Bilateral Cerebral PalsyNCT07367477
Horizontal Versus Vertical Upper Extremity Function in Bilateral Cerebral Palsy
A study testing a designed occupational therapy program to improvement hand skills conducted on a vertical surface. and a designed occupational therapy (OT) program to improvement hand skills conducted on a horizontal surface. in people with Bilateral Cerebral Palsy, run by Raghda Gamal Ateya Abd-Elbary at 1 site in Egypt.
Trial summary
The goal of this quasi-experimental study is to investigate and compare the effects of horizontal and vertical upper extremity performance on hand skills and trunk control in children with bilateral spastic cerebral palsy; could include any of the following: both gender, age ranged from 5 years to 8 years. Read more about this study
- Who is it for?
- Ages 5 to 8 yearsHealthy volunteers can take part
- Conditions the study is for
- Bilateral Cerebral Palsy
- What is being tested?
- a designed occupational therapy program to improvement hand skills conducted on a vertical surface. and a designed occupational therapy (OT) program to improvement hand skills conducted on a horizontal surface.
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 16 Jun 2025to 30 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 5 to 8 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children with BSCP, their chronological age will be ranged from 5 years to 8 years.
- Their level of motor function will be I or II according to Gross Motor Function Classification System - Expanded and Revised.
- The degree of spasticity for these children will ranged from grade 1 to 1⁺ according to Modified Ashworth Scale.
- Their level of fine motor function will be I or II according to The Bimanual Fine Motor Function.
- All children's level of segmental trunk control will be level 7 (full trunk control) according to Segmental Assessment of Trunk Control.
- They will be able to follow instructions during evaluation and treatment.
Who cannot join
- Surgical interference in upper limbs and/or spine that may restrain the child performance during activities.
- Orthopedic problems or fixed deformities in the vertebral column and/or upper extremities.
- Uncontrolled seizures.
- Visual or hearing impairment.
- Receiving special medication affecting muscle and /or mental function.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: HORIZONTAL VERSUS VERTICAL UPPER EXTREMITY PERFORMANCE ON HAND SKILLS AND TRUNK CONTROL IN BILATERAL CEREBRAL PALSY
The goal of this quasi-experimental study is to investigate and compare the effects of horizontal and vertical upper extremity performance on hand skills and trunk control in children with bilateral spastic cerebral palsy; could include any of the following: both gender, age ranged from 5 years to 8 years. The main question it aims to answer [is/are]:
There will be no significant difference effect between horizontal and vertical upper extremity performance on hand skills and trunk control in children with bilateral spastic cerebral palsy.
Read the detailed description
This study aims to investigate the effects of to investigate and compare the effects of horizontal and vertical upper extremity performance on hand skills and trunk control in children with bilateral spastic cerebral palsy. The research will evaluate fine motor proficiency, upper extremity function and trunk stability from sitting through a controlled and structured intervention program.
Participants will undergo designed Occupational Therapy program will be applied for 90 minutes, three days per week for successive three months for the both groups by the researcher The study adopts a quasi-experimental design, with thirty participants allocated into two groups of an equal number, twenty children for each group. Two group will be identified as group (A) and group (B).
Data will be analyzed using paired t-test will be used for within group comparison before and after the intervention, for each variable and independent t-test was used to compare the demographic data and the baseline characteristics of both groups for all measured variables, pre and post treatments, with a significance level set at p < 0.05.
- Conditions
- Bilateral Cerebral Palsy
- Being tested
- a designed occupational therapy program to improvement hand skills conducted on a vertical surface., a designed occupational therapy (OT) program to improvement hand skills conducted on a horizontal surface.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
a designed occupational therapy program to improvement hand skills conducted on a vertical surface.Procedure or surgery
The treatment session will be started by the following exercises for 30 minutes as preparation for hand skill training and the second part of the session will be exercises facilitating fine motor skills a vertical surface for one hour, Three sessions per week will last for 90 minutes, for successive Three months.
a designed occupational therapy (OT) program to improvement hand skills conducted on a horizontal surface.Procedure or surgery
The treatment session will be started by the following exercises for 30 minutes as preparation for hand skill training and the second part of the session will be exercises facilitating fine motor skills a horizontal surface for one hour, Three sessions per week will last for 90 minutes, for successive Three months.
| Study group | Role | What they receive |
|---|---|---|
| Group (A) | Active comparator | Children in this group will receive a designed occupational therapy (OT) program to improvement hand skills conducted on a horizontal surface. Receives: Procedure: a designed occupational therapy (OT) program to improvement hand skills conducted on a horizontal surface. |
| Group (B) | Experimental | Children in this group will receive the same designed OT program given to group (A) conducted on a vertical surface. Receives: Procedure: a designed occupational therapy program to improvement hand skills conducted on a vertical surface. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Fine motor proficiency
Evaluated using the fine motor form of the Bruinink-Oseretsky test for motor proficiency 2nd edition (BOT-2)
Measured: Before and after the three months of treatment
Change in upper extremity function
Evaluated using the Quality of Upper Extremity Skills Test (QUEST)
Measured: Before and after the three months of treatment
Change in trunk stability from sitting
Evaluated using the Trunk Control Measurement Scale (TCMS) to assess static and anticipatory trunk control
Measured: Before and after the three months of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2026
- Study start16 Jun 2025
- Primary completion15 Dec 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bilateral Cerebral PalsyStudies of the same condition, open and under way.
- 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Raghda Gamal Ateya Abd-Elbary
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Raghda Gamal Ateya Abd-Elbary, Cairo University
- Investigators
- Kamal El Sayed Shoukry, Professor Doctor, Study chair, Department of physical therapy for growth and developmental disorder in children and its surgery, Faculty of physical therapy, Cairo UniversityNanees Essam Mohamed, Professor Doctor, Study director, Department of physical therapy for growth and developmental disorder in children and its surgery, Faculty of physical therapy, Cairo UniversityGehan Mosaad Abd El-Maksoud, Professor Doctor, Study director, Department of physical therapy for growth and developmental disorder in children and its surgery, Faculty of physical therapy, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07367477
- Sponsor's protocol ID
- P.T.REC/012/004404
- Status last verified
- Feb 2025
- First submitted
- 18 Jan 2026
- Last updated
- 26 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HORIZONTAL VERSUS VERTICAL UPPER EXTREMITY PERFORMANCE ON HAND SKILLS AND TRUNK CONTROL IN BILATERAL CEREBRAL PALSY
- ClinicalTrials.gov ID
- NCT07367477
- Acronym / sponsor ID
- P.T.REC/012/004404
- Conditions
- Bilateral Cerebral Palsy
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Raghda Gamal Ateya Abd-ElbaryUniversity, hospital or other
- Study start
- 16 Jun 2025 (actual)
- Primary completion
- 15 Dec 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 26 Jan 2026 (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 quasi-experimental study is to investigate and compare the effects of horizontal and vertical upper extremity performance on hand skills and trunk control in children with bilateral spastic cerebral palsy; could include any of the following: both gender, age ranged from 5 years to 8 years. The main question it aims to answer [is/are]:
There will be no significant difference effect between horizontal and vertical upper extremity performance on hand skills and trunk control in children with bilateral spastic cerebral palsy.
Detailed description
This study aims to investigate the effects of to investigate and compare the effects of horizontal and vertical upper extremity performance on hand skills and trunk control in children with bilateral spastic cerebral palsy. The research will evaluate fine motor proficiency, upper extremity function and trunk stability from sitting through a controlled and structured intervention program.
Participants will undergo designed Occupational Therapy program will be applied for 90 minutes, three days per week for successive three months for the both groups by the researcher The study adopts a quasi-experimental design, with thirty participants allocated into two groups of an equal number, twenty children for each group. Two group will be identified as group (A) and group (B).
Data will be analyzed using paired t-test will be used for within group comparison before and after the intervention, for each variable and independent t-test was used to compare the demographic data and the baseline characteristics of both groups for all measured variables, pre and post treatments, with a significance level set at p < 0.05.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group (A) | Active comparator | Procedure: a designed occupational therapy (OT) program to improvement hand skills conducted on a horizontal surface.Children in this group will receive a designed occupational therapy (OT) program to improvement hand skills conducted on a horizontal surface. |
| Group (B) | Experimental | Procedure: a designed occupational therapy program to improvement hand skills conducted on a vertical surface.Children in this group will receive the same designed OT program given to group (A) conducted on a vertical surface. |
Who may qualify
- Ages
- 5 to 8 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Children with BSCP, their chronological age will be ranged from 5 years to 8 years.
- Their level of motor function will be I or II according to Gross Motor Function Classification System - Expanded and Revised.
- The degree of spasticity for these children will ranged from grade 1 to 1⁺ according to Modified Ashworth Scale.
- Their level of fine motor function will be I or II according to The Bimanual Fine Motor Function.
- All children's level of segmental trunk control will be level 7 (full trunk control) according to Segmental Assessment of Trunk Control.
Key exclusion criteria (5 listed)
- Surgical interference in upper limbs and/or spine that may restrain the child performance during activities.
- Orthopedic problems or fixed deformities in the vertebral column and/or upper extremities.
- Uncontrolled seizures.
- Visual or hearing impairment.
- Receiving special medication affecting muscle and /or mental function.
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 |
|---|---|---|
| a designed occupational therapy program to improvement hand skills conducted on a vertical surface.The treatment session will be started by the following exercises for 30 minutes as preparation for hand skill training and the second part of the session will be exercises facilitating fine motor skills a vertical surface for one hour, Three sessions per week will last for 90 minutes, for successive Three months. | Procedure or surgery | Group (B) |
| a designed occupational therapy (OT) program to improvement hand skills conducted on a horizontal surface.The treatment session will be started by the following exercises for 30 minutes as preparation for hand skill training and the second part of the session will be exercises facilitating fine motor skills a horizontal surface for one hour, Three sessions per week will last for 90 minutes, for successive Three months. | Procedure or surgery | Group (A) |
Primary outcome
Change in Fine motor proficiency
Time frame: Before and after the three months of treatment
Evaluated using the fine motor form of the Bruinink-Oseretsky test for motor proficiency 2nd edition (BOT-2)
Change in upper extremity function
Time frame: Before and after the three months of treatment
Evaluated using the Quality of Upper Extremity Skills Test (QUEST)
Change in trunk stability from sitting
Time frame: Before and after the three months of treatment
Evaluated using the Trunk Control Measurement Scale (TCMS) to assess static and anticipatory trunk control
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2026.
- Individual participant dataSharing planned: No
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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.
Kamal El Sayed Shoukry, Professor Doctor study chair
Department of physical therapy for growth and developmental disorder in children and its surgery, Faculty of physical therapy, Cairo University
Nanees Essam Mohamed, Professor Doctor study director
Department of physical therapy for growth and developmental disorder in children and its surgery, Faculty of physical therapy, Cairo University
Gehan Mosaad Abd El-Maksoud, Professor Doctor study director
Department of physical therapy for growth and developmental disorder in children and its surgery, Faculty of physical therapy, Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing a designed occupational therapy program to improvement hand skills conducted on a vertical surface. and a designed occupational therapy (OT) program to improvement hand skills conducted on a horizontal surface. in people with Bilateral Cerebral Palsy, run by Raghda Gamal Ateya Abd-Elbary 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: enrolling by invitation, as of the sponsor's last update on 26 Jan 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?
This study is still under way. Results are not available in the source record yet.
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?
Change in Fine motor proficiency (time frame: Before and after the three months of treatment). 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 26 Jan 2026.