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.: PACTR202308598603482 Date of Approval: 31/08/2023
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Effect of virtual exercices, exergame, Tai Chi and traditional training on psychosocial and physiological outcomes in College North African adolescents with Cerebral Palsy
Official scientific title Effect of virtual exercices, exergame, Tai Chi and traditional training on psychosocial and physiological outcomes in College North African adolescents with Cerebral Palsy
Brief summary describing the background and objectives of the trial Cerebral palsy (CP) is a neurodevelopmental disorder that manifests during infancy or early childhood due to brain injury or developmental abnormalities. Adolescents with CP experience various challenges such as physical spasticity, weak muscle tone, skeletal deformities, and developmental coordination disorders, resulting in impaired balance and limited motor skills. The aim of this study is to investigate the effect of virtual exercices, exergame, Tai Chi and traditional training on psychosocial and physiological outcomes in North adolescents with 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 Physical activity and nutrition
Anticipated trial start date 01/06/2023
Actual trial start date 01/06/2023
Anticipated date of last follow up 31/08/2023
Actual Last follow-up date
Anticipated target sample size (number of participants) 20
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
Crossover: all participants receive all interventions in different sequence during study Randomised Simple randomization using by using procedures such as coin-tossing or dice-rolling Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group virtual exercise One session per week 40 minutes virtual exercise biking using the commercial Virzoom headset (VR) 20
Experimental Group exergame one session per week 40 minutes exergame using xbox kinect games 20
Experimental Group Tai Chi one session per week 40 minutes Tai Chi basic movements. 20
Control Group Traditional therapy one session per week 40 minutes Traditional therapy : standard bike exercice. 20 Dose Comparison
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Adolescent aged between 13 and 17 years, Medical diagnosis of spastic Cerebral Plasy confirmed by a pediatric neurologist; Motor function classified at level I or II according to the Gross Motor Function Classification System (GMFCS V), PA levels below the international norm of less than 1 hour daily at >5 metabolic equivalents (MET), indicating moderate or vigorous intensity , Lack of regular sports participation, defined as less than three sessions per week for 20 minutes or more, Reported issues with mobility in daily life or sports. Engaging in a week of moderate to intense exercise exceeding 150 minutes per week; the Gross Motor Function Classification System level III to V, iii) Behavioral issues that prevent participation in group activities or a movement disorder primarily dyskinetic or atactic in nature, Recent surgery within the previous six months, Botulinum toxin treatment, Serial casting within the recent three months, or scheduled procedures during the intervention period. Adolescent: 13 Year-18 Year 13 Year(s) 17 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 25/01/2022 Comite de protection des personnes sud C.P.P.SUD
Ethics Committee Address
Street address City Postal code Country
Nb 1105 Route Menzel Chaker Cite Erriadh Sfax 3003 Tunisia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Attention, vigor, memory, desicion making, denomination, language,orientation,anger, confusion, self esteem, tension, enjoyment. before and immediately after
Secondary Outcome spasticity pre and immediately after the session
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Sfax Association for the Care of the Physically Handicapped Mohamed Kacem Msedi Sfax 3000 Tunisia
FUNDING SOURCES
Name of source Street address City Postal code Country
Self funded avenue chiheb street el AIN KM 1 Sfax 3000 Tunisia
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Makrem Soudani street el Ain km 1 Sfax 3000 Tunisia Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Makrem Soudani soudani.makrem@gmail.com +21628320527 street el ain km 1
City Postal code Country Position/Affiliation
Sfax 3000 Tunisia researcher
Role Name Email Phone Street address
Public Enquiries Makrem Soudani soudani.makrem@gmail.com +21628320527 street el ain km 1
City Postal code Country Position/Affiliation
Sfax 3000 Tunisia researcher
Role Name Email Phone Street address
Scientific Enquiries Makrem Soudani soudani.makrem@gmail.com +21628320527 street el ain km 1
City Postal code Country Position/Affiliation
Sfax 3000 Tunisia researcher
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data will be available. Individual participant data that underline the results reported in this article, after deidentification (text, tables, figures and appendices) will be shared. Informed Consent Form It will be available in March 2024. This study, conducted in Tunisia, focuses on cognitive function and decision-making in the context of health, utilizing a cross-sectional research design. The scholarly article will be published between June 2023 and March 2024. The study's content will be sourced from a journal. The keywords guiding the search include cognitive function, decision-making, health, RCT, training, virtual reality, and cerebral palsy. Access level details are pending determination.
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