- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07420244
Task-oriented Training Versus Group Circuit Training in Children With Quadriplegic Cerebral Palsy
Task-oriented Training Versus Group Circuit Training in Children With Quadriplegic Cerebral
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Cerebral palsy (CP) is a non-progressive neurological disorder characterized by impairments in movement, posture, and functional abilities, significantly limiting a child's participation in daily activities. Children with quadriplegic cerebral palsy experience greater functional limitations, particularly in gross motor performance and functional capacity, necessitating effective and structured rehabilitation interventions.
Task-oriented training and circuit training are commonly used therapeutic approaches in pediatric neurorehabilitation. Task-oriented training focuses on practicing meaningful, goal-directed functional tasks to enhance motor learning and functional performance whereas group circuit training emphasizes repetitive, structured exercises performed in a circuit format to improve strength, endurance, and motor skills. However, limited evidence exists comparing the effectiveness of these two approaches specifically in children with quadriplegic cerebral palsy.
This randomized controlled trial aims to compare the effects of task-oriented circuit training and group circuit training on functional performance and functional capacity in children with quadriplegic cerebral palsy. Eligible participants will be randomly allocated into two intervention groups. One group will receive task-oriented circuit training combined with conventional physical therapy, while the other group will receive group circuit training along with conventional physical therapy.
Functional performance will be assessed using the Gross Motor Function Measure-88 (GMFM-88), and functional capacity will be evaluated using the Activities Scale for Kids-Capability version (ASK-C). Assessments will be conducted at baseline (pre-intervention) and after completion of the intervention period (post-intervention).
The results of this study are expected to provide evidence regarding the comparative effectiveness of task-oriented circuit training and group circuit training, thereby assisting clinicians in selecting appropriate rehabilitation strategies to improve functional outcomes in children with quadriplegic cerebral palsy.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Noor Fatima, MSPT Neurology
- Phone Number: 03026699547
- Email: 70076588@student.uol.edu.pk
Study Contact Backup
- Name: Dr. Wardah Rauf Physiotherapist, DPT, MSPT-N
- Email: noor_fatima28@outlook.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Children diagnosed with spastic quadriplegic cerebral palsy.
- Age between 7 and 12 years.
- Gross Motor Function Classification System (GMFCS) level II or III.
- Both genders.
- Lower limb spasticity graded between 1 and 1+ on the Modified Ashworth Scale.
- Ability to understand and follow simple instructions.
- No serious or recurrent medical complications.
Exclusion Criteria:
- Presence of fixed orthopedic deformities affecting balance or movement.
- Visual, auditory, vestibular, or perceptual deficits.
- History of seizures or epilepsy.
- Orthopedic surgery or botulinum toxin injections within the past 6 months.
- Participation in other structured rehabilitation programs during the study period.
- Presence of neuromuscular disorders other than cerebral palsy.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Task-Oriented Circuit Training Group
Participants in this group will receive task-oriented circuit training combined with conventional physical therapy.
|
Task-oriented circuit training will include goal directed functional tasks such as sit-to-stand activities, balance tasks, walking-related activities, and functional mobility tasks arranged in a circuit format.
The intervention will focus on improving functional performance through repetitive practice of meaningful tasks.
|
|
Active Comparator: Group Circuit Training Group
Participants in this group will receive a combination of group circuit training and conventional physical therapy.
|
Group circuit training will consist of structured exercise stations that focus on strength, balance, endurance, and gross motor activities, all performed in a group setting.
Exercises will be performed in a circuit format under therapist supervision.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Functional Performance
Time Frame: From baseline to the end of treatment at 16 weeks
|
Functional performance will be assessed using the Gross Motor Function Measure-88 (GMFM-88), which evaluates gross motor abilities across five dimensions (lying/rolling, sitting, crawling/kneeling, standing, walking/running). Ordinal scale 0-3 (0=does not initiate, 3=completes), resulting in a percentage score (0-100%) for each dimension and total score. |
From baseline to the end of treatment at 16 weeks
|
|
Functional Capacity
Time Frame: From baseline to the end of treatment at 16 weeks
|
Functional capacity will be measured using the Activities Scale for Kids-Capability version (ASK-C), a validated questionnaire assessing a child's ability to perform daily activities. This scale consists of 30 items, each rated on a 5-point ordinal scale. 0= with no problem
|
From baseline to the end of treatment at 16 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Noor Fatima, MSPT- Neurology, University of Lahore
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- UOL/IREB/25/15/03/31
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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