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.: PACTR202003828737019 Date of Approval: 18/03/2020
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title efficacy of rectus femoris stretching on pain, range of motion and spatiotemporal gait parameters in patients with knee osteoarthritis
Official scientific title efficacy of rectus femoris stretching on pain, range of motion,spatiotemporal gait parameters and function in patients with knee osteoarthritis
Brief summary describing the background and objectives of the trial Osteoarthritis is actually one of the most common, costly and disabling forms of joint disease, being far more common than rheumatoid arthritis (RA) and other forms of joint disease (Cross et al., 2014). Patients with knee osteoarthritis often report muscle weakness, pain, and decreased range of motion, in turn, these symptoms are associated with limited functional capacity and decreased quality of life (da Silva et al., 2015 ) . Reduced range of motion (ROM) of the joint is supposed to be a characteristic feature of osteoarthritis (OA) (Dekker et al., 2009). Previous studies have reported that patients with knee OA demonstrate worse spatiotemporal gait parameters as they walk slower , have shorter step length and shorter single limb support phase (Debi et al., 2012 and Peixoto et al., 20119 ) . Reduced knee motion and in gait velocity during walking compared to healthy controls (Brinkmann and Mankin ,1998 and ) .
Type of trial RCT
Acronym (If the trial has an acronym then please provide) OA
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 08/04/2020
Actual trial start date 08/04/2020
Anticipated date of last follow up 03/02/2021
Actual Last follow-up date 03/02/2021
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants) 60
Recruitment status Recruiting
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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously 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 stretching exercise for rectus femoris 3times/week 4weeks stretching exercise for rectus femoris with exercises, stretching exercise of hamstring muscle , calf muscle, strength exercise for quadriceps gluteus medius gluteus maximus and calf muscle. 30
Control Group traditional treatment 3times/week 4 weeks patients will receive 15 minute hot pack for preparation and receive stretching calf muscle, hamstring muscle only, strength exercise for quadriceps , gluteus medius, gluteus maximums and calf muscle. 30 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1) The patient's age ranged from 40 to 60 years. 2) Body mass index <30kg/m2. 3) Met the American College of Rheumatology clinical criteria for mild to moderate knee OA. 4) knee pain >20mm on a 100-mmvisual analog scale (VAS) on most days of the previous week. 5) Recent radiographs confirming the presence of knee OA , grade II-III Kellgren Lawrence . 6) Positive Ely’s test for shortening of rectus femoris . 7) Bilateral knee osteoarthritis. 1) Patients with severe OA (grade IV according to K/L classification). 2) Had undergone or will scheduled to undergo joint preservation surgery or total joint arthroplasty. 3) Had systemic arthritic conditions. 4) Congenital or acquired inflammatory or neurological (systemic or local) diseases involving the knee. 5) Repeated treatment with steroids. Middle Aged: 45 Year(s)-64 Year(s) 40 Year(s) 60 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
No 11/03/2020 faculty of physical therapy ethical committee
Ethics Committee Address
Street address City Postal code Country
7th el zayat street giza 12511 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Pain intensity assessment : The scale used was the VAS, which consisted of a line, usually 10cm long, the patient was instructed to place a vertical mark on to indicate his pain, ranging from no pain or discomfort(0), to the worst pain (10) that the patient could feel before and after completion of study
Secondary Outcome knee Range Of Motion ( ROM ) Assessment (Bubble inclinometer): A plastic rounded inclinometer that has a 360-degree rotating dial with fluid indicator. The bubble inclinometer measures the range of motion accurately. before and after completion of study
Secondary Outcome stop watch and gait trainer 2 for spatiotemporal parameters speed measured by six meter walk test by stop watch, then gait trainer 2 to measure step length before and after completion of study
Secondary Outcome physical function assessment ( The Western Ontario and McMaster Universities (WOMAC) scale ) : The WOMAC OA Index is a tested questionnaire to assess symptoms and physical functional disability in patients with OA of the knee before and after completion of study
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
faculty of physical therapy 7th el zayat street giza 11251 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
mostafa mahmoud zalabia 7th el zayat street giza 12511 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor cairo university cairo univarsity street giza 12511 Egypt University
COLLABORATORS
Name Street address City Postal code Country
mohamed elgendy 7th el zayat street giza 12511 Egypt
mohammed ibrahim 7th el zayaat street giza 12511 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator mostafa mahmoud mostafazalabia1990@gmail.com 01271105483 7th el zayat street
City Postal code Country Position/Affiliation
giza 12511 Egypt assisstant lecturer
Role Name Email Phone Street address
Scientific Enquiries mohamed el gendy prof_dr_pt@yahoo.com 01126213339 7th el zayat street
City Postal code Country Position/Affiliation
giza 12511 Egypt professor of physical therapy
Role Name Email Phone Street address
Public Enquiries mohammed ibrahim prof_dr_pt@yahoo.com 01005747169 7th elzayat street
City Postal code Country Position/Affiliation
giza 12511 Egypt lecturer
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes The patient's age ranged from 40 to 60 years,Body mass index <30kg/m2,Met the American College of Rheumatology clinical criteria for mild to moderate knee OA.,knee pain >20mm on a 100-mmvisual analog scale (VAS) on most days of the previous week,Recent radiographs confirming the presence of knee OA , grade II-III Kellgren Lawrence ,Positive Ely’s test for shortening of rectus femoris andBilateral knee osteoarthritis. Study Protocol one year we will publish pain, function,spatiotemporal and function
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