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.: PACTR201908766157563 Date of Approval: 16/08/2019
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Role of Rebound Therapy in the Rehabilitation of Children with Spastic Cerebral Palsy
Official scientific title Role of Rebound Therapy in the Rehabilitation of Children with Spastic Cerebral Palsy
Brief summary describing the background and objectives of the trial Cerebral palsy (CP) is a group of disorders of movement and posture, causing several body impairments. CP is caused by non-progressive disturbance that occurred in the fetal or immature brain. CP symptoms include several motor disorders such as disturbances in sensation, coordination, cognition, communication and behavior in addition to disturbances in postural stability, balance and coordination (Shevell, 2018; Liao and Hwang, 2011). Balance is the ability to maintain the center of body mass over the base of support. CP causes balance impairment which results in decrease in the child’s mobility functions and causing activity limitation and participations restrictions (Laforme Fiss et al., 2019). Motor coordination is the registration of two or more things such as body movements , timing or sensory feedback into a harmonious relationship (Cordo and Gurfinkel, 2004). CP causes disturbances in motor coordination such as difficulties in the routine gross movements as running and jumping, and disturbances in common fine movements like buttoning, clothing or brushing hair (Payne and Isaacs, 2012). Rebound therapy is an exercise therapy which uses mini trampolines, rebounders , Springfree Trampoline and Swiss balls, to provide opportunity to perform recreational movements for individuals with different body structural and functional impairments (Rebound therapy Association, 2019) Purposes of the Study: To evaluate the effect of rebound therapy on gross motor function, balance and gross motor coordination in children with spastic cerebral palsy.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Nervous System Diseases
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 05/08/2019
Actual trial start date
Anticipated date of last follow up 30/06/2021
Actual Last follow-up date
Anticipated target sample size (number of participants) 32
Actual target sample size (number of participants) 32
Recruitment status Active, not 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 Dynamic (adaptive) random allocation such as minimization Allocation was determined by the holder of the sequence who is situated off site Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Rebound Therapy 2-3 times/ week 3-4 Successive months will receive in addition to especially designed exercises using rebound therapy (Mini Trampoline) that include standing, squatting, single limb squatting, kneeling position, kneeling catch and throw a ball, stand while catching and throw a ball, broad jumping with assistance, jumping in place and jumping while catching and throw a ball, for 1 hour three times per week for three successive months. 15
Control Group Physical Therapy Program 2-3 times / week 3-4 months especially designed physical therapy program for children based on Neuro-Developmental treatment (NDT) approach with emphasis on exercise encourage independent standing, Stretches exercises, strengthening exercises, approximation, enhancement and facilitation of gait patterning and ankle ROM exercises for one hour, three times per week for three successive months. 15 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. children with spastic cerebral palsy will be determined according to the sample size calculation, level I according to the Gross Motor Function Classification System (GMFCS) will be selected From the outpatients clinic of the faculty of Physical Therapy Cairo University 2. Their chronological age ranged from 5 to 8 years. 3. Their height will be above 1 meter. 4. The degree of spasticity ranged from 1 to 1+ according to Modified Ashworth’ Scale. 5. Rebound therapy using trampoline will be used as the method of management in the study group in addition to the selected physical therapy program that will be used in both groups, and the treatment sessions will be provided in the out-patient clinic of the faculty of Physical Therapy Cairo University. 1. Any child who is mental abilities is not in the average level. 2. Any child that show vertigo or dizziness. 3. Epilepsy. Child: 6 Year-12 Year,Preschool Child: 2 Year-5 Year 5 Year(s) 11 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 01/09/2019 Research Ethical Committee of Faculty of Physical Therapy Cairo University
Ethics Committee Address
Street address City Postal code Country
7 Ahmed el zayat street from El-Tahrir street in front of Ben El- Sarayat Traffic - Dokki Giza Giza 11432 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The effect of rebound therapy on gross motor coordination , Gross motor function and balance . after 3-4 month of intervention
Secondary Outcome To change the idea of rebound therapy from being considered as intervention method rather than an entertainment tool 1 year after publication
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Outpatients Clinic Faculty of Physical Therapy Cairo University 7 Ahmed el zayat street from El-Tahrir street in front of Ben El- Sarayat Traffic - Dokki - Giza Giza 11432 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Alaa Noureldeen Kora 19 Elmohdeseen buildings , Behind City stars, Nasr city , Cairo Cairo 11371 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Secondary Sponsor Laboratories of the Faculty of Physical Therapy Cairo University 7 Ahmed El Zayat Bien El sarayat, Dokky, Giza Giza 11432 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Faten Hassan Abdelaziem 7 Ahmed ELzayat St. Bien El sarayat, Dokki, Giza Giza 11432 Egypt
Ayman Kilany 33 El Buhouth Street , Dokki Giza 12622 Egypt
Alaa Noureldeen Kora El Qantara El Sharqiya, Ismailia Governorate Ismailia 41636 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Faten Hassan Abdelaziem faten.hassan@pt.cu.edu.eg +201008554818 7 Ahmed ELzayat St. Bien El Sarayat, Dokki, Giza
City Postal code Country Position/Affiliation
Giza 11432 Egypt Professor at the Department of Physical Therapy for Paediatrics Faculty of Physical Therapy Cairo University
Role Name Email Phone Street address
Public Enquiries Amany Abdelfattah elmo3azlddeenallah@gmail.com +201003311449 19 Elmohdeseen Street , Nasr City
City Postal code Country Position/Affiliation
Cairo 11371 Egypt Former Investigator
Role Name Email Phone Street address
Scientific Enquiries Hoda El Talawy hoda_eltalawy@hotmail.com +201006605506 7 Ahmed ELzayat St. Bien El Sarayat, Dokky, Giza
City Postal code Country Position/Affiliation
Giza 11432 Egypt Professor at the Department of Physical Therapy for Paediatrics Faculty of Physical Therapy Cairo University
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes The stability index The Gross motor coordination via BOT The percentage of Gross motor function Informed Consent Form,Statistical Analysis Plan,Study Protocol 2 years Controlled access. The study protocol , statistical analysis plan , consent form , results raw data will be available. Reviewers should be qualified in physical therapy and rehabilitation
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