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.: PACTR202207804171810 Date of Approval: 25/07/2022
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Gait and obesity in autistic children
Official scientific title The Efficacy of Treadmill Walking Program on gait and Body mass index of children with Autism spectrum disorder
Brief summary describing the background and objectives of the trial Autism is a developmental disorder which presents before three years of age . It is a spectrum of pervasive developmental disorders and is found across all ethnic cultures and economic groups. Children with ASD have been found to demonstrate numerous gait stereotypies such as pacing, jumping, hopping, skipping, and spinning. Children with ASD tend to augment their walking stability with a reduced stride length, increased step width and therefore wider base of support, and increased time in the stance phase. Children with ASD have reduced range of motion at the ankle and knee during gait, with increased hip flexion. While exercise studies have been performed with youth diagnosed with severe developmental disabilities including autism, the main interest was the reduction of maladaptive behaviors and not specifically the ability to increase exercise capacity or the reduction of body weight. The overall findings of the studies conducted in these areas are inconclusive.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Mental and Behavioural Disorders
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Rehabilitation
Anticipated trial start date 15/02/2022
Actual trial start date 15/02/2022
Anticipated date of last follow up 30/04/2022
Actual Last follow-up date
Anticipated target sample size (number of participants) 30
Actual target sample size (number of participants)
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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Simple randomization using by using procedures such as coin-tossing or dice-rolling Sealed opaque envelopes Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group conventional physical therapy 3 times per week 8 weeks gait, balance and daily activity training 15 Active-Treatment of Control Group
Control Group typically developing children none null null 15 Dose Comparison
Experimental Group treadmill walking program 3 times per week 8 weeks treadmill walking program progressed in speed and duration 15
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Patients' age ranged from 4 to 9 years old The diagnosis of the autism spectrum disorder groups established according to criteria of DSM-5 and Gilliam Autism Rating Scale They were able to follow simple verbal commands and instructions. History of co-morbid medical (e.g. Tuberous sclerosis) or psychiatric disorder (e.g. Attention deficit hyperactivity disorder). Visual, auditory defects. Diagnosed genetic disorders (e.g. Fragile X disorder). Child: 6 Year-12 Year,Preschool Child: 2 Year-5 Year 4 Year(s) 9 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 05/01/2021 Research ethical committe faculty of physical therapy
Ethics Committee Address
Street address City Postal code Country
7 Ahmed elzyat street Giza 12611 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome gait kinematics 2 points pre and post treatment
Secondary Outcome body mass index 2 points pre and post treatment
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Faculty of Physical Therapy Cairo University 7 Ahmed elzyat street Giza 12611 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Mona Ayad 138 elshourok housing Cairo 4450113 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor faculty of physical therapy Cairo university 7 Ahmed elzyat street Giza 12611 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Mona Ayad 138 elshourok housing Cairo 4450113 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mona Ayad dr_mona_ayad@cu.edu.eg 0201011669150 138 Elshorouk housing Nasr city
City Postal code Country Position/Affiliation
Cairo 11765 Egypt lecturer of pediatric physical therapy Cairo university
Role Name Email Phone Street address
Public Enquiries Mona Ayad dr_mona_ayad@cu.edu.eg 0201011669150 138 Elshourouk housing Nasr city
City Postal code Country Position/Affiliation
Cairo 11765 Egypt lecturer of pediatric physical therapy Cairo university
Role Name Email Phone Street address
Scientific Enquiries Mona Ayad dr_mona_ayad@cu.edu.eg 0201011669150 138 Elshourouk housing Nasr city
City Postal code Country Position/Affiliation
Cairo 11765 Egypt lecturer of pediatric physical therapy Cairo university
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes raw data will not be available results will be shared Informed Consent Form,Study Protocol from study completion and for 12 months researchers interested in the topic
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