NCT07238634

Brief Summary

Cerebral palsy (CP) is a leading cause of permanent motor disability in children, resulting from non-progressive disturbances to the developing brain. Prematurity and low birth weight are major risk factors, with infants under 1500 g having a markedly higher risk. Spastic CP is the most common subtype, and spastic diplegia accounts for 30-40% of cases, primarily affecting the lower limbs and trunk control. CP prevalence has declined in high-income countries but remains higher in low- and middle-income regions, including Pakistan. Beyond clinical challenges, CP imposes a substantial lifelong economic burden. Current management follows the ICF framework, emphasizing function, participation, and independence. Traditional approaches such as the Bobath method show limited evidence compared with task-oriented therapies. Dynamic Movement Intervention (DMI) is a neuroplasticity-based, task-oriented approach emphasizing repetitive functional activities. Trunk-focused dynamic training has shown superior improvements in balance and gross motor function. However, comparative evidence between DMI and Bobath therapy in young children is limited, necessitating further research using validated outcome measures.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
58

participants targeted

Target at P25-P50 for not_applicable

Timeline
1mo left

Started Jan 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress79%
Jan 2026Jun 2026

First Submitted

Initial submission to the registry

November 16, 2025

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 20, 2025

Completed
2 months until next milestone

Study Start

First participant enrolled

January 5, 2026

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 10, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 10, 2026

Last Updated

January 12, 2026

Status Verified

January 1, 2026

Enrollment Period

5 months

First QC Date

November 16, 2025

Last Update Submit

January 8, 2026

Conditions

Keywords

Dynamic Movement InterventionBobath TherapySpastic Cerebral Palsy

Outcome Measures

Primary Outcomes (3)

  • Gross Motor Function Measure-88 (GMFM-88)

    A standardized observational tool used to assess changes in gross motor function across five dimensions, including lying, sitting, crawling, standing, and walking, specifically designed for children with cerebral palsy.

    12 weeks

  • Shoaib Sensorimotor Development Tool (SSDT)

    A specialized tool designed to assess sensorimotor development in children, including sensory integration, motor planning, and coordination. It provides insight into neuromotor function beyond gross motor skills.

    12 weeks

  • Trunk Impairment Scale (TIS)

    Evaluates trunk control through assessments of static sitting balance, dynamic sitting balance, and trunk coordination. It is essential for measuring core stability and postural control improvements.

    12 weeks

Study Arms (2)

Group A

EXPERIMENTAL
Other: Dynamic Movement Intervention

Group B

ACTIVE COMPARATOR
Other: Bobath Therapy

Interventions

Participants will receive Dynamic Movement Intervention (DMI) consisting of task-specific, structured, repetitive, and progressively challenging exercises designed to improve neuromuscular control. The intervention will be delivered for 12 weeks, with evaluations at baseline (week 0), mid-intervention (week 6), and post-intervention (week 12). DMI sessions will include dynamic tasks such as rolling on soft or unstable surfaces to promote trunk rotation and segmental control; sitting balance training on therapy balls or foam pads with perturbations to activate trunk and head righting responses; and trunk stability exercises in quadruped and kneeling positions to enhance coordination and proprioception. Standing activities on balance discs or BOSU balls will target weight shifting, small squats, and multidirectional reaching for balance control, while walking tasks on varied surfaces(foam mats, tactile paths and beams)will challenge gait, coordination, and postural alignment.

Group A

Participants in this group will receive therapy based on the Bobath Concept (Neurodevelopmental Treatment), an evidence-informed, problem-solving approach designed to facilitate normal movement patterns, inhibit abnormal tone, and improve postural control and functional mobility in children with spastic cerebral palsy. The intervention will be implemented over 12 weeks, with evaluations at baseline (week 0), mid-intervention (week 6), and post-intervention (week 12). The Bobath approach emphasizes individualized handling and facilitation techniques aimed at enhancing postural alignment, balance reactions, and coordinated functional movements. The therapist uses guided facilitation at key points of control-such as the pelvis, trunk, and shoulders-to promote normal movement synergies and reduce the influence of spasticity or abnormal reflex patterns.

Group B

Eligibility Criteria

Age2 Years - 4 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Diagnosed with spastic diplegic cerebral palsy.
  • Gross Motor Function Measurement Scale (GMFC) level I to III.
  • Children who have head control.
  • Ability to understand and follow simple instructions.

You may not qualify if:

  • Visual or hearing impairments (e.g., cataract, myopia, deafness).
  • Cognitive problems impacting participation.
  • Uncontrolled convulsions or recent seizure activity.
  • Orthopedic surgeries of the lower limbs, such as dorsal rhizotomy within the last year.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ghurki Trust Teaching Hospital

Lahore, Punjab Province, Pakistan

RECRUITING

Related Publications (2)

  • Park EY, Kim WH. Effect of neurodevelopmental treatment-based physical therapy on the change of muscle strength, spasticity, and gross motor function in children with spastic cerebral palsy. J Phys Ther Sci. 2017 Jun;29(6):966-969. doi: 10.1589/jpts.29.966. Epub 2017 Jun 7.

  • Sah AK, Balaji GK, Agrahara S. Effects of Task-oriented Activities Based on Neurodevelopmental Therapy Principles on Trunk Control, Balance, and Gross Motor Function in Children with Spastic Diplegic Cerebral Palsy: A Single-blinded Randomized Clinical Trial. J Pediatr Neurosci. 2019 Jul-Sep;14(3):120-126. doi: 10.4103/jpn.JPN_35_19. Epub 2019 Sep 27.

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Interventional Study Model: Randomized Clinical Trial (Parallel-Group Design): This study will adopt a randomized clinical trial (RCT) model, employing a parallel-group design to evaluate and compare the effects of two physiotherapeutic interventions-Dynamic Movement Intervention (DMI) and the Bobath (Neurodevelopmental) Approach-on neuromuscular development in children with spastic cerebral palsy. Participants who meet the inclusion criteria will be randomly assigned into two groups: Group A (Experimental Group): will receive Dynamic Movement Intervention (DMI). Group B (Control Group): will receive therapy based on the Bobath Approach. Both groups will undergo intervention sessions of equal duration and frequency under standardized conditions. Pre- and post-intervention assessments will be conducted using validated neuromuscular and functional outcome measures to ensure objectivity.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 16, 2025

First Posted

November 20, 2025

Study Start

January 5, 2026

Primary Completion (Estimated)

June 10, 2026

Study Completion (Estimated)

June 10, 2026

Last Updated

January 12, 2026

Record last verified: 2026-01

Locations