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.: PACTR201907896910981 Date of Approval: 05/07/2019
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Shoulder stabilization exercise and grip strength in Down syndrome child
Official scientific title Influence of Shoulder Stabilization Exercises On Hand Grip Strength in Children With Down Syndrome.
Brief summary describing the background and objectives of the trial Children with Down syndrome present with hypotonia, ligamentous laxity, dysplasia of middle-phalanx of fifth finger, short broad hands and single transverse palmar crease. Hand function comprises of prehensile (power grip and precision handling) and nonprehensile skilled movements which are the important components in the execution of daily living activities. Shoulder stability and coordinated control of the shoulder girdle muscles are important for upper extremity functions and to properly position the hand for delicate manipulation. Hence; there is need to investigate the influence of shoulder stabilization exercises on hand grip strength in children with Down syndrome.
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 02/05/2019
Actual trial start date 02/05/2019
Anticipated date of last follow up 05/07/2019
Actual Last follow-up date 05/07/2019
Anticipated target sample size (number of participants) 40
Actual target sample size (number of participants)
Recruitment status Completed
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 by using procedures such as coin-tossing or dice-rolling Sealed opaque envelopes Masking/blinding used Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group shoulder stabilization exercise 3 times per week 8 weeks experimental group receive five shoulder stabilization exercises plus school activity performed only for the both arms. exercise applied bilaterally includes positions that should be hold for 10 seconds followed by 3 seconds rest and repeated 10 times ( the positions are: prone static, quadruped static, bear position, side sitting with dominant arm support and side sitting with non-dominant arm support). Ten repetitions will be considered one set, and the children will be conducted three sets. A break of 3 minutes will be given between each set. 20
Control Group school activity 3 times per wek 8 weeks control group engaged in school activities for 30 min 20 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1-Children ages will be ranged from 8 to 15 years old. 2-Confirmed diagnosis of Down syndrome by a pediatric neurologist. 3-Independent standing and walking. 4-Functional hearing and vision. 5- Mild mental retardation with IQ level (50-70) by a specialist in the school. Children with Down syndrome will be excluded from the study if they have any of the following:- 1-Pain of upper extremities. 2-Symptomatic neurologic/ orthopedic dysfunction of upper extremities. 3-Injury of cervical region (e.g: atlantoaxial instability). 4-Thyroid disease. 5-Chest wall disorders. 6-Rhuematic and congenital heart disease. 7-History of previous surgical operation. 8-Regular participation in any sport activities. 9-Severe mental retardation. Adolescent: 13 Year-18 Year,Child: 6 Year-12 Year 8 Year(s) 15 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 13/11/2018 scientific research ethics committee
Ethics Committee Address
Street address City Postal code Country
faiyum- beni suef Rd beni-suef 62521 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome hand grip strength pre and post intervention
Secondary Outcome pinch grasp strength pre and post intervention
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Intellectual education school for special needs children 1 Asmaa Zaghlol street- Nasr city Cairo 11765 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
noha elserty 57 elmaksy street Cairo 11672 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor eman wagdy emtidad ramses Cairo 11759 Egypt Individual
COLLABORATORS
Name Street address City Postal code Country
eman wagdy nasr city- emtedad ramsees buildings Cairo 11759 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator eman wagdy famousemo83@yahoo.com +201008079576 emtidad ramses- nasr city
City Postal code Country Position/Affiliation
Cairo 11759 Egypt lecturer of physical therapy
Role Name Email Phone Street address
Public Enquiries Noha Elserty noha_elserty@hotmail.com +201006709648 57 elmaksy street- shobra
City Postal code Country Position/Affiliation
Cairo 11672 Egypt lecturer of physical therapy
Role Name Email Phone Street address
Scientific Enquiries Noha Elserty noha_elserty@hotmail.com +20100679648 57 elmaksy street- shobra
City Postal code Country Position/Affiliation
Cairo 11672 Egypt lecturer of physical therapy
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes all IPD data will be shared including the underlie results in the publication Analytic Code,Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol the IPD data will be shared 6 months after the publication IPD will be shared to researcher who work in the same field and correspond with the corresponding author
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