Quality of Upper Limb FunctionNCT07497100
Relationship Between Upper Limb Function and Participation in Hemiplegic cp
An observational study of Quality of Upper Limb Function and Participation Activities, run by Cairo University at 1 site in Egypt.
Trial summary
The study will be conducted to Assess quality of upper limb function in children with hemiplegic CP. Assess participation activities of children with hemiplegic CP. Assess the relationship between quality of upper limb function and participation activities of children with hemiplegic CP. Read more about this study
- Who is it for?
- Ages 5 to 8 years
- Conditions the study is for
- Quality of Upper Limb Function, Participation Activities, Hemiplegic CP
- How many people
- 72 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2026to 1 May 2026
- Phase
- Observational
- 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
- No healthy volunteers
- Child
Study population: Children with HCP will be selected from the Outpatient Clinic of Faculty of Physical Therapy, Cairo University
Who may be able to join
- Children diagnosed with hemiplegic cerebral palsy.
- Both genders will be included.
- Children's age will be ranging from 5 to 8 years.
- The degree of spasticity in affected upper limb ranges from grade 1, 1+ and 2 according to Modified Ashworth Scale.
- Children are able to understand and respond to simple instructions.
- Children in inclusion education system.
- Parents are of nearly the same socioeconomic level and must have at least an average level of education.
Who cannot join
- Children will be excluded in the presence of the following:
- Severe visual, auditory or perceptual impairment that interfere with the evaluation program.
- Botulinum toxin injection in upper limb or recent orthopedic surgery within last 6 months (Alkan and Bingol,2021).
- Fixed deformities in the affected upper limb. Significant mental or psychological problems that interfere with understanding instructions.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Outpatient clinic of faculty of physical therapy
Cairo
About this study
Official title: Relationship Between Quality of Upper Limb Function and Participation Activities of Children With Hemiplegic Cerebral Palsy
The study will be conducted to
- Assess quality of upper limb function in children with hemiplegic CP.
- Assess participation activities of children with hemiplegic CP.
- Assess the relationship between quality of upper limb function and participation activities of children with hemiplegic CP.
Read the detailed description
Children with HCP are faced with a variety of motor and sensory impairments that have an impact on their arm and hand functioning. Upper limb activity limitations reflect the difficulties experienced during reaching, grasping, manipulating and releasing objects with the hemiplegic arm and hand.
As a result, those children may choose to use their "less-affected" hand instead of the affected hand due to difficulties in using it . Although they can complete certain bimanual tasks primarily using one hand through compensatory strategies, the time required to accomplish these tasks is typically longer than their peers.
An important outcome of rehabilitation services is to optimize children's participation in different life situations such as home, school and in the community .Participation in family and recreational activities provides avenues for children to play, learn skills, make friends and develop self-confidence and belonging. Understanding the link between manual ability and participation is essential in pediatric rehabilitation for children with HCP. Adequate assessment of upper limb function in those children is crucial not only to outline treatment, but also to measure the efficacy of their participation in life areas activities and to allow follow-up over time.
This study highlights how limitations in upper limb manual ability can restrict participation in life areas activities of those children, so it can guide goal-setting in both occupational therapy and physical therapy, emphasizing activities that promote both hand function and participation in life areas activities. Simultaneously this study supports the movement of the growing trend in family-centered and participation-focused therapy.
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of upper limb function will be evaluated using the Quality of Upper Extremity Skills Test (QUEST).
Quality of Upper Extremity Skills test is the used scale. Higher scores indicate better quality of upper extremity movement. A domain score close to 100% reflects near-normal quality of movement. Lower scores indicate reduced control, compensatory movements, or inability to complete tasks.
Measured: 4 months
Child and Adolescent Scale of Participation will be used to assess child participation.
The overall percentage score indicates how much the child is participating in expected ways for their age compared to their peers. A score of 100% means that the child is fully participating in the expected manner.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2026
- Study start1 Jan 2026
- Primary completion1 May 2026 (estimated)
- Study completion1 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Quality of Upper Limb FunctionStudies 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mourine Mounir Amir, Cairo University
- Investigators
- Hoda AbdelAzim El talawy, professor, Principal investigator, Hoda_eltalawy@hotmail.comAmira Fathy Ibrahim, lecturer, Principal investigator, Amirafathy573@gmail.com
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07497100
- Sponsor's protocol ID
- P.T.REC/012/006277
- Status last verified
- Dec 2025
- First submitted
- 23 Mar 2026
- Last updated
- 6 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Krumlinde-Sundholm, L., & Wagner, L. V. (2020). Upper Extremity Assessment and Outcome Evaluation in Cerebral Palsy. Cerebral Palsy, 1569-1597.
Rich TL, Menk JS, Rudser KD, Feyma T, Gillick BT. Less-Affected Hand Function in Children With Hemiparetic Unilateral Cerebral Palsy: A Comparison Study With Typically Developing Peers. Neurorehabil Neural Repair. 2017 Oct-Nov;31(10-11):965-976. doi: 10.1177/1545968317739997. Epub 2017 Nov 12.
PubMed 29130382Pashmdarfard M, Shervin Badv R. The Impact of Manual Ability Level on Participation of Children with Cerebral Palsy in Life Areas: A Cross-Sectional Study. Iran J Child Neurol. 2019 Summer;13(3):83-91.
PubMed 31327972Park H, Choi JY, Yi SH, Park ES, Shim D, Choi TY, Rha DW. Relationship between the more-affected upper limb function and daily activity performance in children with cerebral palsy: a cross-sectional study. BMC Pediatr. 2021 Oct 19;21(1):459. doi: 10.1186/s12887-021-02927-2.
PubMed 34666730Bingöl, H., Günel, M., & Sel, S. A. (2024). Investigation of differences between the representatives of the high-to moderate functional status according to upper limb functions and participation in children with congenital hemiplegic cerebral palsy: A cross-sectional study. Bingöl Üniversitesi Sağlık Dergisi, 5(1), 1-10.
Alghamdi MS, Chiarello LA, Palisano RJ, McCoy SW. Understanding participation of children with cerebral palsy in family and recreational activities. Res Dev Disabil. 2017 Oct;69:96-104. doi: 10.1016/j.ridd.2017.07.006. Epub 2017 Aug 30.
PubMed 28843215Alkan H and Bingöl H (2021). The effect of the function of forearm supination on participation activities and communication skills of children with Hemiparetic Cerebral Palsy. Hacettepe University Faculty of Health Sciences Journal. Dec 31;8(3):487-99.
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship Between Quality of Upper Limb Function and Participation Activities of Children With Hemiplegic Cerebral Palsy
- ClinicalTrials.gov ID
- NCT07497100
- Acronym / sponsor ID
- P.T.REC/012/006277
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jan 2026 (actual)
- Primary completion
- 1 May 2026 (estimated)
- Study completion
- 1 May 2026 (estimated)
- First posted
- 27 Mar 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 study will be conducted to
- Assess quality of upper limb function in children with hemiplegic CP.
- Assess participation activities of children with hemiplegic CP.
- Assess the relationship between quality of upper limb function and participation activities of children with hemiplegic CP.
Detailed description
Children with HCP are faced with a variety of motor and sensory impairments that have an impact on their arm and hand functioning. Upper limb activity limitations reflect the difficulties experienced during reaching, grasping, manipulating and releasing objects with the hemiplegic arm and hand.
As a result, those children may choose to use their "less-affected" hand instead of the affected hand due to difficulties in using it . Although they can complete certain bimanual tasks primarily using one hand through compensatory strategies, the time required to accomplish these tasks is typically longer than their peers.
An important outcome of rehabilitation services is to optimize children's participation in different life situations such as home, school and in the community .Participation in family and recreational activities provides avenues for children to play, learn skills, make friends and develop self-confidence and belonging. Understanding the link between manual ability and participation is essential in pediatric rehabilitation for children with HCP. Adequate assessment of upper limb function in those children is crucial not only to outline treatment, but also to measure the efficacy of their participation in life areas activities and to allow follow-up over time.
This study highlights how limitations in upper limb manual ability can restrict participation in life areas activities of those children, so it can guide goal-setting in both occupational therapy and physical therapy, emphasizing activities that promote both hand function and participation in life areas activities. Simultaneously this study supports the movement of the growing trend in family-centered and participation-focused therapy.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 5 to 8 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children with HCP will be selected from the Outpatient Clinic of Faculty of Physical Therapy, Cairo University
Key inclusion criteria (7 listed)
- Children diagnosed with hemiplegic cerebral palsy.
- Both genders will be included.
- Children's age will be ranging from 5 to 8 years.
- The degree of spasticity in affected upper limb ranges from grade 1, 1+ and 2 according to Modified Ashworth Scale.
- Children are able to understand and respond to simple instructions.
Key exclusion criteria (4 listed)
- Children will be excluded in the presence of the following:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Quality of upper limb function will be evaluated using the Quality of Upper Extremity Skills Test (QUEST).
Time frame: 4 months
Quality of Upper Extremity Skills test is the used scale. Higher scores indicate better quality of upper extremity movement. A domain score close to 100% reflects near-normal quality of movement. Lower scores indicate reduced control, compensatory movements, or inability to complete tasks.
Child and Adolescent Scale of Participation will be used to assess child participation.
Time frame: 4 months
The overall percentage score indicates how much the child is participating in expected ways for their age compared to their peers. A score of 100% means that the child is fully participating in the expected manner.
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 6 Apr 2026.
- BackgroundKrumlinde-Sundholm, L., & Wagner, L. V. (2020). Upper Extremity Assessment and Outcome Evaluation in Cerebral Palsy. Cerebral Palsy, 1569-1597.
- Background: PubMed 29130382Rich TL, Menk JS, Rudser KD, Feyma T, Gillick BT. Less-Affected Hand Function in Children With Hemiparetic Unilateral Cerebral Palsy: A Comparison Study With Typically Developing Peers. Neurorehabil Neural Repair. 2017 Oct-Nov;31(10-11):965-976. doi: 10.1177/1545968317739997. Epub 2017 Nov 12.
- Background: PubMed 31327972Pashmdarfard M, Shervin Badv R. The Impact of Manual Ability Level on Participation of Children with Cerebral Palsy in Life Areas: A Cross-Sectional Study. Iran J Child Neurol. 2019 Summer;13(3):83-91.
- Background: PubMed 34666730Park H, Choi JY, Yi SH, Park ES, Shim D, Choi TY, Rha DW. Relationship between the more-affected upper limb function and daily activity performance in children with cerebral palsy: a cross-sectional study. BMC Pediatr. 2021 Oct 19;21(1):459. doi: 10.1186/s12887-021-02927-2.
- BackgroundBingöl, H., Günel, M., & Sel, S. A. (2024). Investigation of differences between the representatives of the high-to moderate functional status according to upper limb functions and participation in children with congenital hemiplegic cerebral palsy: A cross-sectional study. Bingöl Üniversitesi Sağlık Dergisi, 5(1), 1-10.
- Background: PubMed 28843215Alghamdi MS, Chiarello LA, Palisano RJ, McCoy SW. Understanding participation of children with cerebral palsy in family and recreational activities. Res Dev Disabil. 2017 Oct;69:96-104. doi: 10.1016/j.ridd.2017.07.006. Epub 2017 Aug 30.
- BackgroundAlkan H and Bingöl H (2021). The effect of the function of forearm supination on participation activities and communication skills of children with Hemiparetic Cerebral Palsy. Hacettepe University Faculty of Health Sciences Journal. Dec 31;8(3):487-99.
- 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.
Hoda AbdelAzim El talawy, professor principal investigator
Hoda_eltalawy@hotmail.com
Amira Fathy Ibrahim, lecturer principal investigator
Amirafathy573@gmail.com
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 Quality of Upper Limb Function and Participation Activities, 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 7 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 6 Apr 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?
Contact Mourine Mounir Amir (01274996490, mourine.mounir15@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of upper limb function will be evaluated using the Quality of Upper Extremity Skills Test (QUEST). (time frame: 4 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07497100, which also lists 7 linked publications.
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 6 Apr 2026.