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Active, Not Recruiting

NCT Number: NCT07534228

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

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Cerebral Palsy Spastic Diplegia Brain Damage, Chronic Brain Diseases Central Nervous System Diseases Cerebral Palsy Muscle Hypertonia Muscle Spasticity Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

8 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Lahore teaching hospital

Lahore, Punjab Province, 54000, Pakistan

About this study

To compare the efficacy of play-based therapy versus NDT in improving fine motor skills in children with Spastic Diplegic Cerebral Palsy.

Inclusion criteria

  • Confirmed medical diagnosis of spastic diplegic cerebral palsy by a healthcare professional.
  • Children aged between 8 to 12 years old (Raipure, Kovela, & Harjpal, 2023).
  • 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).(Raipure et al., 2023).
  • 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.(Raipure et al., 2023).

All participants will be given the intervention for 45 minutes, 4 days a week, for 3 consecutive weeks.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Group B Play-Based Therapy

Other

Building blocks, puzzles, Arts and crafts. frequency 4 days a week for 12 consecutive weeks time duration is 45 minutes per session

Group A NDT

Other

Resistance Bands, Small Dumbbells, Stress Ball Squeezes frequency is 4 days a week for 12 consecutive weeks.

time: 40 minutes per session

Primary outcomes

  1. Peabody Developmental Motor Scales (PDMS-2)

    Time frame: from enrollment to the end of treatment at 12 weeks

    for evaluating fine motor skills.

  2. Modified Ashworth Scale (MAS)

    Time frame: at the time of enrollment and at the end of 12 week

    To measure muscle spasticity (tone) in the limbs.

Secondary outcomes

  1. CHQ

    Time frame: at the time of enrollment then 8 week and then 12 week

    To measure health-related quality of life

Sponsors and collaborators

Lead sponsor

University of Lahore

Other

Registry information

Official study title

Play-based Therapy Versus Neurodevelopmental Therapy in Children With Diplegic Cerebral Palsy

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Apr 16, 2026
Registry last updated
Apr 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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