NCT07534228

Brief 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

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 31, 2025

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

April 9, 2026

Completed
6 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 15, 2026

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 16, 2026

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 17, 2026

Completed
Last Updated

April 16, 2026

Status Verified

November 1, 2025

Enrollment Period

8 months

First QC Date

April 9, 2026

Last Update Submit

April 9, 2026

Conditions

Cerebral Palsy Spastic Diplegia

Keywords

Neurodevelopmental TherapyPlay Based TherapySpastic diplegic cerebral palsyFine motor skillsSpasticityQuality of life

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (1)

  • CHQ

    at the time of enrollment then 8 week and then 12 week

Study Arms (2)

Group A NDT

EXPERIMENTAL

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

Group B Play-Based Therapy

EXPERIMENTAL

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

Interventions

Group B Play-Based TherapyOTHER

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

Group B Play-Based Therapy
Group A NDTOTHER

Resistance Bands, Small Dumbbells, Stress Ball Squeezes frequency is 4 days a week for 12 consecutive weeks. time: 40 minutes per session

Group A NDT

Eligibility Criteria

Age8 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Lahore teaching hospital

Lahore, Punjab Province, 54000, Pakistan

Location

MeSH Terms

Conditions

Cerebral PalsyMuscle Spasticity

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMuscular DiseasesMusculoskeletal DiseasesMuscle HypertoniaNeuromuscular ManifestationsNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Hira Majeed Bhutta, MS-NMPT

    University of Lahore

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 9, 2026

First Posted

April 16, 2026

Study Start

August 31, 2025

Primary Completion

April 15, 2026

Study Completion

April 17, 2026

Last Updated

April 16, 2026

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Locations

PA(1)