Hemiplegic Cerebral PalsyNCT06502639
Effects of Theraplay on Hand in Cerebral Palsy
A study testing theraplay program and conventional physical therapy in people with Hemiplegic Cerebral Palsy, run by Riphah International University at 1 site in Pakistan.
Trial summary
Among the neurological conditions known as cerebral palsy are those that impact muscle tone, mobility, and cooperation. Cerebral palsy that affects only one side of the body is known as hemiplegic cerebral palsy. Read more about this study
- Who is it for?
- Ages 6 to 12 years, women only
- Conditions the study is for
- Hemiplegic Cerebral Palsy
- What is being tested?
- theraplay program and conventional physical therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Jun 2024to 8 Aug 2024
- 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
- Women only
- No healthy volunteers
- Child
Who may be able to join
- Ages of both boys and girls range from 6 to 12 years
- Based on the Modified Ashworth Scale, the degree of spasticity is between 1 and 1+.
- Capable of grasping, releasing, and reaching with the afflicted hand
- Capable of comprehending and adhering to instructions
Who cannot join
- Children with mixed C.P., ataxic, athetoid, and mental retardation
- Visual and auditory issues
- Upper limb congenital malformations, Convulsions
- Youngsters who have recently sustained upper extremity trauma
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Riphah International University
Lahore, Punjab Province, 54000
About this study
Official title: Effects of Tharaplay Program on Hand Dexterity in Children With Hemiplegic Cerebral Palsy
Among the neurological conditions known as cerebral palsy are those that impact muscle tone, mobility, and cooperation. Cerebral palsy that affects only one side of the body is known as hemiplegic cerebral palsy. Damage to one side of the brain causes this disorder, which usually manifests as before, in the middle of, or soon after birth. The ability to use one\'s hands with coordination and expertise to accomplish tasks that call for control and accuracy is known as hand dexterity. For those who have cerebral palsy, hand dexterity can be a major issue. Developing hand dexterity is crucial as it might augment an individual\'s capacity to execute routine tasks and attain greater autonomy.Convenient sampling will be used to carry out a randomized control study.
Twenty two subjects will be divided into two groups at random. The experimental group will receive Theraplay therapy, which is a program that includes various play-based activities like playing with wooden puzzles, clay and blocks, making wraps, bubble tennis, and special handshakes, claps, and high fives, in addition to designed conventional therapy. The control group will receive designed conventional physical therapy exercises for the affected hand, such as hand weight-bearing exercises, stretching and strengthening exercises, and exercises using sponge balls.
Read more
The course of treatment will run for eight weeks. As outcome measures, the GMFCS and MACS scales, the box and block test, finger tapping, and the nine-hole peg test will be employed.
Data will be analyzed on SPSS version 25; the normality of the data will be checked and tests will be applied according to the normality of the data either it will be a parametric test or non parametric based on the normality.
Read the detailed description
Group A: The control group will receive a designed conventional physical therapy program for the affected hand like stretching and strengthening exercises, sponge ball exercises to the hand, and hand weight bearing exercises.
Group B: The experimental group will receive Theraplay therapy or a program and different play-based activities like playing with wooden puzzles and playing with clay and blocks, special handshake claps high fives, making wraps, and bubble tennis in addition to designed conventional therapy.
- Conditions
- Hemiplegic Cerebral Palsy
- Being tested
- theraplay program, conventional physical therapy
- Keywords
- cp, hand dexterity, theraplay
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
theraplay programOther
A play therapy method called "thermaplay" aids in children's development of stronger bonds and relationships with others. It emphasizes the parts of communication that are nonverbal. When it comes to giving cerebral palsy children with hand therapy that is both effective and motivating, fun approaches have been shown to be both successful and appealing.
conventional physical therapyOther
conventional physical therapy program for like stretching and strengthening exercises, sponge ball exercises to the hand, and hand weight bearing exercises
| Study group | Role | What they receive |
|---|---|---|
| conventional therapy | Active comparator | The control group will receive a designed conventional physical therapy program for the affected hand like stretching and strengthening exercises, sponge ball exercises to the hand, and hand weight bearing exercises. Receives: Other: conventional physical therapy |
| conventional therapy along with theraplay program | Experimental | The experimental group will receive Theraplay therapy or a program and different play-based activities like playing with wooden puzzles and playing with clay and blocks, special handshake claps high fives, making wraps, and bubble tennis in addition to designed conventional therapy. Receives: Other: theraplay program |
What is being measured
The primary outcome is the main question the study is designed to answer.
modified ashworth scale
The Modified Ashworth Scale (MAS) is a commonly used clinical assessment tool to evaluate muscle tone and spasticity in individuals with neurological conditions such as spastic cerebral palsy. It is a reliable and valid method for grading muscle resistance during passive movement. interrater reliability of AS and MAS varied from moderate to good. ICC scores of AS were between 0.54 and 0.78 and MAS were between 0.61-0.87. Test-retest results of AS and MAS varied from poor to good. ICC values were between 0.31 and 0.82 for AS and between 0.36 and 0.83 for MAS.
Measured: 8 weeks
ABILHAND-KID
a clinical instrument for assessing children with cerebral palsy's physical dexterity. The parents rated 21 largely bimanual elements that made up the ABILHAND-Kids scale. Because the parents gave a more accurate assessment of their kids' abilities than the kids did, the measurement range was larger, the reliability (R=0.94) was higher, and the results were consistent over time.
Measured: 8 Weeks
Manual Ability Classification scale
The purpose of the Manual Ability Classification System is to categorize the ways in which kids with cerebral palsy use their hands to handle items during everyday tasks. The categorization is intended to represent the child's average manual performance rather than their maximum ability. There are five levels to it.
Measured: 8 weeks
Gross Motor Functional Classification Scale
The most widely used scale by pediatric professionals to characterize the degree of gross motor impairment in children with cerebral palsy is the GMFCS. The five-level Gross Motor Function Classification System is used to categorize children with cerebral palsy according to their current gross motor ability, their limits in gross motor function, and whether or not they require assistive technology or wheeled mobility.
Measured: 8 weeks
Box And Block Test
During therapy, a functional test called the Box and Blocks Test is performed to gauge a child with cerebral palsy's gross manual dexterity. The exam consists of a box with a center partition.
Measured: 8 weeks
Nine Hole Peg Test
Patients with cerebral palsy can have their finger dexterity measured with the Nine Hole Peg Test.The patient picks up each of the nine pegs as fast as they can and inserts them into the nine holes in this test using a start command that starts a stopwatch.
Measured: 8 weeks
Finger Tapping Test
The Finger Tapping Test, sometimes called the Tapping Speed Assessment, is one of the many tools available to assess motor control and the condition of the neuromuscular system.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2024
- Study start1 Jun 2024
- Primary completion1 Aug 2024
- Study completion8 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Hemiplegic Cerebral PalsyStudies of the same condition, open and under way.
- More trials run by Riphah International 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
- it will randomized controlled trial in which non probability convenient sampling will be used. Two groups of 6-12 years will be performed in which participant will randomly divided. Group A will recieve conventional therapy and Group B will recieve conventional therapy with theraplay program.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- sidra jamal, MS, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06502639
- Sponsor's protocol ID
- REC/RCR&AHS/23/0777
- Status last verified
- Dec 2024
- First submitted
- 11 Jun 2024
- Last updated
- 27 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sadowska M, Sarecka-Hujar B, Kopyta I. Cerebral Palsy: Current Opinions on Definition, Epidemiology, Risk Factors, Classification and Treatment Options. Neuropsychiatr Dis Treat. 2020 Jun 12;16:1505-1518. doi: 10.2147/NDT.S235165. eCollection 2020.
PubMed 32606703Tahsin Z. Effect of hand activities group therapy program on ADL performance of children with cerebral palsy at CENTRE FOR THE REHABILITATION OF THE PARALYSED (CRP): Bangladesh Health Professions Institute, Faculty of Medicine, the University …; 2019.
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Tharaplay Program on Hand Dexterity in Children With Hemiplegic Cerebral Palsy
- ClinicalTrials.gov ID
- NCT06502639
- Acronym / sponsor ID
- REC/RCR&AHS/23/0777
- Conditions
- Hemiplegic Cerebral Palsy
- Keywords
- cp, hand dexterity, theraplay
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- 1 Aug 2024 (actual)
- Study completion
- 8 Aug 2024 (actual)
- First posted
- 16 Jul 2024 (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.
Among the neurological conditions known as cerebral palsy are those that impact muscle tone, mobility, and cooperation. Cerebral palsy that affects only one side of the body is known as hemiplegic cerebral palsy. Damage to one side of the brain causes this disorder, which usually manifests as before, in the middle of, or soon after birth. The ability to use one\'s hands with coordination and expertise to accomplish tasks that call for control and accuracy is known as hand dexterity. For those who have cerebral palsy, hand dexterity can be a major issue. Developing hand dexterity is crucial as it might augment an individual\'s capacity to execute routine tasks and attain greater autonomy.Convenient sampling will be used to carry out a randomized control study.
Twenty two subjects will be divided into two groups at random. The experimental group will receive Theraplay therapy, which is a program that includes various play-based activities like playing with wooden puzzles, clay and blocks, making wraps, bubble tennis, and special handshakes, claps, and high fives, in addition to designed conventional therapy. The control group will receive designed conventional physical therapy exercises for the affected hand, such as hand weight-bearing exercises, stretching and strengthening exercises, and exercises using sponge balls.
The course of treatment will run for eight weeks. As outcome measures, the GMFCS and MACS scales, the box and block test, finger tapping, and the nine-hole peg test will be employed.
Data will be analyzed on SPSS version 25; the normality of the data will be checked and tests will be applied according to the normality of the data either it will be a parametric test or non parametric based on the normality.
Detailed description
Group A: The control group will receive a designed conventional physical therapy program for the affected hand like stretching and strengthening exercises, sponge ball exercises to the hand, and hand weight bearing exercises.
Group B: The experimental group will receive Theraplay therapy or a program and different play-based activities like playing with wooden puzzles and playing with clay and blocks, special handshake claps high fives, making wraps, and bubble tennis in addition to designed conventional therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- it will randomized controlled trial in which non probability convenient sampling will be used. Two groups of 6-12 years will be performed in which participant will randomly divided. Group A will recieve conventional therapy and Group B will recieve conventional therapy with theraplay program.
| Arm | Type | Receives |
|---|---|---|
| conventional therapy | Active comparator | Other: conventional physical therapyThe control group will receive a designed conventional physical therapy program for the affected hand like stretching and strengthening exercises, sponge ball exercises to the hand, and hand weight bearing exercises. |
| conventional therapy along with theraplay program | Experimental | Other: theraplay programThe experimental group will receive Theraplay therapy or a program and different play-based activities like playing with wooden puzzles and playing with clay and blocks, special handshake claps high fives, making wraps, and bubble tennis in addition to designed conventional therapy. |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Ages of both boys and girls range from 6 to 12 years
- Based on the Modified Ashworth Scale, the degree of spasticity is between 1 and 1+.
- Capable of grasping, releasing, and reaching with the afflicted hand
- Capable of comprehending and adhering to instructions
Key exclusion criteria (4 listed)
- Children with mixed C.P., ataxic, athetoid, and mental retardation
- Visual and auditory issues
- Upper limb congenital malformations, Convulsions
- Youngsters who have recently sustained upper extremity trauma
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 |
|---|---|---|
| theraplay programA play therapy method called "thermaplay" aids in children's development of stronger bonds and relationships with others. It emphasizes the parts of communication that are nonverbal. When it comes to giving cerebral palsy children with hand therapy that is both effective and motivating, fun approaches have been shown to be both successful and appealing. | Other | conventional therapy along with theraplay program |
| conventional physical therapyconventional physical therapy program for like stretching and strengthening exercises, sponge ball exercises to the hand, and hand weight bearing exercises | Other | conventional therapy |
Primary outcome
modified ashworth scale
Time frame: 8 weeks
The Modified Ashworth Scale (MAS) is a commonly used clinical assessment tool to evaluate muscle tone and spasticity in individuals with neurological conditions such as spastic cerebral palsy. It is a reliable and valid method for grading muscle resistance during passive movement. interrater reliability of AS and MAS varied from moderate to good. ICC scores of AS were between 0.54 and 0.78 and MAS were between 0.61-0.87. Test-retest results of AS and MAS varied from poor to good. ICC values were between 0.31 and 0.82 for AS and between 0.36 and 0.83 for MAS.
ABILHAND-KID
Time frame: 8 Weeks
a clinical instrument for assessing children with cerebral palsy's physical dexterity. The parents rated 21 largely bimanual elements that made up the ABILHAND-Kids scale. Because the parents gave a more accurate assessment of their kids' abilities than the kids did, the measurement range was larger, the reliability (R=0.94) was higher, and the results were consistent over time.
Manual Ability Classification scale
Time frame: 8 weeks
The purpose of the Manual Ability Classification System is to categorize the ways in which kids with cerebral palsy use their hands to handle items during everyday tasks. The categorization is intended to represent the child's average manual performance rather than their maximum ability. There are five levels to it.
Gross Motor Functional Classification Scale
Time frame: 8 weeks
The most widely used scale by pediatric professionals to characterize the degree of gross motor impairment in children with cerebral palsy is the GMFCS. The five-level Gross Motor Function Classification System is used to categorize children with cerebral palsy according to their current gross motor ability, their limits in gross motor function, and whether or not they require assistive technology or wheeled mobility.
Box And Block Test
Time frame: 8 weeks
During therapy, a functional test called the Box and Blocks Test is performed to gauge a child with cerebral palsy's gross manual dexterity. The exam consists of a box with a center partition.
Nine Hole Peg Test
Time frame: 8 weeks
Patients with cerebral palsy can have their finger dexterity measured with the Nine Hole Peg Test.The patient picks up each of the nine pegs as fast as they can and inserts them into the nine holes in this test using a start command that starts a stopwatch.
Finger Tapping Test
Time frame: 8 weeks
The Finger Tapping Test, sometimes called the Tapping Speed Assessment, is one of the many tools available to assess motor control and the condition of the neuromuscular system.
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 27 Dec 2024.
- Background: PubMed 32606703Sadowska M, Sarecka-Hujar B, Kopyta I. Cerebral Palsy: Current Opinions on Definition, Epidemiology, Risk Factors, Classification and Treatment Options. Neuropsychiatr Dis Treat. 2020 Jun 12;16:1505-1518. doi: 10.2147/NDT.S235165. eCollection 2020.
- BackgroundTahsin Z. Effect of hand activities group therapy program on ADL performance of children with cerebral palsy at CENTRE FOR THE REHABILITATION OF THE PARALYSED (CRP): Bangladesh Health Professions Institute, Faculty of Medicine, the University …; 2019.
- 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. This study is not recruiting at the moment.
sidra jamal, MS principal investigator
Riphah International 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 theraplay program and conventional physical therapy 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 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: finished, as of the sponsor's last update on 27 Dec 2024. 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?
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?
modified ashworth scale (time frame: 8 weeks). The study lists 7 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 NCT06502639, which also lists 2 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 27 Dec 2024.