Sensory Integration Versus Bobath on Hand Function in Hemiplegia

April 24, 2025 updated by: Radwa Gomaa Abd El aziz Said, Cairo University

Sensory Motor Integration Versus Bobath Approach on Hand Functions in Hemiplegia Cerebral Palsy Children

Hand skills do not develop in isolation; it is the result of neurologic development, physiologic maturation and adaptation, and functional development of learned patterns of motion and motor learning Hand skills in HCP are very complex and sensitive as it considered the main issue in playing and achieving milestones, so identification of this problem and its solution is very essential and play a miserable rule in adaptive response which is a basis of child's occupation. so, the current study is conducting to investigate the difference between sensory motor integration approach and bobath technique on hand function as manual dexterity, fine motor precision and fine motor integration on children with hemiplegic cerebral palsy

Study Overview

Status

Active, not recruiting

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:

    1. Preparation phase
    2. 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

Interventional

Enrollment (Estimated)

52

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Giza, Egypt
        • Faculty of physical therapy Dokki,Giza Egypt,

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Age ranges from 6 to 12 years.
  2. Both genders.
  3. Diagnosis of hemiplegia.
  4. Level II-III on Manual Ability Classification System (MACS)
  5. Spasticity grade 2 to 3 on Modified Ashworth Scale (MAS)
  6. Level II-III on Gross Motor Classification System (GMCS)

Exclusion Criteria:

  1. Significant mental or psychological problems.
  2. Significant visual/auditory problem.
  3. Botox injection and/or surgery of the affected upper limb in the past 12 months.
  4. Surgical procedures of the affected upper limb.
  5. Fixed deformities in the affected upper limb.
  6. Comorbid physical diseases such as myopathy, neuropathy, and other central and peripheral nervous system disorders.

    -

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

  • Study group "1" will receive regular physical therapy for 45 minutes/time in addition to sensory motor integration for 45 minutes/time 3 days per week for 3 months
Experimental: - Study group "2" will receive regular physical therapy for 45 minutes/time in addition to bobath

*study group ( 2) bobath techniquefor 45 minutes/time 3 days per week for 3 months in the form of:

  1. Preparation phase
  2. Intervention program (Movement facilitation &Functional training)

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

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2024

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

January 1, 2027

Study Registration Dates

First Submitted

February 27, 2025

First Submitted That Met QC Criteria

April 24, 2025

First Posted (Actual)

May 2, 2025

Study Record Updates

Last Update Posted (Actual)

May 2, 2025

Last Update Submitted That Met QC Criteria

April 24, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

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)?

YES

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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