- Sarayat Traffic, Ad Doqi, Giza District, Giza Governorate
City Postal code Country Position/Affiliation
Giza 11432 Egypt assistant professor of physical therapy
Role Name Email Phone Street address
Scientific Enquiries Dina Sayed Abdallah drdinasayed_pt@yahoo.com 00201282742057 El-Tahrir st. - in front of Ben El- Sarayat Traffic, Ad Doqi, Giza District, Giza Governorate
City Postal code Country Position/Affiliation
Giza 11432 Egypt lecturer of physical therapy
Role Name Email Phone Street address
Public Enquiries Mohamed Ahmed Behiry behirycenter@gmail.com 00201005147878 International Coastal Rd, Al Hafir WA Al Amal, Gamsa, Dakahlia Governorate
City Postal code Country Position/Affiliation
Dakahlia 7730103 Egypt Assistant professor of physical therapy
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Data obtained through this study may be provided to qualified researchers. Data or samples shared will be coded, with no PHI included. Approval of the request and execution of all applicable agreements (i.e. a material transfer agreement) are prerequisites to the sharing of data with the requesting party. Clinical Study Report Data requests can be submitted starting 9 months after article publication and the data will be made accessible for up to 24 months. Extensions will be considered on a case-by-case basis.” open
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information