- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06955247
Sensory Integration Versus Bobath on Hand Function in Hemiplegia
Sensory Motor Integration Versus Bobath Approach on Hand Functions in Hemiplegia Cerebral Palsy Children
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Sensory integration therapy is the therapeutic mechanism of pediatrics through sensory augmentation which involves the child in enriched playful tasks, promoting a meaningful motor response. The sensory integration theories assume that an affected sensory reception would result in a defect or delay in the development of milestones among children with motor disorders.
The bobath approach provided a new reference aimed to normalize tone and facilitate volitional and automatic movement which tailors based on the patient's individual problems and situational context to manage problems with movement against gravity and postural control Participants will be assigned randomly into two groups of equal number (study group 1 and study group 2 )26 child in each group
- Study group "1" will receive regular physical therapy in addition to sensory motor integration for 45 minutes/time ,3 days per week for 3 months Treatment program included two parts: tactile sensation and proprioception stimulation programs. Each of them accounted half of the session
Study group"2" will receive regular physical therapy in addition to bobath therapy for 45 minutes/time 3 days per week for 3 months in the form of:
- Preparation phase
- Intervention program (Movement facilitation &Functional training) base line assessment and after three months re assessment will be taken for both groups using surface electromyography and Bruininks-Oseretsky Test of Motor Proficiency 2nd Edition
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Giza, Egypt
- Faculty of physical therapy Dokki,Giza Egypt,
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age ranges from 6 to 12 years.
- Both genders.
- Diagnosis of hemiplegia.
- Level II-III on Manual Ability Classification System (MACS)
- Spasticity grade 2 to 3 on Modified Ashworth Scale (MAS)
- Level II-III on Gross Motor Classification System (GMCS)
Exclusion Criteria:
- Significant mental or psychological problems.
- Significant visual/auditory problem.
- Botox injection and/or surgery of the affected upper limb in the past 12 months.
- Surgical procedures of the affected upper limb.
- Fixed deformities in the affected upper limb.
Comorbid physical diseases such as myopathy, neuropathy, and other central and peripheral nervous system disorders.
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Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Subjects will be randomly allocated in to equal two study groups: - Study group "1" will receiv
Subjects will be randomly allocated in to equal two study groups 26 in each group
|
|
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Experimental: - Study group "2" will receive regular physical therapy for 45 minutes/time in addition to bobath
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*study group ( 2) bobath techniquefor 45 minutes/time 3 days per week for 3 months in the form of:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Hand functions
Time Frame: 45-60 minutes
|
Hand functions as manual dexterity, fine motor precision and fine motor integration will be assessed using Bruininks-Oseretsky Test of Motor Proficiency 2nd Edition
|
45-60 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Spasticity
Time Frame: 10 minutes
|
Spasticity will be assessed using electromyographic apparatus (H/M ratio )
|
10 minutes
|
Collaborators and Investigators
Sponsor
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 (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- P.T.RCT/012/005588
- radwa gomaa abd el AZIZ (Registry Identifier: radwa gomaa abd el AZIZ)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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.
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