Cerebral Palsy Spastic DiplegiaNCT07534228
Comparative Effects of Play-Based Therapy and NDT in Diplegic CP
A study testing Group B Play-Based Therapy and Group A NDT in people with Cerebral Palsy Spastic Diplegia, run by University of Lahore at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 12 years
- Conditions the study is for
- Cerebral Palsy Spastic Diplegia
- What is being tested?
- Group B Play-Based Therapy and Group A NDT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 sitePakistan
- Study dates
- 31 Aug 2025to 17 Apr 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
University of Lahore teaching hospital
Lahore, Punjab Province, 54000
About this study
Official title: 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.
Read more
- 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).
- 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
Read the 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.
- Conditions
- Cerebral Palsy Spastic Diplegia
- Being tested
- Group B Play-Based Therapy, Group A NDT
- Keywords
- Neurodevelopmental Therapy, Play Based Therapy, Spastic diplegic cerebral palsy, Fine motor skills, Spasticity, Quality of life
- Medical subject headings
- Cerebral Palsy, Muscle Spasticity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 A NDTOther
Resistance Bands, Small Dumbbells, Stress Ball Squeezes frequency is 4 days a week for 12 consecutive weeks.
time: 40 minutes per session
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). Receives: Other: Group B Play-Based Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peabody Developmental Motor Scales (PDMS-2)
for evaluating fine motor skills.
Measured: from enrollment to the end of treatment at 12 weeks
Modified Ashworth Scale (MAS)
To measure muscle spasticity (tone) in the limbs.
Measured: at the time of enrollment and at the end of 12 week
Secondary outcomes (1)
CHQ
To measure health-related quality of life
Measured: at the time of enrollment then 8 week and then 12 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2026
- Study start31 Aug 2025
- Primary completion15 Apr 2026 (estimated)
- Study completion17 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral Palsy Spastic DiplegiaStudies of the same condition, open and under way.
- More trials run by University of LahoreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Lahore
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hira Majeed Bhutta, MS-NMPT, Study chair, University of Lahore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07534228
- Sponsor's protocol ID
- UOL/IREB/25/09/0033
- Status last verified
- Nov 2025
- First submitted
- 9 Apr 2026
- Last updated
- 16 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Play-based Therapy Versus Neurodevelopmental Therapy in Children With Diplegic Cerebral Palsy
- ClinicalTrials.gov ID
- NCT07534228
- Acronym / sponsor ID
- UOL/IREB/25/09/0033
- Conditions
- Cerebral Palsy Spastic Diplegia
- Keywords
- Neurodevelopmental Therapy, Play Based Therapy, Spastic diplegic cerebral palsy, Fine motor skills, Spasticity, Quality of life
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of LahoreUniversity, hospital or other
- Study start
- 31 Aug 2025 (actual)
- Primary completion
- 15 Apr 2026 (estimated)
- Study completion
- 17 Apr 2026 (estimated)
- First posted
- 16 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
- 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
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A NDT | Experimental | Other: Group A NDT5-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). |
| Group B Play-Based Therapy | Experimental | Other: Group B Play-Based Therapy5-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). |
Who may qualify
- Ages
- 8 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Group B Play-Based TherapyBuilding blocks, puzzles, Arts and crafts. frequency 4 days a week for 12 consecutive weeks time duration is 45 minutes per session | Other | Group B Play-Based Therapy |
| Group A NDTResistance Bands, Small Dumbbells, Stress Ball Squeezes frequency is 4 days a week for 12 consecutive weeks. time: 40 minutes per session | Other | Group A NDT |
Primary outcome
Peabody Developmental Motor Scales (PDMS-2)
Time frame: from enrollment to the end of treatment at 12 weeks
for evaluating fine motor skills.
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.
1 secondary outcome
CHQ
Time frame: at the time of enrollment then 8 week and then 12 week
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2026.
- Individual participant dataSharing planned: No
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Additional Effects on tDCS With AOT on Lower Limb Functions on Children With Diplegic CP
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Dual-Task Training in Children With Spastic Diplegic Cerebral Palsy
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Sleep Quality, Caregiver Burden, Stress, and Self-Efficacy in Parents of Children With Spastic Diplegic Cerebral Palsy: A Comparison by Night Orthosis Use
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Effects of Transcranial Direct Current Stimulation Combined With Virtual Reality on Gait and Self-Esteem in Children With Spastic Cerebral Palsy
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hira Majeed Bhutta, MS-NMPT study chair
University of Lahore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group B Play-Based Therapy and Group A NDT in people with Cerebral Palsy Spastic Diplegia, run by University of Lahore at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 16 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peabody Developmental Motor Scales (PDMS-2) (time frame: from enrollment to the end of treatment at 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2026.