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.: PACTR202006704135699 Date of Approval: 17/06/2020
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Effects of whole body vibration on quadriceps and hamstring muscles strength and lower extremity performance in children with cerebral palsy: A randomized controlled trial
Official scientific title Effects of whole body vibration on quadriceps and hamstring performance cerebral palsy children
Brief summary describing the background and objectives of the trial Background and objectives: Quadriceps and hamstring muscles are affected in hemiplegic cerebral palsy (CP) which are important for functional activities as standing and walking. So, this study aimed to examine the effects of whole-body vibration (WBV) training in conjunction with conventional physical therapy on quadriceps and hamstring muscles strength, endurance, and power in children with CP.
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 01/09/2019
Actual trial start date 01/09/2019
Anticipated date of last follow up 29/02/2020
Actual Last follow-up date 29/02/2020
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 physical therapy program 3 times/week for 2 successive months, one hour each session by the same physical therapist for 8 weeks of intervention The control group received the regular physical therapy program for rehabilitation of such patients which includes; 1) 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), 2) strength training to hip flexor, knee extensor, ankle dorsiflexor, 3) 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, 4) 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, 5) facilitation of single limb support, 6) balance training from different positions, from quadruped position, kneeling, half kneeling and standing position on mat and tilting board, 7) 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 , 8) 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. 20 Active-Treatment of Control Group
Experimental Group physical therapy program and Whole Body Vibration 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.the treatment program 3 times/week for 2 successive months, one hour each session by the same physical therapist for 8 weeks of intervention The study group received the previously mentioned physical therapy program and Whole Body Vibration training session by using a WBV platform (Galileo Med L Plus model 2000, Novotech Medical GmbH, Germany). The WBV program composed of number of positions as the children stand in erect position, stand on one leg and stand facing hand rails on vibrating platform. This platform vibrates horizontally at frequency ranged from 10-25 Hz that increases gradually with amplitude 2 mm 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. 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. 4- patient receiving anti spastic drugs. 5- 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 05/01/2020 Scientific Research Ethics Committee Faculty of physical therapy Cairo uneversity
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 increased the strength, power and endurance of quadriceps and hamstring muscles in children with hemiparetic CP After 8 weeks of intervention
Secondary Outcome improve gait in children with hemiparetic CP 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 Investigator 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 Giza 11865 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Rania Galal 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 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 Eman El Hadidy eman.elhadidy@pt.cu.edu.eg +201223375282 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 pediatric physical therapy 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
Yes Addition of WBV training to the conventional physical therapy is more effective in enhancing quadriceps and hamstring muscles strength, power and endurance in children with hemiparetic CP compared to conventional physical therapy alone. Therefore, combination of WBV training with conventional physical therapy should be considered during designing a rehabilitation program for children with spastic CP. 06/05/2020 30/05/2020
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks No link
Changes to trial information