Hemiplegic Cerebral PalsyNCT07244081
Kinesiotherapy on Upper Limb Function and Activities of Daily Living in Children With Hemiplegic Cerebral Palsy
A study testing experimental in people with Hemiplegic Cerebral Palsy, run by Riphah International University at 1 site in Pakistan.
Trial summary
This study will be randomized controlled trial, data will be collected from BASES special education school sialkot , Allama Iqbal Memorial Hospital, sialkot and Lahore. The study will include 28 patients equally divided into two groups and randomly allocated. Read more about this study
- Who is it for?
- Ages 8 to 13 years
- Conditions the study is for
- Hemiplegic Cerebral Palsy
- What is being tested?
- experimental
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 sitePakistan
- Study dates
- 22 Oct 2025to 30 Jan 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 8 to 13 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age: 8-13 years old both sexes
- Ability to follow simple instructions, able to sit or stand with support to participate in physical therapy sessions( MACS level Ⅰ-Ⅲ)(9) and (GMFCS level Ⅰ-Ⅲ)(10)
- Ability to communicate needs and discomfort (verbally or non-verbally)
- No concurrent participation in other physical therapy or rehabilitation programs
Who cannot join
- Severe visual and hearing impairments that would hinder participation
- Severe cognitive or intellectual disabilities that would impede understanding of instructions
- History of seizures or other neurological conditions that may impact participation
- Recent (within 6 months) or planned orthopedic surgery
- Concurrent use of botulinum toxin injections or oral medications affecting muscle tone(2).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site, 1 recruiting
- Recruiting
Maria
Sialkot, Punjab Province, 51040
maria, MS, 03000209022, bases.sialkot49@gmail.com
About this study
Official title: Effects of Kinesiotherapy on Upper Limb Function and Activities of Daily Living in Children With Hemiplegic Cerebral Palsy
This study will be randomized controlled trial, data will be collected from BASES special education school sialkot , Allama Iqbal Memorial Hospital, sialkot and Lahore. The study will include 28 patients equally divided into two groups and randomly allocated. Inclusion criteria for the study will be age of 8-13 years old of both sexes, ability to follow simple instructions, able to sit or stand with support to participate in physical therapy sessions( MACS level Ⅰ-Ⅲ) and (GMFCS level Ⅰ-Ⅲ), ability to communicate needs and discomfort (verbally or non-verbally), No concurrent participation in other physical therapy and excluded with Severe visual and hearing impairments, severe cognitive disabilities, History of seizures, Recent (within 6 months) or planned orthopedic surgery, Concurrent use of botulinum toxin injections. Experimental group will perform both Kinesiotherapy protocol and conventional physical therapy while Control group will perform only conventional physical therapy for 8 weeks 2-3 times weekly with 45 min of each session. Outcomes to be analyzed will be upper limb function and Activities of daily living (ADLs). Tools used for data collection will be Action Research Arm (ARA) test, Pediatric Evaluation of Disability Inventory (PEDI). Data will be analyzed through SPSS version 26, 27.
Read the detailed description
Cerebral palsy (CP) is a non progressive neurodevelopmental disorder affecting motor function, resulting from damage to the brain. Hemiplegic CP specifically impacting one side of the body with upper extremity generally more effected than the lower. Twenty percent of children with spastic CP have hemiplegia. Upper limb dysfunction and limited activities of daily living (ADLs) significantly impact quality of life, social participation, and independence. Kinesiotherapy, a movement-based therapy that incorporates movements to improve strength, function and mobility. shows promise effects on stroke patients, but its effectiveness on hemiplegic cerebral palsy requires rigorous investigation. This study aims to investigate the effectiveness of kinesiotherapy in improving upper limb function and ADLs in children with hemiplegic cerebral palsy.
This study will be randomized controlled trial, data will be collected from BASES special education school sialkot , Allama Iqbal Memorial Hospital, sialkot and Lahore. The study will include 28 patients equally divided into two groups and randomly allocated. Inclusion criteria for the study will be age of 8-13 years old of both sexes, ability to follow simple instructions, able to sit or stand with support to participate in physical therapy sessions( MACS level Ⅰ-Ⅲ) and (GMFCS level Ⅰ-Ⅲ), ability to communicate needs and discomfort (verbally or non-verbally), No concurrent participation in other physical therapy and excluded with Severe visual and hearing impairments, severe cognitive disabilities, History of seizures, Recent (within 6 months) or planned orthopedic surgery, Concurrent use of botulinum toxin injections. Experimental group will perform both Kinesiotherapy protocol and conventional physical therapy while Control group will perform only conventional physical therapy for 8 weeks 2-3 times weekly with 45 min of each session. Outcomes to be analyzed will be upper limb function and Activities of daily living (ADLs). Tools used for data collection will be Action Research Arm (ARA) test, Pediatric Evaluation of Disability Inventory (PEDI). Data will be analyzed through SPSS version 26, 27.
- Conditions
- Hemiplegic Cerebral Palsy
- Being tested
- control, experimental
- Keywords
- Kinesiotherapy, Hemiplegic Cerebral Palsy, Upper limb function, ADLs
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
controlOther
Also called baseline
Following baseline assessments, participants will begin their respective 8-week intervention program with 2-3 times per week. The group A will receive base line conventional exercise program with standard physical therapy interventions as follow:
- Stretching of tight muscles of affected upper limb.
- Weight bearing of affected upper limb.
- Manual dexterity exercises like grasp release, pack board activities.
- Teaching of ADLs.
- Functional task practice(2)
experimentalOther
Also called kinesiotherapy
Following baseline assessments, participants will begin their respective 8-week intervention program with 2-3 times per week. The group A will receive base line conventional exercise program with standard physical therapy interventions as follow:
- Stretching of tight muscles of affected upper limb.
- Weight bearing of affected upper limb.
- Manual dexterity exercises like grasp release, pack board activities.
- Teaching of ADLs.
- Functional task practice(2)
| Study group | Role | What they receive |
|---|---|---|
| control group | Other | Following baseline assessments, participants will begin their respective 8-week intervention program with 2-3 times per week. The group A will receive base line conventional exercise program with standard physical therapy interventions as follow:
* Stretching of tight muscles of affected upper limb.
* Weight bearing of affected upper limb.
* Manual dexterity exercises like grasp release, pack board activities.
* Teaching of ADLs.
* Functional task practice(2) Receives: Other: control |
| experimental group | Experimental | Kinesiotherapy tailored exercises focusing on movement and exercise, The movements are as follows:Sitting on a chair, the participant had to lean forward to pick up an object previously placed on the floor.Sitting on a chair, the participant had to rotate the upper body, reaching out and grabbing an object on its side, at the height of his shoulders.Sitting on a chair, the participant had to clasp his hands and flex the shoulders.
Sitting on a chair in front of a table, the participant had to take objects numbered in ascending order and hand them over to the therapist.
Sitting on a chair holding a stick, the participant had to place one hand above the other, raising his hands as if holding on to the stick.Sitting on a chair in front of a table, the patient had to find similar playing cards. All cards were face down. Sitting on a stretcher, the participant had to laterally tilt his trunk, putting the weight on the upper limbs. The therapist maintained the elbow extension Receives: Other: experimental |
What is being measured
The primary outcome is the main question the study is designed to answer.
action arm research arm test
The Action Research Arm Test (ARAT) is a 19 item observational measures used by physical therapists and other health care professionals to assess upper extremity performance (coordination, dexterity and functioning) in stroke recovery, brain injury and multiple sclerosis populations. Items comprising the ARAT are categorized into four subscales (grasp, grip, pinch and gross movement) and arranged in order of decreasing difficulty, with the most difficult task examined first, followed by the least difficult task maximum score 57 means better performance
Measured: baseline, 8 weeks
pediatric evaluation of disability inventory
The PEDI is a standardized clinical assessment tool designed to measure the functional performance of children with typical development whose chronological age is below 7.5 years old, and the functional performance of children with disabilities whose functional capabilities are below those of a 7.5-year-old child. The PEDI can be used for children with developmental disabilities aged 6 months to 21 years and for individuals without disabilities aged less than 7 years(12) The PEDI is composed of 3 domains: functional skill, caregiver assistance, and modification. Each domain includes 3 sub-domains: self-care, mobility, and social function. The functional skill domain, which was used for measuring ADL performance, consists of 197 specific questions. Each child is assigned either 1 point for being capable of performing the assigned task or 0 points for incomplete performance or being unable to perform the task. The reliability of the functional skill subscale of the PEDI is very high.
Measured: baseline, 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2025
- Study start22 Oct 2025
- Primary completion30 Jan 2026 (estimated)
- Study completion30 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hemiplegic 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- . The study will include 28 patients equally divided into two groups and randomly allocated. Inclusion criteria for the study will be age of 8-13 years old of both sexes, ability to follow simple instructions, able to sit or stand with support to participate in physical therapy sessions( MACS level Ⅰ-Ⅲ) and (GMFCS level Ⅰ-Ⅲ), ability to communicate needs and discomfort (verbally or non-verbally), No concurrent participation in other physical therapy and excluded with Severe visual and hearing impairments, severe cognitive disabilities, History of seizures, Recent (within 6 months) or planned orthopedic surgery, Concurrent use of botulinum toxin injections. Experimental group will perform both Kinesiotherapy protocol and conventional physical therapy while Control group will perform only conventional physical therapy for 8 weeks 2-3 times weekly with 45 min of each session. Outcomes to be analyzed will be upper limb function and Activities of daily living (ADLs).
- Masking
- None (open label)
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Naima Andleeb, MS PT, Principal investigator, Riphah Internatonal university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07244081
- Sponsor's protocol ID
- REC/RCR&AHS/NAIMAANDLEEB
- Status last verified
- Nov 2025
- First submitted
- 17 Nov 2025
- Last updated
- 24 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Alberti EJ, Targa ADS, Pichorim SF, Brawerman A. Ludic Table: a comparative study between playful rehabilitation and kinesiotherapy in restricting upper limb movements in individuals with stroke. Med Biol Eng Comput. 2022 Apr;60(4):1187-1198. doi: 10.1007/s11517-022-02532-0. Epub 2022 Mar 4.
PubMed 35244860
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Kinesiotherapy on Upper Limb Function and Activities of Daily Living in Children With Hemiplegic Cerebral Palsy
- ClinicalTrials.gov ID
- NCT07244081
- Acronym / sponsor ID
- REC/RCR&AHS/NAIMAANDLEEB
- Conditions
- Hemiplegic Cerebral Palsy
- Keywords
- Kinesiotherapy, Hemiplegic Cerebral Palsy, Upper limb function, ADLs
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 22 Oct 2025 (actual)
- Primary completion
- 30 Jan 2026 (estimated)
- Study completion
- 30 Jan 2026 (estimated)
- First posted
- 24 Nov 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.
This study will be randomized controlled trial, data will be collected from BASES special education school sialkot , Allama Iqbal Memorial Hospital, sialkot and Lahore. The study will include 28 patients equally divided into two groups and randomly allocated. Inclusion criteria for the study will be age of 8-13 years old of both sexes, ability to follow simple instructions, able to sit or stand with support to participate in physical therapy sessions( MACS level Ⅰ-Ⅲ) and (GMFCS level Ⅰ-Ⅲ), ability to communicate needs and discomfort (verbally or non-verbally), No concurrent participation in other physical therapy and excluded with Severe visual and hearing impairments, severe cognitive disabilities, History of seizures, Recent (within 6 months) or planned orthopedic surgery, Concurrent use of botulinum toxin injections. Experimental group will perform both Kinesiotherapy protocol and conventional physical therapy while Control group will perform only conventional physical therapy for 8 weeks 2-3 times weekly with 45 min of each session. Outcomes to be analyzed will be upper limb function and Activities of daily living (ADLs). Tools used for data collection will be Action Research Arm (ARA) test, Pediatric Evaluation of Disability Inventory (PEDI). Data will be analyzed through SPSS version 26, 27.
Detailed description
Cerebral palsy (CP) is a non progressive neurodevelopmental disorder affecting motor function, resulting from damage to the brain. Hemiplegic CP specifically impacting one side of the body with upper extremity generally more effected than the lower. Twenty percent of children with spastic CP have hemiplegia. Upper limb dysfunction and limited activities of daily living (ADLs) significantly impact quality of life, social participation, and independence. Kinesiotherapy, a movement-based therapy that incorporates movements to improve strength, function and mobility. shows promise effects on stroke patients, but its effectiveness on hemiplegic cerebral palsy requires rigorous investigation. This study aims to investigate the effectiveness of kinesiotherapy in improving upper limb function and ADLs in children with hemiplegic cerebral palsy.
This study will be randomized controlled trial, data will be collected from BASES special education school sialkot , Allama Iqbal Memorial Hospital, sialkot and Lahore. The study will include 28 patients equally divided into two groups and randomly allocated. Inclusion criteria for the study will be age of 8-13 years old of both sexes, ability to follow simple instructions, able to sit or stand with support to participate in physical therapy sessions( MACS level Ⅰ-Ⅲ) and (GMFCS level Ⅰ-Ⅲ), ability to communicate needs and discomfort (verbally or non-verbally), No concurrent participation in other physical therapy and excluded with Severe visual and hearing impairments, severe cognitive disabilities, History of seizures, Recent (within 6 months) or planned orthopedic surgery, Concurrent use of botulinum toxin injections. Experimental group will perform both Kinesiotherapy protocol and conventional physical therapy while Control group will perform only conventional physical therapy for 8 weeks 2-3 times weekly with 45 min of each session. Outcomes to be analyzed will be upper limb function and Activities of daily living (ADLs). Tools used for data collection will be Action Research Arm (ARA) test, Pediatric Evaluation of Disability Inventory (PEDI). Data will be analyzed through SPSS version 26, 27.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- . The study will include 28 patients equally divided into two groups and randomly allocated. Inclusion criteria for the study will be age of 8-13 years old of both sexes, ability to follow simple instructions, able to sit or stand with support to participate in physical therapy sessions( MACS level Ⅰ-Ⅲ) and (GMFCS level Ⅰ-Ⅲ), ability to communicate needs and discomfort (verbally or non-verbally), No concurrent participation in other physical therapy and excluded with Severe visual and hearing impairments, severe cognitive disabilities, History of seizures, Recent (within 6 months) or planned orthopedic surgery, Concurrent use of botulinum toxin injections. Experimental group will perform both Kinesiotherapy protocol and conventional physical therapy while Control group will perform only conventional physical therapy for 8 weeks 2-3 times weekly with 45 min of each session. Outcomes to be analyzed will be upper limb function and Activities of daily living (ADLs).
| Arm | Type | Receives |
|---|---|---|
| control group | Other | Other: controlFollowing baseline assessments, participants will begin their respective 8-week intervention program with 2-3 times per week. The group A will receive base line conventional exercise program with standard physical therapy interventions as follow: * Stretching of tight muscles of affected upper limb. * Weight bearing of affected upper limb. * Manual dexterity exercises like grasp release, pack board activities. * Teaching of ADLs. * Functional task practice(2) |
| experimental group | Experimental | Other: experimentalKinesiotherapy tailored exercises focusing on movement and exercise, The movements are as follows:Sitting on a chair, the participant had to lean forward to pick up an object previously placed on the floor.Sitting on a chair, the participant had to rotate the upper body, reaching out and grabbing an object on its side, at the height of his shoulders.Sitting on a chair, the participant had to clasp his hands and flex the shoulders. Sitting on a chair in front of a table, the participant had to take objects numbered in ascending order and hand them over to the therapist. Sitting on a chair holding a stick, the participant had to place one hand above the other, raising his hands as if holding on to the stick.Sitting on a chair in front of a table, the patient had to find similar playing cards. All cards were face down. Sitting on a stretcher, the participant had to laterally tilt his trunk, putting the weight on the upper limbs. The therapist maintained the elbow extension |
Who may qualify
- Ages
- 8 to 13 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Age: 8-13 years old both sexes
- Ability to follow simple instructions, able to sit or stand with support to participate in physical therapy sessions( MACS level Ⅰ-Ⅲ)(9) and (GMFCS level Ⅰ-Ⅲ)(10)
- Ability to communicate needs and discomfort (verbally or non-verbally)
- No concurrent participation in other physical therapy or rehabilitation programs
Key exclusion criteria (5 listed)
- Severe visual and hearing impairments that would hinder participation
- Severe cognitive or intellectual disabilities that would impede understanding of instructions
- History of seizures or other neurological conditions that may impact participation
- Recent (within 6 months) or planned orthopedic surgery
- Concurrent use of botulinum toxin injections or oral medications affecting muscle tone(2).
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 |
|---|---|---|
| controlAlso: baselineFollowing baseline assessments, participants will begin their respective 8-week intervention program with 2-3 times per week. The group A will receive base line conventional exercise program with standard physical therapy interventions as follow: * Stretching of tight muscles of affected upper limb. * Weight bearing of affected upper limb. * Manual dexterity exercises like grasp release, pack board activities. * Teaching of ADLs. * Functional task practice(2) | Other | control group |
| experimentalAlso: kinesiotherapyFollowing baseline assessments, participants will begin their respective 8-week intervention program with 2-3 times per week. The group A will receive base line conventional exercise program with standard physical therapy interventions as follow: * Stretching of tight muscles of affected upper limb. * Weight bearing of affected upper limb. * Manual dexterity exercises like grasp release, pack board activities. * Teaching of ADLs. * Functional task practice(2) | Other | experimental group |
Primary outcome
action arm research arm test
Time frame: baseline, 8 weeks
The Action Research Arm Test (ARAT) is a 19 item observational measures used by physical therapists and other health care professionals to assess upper extremity performance (coordination, dexterity and functioning) in stroke recovery, brain injury and multiple sclerosis populations. Items comprising the ARAT are categorized into four subscales (grasp, grip, pinch and gross movement) and arranged in order of decreasing difficulty, with the most difficult task examined first, followed by the least difficult task maximum score 57 means better performance
pediatric evaluation of disability inventory
Time frame: baseline, 8 weeks
The PEDI is a standardized clinical assessment tool designed to measure the functional performance of children with typical development whose chronological age is below 7.5 years old, and the functional performance of children with disabilities whose functional capabilities are below those of a 7.5-year-old child. The PEDI can be used for children with developmental disabilities aged 6 months to 21 years and for individuals without disabilities aged less than 7 years(12) The PEDI is composed of 3 domains: functional skill, caregiver assistance, and modification. Each domain includes 3 sub-domains: self-care, mobility, and social function. The functional skill domain, which was used for measuring ADL performance, consists of 197 specific questions. Each child is assigned either 1 point for being capable of performing the assigned task or 0 points for incomplete performance or being unable to perform the task. The reliability of the functional skill subscale of the PEDI is very high.
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 24 Nov 2025.
- Background: PubMed 35244860Alberti EJ, Targa ADS, Pichorim SF, Brawerman A. Ludic Table: a comparative study between playful rehabilitation and kinesiotherapy in restricting upper limb movements in individuals with stroke. Med Biol Eng Comput. 2022 Apr;60(4):1187-1198. doi: 10.1007/s11517-022-02532-0. Epub 2022 Mar 4.
- 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.
Naima Andleeb, MS PT principal investigator
Riphah Internatonal 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 experimental in people with Hemiplegic Cerebral Palsy, run by Riphah International University at 1 site in Pakistan.
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 4 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: looking for participants now, as of the sponsor's last update on 24 Nov 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 Pakistan. 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 imran amjad, Phd (9233224390125, imran.amjad@riphah.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
action arm research arm test (time frame: baseline, 8 weeks). 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 NCT07244081, which also lists 1 linked publication.
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 24 Nov 2025; AzTrials last refreshed its copy on 26 Oct 2026.