Cerebral PalsyNCT06240988
Effects of CIMT With and Without MIT on Upper Limb of Children With Hemiparetic CP
A study testing Modified Constraint Induced Movement Therapy and Motor Imagery Technique in people with Cerebral Palsy, run by Riphah International University at 1 site in Pakistan.
Trial summary
Cerebral Palsy (CP) is a major cause of motor disability in children. Among these CP children, approximately one third have hemiparetic cerebral palsy. Hemiparetic cerebral palsy is more impairment of one side of the body as a result of non-progressive disturbances in premature brain.To determine the effects of… Read more about this study
- Who is it for?
- Ages 6 to 14 years
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- Modified Constraint Induced Movement Therapy and Motor Imagery Technique
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Dec 2023to 15 Feb 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 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age 6 to 14 years were included.
- Diagnosed of hemiparetic cerebral palsy and typically developing controls.
- Both gender is included i-e, male and female.
- Children included having motor impairments of upper limb.
- All children had normal or corrected vision and the ability to discriminate between right and left.
Who cannot join
- History of neurosensory and neuropsychiatric impairments.
- Presence of contractures in the affected upper limb.
- Surgery in the previous six months.
- Uncontrolled epilepsy
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 Constraint Induced Movement Therapy With and Without Motor Imagery Technique on Upper Limb of Children With Hemiparetic Cerebral Palsy
Cerebral Palsy (CP) is a major cause of motor disability in children. Among these CP children, approximately one third have hemiparetic cerebral palsy. Hemiparetic cerebral palsy is more impairment of one side of the body as a result of non-progressive disturbances in premature brain.To determine the effects of implementing a practice period of modified constraint induced movement therapy in a virtual environment on hand function in chidren with hemiparetic cerebral palsy.
Read the detailed description
To determine the effects of implementing a practice period of modified constraint induced movement therapy in a virtual environment on hand function in chidren with hemiparetic cerebral palsy.The term Modified constraint-induced movement therapy is a form of rehabilitation therapy that limits the less paretic side, and through repeated and concentrated training improve the upper limb function of the paretic side. Motor imagery is a cognitive process in which a subject imagines that he or she performs a movement without actually performing the movement and without even tensing the muscles. Modified Constraint induced movement therapy can be utilized in both the lower and upper extremities with the motor imagery technique for psychological or occupational therapy and in affecting which one is better for speedy recovery.
- Conditions
- Cerebral Palsy
- Being tested
- Modified Constraint Induced Movement Therapy, Motor Imagery Technique
- Keywords
- MCIMT, Motor Imagery Technique, Hemiparetic CP, RCT
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modified Constraint Induced Movement TherapyDevice
Modified Constraint Induced Movement Therapy
Motor Imagery TechniqueOther
Motor Imagery Technique
| Study group | Role | What they receive |
|---|---|---|
| Modified Constraint Induced Movement Therapy | Experimental | Group that will be provided with Modified Constraint Induced Movement Therapy. A protocol of 10 minutes of MCIMT therapy will be given including constraints. Receives: Device: Modified Constraint Induced Movement Therapy |
| Motor Imagery Technique | Experimental | Group that will be provided with Motor Imagery Technique by grasping an object and placing it into a container, or in imagining to perform the same action. Receives: Other: Motor Imagery Technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
QUEST (Quality of Upper Extremity Skills Test)
Item The Quality of Upper Extremity Skills Test is an outcome measure designed to evaluate movement patterns and hand function in children with cerebral palsy. The QUEST is both reliable and valid. The purpose of the QUEST is to evaluate quality of upper extremity function in four domains: dissociated movement,grasp,protective extension, and weight bearing. Scores of 1 or 2, determined by quality of assessed position or movement; 1 if movement quality is not achieved, 2 if movement quality is achieved. Item scores are summed; formulas are used to calculate percentages for each domain. Domain percentages are summed and divided by number of domains to obtain total score. Minimum score = 0, Maximum score = 100.
Measured: 8 weeks
Secondary outcomes (1)
Box and Block Test (BBT)
The Box and Block Test (BBT) measures unilateral gross manual dexterity. It is a quick, simple and inexpensive test. It can be used with a wide range of populations. Clients are scored based on the number of blocks transferred from one compartment to the other compartment in 60 seconds. Score each hand separately. Higher scores are indicative of better manual dexterity. During the performance of the BBT, the evaluator should be aware of whether the client's fingertips are crossing the partition. Blocks should be counted only when this condition is respected. Furthermore, if two blocks are transferred at once, only one block will be counted. Blocks that fall outside the box, after trespassing the partition, even if they don't make it to the other compartment, should be counted.
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 posted5 Feb 2024
- Study start1 Dec 2023
- Primary completion15 Feb 2024
- Study completion15 Feb 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 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 be Randomized Controlled Trial in which non probability convenient sampling technique will be used. two groups of 6 to 14 years of age will be formed in which participants will be randomly divided. Group A will be given Modified CIMT and the other group B will receive motor imagery technique on upper limb in hemiparetic CP.
- 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
- Khansa Khalid, MS, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06240988
- Sponsor's protocol ID
- REC/RCR&AHS/23/0743
- Status last verified
- Jun 2024
- First submitted
- 26 Dec 2023
- Last updated
- 13 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Humphreys P, Whiting S, Pham B. Hemiparetic cerebral palsy: clinical pattern and imaging in prediction of outcome. Can J Neurol Sci. 2000 Aug;27(3):210-9.
PubMed 10975533Steenbergen B, Gordon AM. Activity limitation in hemiplegic cerebral palsy: evidence for disorders in motor planning. Dev Med Child Neurol. 2006 Sep;48(9):780-3. doi: 10.1017/S0012162206001666.
PubMed 16904028
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Constraint Induced Movement Therapy With and Without Motor Imagery Technique on Upper Limb of Children With Hemiparetic Cerebral Palsy
- ClinicalTrials.gov ID
- NCT06240988
- Acronym / sponsor ID
- REC/RCR&AHS/23/0743
- Conditions
- Cerebral Palsy
- Keywords
- MCIMT, Motor Imagery Technique, Hemiparetic CP, RCT
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 15 Feb 2024 (actual)
- Study completion
- 15 Feb 2024 (actual)
- First posted
- 5 Feb 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.
Cerebral Palsy (CP) is a major cause of motor disability in children. Among these CP children, approximately one third have hemiparetic cerebral palsy. Hemiparetic cerebral palsy is more impairment of one side of the body as a result of non-progressive disturbances in premature brain.To determine the effects of implementing a practice period of modified constraint induced movement therapy in a virtual environment on hand function in chidren with hemiparetic cerebral palsy.
Detailed description
To determine the effects of implementing a practice period of modified constraint induced movement therapy in a virtual environment on hand function in chidren with hemiparetic cerebral palsy.The term Modified constraint-induced movement therapy is a form of rehabilitation therapy that limits the less paretic side, and through repeated and concentrated training improve the upper limb function of the paretic side. Motor imagery is a cognitive process in which a subject imagines that he or she performs a movement without actually performing the movement and without even tensing the muscles. Modified Constraint induced movement therapy can be utilized in both the lower and upper extremities with the motor imagery technique for psychological or occupational therapy and in affecting which one is better for speedy recovery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- It will be Randomized Controlled Trial in which non probability convenient sampling technique will be used. two groups of 6 to 14 years of age will be formed in which participants will be randomly divided. Group A will be given Modified CIMT and the other group B will receive motor imagery technique on upper limb in hemiparetic CP.
| Arm | Type | Receives |
|---|---|---|
| Modified Constraint Induced Movement Therapy | Experimental | Device: Modified Constraint Induced Movement TherapyGroup that will be provided with Modified Constraint Induced Movement Therapy. A protocol of 10 minutes of MCIMT therapy will be given including constraints. |
| Motor Imagery Technique | Experimental | Other: Motor Imagery TechniqueGroup that will be provided with Motor Imagery Technique by grasping an object and placing it into a container, or in imagining to perform the same action. |
Who may qualify
- Ages
- 6 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Age 6 to 14 years were included.
- Diagnosed of hemiparetic cerebral palsy and typically developing controls.
- Both gender is included i-e, male and female.
- Children included having motor impairments of upper limb.
- All children had normal or corrected vision and the ability to discriminate between right and left.
Key exclusion criteria (4 listed)
- History of neurosensory and neuropsychiatric impairments.
- Presence of contractures in the affected upper limb.
- Surgery in the previous six months.
- Uncontrolled epilepsy
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 |
|---|---|---|
| Modified Constraint Induced Movement TherapyModified Constraint Induced Movement Therapy | Device | Modified Constraint Induced Movement Therapy |
| Motor Imagery TechniqueMotor Imagery Technique | Other | Motor Imagery Technique |
Primary outcome
QUEST (Quality of Upper Extremity Skills Test)
Time frame: 8 weeks
Item The Quality of Upper Extremity Skills Test is an outcome measure designed to evaluate movement patterns and hand function in children with cerebral palsy. The QUEST is both reliable and valid. The purpose of the QUEST is to evaluate quality of upper extremity function in four domains: dissociated movement,grasp,protective extension, and weight bearing. Scores of 1 or 2, determined by quality of assessed position or movement; 1 if movement quality is not achieved, 2 if movement quality is achieved. Item scores are summed; formulas are used to calculate percentages for each domain. Domain percentages are summed and divided by number of domains to obtain total score. Minimum score = 0, Maximum score = 100.
1 secondary outcome
Box and Block Test (BBT)
Time frame: 8 weeks
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 13 Jun 2024.
- Background: PubMed 10975533Humphreys P, Whiting S, Pham B. Hemiparetic cerebral palsy: clinical pattern and imaging in prediction of outcome. Can J Neurol Sci. 2000 Aug;27(3):210-9.
- Background: PubMed 16904028Steenbergen B, Gordon AM. Activity limitation in hemiplegic cerebral palsy: evidence for disorders in motor planning. Dev Med Child Neurol. 2006 Sep;48(9):780-3. doi: 10.1017/S0012162206001666.
- 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.
Khansa Khalid, 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 Modified Constraint Induced Movement Therapy and Motor Imagery Technique 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 5 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 13 Jun 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?
QUEST (Quality of Upper Extremity Skills Test) (time frame: 8 weeks). 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 NCT06240988, 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 13 Jun 2024.