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

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

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

Study Overview

• Status: Active, not recruiting
• Conditions: Cerebral Palsy Spastic Diplegia
• Intervention / Treatment: Other: Group A NDT; Other: Group B Play-Based Therapy

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Pakistan
  • Punjab Province
    • Lahore, Punjab Province, Pakistan, 54000
      • University of Lahore Teaching Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group A 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).	Other: Group A NDT; Resistance Bands, Small Dumbbells, Stress Ball Squeezes frequency is 4 days a week for 12 consecutive weeks. time: 40 minutes per session
Experimental: Group B Play-Based Therapy; 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).	Other: Group B Play-Based Therapy; Building blocks, puzzles, Arts and crafts. frequency 4 days a week for 12 consecutive weeks time duration is 45 minutes per session

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Peabody Developmental Motor Scales (PDMS-2)	for evaluating fine motor skills.	from enrollment to the end of treatment at 12 weeks
Modified Ashworth Scale (MAS)	To measure muscle spasticity (tone) in the limbs.	at the time of enrollment and at the end of 12 week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
CHQ	To measure health-related quality of life	at the time of enrollment then 8 week and then 12 week

Collaborators and Investigators

• Sponsor: University of Lahore
• Investigators: Study Chair: Hira Majeed Bhutta, MS-NMPT, University of Lahore

Study record dates

Study Major Dates

• Study Start (Actual): August 31, 2025
• Primary Completion (Estimated): April 15, 2026
• Study Completion (Estimated): April 17, 2026

Study Registration Dates

• First Submitted: April 9, 2026
• First Submitted That Met QC Criteria: April 9, 2026
• First Posted (Actual): April 16, 2026

Study Record Updates

• Last Update Posted (Actual): April 16, 2026
• Last Update Submitted That Met QC Criteria: April 9, 2026
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: Quality of life; Spasticity; Fine motor skills; Neurodevelopmental Therapy; Play Based Therapy; Spastic diplegic cerebral palsy
• Additional Relevant MeSH Terms: Neurologic Manifestations; Musculoskeletal Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Muscular Diseases; Muscle Hypertonia; Neuromuscular Manifestations; Brain Damage, Chronic; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Muscle Spasticity; Cerebral Palsy
• Other Study ID Numbers: UOL/IREB/25/09/0033

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No