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.: PACTR201804003309197 Date of Approval: 07/04/2018
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title The impact of auditory rhythmic cueing on gross motor skills in children with autism
Official scientific title The impact of auditory rhythmic cueing on gross motor skills in children with autism
Brief summary describing the background and objectives of the trial A total of 30 autistic children aged 8¿10 years with mild to moderate autistic features participated in this study. They were randomly allocated to either the control group (n=15), which underwent a specially designed physical therapy program, or the study group (n=15), which underwent the same program in addition to gait training with rhythmic auditory stimulation. The Bruininks-Oseretsky Test of Motor Proficiency 2nd Edition was used to assess gross motor skills at baseline and after 3 months of intervention.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Autism,Mental and Behavioural Disorders,Paediatrics
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Rehabilitation
Anticipated trial start date 17/09/2017
Actual trial start date 24/09/2017
Anticipated date of last follow up 01/03/2018
Actual Last follow-up date 08/03/2018
Anticipated target sample size (number of participants) 40
Actual target sample size (number of participants) 30
Recruitment status Stopped early/ terminated
Publication URL https://www.jstage.jst.go.jp/browse/jpts/-char/en
Secondary Ids Issuing authority/Trial register
Ethics Review Committee of the Faculty of Physical Therapy, Cairo University, Egypt P.T. REC/012/001849
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 randomisation using by using procedures such as coin-tossing or dice-rolling Sealed opaque envelopes Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group gait training with rhythmic auditory stimulation 30 min/session, 3 times/week 3 successive months To apply the RAS protocol, the MIDI Cubase musical instrument digital interface program along with a metronome was used to control the rhythmic tempo for each participant. The metronome beats were played over the music in order to enhance the rhythmic recognition for each child. The metronome set up was matched directly with the child¿s step pattern. The playback equipment and speakers 15
Control Group Specially designed physical therapy program 1 hour, 3times/week 3 successive months strengthening exercises for the trunk and extremities,balance training from different positions, stoop and recover from standing, facilitation of anticipatory mechanism, gait training using different obstacles, and ascending and descending stairs on alternate feet. 15 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
- They had borderline IQ and were able to follow verbal instructions during the testing and treatment procedures. - All children 90 were able to walk independently for at least 10 m without a walking aid. Children were excluded from this study if 91 they had auditory, visual, or respiratory deficits, or fixed deformities of the extremities. 8 Year(s) 10 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 11/02/2018 Ethics Review Committee of the Faculty of Physical Therapy, Cairo University, Egypt
Ethics Committee Address
Street address City Postal code Country
7 Ahmed Al-Zayyat Dokki Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Gross motor skills, scale score ( Bilateral coordination, Balance, Strength, Running speed and agility) - before the intervention program. - after the intervention program.
Secondary Outcome Gross motor skills, Standard score ( Body coordination, strength and agility) - before the intervention program. - after the intervention program.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Men Hakky At'lem Mogama' Elmahakem St. Mansoura 35111 Egypt
Bedaya Physical Therapy Centre Abdelsalam Aref st. Mansoura 35111 Egypt
Erada Toreel st. Mansoura 35111 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
No Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Secondary Sponsor Faculty of Physical Therapy - Cairo University 7 Ahmed Al-Zayyat Dokki Egypt University
COLLABORATORS
Name Street address City Postal code Country
Samah Attia Tolba El Shemy 7 Ahmed Al-Zayyat Dokki Egypt
Mohamed Salah El-Sayed Awad 7 Ahmed Al-Zayyat Dokki Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Samah Attia El Shemy Samah_elshemy@yahoo.com 00201005014313 7 Ahmed Alzyat st. Giza -Egypt
City Postal code Country Position/Affiliation
Dokki Egypt Assistant Professor of Pediatric Physical Therapy, Cairo University¿
Role Name Email Phone Street address
Public Enquiries Mohamed Salah El-Sayed melsayed@horus.edu.eg 002001017173755 13 Al-Quds st. Mubarak City - Mansoura
City Postal code Country Position/Affiliation
Mansoura Egypt Demonstrator in the department of faculty of Physical Therapy ¿ Horus University in Egypt.
Role Name Email Phone Street address
Scientific Enquiries Samah Attia El Shemy Samah_elshemy@yahoo.com 00201005014313 7 Ahmed Elzayat street, Dokki
City Postal code Country Position/Affiliation
Dokki Egypt Assistant Professor of Pediatric Physical Therapy, Cairo University¿
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
URL Results Available Results Summary Result Posting Date First Journal Publication Date
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