- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07238634
Effects of DMI vs Bobath on Neuromuscular Development in CP (DMINDTSCP)
Comparative Effects of Dynamic Movement Intervention and Bobath Approach on Neuromuscular Development in Spastic Cerebral Palsy
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Cerebral palsy (CP) is a major cause of permanent motor disability in childhood and is defined as a group of non-progressive disorders affecting movement and posture due to disturbances in the developing fetal or infant brain. Its etiology is multifactorial, with prematurity and low birth weight identified as the strongest risk factors. Population-based European studies indicate that infants weighing less than 1500 g at birth have up to a 70-fold greater risk of developing CP compared with those born weighing over 2500 g.
Spastic CP is the most prevalent subtype, with spastic diplegia accounting for approximately 30-40% of cases. This subtype primarily affects the lower extremities and is characterized by increased muscle tone, poor trunk control, and persistent limitations in functional mobility. Clinical presentation varies from isolated motor deficits in focal brain injury to complex impairments involving sensory, cognitive, communicative, and behavioral domains when brain involvement is extensive.
Recent meta-analyses report a decline in CP prevalence in high-income countries to approximately 1.6 per 1,000 live births, whereas substantially higher rates, up to 3.4 per 1,000 live births, persist in low- and middle-income countries. In Pakistan, regional data from Khyber Pakhtunkhwa report a prevalence of 1.22 per 1,000 live births, with a male predominance. Beyond clinical impact, CP imposes a considerable economic burden, with estimated lifetime costs exceeding USD 860,000 per affected individual.
Current CP management aligns with the International Classification of Functioning, Disability, and Health (ICF) framework, emphasizing activity, participation, and functional independence. Although early intervention benefits cognitive outcomes, sustained improvements in motor function remain inconsistent. Traditional neurodevelopmental approaches, particularly the Bobath method, focus on tone regulation and movement facilitation; however, systematic reviews indicate limited evidence supporting their superiority over task-oriented therapies. Consequently, contemporary guidelines advocate for evidence-based, goal-directed interventions that yield meaningful functional outcomes.
Dynamic Movement Intervention (DMI) is a task-based therapeutic approach grounded in neuroplasticity principles, emphasizing repetitive, progressive, and functionally relevant activities. Given the proximal-to-distal pattern of motor development, trunk control is fundamental for balance, coordination, and mobility. Evidence suggests that trunk-focused training on dynamic surfaces enhances postural control, sensory integration, and gross motor function more effectively than static surface exercises. Task-oriented training further promotes motor learning through repetition of meaningful activities, facilitating adaptive reorganization of motor pathways.
Randomized trials and systematic reviews support the effectiveness of trunk-targeted and task-oriented interventions in improving trunk stability, balance, and gross motor function in children with CP. However, direct comparisons between DMI and the Bobath approach remain limited, particularly in young children with spastic diplegic CP. Moreover, the Trunk Impairment Scale (TIS), a validated predictor of functional mobility, has been underutilized as a primary outcome measure. This study aims to address these gaps by comparing the effects of DMI and Bobath therapy on neuromuscular development in children aged 2-4 years with spastic diplegic CP using validated outcome measures, including the GMFM-88, SSDT, and TIS.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Atiqa Niamat
- Phone Number: 03039559523
- Email: atiqaniamat09@gmail.com
Study Locations
-
-
Punjab Province
-
Lahore, Punjab Province, Pakistan
- Recruiting
- Ghurki Trust Teaching Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Group A
|
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.
|
|
Active Comparator: Group B
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Gross Motor Function Measure-88 (GMFM-88)
Time Frame: 12 weeks
|
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)
Time Frame: 12 weeks
|
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)
Time Frame: 12 weeks
|
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
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Cerebral Palsy Quality of Life Questionnaire for Children (CP QOL-Child)
Time Frame: 12 weeks
|
A validated caregiver-reported questionnaire that evaluates health-related quality of life in children with cerebral palsy.
It covers emotional well-being, social participation, physical health, and overall life satisfaction.
|
12 weeks
|
Collaborators and Investigators
Publications and helpful links
General Publications
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- UBS24LMSPT027
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Bobath Therapy
-
Universidad Rey Juan CarlosCompletedVirtual Reality | Bobath Therapy | Postural Control | Home Exercise ProgramSpain
-
Pamukkale UniversityCompletedDown Syndrome | Motor Performance | Bobath Therapy | Vojta TechniqueTurkey
-
University of SevilleCompletedGait | Physical Therapy | Sports Physical Therapy | Exercise TherapySpain
-
Inova Health Care ServicesRecruitingGynecologic Cancer | Exercise Therapy | Radiation TherapyUnited States
-
Biotronik SE & Co. KGCompletedCardiac Resynchronization Therapy | Pacemaker TherapyGermany, Austria, Spain, Switzerland
-
University of Sao PauloUnknownFrail Elderly | Exercise Therapy | Physical Therapy Techniques
-
Catarina TeixeiraCompletedCognitive Behavioral Therapy | Emotion Focused TherapyPortugal
-
Palo Alto Veterans Institute for ResearchCompletedWritten Exposure Therapy | Imaginal Exposure TherapyUnited States
-
University of Rhode IslandCompletedCognitive Behavior Therapy | Relaxation Therapy | Motivational Intervention | Nicotine AnonymousUnited States
-
Chang Gung Memorial HospitalRecruitingOccupational Therapy | Clinical Competence | Occupational Therapy EducationTaiwan
Clinical Trials on Dynamic Movement Intervention
-
Cairo UniversityRecruiting
-
University of South CarolinaCompleted
-
Riphah International UniversityCompleted
-
Uşak UniversityCompletedAdolescent | Healhty | Football | Warm-upTurkey (Türkiye)
-
University Hospital of FerraraUniversità degli Studi di FerraraRecruiting
-
Trustees of Dartmouth CollegeNational Institutes of Health (NIH)Not yet recruitingAnorexia Nervosa | Bulimia Nervosa | Eating Disorders | Binge Eating Disorder | Other Specified Feeding or Eating Disorder
-
Rigshospitalet, DenmarkChromaviso A/SRecruitingStroke | Circadian Dysregulation | Post Stroke Fatigue | Post Stroke DepressionDenmark
-
Hillel Yaffe Medical CenterUnknownBorderline Personality DisorderIsrael
-
Philips Clinical & Medical Affairs GlobalCompletedCoronary Artery DiseaseIsrael, United States, Belgium, Spain
-
Ewan ThomasCompleted