Cerebral Palsy, HemiplegicHeSPoMNCT06989034
Sensory Processing, Postural Stability, and Selective Motor Control in Children With Hemiplegia
An observational study of Cerebral Palsy, Hemiplegic and Sensory Processing Disorder, run by Cairo University at 1 site in Egypt.
Trial summary
The goal of this observational case-control study is to examine the relationship between sensory processing abilities, postural stability, and selective motor control (SMC) in children aged 6-10 years with hemiplegic cerebral palsy (CP). Read more about this study
- Who is it for?
- Ages 6 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Cerebral Palsy, Hemiplegic, Sensory Processing Disorder, Postural Balance
- What is being tested?
- Child Sensory Profile 2 (SP2) for Sensory processing abilities and HUMAC Balance System for Postural stability evaluation
- Type of treatment
- Pill or oral medicine
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Jan 2023to 2 Jan 2024
- Phase
- Observational
- 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 10 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: The study population divided into two groups. The first group includes 30 children diagnosed with spastic hemiplegic cerebral palsy (CP), a condition characterized by motor impairments affecting one side of the body due to early brain damage. These children are recruited from the outpatient clinic of the Faculty of Physical Therapy, Cairo University. The second group includes 30 age- and sex-matched typically developing children (TDC) who have no known neurological, orthopedic, or sensory processing disorders. These children are selected from mainstream schools in Luxor Governorate and are expected to exhibit typical development in sensory processing, motor control, and postural stability. The children in the CP group are part of a clinical setting with prior diagnoses and care, while the TDC group is sourced from an educational setting. The study aims to compare sensory processing abilities, postural stability, and selective motor control
Who may be able to join
- Diagnosis of spastic hemiplegic cerebral palsy
- Age between 6 and 10 years
- GMFCS levels I or II
- Modified Ashworth Scale score of 1 or 1+ (mild spasticity)
- Ability to follow simple instructions
- Caregiver with sufficient English language proficiency
Who cannot join
- Botulinum toxin injections within the past 6 months
- Visual or auditory impairments
- Orthopedic or neurosurgical intervention to limbs or spine
- Musculoskeletal deformities
- History of seizures
Trial locations and contacts
1 site in 1 country.
Egypt1 site
outpatient clinic, Faculty of Physical Therapy, Cairo University
Giza, Cairo Governorate, 12613
About this study
Official title: Sensory Processing Abilities in Relation to Postural Stability and Selective Motor Control in Children With Hemiplegia.
The goal of this observational case-control study is to examine the relationship between sensory processing abilities, postural stability, and selective motor control (SMC) in children aged 6-10 years with hemiplegic cerebral palsy (CP). The study compares outcomes in children with hemiplegic CP to age-matched typically developing children (TDC). It aims to determine how differences in sensory processing may relate to motor control and balance deficits in this population.
Read the detailed description
This study investigated the associations between sensory processing abilities, postural stability, and selective voluntary motor control (SVMC) in children diagnosed with hemiplegic cerebral palsy (CP), and compared these findings to age-matched typically developing children (TDC). Thirty children with hemiplegic CP and thirty TDC aged 6-10 years were recruited based on predefined inclusion and exclusion criteria. Children with CP were selected from the outpatient clinic at the Faculty of Physical Therapy, Cairo University.
The study used validated clinical tools: the Child Sensory Profile 2 (SP2) to assess sensory processing abilities across multiple sensory systems and behavioral domains; the HUMAC balance system to evaluate postural stability through modified clinical tests of sensory integration, center of pressure testing, and limits of stability assessments; the Test of Arm Selective Control (TASC) and the Selective Control Assessment of the Lower Extremity (SCALE) to evaluate upper and lower limb SVMC, respectively.
All participants were assessed in a controlled clinical setting, and statistical comparisons were made between the two groups. The study also examined the correlations between sensory profile data and motor/postural outcomes. Ethical approval was obtained, and informed consent was secured from all caregivers. The results are intended to provide insights into the interaction between sensory processing and motor control deficits in children with hemiplegia and to support clinicians in tailoring interventions based on sensory-motor integration profiles.
- Conditions
- Cerebral Palsy, Hemiplegic, Sensory Processing Disorder, Postural Balance, Motor Skills Disorders
- Being tested
- Child Sensory Profile 2 (SP2) for Sensory processing abilities, HUMAC Balance System for Postural stability evaluation, Selective Motor Control Evaluation for the upper and lower extremities
- Keywords
- sensory processing abilities, Postural stability, selective voluntary motor control, unilateral cerebral palsy, child sensory profile 2
- Medical subject headings
- Cerebral Palsy, Motor Skills Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Child Sensory Profile 2 (SP2) for Sensory processing abilitiesOther
Sensory processing abilities are evaluated using the Child Sensory Profile 2 (SP2), an 86-item caregiver questionnaire assessing six sensory systems (auditory, visual, touch, movement, body position, and oral) and three behavioral domains (conduct, social-emotional, and attentional).
HUMAC Balance System for Postural stability evaluationOther
Postural stability is assessed using the HUMAC Balance System, incorporating tests such as:
- The Modified Clinical Test of Sensory Integration of Balance (mCTSIB)
- Limits of Stability (LOS) at difficulty levels 4 and 6
- Center of Pressure (COP) metrics
Selective Motor Control Evaluation for the upper and lower extremitiesOther
Selective voluntary motor control is evaluated using the following tools:
- Test of Arm Selective Control (TASC) for the upper extremities
- Selective Control Assessment of the Lower Extremity (SCALE) for the lower extremities
| Study group | Role | What they receive |
|---|---|---|
| The hemiplegic cerebral palsy (CP) group | The hemiplegic cerebral palsy (CP) group consists of 30 children diagnosed with spastic hemiplegic CP, a type of CP characterized by motor impairment predominantly on one side of the body. These children were aged between 6 and 10 years and had GMFCS levels I or II, indicating mild to moderate functional limitations. They exhibited mild spasticity, as indicated by Modified Ashworth Scale scores of 1 or 1+, and were able to follow simple instructions. The hemiplegic CP group was included to investigate sensory processing, postural stability, and selective voluntary motor control (SVMC) impairments associated with spastic hemiplegia. Receives: Other: Child Sensory Profile 2 (SP2) for Sensory processing abilities; Other: HUMAC Balance System for Postural stability evaluation; Other: Selective Motor Control Evaluation for the upper and lower extremities | |
| typically developing children (TDC) group | The control group consisted of 30 typically developing children (TDC) who were matched to the hemiplegic CP group based on age and sex. The control group served as a comparison to the CP group, allowing for the evaluation of typical sensory processing, postural stability, and selective voluntary motor control patterns in children without any clinical motor impairments. The children in the control group were expected to perform within typical developmental ranges for sensory and motor function, providing a baseline for assessing the motor and sensory processing deficits in the hemiplegic CP group. Receives: Other: Child Sensory Profile 2 (SP2) for Sensory processing abilities; Other: HUMAC Balance System for Postural stability evaluation; Other: Selective Motor Control Evaluation for the upper and lower extremities |
What is being measured
The primary outcome is the main question the study is designed to answer.
ensory Profile 2 (SP2) Total and Subscale Scores
Scores across sensory domains and behavioral responses will be compared between groups and correlated with motor outcomes.
Measured: Single assessment session (within a 1-day visit)
HUMAC Balance Scores (COP, LOS, mCTSIB)
Quantitative balance parameters will be analyzed between groups.
Measured: Single assessment session (within a 1-day visit)
TASC and SCALE Scores
Selective motor control scores (range 0-2 per joint movement) will be summed and analyzed.
Measured: Single assessment session (within a 1-day visit)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2025
- Study start15 Jan 2023
- Primary completion22 Aug 2023
- Study completion2 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral Palsy, HemiplegicStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Reham Fathi Fouad Hussein, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06989034
- Sponsor's protocol ID
- P.T.REC/012/004244
- Acronym
- HeSPoM
- Status last verified
- Apr 2025
- First submitted
- 17 May 2025
- Last updated
- 25 May 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sensory Processing Abilities in Relation to Postural Stability and Selective Motor Control in Children With Hemiplegia.
- ClinicalTrials.gov ID
- NCT06989034
- Acronym / sponsor ID
- HeSPoM / P.T.REC/012/004244
- Conditions
- Cerebral Palsy, Hemiplegic, Sensory Processing Disorder, Postural Balance, Motor Skills Disorders
- Keywords
- sensory processing abilities, Postural stability, selective voluntary motor control, unilateral cerebral palsy, child sensory profile 2
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 15 Jan 2023 (actual)
- Primary completion
- 22 Aug 2023 (actual)
- Study completion
- 2 Jan 2024 (actual)
- First posted
- 25 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.
The goal of this observational case-control study is to examine the relationship between sensory processing abilities, postural stability, and selective motor control (SMC) in children aged 6-10 years with hemiplegic cerebral palsy (CP). The study compares outcomes in children with hemiplegic CP to age-matched typically developing children (TDC). It aims to determine how differences in sensory processing may relate to motor control and balance deficits in this population.
Detailed description
This study investigated the associations between sensory processing abilities, postural stability, and selective voluntary motor control (SVMC) in children diagnosed with hemiplegic cerebral palsy (CP), and compared these findings to age-matched typically developing children (TDC). Thirty children with hemiplegic CP and thirty TDC aged 6-10 years were recruited based on predefined inclusion and exclusion criteria. Children with CP were selected from the outpatient clinic at the Faculty of Physical Therapy, Cairo University.
The study used validated clinical tools: the Child Sensory Profile 2 (SP2) to assess sensory processing abilities across multiple sensory systems and behavioral domains; the HUMAC balance system to evaluate postural stability through modified clinical tests of sensory integration, center of pressure testing, and limits of stability assessments; the Test of Arm Selective Control (TASC) and the Selective Control Assessment of the Lower Extremity (SCALE) to evaluate upper and lower limb SVMC, respectively.
All participants were assessed in a controlled clinical setting, and statistical comparisons were made between the two groups. The study also examined the correlations between sensory profile data and motor/postural outcomes. Ethical approval was obtained, and informed consent was secured from all caregivers. The results are intended to provide insights into the interaction between sensory processing and motor control deficits in children with hemiplegia and to support clinicians in tailoring interventions based on sensory-motor integration profiles.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The hemiplegic cerebral palsy (CP) group | – | Other: Child Sensory Profile 2 (SP2) for Sensory processing abilities, Other: HUMAC Balance System for Postural stability evaluation, Other: Selective Motor Control Evaluation for the upper and lower extremitiesThe hemiplegic cerebral palsy (CP) group consists of 30 children diagnosed with spastic hemiplegic CP, a type of CP characterized by motor impairment predominantly on one side of the body. These children were aged between 6 and 10 years and had GMFCS levels I or II, indicating mild to moderate functional limitations. They exhibited mild spasticity, as indicated by Modified Ashworth Scale scores of 1 or 1+, and were able to follow simple instructions. The hemiplegic CP group was included to investigate sensory processing, postural stability, and selective voluntary motor control (SVMC) impairments associated with spastic hemiplegia. |
| typically developing children (TDC) group | – | Other: Child Sensory Profile 2 (SP2) for Sensory processing abilities, Other: HUMAC Balance System for Postural stability evaluation, Other: Selective Motor Control Evaluation for the upper and lower extremitiesThe control group consisted of 30 typically developing children (TDC) who were matched to the hemiplegic CP group based on age and sex. The control group served as a comparison to the CP group, allowing for the evaluation of typical sensory processing, postural stability, and selective voluntary motor control patterns in children without any clinical motor impairments. The children in the control group were expected to perform within typical developmental ranges for sensory and motor function, providing a baseline for assessing the motor and sensory processing deficits in the hemiplegic CP group. |
Who may qualify
- Ages
- 6 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- The study population divided into two groups. The first group includes 30 children diagnosed with spastic hemiplegic cerebral palsy (CP), a condition characterized by motor impairments affecting one side of the body due to early brain damage. These children are recruited from the outpatient clinic of the Faculty of Physical Therapy, Cairo University. The second group includes 30 age- and sex-matched typically developing children (TDC) who have no known neurological, orthopedic, or sensory processing disorders. These children are selected from mainstream schools in Luxor Governorate and are expected to exhibit typical development in sensory processing, motor control, and postural stability. The children in the CP group are part of a clinical setting with prior diagnoses and care, while the TDC group is sourced from an educational setting. The study aims to compare sensory processing abilities, postural stability, and selective motor control
Key inclusion criteria (6 listed)
- Diagnosis of spastic hemiplegic cerebral palsy
- Age between 6 and 10 years
- GMFCS levels I or II
- Modified Ashworth Scale score of 1 or 1+ (mild spasticity)
- Ability to follow simple instructions
Key exclusion criteria (5 listed)
- Botulinum toxin injections within the past 6 months
- Visual or auditory impairments
- Orthopedic or neurosurgical intervention to limbs or spine
- Musculoskeletal deformities
- History of seizures
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 |
|---|---|---|
| Child Sensory Profile 2 (SP2) for Sensory processing abilitiesSensory processing abilities are evaluated using the Child Sensory Profile 2 (SP2), an 86-item caregiver questionnaire assessing six sensory systems (auditory, visual, touch, movement, body position, and oral) and three behavioral domains (conduct, social-emotional, and attentional). | Other | The hemiplegic cerebral palsy (CP) group, typically developing children (TDC) group |
| HUMAC Balance System for Postural stability evaluationPostural stability is assessed using the HUMAC Balance System, incorporating tests such as: * The Modified Clinical Test of Sensory Integration of Balance (mCTSIB) * Limits of Stability (LOS) at difficulty levels 4 and 6 * Center of Pressure (COP) metrics | Other | The hemiplegic cerebral palsy (CP) group, typically developing children (TDC) group |
| Selective Motor Control Evaluation for the upper and lower extremitiesSelective voluntary motor control is evaluated using the following tools: * Test of Arm Selective Control (TASC) for the upper extremities * Selective Control Assessment of the Lower Extremity (SCALE) for the lower extremities | Other | The hemiplegic cerebral palsy (CP) group, typically developing children (TDC) group |
Primary outcome
ensory Profile 2 (SP2) Total and Subscale Scores
Time frame: Single assessment session (within a 1-day visit)
Scores across sensory domains and behavioral responses will be compared between groups and correlated with motor outcomes.
HUMAC Balance Scores (COP, LOS, mCTSIB)
Time frame: Single assessment session (within a 1-day visit)
Quantitative balance parameters will be analyzed between groups.
TASC and SCALE Scores
Time frame: Single assessment session (within a 1-day visit)
Selective motor control scores (range 0-2 per joint movement) will be summed and analyzed.
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 25 May 2025.
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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?
An observational study of Cerebral Palsy, Hemiplegic and Sensory Processing Disorder, 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 5 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 25 May 2025. 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?
ensory Profile 2 (SP2) Total and Subscale Scores (time frame: Single assessment session (within a 1-day visit)). The study lists 3 primary outcomes in all. 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 25 May 2025.