Active — Not RecruitingNot Applicable

Comparative Effects of Play-Based Therapy and NDT in Diplegic CP

Pakistan30 participantsStarted 2025-08-31

Plain-language summary

To compare the efficacy of play-based therapy versus NDT in improving fine motor skills in children with Spastic Diplegic Cerebral Palsy. Baseline Assessments (Pre-Intervention) To Establish baseline motor function, balance, and goals. * Standardized Tools (Conducted in Week 1): * Peabody Developmental Motor Scales (PDMS-2): Evaluate gross and fine motor skills. * Modified Ashworth Scale: Assess spasticity in lower and upper limbs. * Pediatric Balance Scale (PBS): Measure static and dynamic balance. * Parent/Child Goal Setting: Identify individualized goals (e.g., stair climbing, dressing independence). 1\. Play-Based Therapy (PBT) * 5-Minute Warm-Up: Gentle play (e.g., rolling a ball, stretching with ribbons) * Building Blocks: Focus on fine motor control, bilateral coordination, and problem-solving. * Puzzles: Enhance spatial awareness, grip strength, and cognitive engagement. * Arts and Crafts: Promote hand-eye coordination (e.g., cutting, drawing) and creativity. * Frequency: 4 days a week, for 3 consecutive weeks * Intensity: Moderate effort; tasks tailored to the child's skill level (e.g., 5 piece puzzles progressing to 10-piece). * Time: 45-minute sessions (30 minutes active play, 10 minutes rest/reinforcement). 2. Neurodevelopmental Therapy (NDT) * 5-Minute Warm-Up: Light mobility exercises (e.g., Hand pumps, seated marching). * Resistance Bands: Strengthen upper limbs (e.g. Bicep curls, shoulder abduction, chest presses.). * Small Dumbbells: Improve upper body strength (1-2 lbs for shoulder/arm exercises). * Stress Ball Squeezes: Enhance grip strength and hand function (5-10 reps/session). * Frequency: 4 days a week, for 3 consecutive weeks * Intensity: Moderate resistance; emphasize alignment and controlled movement * Time: 40-minute sessions (30 minutes active exercise, 10 minutes rest/feedback). Outcome Measures * Peabody Developmental Motor Scales (PDMS-2): for evaluating fine motor skills. * Modified Ashworth Scale (MAS): To measure muscle spasticity (tone) in the limbs. * CHQ: To measure health-related quality of life

Who can participate

Age range

8 Years – 12 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Confirmed medical diagnosis of spastic diplegic cerebral palsy by a healthcare professional. * Children aged between 8 to 12 years old. * Documented difficulties in fine motor skills, assessed by a standardized motor skills evaluation tool. * Ability to understand and follow instructions, with or without assistance, to participate in the therapy sessions. * Written informed consent from parents or legal guardians, allowing the child to participate in the study. Exclusion Criteria: * Presence of any other significant medical condition that might interfere * Diagnosis of other forms of cerebral palsy (e.g., hemiplegic, quadriplegic). * Severe cognitive impairments that would prevent understanding or participation in the therapy sessions. * Presence of uncontrolled medical conditions (e.g., severe epilepsy, cardiac conditions) that would pose a risk during physical activity. * Previous extensive therapy for fine motor skills in the past 6 months, which might influence the study outcomes. * Lack of compliance or cooperation from the child or parents/guardians during a preliminary assessment.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Peabody Developmental Motor Scales (PDMS-2)

Timeframe: from enrollment to the end of treatment at 12 weeks

Modified Ashworth Scale (MAS)

Timeframe: at the time of enrollment and at the end of 12 week

Trial details

NCT IDNCT07534228

SponsorUniversity of Lahore

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-04-15

View on ClinicalTrials.gov More Cerebral Palsy Spastic Diplegia trials