Cerebral PalsyNCT06522464
Modified Constraint Induced Movement Therapy With And Without Cross Education In Cerebral Palsy
A study testing Group A: mCIMT with cross-education and Group B: mCIMT without cross-education in people with Cerebral Palsy, run by Riphah International University at 1 site in Pakistan.
Trial summary
A nonprogressive injury to the growing brain, cerebral palsy can impair a child's speech, intellectual ability, and motor development. The kind of impairment will correspond with the affected brain region. Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- Group A: mCIMT with cross-education and Group B: mCIMT without cross-education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 sitePakistan
- Study dates
- 30 Jun 2024to 30 Oct 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
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age 6 - 12 years old CP hemiparetic children
- having the ability to grasp and release light objects, with an extension of at least 20° of the wrist and 10° of the metacarpophalangeal joints of the fingers (from full flexion of the affected hand)
- having impairment of hand function at levels I to III of the Manual Activity Classification System (MACS)(14).
Who cannot join
- having visual or auditory disorder
- being subject to seizures or having health problems not associated with CP
- having predominant spasticity or contracture grades more than Grade 3 of the Modified Ashworth Scale in wrist and finger flexors, forearm pronators, and/or thumb adductors
- having received Botulinum neurotoxin injections and/or surgical interventions in the 6-month period before the study
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Rich Care A Rehabilitation Clinic
Lahore, Punjab Province, 37110
About this study
Official title: Effects Of Modified Constraint Induced Movement Therapy With And Without Cross Education On Upper Limb Function In Cerebral Palsy
A nonprogressive injury to the growing brain, cerebral palsy can impair a child's speech, intellectual ability, and motor development. The kind of impairment will correspond with the affected brain region. Cross education is the process of improving one's strength or skill on the contralateral limb after undergoing unilateral training or practice. This is typically done with a mirror, which activates the mirror neuron on the ipsilateral side. CI, or Constraint-Induced Movement Therapy (CIMT), is a "rehabilitative strategy". It is intended to help people affected by stroke or other neurological problems utilize an affected extremity more functionally. It restrains the limb that is neurologically stronger while applying mass practice concepts. It has also been described as a behavioral approach to neurorehabilitation, with a focus on shaping as a recurring theme, and it uses basic behavioral approaches. The study's objective is to ascertain how cross-education using mCIMT affects cerebral palsy that is hemiparetic.
The Pakistan Society for the Rehabilitation of the Disabled, Lahore (PSRD), Rising Sun Institute for Special Children DHA, and ARK campus Lahore will all provide data for the present study, which is a randomized controlled experiment. Twenty-two volunteers will be randomly assigned to two equal groups for the study. Children with hemiperatic cerebral palsy, aged 6 to 12, of any gender, who have up to 20 degrees of wrist extension, 10 degrees of thumb abduction, and up to 10 degrees of finger extension are eligible to participate in the study. Exclusion criteria included significant shoulder subluxation, uncontrolled systemic hypertension, prior stroke, severe heart failure, and a mini mental state evaluation score of less than 24. The control group will receive conventional physical therapy, whereas the experimental group will receive cross-training using mCIMT and RPT. Result The results before and after the intervention will be analyzed using the Fugl Meyer Upper Extremity Scale and Upper Extremity Functional Index Scale, Jebsen-Taylor Hand Function Test, and Block and Box manual Dexterity Test. Data analysis will be conducted using SPSS version 23.00.
Read the detailed description
Group A:
For ten weeks, Group A will follow the mCIMT Protocol, which entails 30 minutes of one-on-one therapy three days a week and five hours a day (weekdays) of constraint.
In addition, the student will receive extra cross-education, which will involve practicing reaching tasks, wrist flexion and extension, and non-paretic hand opening and closing for 30 minutes. Activities include building a tower out of cubes in various colors, sorting cubes of similar colors and forms together (square cubes in a column, cylindrical cubes together), gripping a hammer, and various cube and triangular shapes. putting balls in their column, placing various-sized circular forms in their proper locations, and moving items between both hands (18). We'll utilize weight cuffs for every activity.
Group B:
For ten weeks, Group B will follow the mCIMT Protocol, which entails 30 minutes of one-on-one therapy three days a week and five hours a day (weekdays) of confinement.
- Conditions
- Cerebral Palsy
- Being tested
- Group A: mCIMT with cross-education, Group B: mCIMT without cross-education
- Keywords
- Cerebral Palsy, Cross education, Modified Constraint-induced, Movement Therapy, dexterity function.
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group A: mCIMT with cross-educationOther
For ten weeks, Group A will follow the mCIMT Protocol, which entails 30 minutes of one-on-one therapy three days a week and five hours a day (weekdays) of constraint.
In addition, the student will receive extra cross-education, which will involve practicing reaching tasks, wrist flexion and extension, and non-paretic hand opening and closing for 30 minutes. Activities include building a tower out of cubes in various colors, sorting cubes of similar colors and forms together (square cubes in a column, cylindrical cubes together), gripping a hammer, and various cube and triangular shapes. putting balls in their column, placing various-sized circular forms in their proper locations, and moving items between both hands (18). We'll utilize weight cuffs for every activity.
Group B: mCIMT without cross-educationOther
For ten weeks, Group B will follow the mCIMT Protocol, which entails 30 minutes of one-on-one therapy three days a week and five hours a day (weekdays) of confinement.
| Study group | Role | What they receive |
|---|---|---|
| Group A: mCIMT with cross-education | Experimental | For ten weeks, Group A will follow the mCIMT Protocol, which entails 30 minutes of one-on-one therapy three days a week and five hours a day (weekdays) of constraint.
In addition, the student will receive extra cross-education, which will involve practicing reaching tasks, wrist flexion and extension, and non-paretic hand opening and closing for 30 minutes. Activities include building a tower out of cubes in various colors, sorting cubes of similar colors and forms together (square cubes in a column, cylindrical cubes together), gripping a hammer, and various cube and triangular shapes. putting balls in their column, placing various-sized circular forms in their proper locations, and moving items between both hands. We'll utilize weight cuffs for every activity. Receives: Other: Group A: mCIMT with cross-education |
| Group B: mCIMT without cross-education | Active comparator | For ten weeks, Group B will follow the mCIMT Protocol, which entails 30 minutes of one-on-one therapy three days a week and five hours a day (weekdays) of confinement. Receives: Other: Group B: mCIMT without cross-education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Upper Extremity Functional Index Scale:
Patients with disabilities to their upper limbs can have their functional limitations evaluated using the UEFI. It can be used to track changes in functional status over time and assess how well treatment plans are working. Currently, UEFI 20-item and UEFI 15-item are the two versions available. The UEFI is designed to be used by people who have musculoskeletal dysfunction of the upper extremities (shoulder, elbow, wrist, and hand). The scores on the UEFI range from 0 to 4, where 0 denotes extreme difficulty and 4 denotes no difficulty at all. The total score is the sum of the individual scores. The possible range for the UEFI 20-item is 0 to 80, where 80 represents the highest functioning state and 0 the lowest.
Measured: 10 weeks
Jebsen-Taylor Hand Function Test:
This standardized and objective test uses simulated activities of daily living (ADL) to assess fine and gross motor function in the hands. Writing, simulated page flipping, lifting tiny things, simulated feeding, stacking, and lifting large, light, and heavy objects are the seven subsets of the JTHFT. It is an accurate instrument for measuring hand dysfunctions in a range of patient demographics. The JTHFT takes 15 to 45 minutes to complete. Better performance is shown by shorter times.
Measured: 10 weeks
Box and Block Test (BBT):
The BBT is made up of 150 blocks and a wooden box with a partition dividing it into two sections. requesting that the client transfer the greatest number of blocks, one by one, in 60 seconds from one box compartment to another of equal size. It is especially appropriate for kids for a number of reasons. First, the BBT assessment approach looks at basic manual dexterity skills for growing kids, like gripping, holding, transferring, and releasing. Second, the BBT's instructions are straightforward to understand, and the task itself is simple. Third, the job may be completed in just one minute, which is appropriate for the majority of children's attention spans.
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2024
- Study start30 Jun 2024
- Primary completion30 Oct 2024
- Study completion30 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for 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
- Model description
- It will be randomized control trial in which non probability convenient sampling will be used. Two groups of age 6 - 12 years old CP hemiparetic children having the ability to grasp and release light objects, with an extension of at least 20° of the wrist and 10° of the metacarpophalangeal joints of the fingers (from full flexion of the affected hand will be formed in which participants will be randomly divided. Group A will follow the mCIMT Protocol with additional cross education will be given and group B will follow the mCIMT Protocol.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fareeha Kausar, BS-PT, Principal investigator, Riphah International University Lahore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06522464
- Sponsor's protocol ID
- REC/RCR&AHS/23/0772
- Status last verified
- Mar 2025
- First submitted
- 22 Jul 2024
- Last updated
- 12 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Jones MW, Morgan E, Shelton JE, Thorogood C. Cerebral palsy: introduction and diagnosis (part I). J Pediatr Health Care. 2007 May-Jun;21(3):146-52. doi: 10.1016/j.pedhc.2006.06.007.
PubMed 17478303Zulu O, Lupenga J, Simpamba MM, Banda MC. Efficacy of Constraint Induced Movement Therapy and Mirror Therapy in Improving Upper Extremity Function in Late Subacute and Chronic Stroke Patients: A randomized crossover trial. Journal of Preventive and Rehabilitative Medicine. 2023;5(2):136-45.
Green LA, Gabriel DA. The cross education of strength and skill following unilateral strength training in the upper and lower limbs. J Neurophysiol. 2018 Aug 1;120(2):468-479. doi: 10.1152/jn.00116.2018. Epub 2018 Apr 18.
PubMed 29668382
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects Of Modified Constraint Induced Movement Therapy With And Without Cross Education On Upper Limb Function In Cerebral Palsy
- ClinicalTrials.gov ID
- NCT06522464
- Acronym / sponsor ID
- REC/RCR&AHS/23/0772
- Conditions
- Cerebral Palsy
- Keywords
- Cerebral Palsy, Cross education, Modified Constraint-induced, Movement Therapy, dexterity function.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 30 Jun 2024 (actual)
- Primary completion
- 30 Oct 2024 (actual)
- Study completion
- 30 Oct 2024 (actual)
- First posted
- 26 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.
A nonprogressive injury to the growing brain, cerebral palsy can impair a child's speech, intellectual ability, and motor development. The kind of impairment will correspond with the affected brain region. Cross education is the process of improving one's strength or skill on the contralateral limb after undergoing unilateral training or practice. This is typically done with a mirror, which activates the mirror neuron on the ipsilateral side. CI, or Constraint-Induced Movement Therapy (CIMT), is a "rehabilitative strategy". It is intended to help people affected by stroke or other neurological problems utilize an affected extremity more functionally. It restrains the limb that is neurologically stronger while applying mass practice concepts. It has also been described as a behavioral approach to neurorehabilitation, with a focus on shaping as a recurring theme, and it uses basic behavioral approaches. The study's objective is to ascertain how cross-education using mCIMT affects cerebral palsy that is hemiparetic.
The Pakistan Society for the Rehabilitation of the Disabled, Lahore (PSRD), Rising Sun Institute for Special Children DHA, and ARK campus Lahore will all provide data for the present study, which is a randomized controlled experiment. Twenty-two volunteers will be randomly assigned to two equal groups for the study. Children with hemiperatic cerebral palsy, aged 6 to 12, of any gender, who have up to 20 degrees of wrist extension, 10 degrees of thumb abduction, and up to 10 degrees of finger extension are eligible to participate in the study. Exclusion criteria included significant shoulder subluxation, uncontrolled systemic hypertension, prior stroke, severe heart failure, and a mini mental state evaluation score of less than 24. The control group will receive conventional physical therapy, whereas the experimental group will receive cross-training using mCIMT and RPT. Result The results before and after the intervention will be analyzed using the Fugl Meyer Upper Extremity Scale and Upper Extremity Functional Index Scale, Jebsen-Taylor Hand Function Test, and Block and Box manual Dexterity Test. Data analysis will be conducted using SPSS version 23.00.
Detailed description
Group A:
For ten weeks, Group A will follow the mCIMT Protocol, which entails 30 minutes of one-on-one therapy three days a week and five hours a day (weekdays) of constraint.
In addition, the student will receive extra cross-education, which will involve practicing reaching tasks, wrist flexion and extension, and non-paretic hand opening and closing for 30 minutes. Activities include building a tower out of cubes in various colors, sorting cubes of similar colors and forms together (square cubes in a column, cylindrical cubes together), gripping a hammer, and various cube and triangular shapes. putting balls in their column, placing various-sized circular forms in their proper locations, and moving items between both hands (18). We'll utilize weight cuffs for every activity.
Group B:
For ten weeks, Group B will follow the mCIMT Protocol, which entails 30 minutes of one-on-one therapy three days a week and five hours a day (weekdays) of confinement.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- It will be randomized control trial in which non probability convenient sampling will be used. Two groups of age 6 - 12 years old CP hemiparetic children having the ability to grasp and release light objects, with an extension of at least 20° of the wrist and 10° of the metacarpophalangeal joints of the fingers (from full flexion of the affected hand will be formed in which participants will be randomly divided. Group A will follow the mCIMT Protocol with additional cross education will be given and group B will follow the mCIMT Protocol.
| Arm | Type | Receives |
|---|---|---|
| Group A: mCIMT with cross-education | Experimental | Other: Group A: mCIMT with cross-educationFor ten weeks, Group A will follow the mCIMT Protocol, which entails 30 minutes of one-on-one therapy three days a week and five hours a day (weekdays) of constraint. In addition, the student will receive extra cross-education, which will involve practicing reaching tasks, wrist flexion and extension, and non-paretic hand opening and closing for 30 minutes. Activities include building a tower out of cubes in various colors, sorting cubes of similar colors and forms together (square cubes in a column, cylindrical cubes together), gripping a hammer, and various cube and triangular shapes. putting balls in their column, placing various-sized circular forms in their proper locations, and moving items between both hands. We'll utilize weight cuffs for every activity. |
| Group B: mCIMT without cross-education | Active comparator | Other: Group B: mCIMT without cross-educationFor ten weeks, Group B will follow the mCIMT Protocol, which entails 30 minutes of one-on-one therapy three days a week and five hours a day (weekdays) of confinement. |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Age 6 - 12 years old CP hemiparetic children
- having the ability to grasp and release light objects, with an extension of at least 20° of the wrist and 10° of the metacarpophalangeal joints of the fingers (from full flexion of the affected hand)
- having impairment of hand function at levels I to III of the Manual Activity Classification System (MACS)(14).
Key exclusion criteria (4 listed)
- having visual or auditory disorder
- being subject to seizures or having health problems not associated with CP
- having predominant spasticity or contracture grades more than Grade 3 of the Modified Ashworth Scale in wrist and finger flexors, forearm pronators, and/or thumb adductors
- having received Botulinum neurotoxin injections and/or surgical interventions in the 6-month period before the study
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 |
|---|---|---|
| Group A: mCIMT with cross-educationFor ten weeks, Group A will follow the mCIMT Protocol, which entails 30 minutes of one-on-one therapy three days a week and five hours a day (weekdays) of constraint. In addition, the student will receive extra cross-education, which will involve practicing reaching tasks, wrist flexion and extension, and non-paretic hand opening and closing for 30 minutes. Activities include building a tower out of cubes in various colors, sorting cubes of similar colors and forms together (square cubes in a column, cylindrical cubes together), gripping a hammer, and various cube and triangular shapes. putting balls in their column, placing various-sized circular forms in their proper locations, and moving items between both hands (18). We'll utilize weight cuffs for every activity. | Other | Group A: mCIMT with cross-education |
| Group B: mCIMT without cross-educationFor ten weeks, Group B will follow the mCIMT Protocol, which entails 30 minutes of one-on-one therapy three days a week and five hours a day (weekdays) of confinement. | Other | Group B: mCIMT without cross-education |
Primary outcome
Upper Extremity Functional Index Scale:
Time frame: 10 weeks
Patients with disabilities to their upper limbs can have their functional limitations evaluated using the UEFI. It can be used to track changes in functional status over time and assess how well treatment plans are working. Currently, UEFI 20-item and UEFI 15-item are the two versions available. The UEFI is designed to be used by people who have musculoskeletal dysfunction of the upper extremities (shoulder, elbow, wrist, and hand). The scores on the UEFI range from 0 to 4, where 0 denotes extreme difficulty and 4 denotes no difficulty at all. The total score is the sum of the individual scores. The possible range for the UEFI 20-item is 0 to 80, where 80 represents the highest functioning state and 0 the lowest.
Jebsen-Taylor Hand Function Test:
Time frame: 10 weeks
This standardized and objective test uses simulated activities of daily living (ADL) to assess fine and gross motor function in the hands. Writing, simulated page flipping, lifting tiny things, simulated feeding, stacking, and lifting large, light, and heavy objects are the seven subsets of the JTHFT. It is an accurate instrument for measuring hand dysfunctions in a range of patient demographics. The JTHFT takes 15 to 45 minutes to complete. Better performance is shown by shorter times.
Box and Block Test (BBT):
Time frame: 10 weeks
The BBT is made up of 150 blocks and a wooden box with a partition dividing it into two sections. requesting that the client transfer the greatest number of blocks, one by one, in 60 seconds from one box compartment to another of equal size. It is especially appropriate for kids for a number of reasons. First, the BBT assessment approach looks at basic manual dexterity skills for growing kids, like gripping, holding, transferring, and releasing. Second, the BBT's instructions are straightforward to understand, and the task itself is simple. Third, the job may be completed in just one minute, which is appropriate for the majority of children's attention spans.
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 12 Mar 2025.
- Background: PubMed 17478303Jones MW, Morgan E, Shelton JE, Thorogood C. Cerebral palsy: introduction and diagnosis (part I). J Pediatr Health Care. 2007 May-Jun;21(3):146-52. doi: 10.1016/j.pedhc.2006.06.007.
- BackgroundZulu O, Lupenga J, Simpamba MM, Banda MC. Efficacy of Constraint Induced Movement Therapy and Mirror Therapy in Improving Upper Extremity Function in Late Subacute and Chronic Stroke Patients: A randomized crossover trial. Journal of Preventive and Rehabilitative Medicine. 2023;5(2):136-45.
- Background: PubMed 29668382Green LA, Gabriel DA. The cross education of strength and skill following unilateral strength training in the upper and lower limbs. J Neurophysiol. 2018 Aug 1;120(2):468-479. doi: 10.1152/jn.00116.2018. Epub 2018 Apr 18.
- 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.
Fareeha Kausar, BS-PT principal investigator
Riphah International University Lahore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group A: mCIMT with cross-education and Group B: mCIMT without cross-education in people with 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 3 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 12 Mar 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?
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?
Upper Extremity Functional Index Scale: (time frame: 10 weeks). 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?
On the ClinicalTrials.gov record for NCT06522464, which also lists 3 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 12 Mar 2025; AzTrials last refreshed its copy on 1 Nov 2026.