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.: PACTR202104880476288 Date of Approval: 16/04/2021
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Effects of whole-body vibration exercise on hamstrings-to-quadriceps ratios, walking ability and balance in children with hemiparetic cerebral palsy
Official scientific title Effects of whole-body vibration exercise on hamstrings-to-quadriceps ratios, walking performance and postural control in children with hemiparetic cerebral palsy: a randomized controlled study
Brief summary describing the background and objectives of the trial PURPOSE: To investigate the effects of WBV training associated with conventional physical therapy on the hamstrings-to-quadriceps ratios, walking performance, and postural control in children with hemiparetic CP. BACKGROUND: Children with CP have poor muscle strength and control, which limit functional activities as standing and walking [7]. Also, the quadriceps and hamstring muscles are affected in hemiplegic CP which are important for functional activities as transitioning from sitting to standing, ascending, descending stairs, and antigravity control during stance phase of gait [8]. The whole body vibration (WBV) training is an exercise program performed with the body on a vibration platform [9]. These vibrations can stimulate the muscle spindles’ primary endings and thereby activate motor neurons, which cause muscle contraction, similar to the tonic vibration reflex [10]. Therefore, WBV has positive effects on muscle performance [11]. WBV exercise increases muscle strength and power that could lead to improvements in the quality of the neuromuscular functions. It reduces the rehabilitation time compared with other traditional resistance training programs [12]. Whole body vibration has also been proposed as a treatment for children and adults with spastic CP. It is simply applied while subjects stand on an oscillating platform. Some studies have shown that whole body vibration decreases the spasticity of patients with stroke, spinal cord injury and multiple sclerosis [13–15]. A whole body vibration intervention decreases spasticity and improves walking speed, muscle strength and gross motor function without any side effects in adults with CP [14]. WBV training has beneficial effects on improvements of leg muscle strength, bone mineral density (BMD), back pain and health-related quality of life [16]. Moreover, Wren et al. [17] showed significant improvement in their lower limbs muscle function and bone mass in children with reduced mobility and/or decreased bone mass.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Paediatrics
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 25/04/2021
Actual trial start date
Anticipated date of last follow up 25/06/2021
Actual Last follow-up date
Anticipated target sample size (number of participants) 44
Actual target sample size (number of participants) 40
Recruitment status Closed to recruitment,follow-up continuing
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 Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group regular physical therapy program for rehabilitation of such patients 3 times/week , one hour each session. For 2 successive months The control group will receive the regular physical therapy program for rehabilitation of such patients which includes stretching exercise to maintain the length and elastic properties of the muscles which are liable to tightness especially Achilles tendon, hamstring, hip flexor and adductor (for lower extremity) shoulder internal rotator, elbow and wrist flexor, pronator, ulnar deviator (for upper extremity), strength training to hip flexor, knee extensor, ankle dorsiflexor, facilitation of postural reactions to improve postural mechanisms via variety of exercises applied on ball and balance board through tilting from different positions in forward, backward and sideways, approximation as a proprioceptive training applied in a slow and rhythmic manner for upper limbs, lower limbs and trunk to control spasticity and stimulate the joint mechanoreceptors from semi reclined and quadruped positions, facilitation of single limb support, balance training from different positions, from quadruped position, kneeling, half kneeling and standing position on mat and tilting board, facilitation of parachutes reactions by applying fast and large amplitude of the stimulus to train saving reactions from sitting on roll, also from standing position by pushing the child to enhance the child to take protective steps either forward, backward or sideways to regain balance [23], gait training activities also will be important elements for balance training including training of walking on different floor surfaces (Spongy and hard surfaces) on mat, on the floor and on the carpets [24]. 20 Active-Treatment of Control Group
Experimental Group whole body vibration 3 times/week , one hour each session. for 2 successive months The study group will receive the previously mentioned physical therapy program and whole body vibration session by using a whole body vibration platform. The whole body vibration program composed of number of positions as the children stand in erect position, stand on one leg and stand facing hand rails according to Ibrahim et al.[25] on vibrating platform. This platform vibrates horizontally at frequency ranged from 10-25 Hz that increases gradually [26]. The program duration of each position was 2 minutes first month and increased to be 3 minutes second month, rest period between each position was one minute in first month, half a minute in second month. The duration of the vibration exposure was 10 minutes. Manual mode will be selected for maximum efficiency of exercising and to prevent accommodation. 20
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1- spasticity ranged from 1 to 1+ grade according to modified Ashwarth scale [19] 2- Able to understands and follow verbal commands and instruction included in both evaluation and treatment. 3- They were able to stand alone and walk whatever gait pattern is, 4- Their height were 1 meter or more to be able to stand on WBV device and their hands grasping the hand rails 1- patients with visual or auditory defects, 2- patients with fixed deformities in either one of the lower extremities, 3- patient with history of convulsions, patient receiving anti spastic drugs 4- patients with history of surgical interference in the lower limbs musculoskeletal system Child: 6 Year-12 Year 4 Year(s) 8 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 07/02/2021 Scientific Research Ethics Committee Faculty of physical therapy Cairo university
Ethics Committee Address
Street address City Postal code Country
7 U Ahmed Zayat - Ben El- Sarayat - Dokki, Giza Cairo 11865 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Increase the walking performance in children with hemiparetic CP After 8 weeks of intervention
Primary Outcome Increase the quadriceps and hamstring muscles strength ratio in children with hemiparetic CP After 8 weeks of intervention
Primary Outcome Increase the overall, anteroposterior, and mediolateral stability indices in children with hemiparetic CP After 8 weeks of intervention
Secondary Outcome Improve the postural control and gait in children with hemiparertic CP After 8 weeks of intervention
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Faculty of physical therapy Cairo university El-Tahrir st. - in front of Ben El- Sarayat Traffic - Dokki- Giza Cairo 11865 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Principal Invesigator El-Tahrir st. - in front of Ben El- Sarayat Traffic - Dokki- Giza Cairo 11865 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Faculty of Physical therapy Cairo University El-Tahrir st. - in front of Ben El- Sarayat Traffic - Dokki- Giza Cairo 11865 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Dr. Amr almaz El-Tahrir st. - in front of Ben El- Sarayat Traffic - Dokki- Giza Cairo 11865 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Rania G. Hegazy raniagalal2011@yahoo.com +201027466206 El-Tahrir st. - in front of Ben El- Sarayat Traffic - Dokki- Giza
City Postal code Country Position/Affiliation
Cairo 11865 Egypt Lecturer in pediatric physical therapy department Faculty of Physical Therapy Cairo University
Role Name Email Phone Street address
Public Enquiries Amr Almaz Abdelaziem amralmaz@yahoo.com 00201006229996 El-Tahrir st. - in front of Ben El- Sarayat Traffic - Dokki- Giza
City Postal code Country Position/Affiliation
Cairo 11865 Egypt Professor in department of Bio mechanics Faculty of Physical therapy Cairo university
Role Name Email Phone Street address
Scientific Enquiries Rania G. Hegazy raniagalal2011@yahoo.com +201027466206 El-Tahrir st. - in front of Ben El- Sarayat Traffic - Dokki- Giza
City Postal code Country Position/Affiliation
Cairo 11865 Egypt Lecturer in pediatric physical therapy department Faculty of Physical Therapy Cairo University
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All of the individual participant data collected during and after deidentification Analytic Code,Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol Immediately following publication Open access
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