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.: PACTR202508833841732 Date of Registration: 01/08/2025
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Effects of structured physical exercise program and relaxation modalities on the quality of life, cognitive function, gross motor function, spasticity, and muscle strength of children and adolescents with cerebral palsy.
Official scientific title Effects of structured physical exercise program and relaxation modalities on the quality of life, cognitive function, gross motor function, spasticity, and muscle strength of children and adolescents with cerebral palsy.
Brief summary describing the background and objectives of the trial Cerebral palsy (CP) affects approximately 1.5 to more than 4 per 1,000 live births worldwide (Physiopedia, 2024) and it is the leading cause of disability in children globally. Children and adolescents with CP face challenges related to motor control, communication, and daily activities. Executive function deficits further impact their ability to plan, organize, and adapt to changing situations. Physical activity and relaxation techniques have shown promise in improving these outcomes and quality of life, but rigorous research is needed to establish their efficacy. Objectives 1. Systematic Review: i. Conduct a rigorous systematic review of relevant literature on the effects of physical activities in children and adolescents with cerebral palsy. ii. Synthesize evidence related to QOL, cognitive function, functional performance, and neuromuscular system. 2. Cross-Sectional Study: i. Assess baseline characteristics of children and adolescents with cerebral palsy. ii. Measure QOL, cognitive function, functional performance using standardized tools. 3. Randomized Controlled Trial (RCT): i. Randomly assign participants to physical activity, relaxation, or combined intervention groups. Implement physical activities and relaxation interventions. ii. Evaluate changes in the identified outcomes over a specified period. iii. Perform rigorous statistical analyses to determine intervention efficacy.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Musculoskeletal Diseases,Orthopaedics,Pregnancy and Childbirth
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Rehabilitation
Anticipated trial start date 27/05/2025
Actual trial start date 31/05/2025
Anticipated date of last follow up 26/08/2025
Actual Last follow-up date 31/07/2025
Anticipated target sample size (number of participants) 35
Actual target sample size (number of participants) 35
Recruitment status 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
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using a randomization table created by a computer software program Numbered containers Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Physical exercise and resistant exercises and aerobic exercise and both combined and relaxation Each training session will be 1 hour 30 minutes long. The program will last for 12 weeks, with 5 days a week of training. o The intervention program will focus on a variety of activities to address different motor functions: i. Aerobic Exercise: Adapted cycling, or wheelchair-based activities. ii. Strength Training: This will be administered using, bodyweight exercises, or modified weightlifting. iii. Balance and Coordination: Stability exercises will be administered using the wobble board. iv. Functional Movements: Patients will practice functional tasks (e.g., transfers, reaching, standing).  Intervention will include both weight-bearing and non-weight-bearing exercises. 20
Control Group NDT 30 minutes 12 weeks Standard care (NDT) 15 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
 Children and adolescents diagnosed with cerebral palsy that is spastic in nature  Age range (e.g., 6 to 17 years)  Severe comorbidities that may interfere with study outcomes.  Inability to participate in physical activities or relaxation sessions.  Patients were excluded if they had unstable seizures, Adolescent: 13 Year-18 Year,Child: 6 Year-12 Year 6 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 25/10/2024 University of Nigeria Teaching Hospital Health Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
University of Nigeria Teaching Hospital Ituku Ozalla, P.M.B. 01129, Enugu Enugu 400102 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome  Quality of Life: Assess using validated questionnaires (CP Quality of life(CP QOL-Child) and (CP QOL-Teen) questionnaire). 10 weeks
Secondary Outcome  Functional Performance: Will evaluate motor skills, mobility, and daily activities (Gross Motor Function Measure).  Cognitive Function: Administer cognitive tests (Modified Stroop test).  Neuromuscular system: Assess muscle strength and spasticity (oxford muscle grading technique and modified Ashworth scale).  Adherence to Interventions: Monitor attendance and compliance. 10weeks after intervention
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
University of Nigerian Teaching Hospital University of Nigerian Teaching Hospital Ituku Ozalla Enugu 400102 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Ohaike Stella University of Nigeria Teaching Hospital Ituku Ozalla P.M.B. 01129 Enugu 400102 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Ohaike Stella University of Nigeria Teaching Hospital, Ituku Ozalla P.M.B. 01129 Enugu 400102 Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
Sam Ibeneme University of Nigeria Teaching Hospital Ituku Ozalla P.M.B 01129 Enugu 400102 Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Stella Ohaike ohaikestella71@gmail.com 08037820402 University of Nigeria Teaching Hospital Ituku Ozalla, P.M.B. 01129
City Postal code Country Position/Affiliation
Enugu 400102 Nigeria Researcher
Role Name Email Phone Street address
Scientific Enquiries Sam Ibeneme sam.ibeneme@unn.edu.ng 07038138435 University Of Nigeria Teaching Hospital Ituku Ozalla, P.M.B. 01129
City Postal code Country Position/Affiliation
Enugu 4000102 Nigeria Researcher
Role Name Email Phone Street address
Public Enquiries Princess Ferdinand princess.ferdinand2017@gmail.com 09030035563 University of Nigeria Teahing Hospital Ituku Ozalla, P.M.B. 01129
City Postal code Country Position/Affiliation
Enugu 400102 Nigeria Researcher
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Cerebral palsy (CP) is a group of permanent disorders of movement and posture development, attributed to non-progressive disturbances in the developing fetal or infant brain. Children and adolescents with CP often experience reduced functional capacity, impaired cognition, muscle weakness, spasticity, and lower quality of life. Various interventions such as physical activity (e.g., aerobic training, resistance training, stretching, therapeutic exercises) and relaxation modalities (e.g., yoga, meditation, massage, breathing exercises) have shown promise in addressing these concerns. While aggregate data meta-analyses have been conducted, they are limited by publication bias and heterogeneity in outcome reporting. An Individual Participant Data (IPD) meta-analysis enables a more precise and comprehensive synthesis by using raw data from each participant across studies. This approach allows for subgroup analysis (e.g., age, severity level) and adjustment for confounders. Informed Consent Form 23/08/2025-23/12/2025 Ohaike Stella Ifeanyinwa
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
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 31/07/2025 initial error Experimental Group, Relaxation exercises, Each training session will be 30 minutes long, resulting in a total dose of 25 hours. , The program will last for 10 weeks, with 5 days a week of training., o The intervention program will focus on a variety of activities to address different motor functions: i. Aerobic Exercise: Adapted cycling, or wheelchair-based activities. ii. Strength Training: This will be administered using, bodyweight exercises, or modified weightlifting. iii. Balance and Coordination: Stability exercises will be administered using the wobble board. iv. Functional Movements: Patients will practice functional tasks (e.g., transfers, reaching, standing).  Intervention will include both weight-bearing and non-weight-bearing exercises. , 20, Experimental Group, Physical exercise and resistant exercises and aerobic exercise and both combined and relaxation, Each training session will be 1 hour 30 minutes long. , The program will last for 12 weeks, with 5 days a week of training., o The intervention program will focus on a variety of activities to address different motor functions: i. Aerobic Exercise: Adapted cycling, or wheelchair-based activities. ii. Strength Training: This will be administered using, bodyweight exercises, or modified weightlifting. iii. Balance and Coordination: Stability exercises will be administered using the wobble board. iv. Functional Movements: Patients will practice functional tasks (e.g., transfers, reaching, standing).  Intervention will include both weight-bearing and non-weight-bearing exercises. , 20,
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 24/07/2025 iniial error Experimental Group, NDT,  5-10 minutes,  The duration will be adjusted based on individual attention span and comfort, Will continue with standard care (NDT)., 20, Experimental Group, NDT,  5-10 minutes,  The duration will be adjusted based on individual attention span and comfort, Will continue with standard care (NDT)., 15,
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 31/07/2025 initial error Control Group, NDT, 5-10 minutes, 10 weeks, Standard care (NDT), 15, Active-Treatment of Control Group Control Group, NDT, 30 minutes, 12 weeks, Standard care (NDT), 15, Active-Treatment of Control Group