Children With HemiplegiaNCT06955247
Sensory Integration Versus Bobath on Hand Function in Hemiplegia
A study testing sensory motor integration and bobath technique in people with Children With Hemiplegia, run by Cairo University at 1 site in Egypt.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Children With Hemiplegia
- What is being tested?
- sensory motor integration and bobath technique
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2025to 1 Apr 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 6 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age ranges from 6 to 12 years.
- Both genders.
- Diagnosis of hemiplegia.
- Level II-III on Manual Ability Classification System (MACS)
- Spasticity grade 1to 1+ on Modified Ashworth Scale (MAS)
- Level II-III on Gross Motor Classification System (GMCS)
Who cannot join
- 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.
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read the 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 )25 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
- Conditions
- Children With Hemiplegia
- Being tested
- sensory motor integration, bobath technique
- Keywords
- sensory integration, Hand function
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sensory motor integrationOther
Study group (1) 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 and in terms of the type of activity it was divided into three categories: active, passive
bobath techniqueOther
*study group ( 2) bobath techniquefor 45 minutes/time 3 days per week for 3 months in the form of:
- Preparation phase
- Intervention program (Movement facilitation \&Functional training)
| Study group | Role | What they receive |
|---|---|---|
| Subjects will be randomly allocated in to equal two study groups: - Study group "1" will receiv | Experimental | Subjects will be randomly allocated in to equal two study groups 25 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 Receives: Other: sensory motor integration |
| - Study group "2" will receive regular physical therapy for 45 minutes/time in addition to bobath | Experimental | Not described Receives: Other: bobath technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hand functions
Hand functions as manual dexterity, fine motor precision and fine motor integration will be assessed using Bruininks-Oseretsky Test of Motor Proficiency 2nd Edition
Measured: 45-60 minutes
Secondary outcomes (1)
Spasticity
Spasticity will be assessed using electromyographic apparatus (H/M ratio )
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2025
- Study start1 Feb 2025
- Primary completion1 Apr 2026
- Study completion1 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Children With HemiplegiaStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe 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
- Model description
- Subjects will be randomly allocated in to equal two study groups: * Study group "1" will receive sensory motor integration in addition to regular physical therapy * Study group "2" will receive bobath technique in addition to regular physical therapy
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Radwa Gomaa Abd El aziz Said, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06955247
- Sponsor's protocol ID
- P.T.REC/012/005588
- Other IDs
- radwa gomaa abd el AZIZ
- Status last verified
- Apr 2025
- First submitted
- 27 Feb 2025
- Last updated
- 29 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sensory Motor Integration Versus Bobath Approach on Hand Functions in Hemiplegia Cerebral Palsy Children
- ClinicalTrials.gov ID
- NCT06955247
- Acronym / sponsor ID
- P.T.REC/012/005588
- Conditions
- Children With Hemiplegia
- Keywords
- sensory integration, Hand function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Feb 2025 (actual)
- Primary completion
- 1 Apr 2026 (actual)
- Study completion
- 1 Apr 2026 (actual)
- First posted
- 2 May 2025 (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.
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
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 )25 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Subjects will be randomly allocated in to equal two study groups: * Study group "1" will receive sensory motor integration in addition to regular physical therapy * Study group "2" will receive bobath technique in addition to regular physical therapy
| Arm | Type | Receives |
|---|---|---|
| Subjects will be randomly allocated in to equal two study groups: - Study group "1" will receiv | Experimental | Other: sensory motor integrationSubjects will be randomly allocated in to equal two study groups 25 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 |
| - Study group "2" will receive regular physical therapy for 45 minutes/time in addition to bobath | Experimental | Other: bobath technique |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Age ranges from 6 to 12 years.
- Both genders.
- Diagnosis of hemiplegia.
- Level II-III on Manual Ability Classification System (MACS)
- Spasticity grade 1to 1+ on Modified Ashworth Scale (MAS)
Key exclusion criteria (7 listed)
- 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.
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 |
|---|---|---|
| sensory motor integrationStudy group (1) 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 and in terms of the type of activity it was divided into three categories: active, passive | Other | Subjects will be randomly allocated in to equal two study groups: - Study group "1" will receiv |
| bobath technique*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) | Other | - Study group "2" will receive regular physical therapy for 45 minutes/time in addition to bobath |
Primary outcome
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
1 secondary outcome
Spasticity
Time frame: 10 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2026.
- Individual participant dataSharing planned: Yes
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Electromyography Biofeedback Training Versus Mirror Therapy on Muscle Activity, Range of Motion and Function of Upper Limb in Children With Hemiplegia
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing sensory motor integration and bobath technique in people with Children With Hemiplegia, run by Cairo University at 1 site in Egypt.
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 6 inclusion and 7 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: finished, as of the sponsor's last update on 29 Jun 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 Egypt. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Hand functions (time frame: 45-60 minutes). 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 29 Jun 2026.