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.: PACTR202010869767272 Date of Approval: 26/10/2020
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Effect of Oscillatory Whole Body Vibration versus Neuromuscular Exercise on Static and Dynamic Balance in patients with Knee Osteoarthritis
Official scientific title Effect of Oscillatory Whole Body Vibration versus Neuromuscular Exercise on Static and Dynamic Balance in patients with Knee Osteoarthritis
Brief summary describing the background and objectives of the trial Degenerative OA of the knee is one of the most common forms of OA worldwide . Knee OA results in progressive loss of function including: gait, stair climbing and other physical activities which involve lower limb. In fact, it reduces the quality of life . Balance is critical for mobility and carrying on activities of daily living . People with knee OA display some impairment in dynamic balance and lacked ability to maintain standing balance while carrying over a potentially destabilizing task .Whole-body vibration (WBV) is the exercise program that is improved the joint proprioception, balance, and flexibility of sedentary and older individuals . In recent years, a systematic review and meta-analysis study conducted by Rogan et al. (Rogan et al., 2015) reported that WBV has been introduced as a training method to improve muscle power and strength in older adults. Neuromuscular exercise is a special program aimed at restoring motor control through maximizing sensory input from different parts of the body to improve balance and overall function level of the patient . The neuromuscular exercise is based on biomechanical and neuromuscular principles and aims to improve sensorimotor (neuromuscular) control and achieve compensatory functional joint stabilization by addressing the quality of movement in all 3 movement planes in KOA patients.So this study will compare the effect of WBV exercises with the effect of neuromuscular exercises on static and dynamic balance in patients with KOA.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) KOA
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 20/10/2020
Actual trial start date
Anticipated date of last follow up 01/03/2021
Actual Last follow-up date
Anticipated target sample size (number of participants) 36
Actual target sample size (number of participants)
Recruitment status Not yet 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 Whole body vibration exercise 3 days per week 6 weeks The participants will stand on the platform and without shoes. Each session of WBV exercise will last 30 min (60 s for vibration, and 60 s for rest). The vibration parameters in the WBV training group will be as follows: 1- Frequency(35–40 Hz) 2- Amplitude (4–6 mm) 3- Acceleration ranged from (2–5g). 4- Direction oscillatory These parameters were considered sufficient by Delecluse for achieving the desired physiologic effects (Delecluse et al., 2003). 12
Control Group knee exercise program 3 days per week 6 weeks 1st and 2nd weeks: Range of motion and stretching exercises will be applied to hamstring and calf muscle, and quadriceps and hamstring isometric strengthening exercise. 3rd and 4th weeks (in addition): Straight leg raising exercises, short-arc terminal extension exercise for the knee joint, and isometric exercises for the abductor and adductor muscles of the hip. 5th and 6th weeks (in addition): Short-arc terminal extension exercise with resistance for the knee joint and isotonic strengthening exercise with resistance for the hamstring muscles. 12 Active-Treatment of Control Group
Experimental Group Neuromuscular exercise 3 days per week 6 weeks Each exercise session consisted of warming up, NEMEXs, and cooling down. Warming up involved ergometer cycling, treadmill walking, or stepping exercise for 10 minutes at a ‘‘rather strenuous’’ level (Borg et al., 1985). Neuromuscular exercises comprised 11 exercises with the following key elements: functional performance, postural control, lower extremity muscle strength, balance, and functional stability of the trunk and knee. The exercises will be mainly performed in a closed kinetic chain. Each exercise was performed in 2 sets of 12 repetitions, with rest time corresponding to the duration of 1 set. The exercises will be performed bilaterally. To allow for progression, 4 levels of difficulty were available for each exercise except for the kettlebell swing and cable/elastic-band exercises, which had 3 levels each. Patients will be progressed when the supervising physiotherapist deemed that an exercise was performed with good sensorimotor control and good quality (by visual inspection) and patients perceived that they could perform the movement with minimal exertion and with control of the movement. Cooling down included gait retraining (eg, walking in various ways, including backward with an emphasis on alignment) and stretching exercises for the lower extremity muscles (10 minutes) (Villadsen et al., 2014). Based on earlier studies (Fransen et al., 2015 and Ageberg et al., 2010) the intervention period will be set to 6 weeks, with 3weekly sessions (30 minutes each session). 12
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
o Patients with chronic bilateral or unilateral KOA and their osteoarthritic changes on radiograph showing grades II or III on KL scale (Kellgren and Lawrence, 1957). o Age ranged from 45 to 55 years (Lawrence et al., 2008). o Both genders (male and female). o Body mass index ranged from 25-29.9 kg/m2 o Rheumatoid arthritic condition. o Diabetic patients. o Previous knee operation. o Visual and vestibular problems. o Corticosteroids injection (within last 6 months). o Any lower limb fractures or deformities. o Participants who have neurological condition that affected their balance or movement (i.e. Parkinson's or Multiple sclerosis) and vascular disorders. Middle Aged: 45 Year(s)-64 Year(s) 45 Year(s) 55 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 24/06/2020 physical therapy Cairo university
Ethics Committee Address
Street address City Postal code Country
7th el zayat university giza 12511 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome static and dynamic balance before and after treatment
Secondary Outcome proprioception, pain, functional and maximum voluntary contraction before and after treatment
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
faculty of physical therapy 7th elzayat street giza 12511 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
aya T Allah Eissa 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 university street giza 12511 Egypt University
COLLABORATORS
Name Street address City Postal code Country
RAGIA Mohamed Kamel RASHAD 7th el zayat street giza 12511 Egypt
ENAS El Sayed Mohamed ABUTALEB 7 th el zayat street giza 12511 Egypt
Rania Reda Mohamed 7th el zayat street giza 12511 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Aya T Allah Eissa Aya_eissa88@yahoo.com 0201118862236 7th el zayat street
City Postal code Country Position/Affiliation
giza 12511 Egypt physiotherapist
Role Name Email Phone Street address
Scientific Enquiries RAGIA Mohamed aya_eissa88@yahoo.com 0201118862236 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 ENAS El Sayed Enas_abuTaleb@yahoo.com 0201152588308 7th el zayat street
City Postal code Country Position/Affiliation
giza 12511 Egypt Assistant Professor of physical therapy
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Will individual participant data be available (including data dictionaries)? Yes What data in particular will be shared? we will share the results of : 1- static and dynamic balance 2- proprioception 3- pain 4- functional 5- maximum voluntary contraction What other documents will be available? study protocol When will data be available (start and end date)? Not applicable With who? Not applicable For what types of analyses? Not applicable By what mechanism will date be made available? Not applicable Study Protocol one year the criteria will be accessed by the publication of trials in international journal
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