Hemiplegic Cerebral PalsyNCT06294444
Comparison of Constraint Induced Movement Therapy and Mirror Therapy
A study testing Constraint Induced Movement Therapy and Mirror therapy in people with Hemiplegic Cerebral Palsy, run by Riphah International University at 2 sites in Pakistan.
Trial summary
Hemiplegia in infants and children is a type of Cerebral Palsy that results from damage to the part (hemisphere) of the brain that controls muscle movements. This damage may occur before, during or shortly after birth. The term hemiplegia means that the paralysis is on one vertical half of the body. Read more about this study
- Who is it for?
- Ages 6 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Hemiplegic Cerebral Palsy
- What is being tested?
- Constraint Induced Movement Therapy and Mirror therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesPakistan
- Study dates
- 1 Dec 2023to 15 Mar 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
- Healthy volunteers accepted
- Child
Who may be able to join
- Medically diagnosed with Hemiplegic CP
- Age ranges btween3-12 years
- Hemiplegic CP with motor disability
- No major contractures of upper limb muscle
- Both genders were included
- Able to follow command
- No orthopedic surgery during the previous six months(8)
Who cannot join
- Functional limb
- Patients with contracture
- Patient with sensory,cognitive and perceptual disorders
- Patient with seizures
- Patient with orthopedic surgery
Trial locations and contacts
2 sites in 1 country.
Pakistan2 sites
Imran Amjad
Lahore, Punjab Province, 54000
Riphah International University
Lahore, Punjab Province
About this study
Official title: Effects of CIMT With and Without Mirror Therapy on Upper Limb Function in Children With Hemiplegic Cerebral Palsy
Hemiplegia in infants and children is a type of Cerebral Palsy that results from damage to the part (hemisphere) of the brain that controls muscle movements. This damage may occur before, during or shortly after birth. The term hemiplegia means that the paralysis is on one vertical half of the body. The aim of this study will be the to know the effect of mCIMT with and without mirror therapy on upper limb function in children with hemiplegic cerebral palsy. A randomized control trial will be conducted at Sheikh Zayed Hospital, RYK through convenience sampling technique on 30 patients which will be allocated through simple random sampling through sealed opaque enveloped into group A and group B. Group A will be treated with mCIMT and Group B will be treated with mCIMT and mirror therapy. Outcome measure will be conducted through pain and disability questionnaire after 6 weeks. Data will be analyzed using SPSS software version 21. After assessing normality of data by Shapiro - wilk test, it will be decided either parametric or non-parametric test will be used within a group or between two groups. mCIMT with and without mirror therapy will be applied in patients with hemiplegic cerebral palsy to see the effect on upper limb function.
Read the detailed description
Patients who will meet the inclusion criteria will be recruited by convenience sampling technique and allocated to groups by simple randomization process by sealed opaque enveloped labeled as 0 for Group A and 1 for Group B.
After taking consent from the patients parents with hemiplegic CP of both genders will be randomized into two equal groups. Patients from physical therapy department will be assessed with CHEQ and Melbourne Assessment of the Unilateral Upper Limb Function (MAULF) and the Functional Hand Grip Test (FHGT) . At start of study, a formal educational session, lasting about 30 min will be given by physiotherapist.
Group A: This group patients will be treated with mCIMT, the forced use of the affected arm by restraining the unaffected arm, with a sling or a hand splint, during dedicated exercise sections or usual ADLs (90% of waking hours).Massed practice (eight hours of exercise) of the affected arm through a shaping method, where shaping involves a commonly operant conditioning method in which a behavioural objective (in this case 'movement') is approached in small steps of progressively increasing difficulty. The participant is rewarded with enthusiastic approval for improvement, but never blamed or punished for failure. This therapy will be given 4hrs daily for 6 weeks. The results will be based upon pre and post evaluation.
Group B: These patients will be treated with mCIMT and mirror therapy. Children were taught repetitive symmetrical upper limbs exercises: with modelling-clay in each hand to elicit bilateral thumb-finger pinch and grasping. They performed these during a 15-minute daily routine at home with mCIMT (forced use of arm and massed practice 4hrs of exercise of affected arm). This combination of therapy will be given for 6 weeks. The results will be seen through pre and post evaluation.
- Conditions
- Hemiplegic Cerebral Palsy
- Being tested
- Constraint Induced Movement Therapy, Mirror therapy
- Keywords
- mCIMT, Hemiplegia, Mirror therapy
- Medical subject headings
- Hemiplegia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Constraint Induced Movement TherapyOther
Also called Mirror Therapy
Group A: This group patients will be treated with mCIMT, the forced use of the affected arm by restraining the unaffected arm, with a sling or a hand splint, during dedicated exercise sections or usual ADLs (90% of waking hours).Massed practice (eight hours of exercise) of the affected arm through a shaping method, where shaping involves a commonly operant conditioning method in which a behavioural objective (in this case 'movement') is approached in small steps of progressively increasing difficulty. The participant is rewarded with enthusiastic approval for improvement, but never blamed or punished for failure. This therapy will be given 4hrs daily for 6 weeks. The results will be based upon pre and post evaluation.
Mirror therapyOther
Group B: These patients will be treated with mCIMT and mirror therapy. Children were taught repetitive symmetrical upper limbs exercises: with modelling-clay in each hand to elicit bilateral thumb-finger pinch and grasping. They performed these during a 15-minute daily routine at home with mCIMT (forced use of arm and massed practice 4hrs of exercise of affected arm). This combination of therapy will be given for 6 weeks. The results will be seen through pre and post evaluation.
| Study group | Role | What they receive |
|---|---|---|
| Constraint induced Movement Therapy | Experimental | Group of 15 members will be given constraint induced movement therapy for 6 weeks. Receives: Other: Constraint Induced Movement Therapy |
| Mirror therapy group | Experimental | Group of 15 members will be given modified constraint induced movement therapy with mirror theray for 6 weeks. Receives: Other: Mirror therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
fine motor skills
The Melbourne Assessment 2 (MA2): a test of quality of unilateral upper limb function. Is a criterion-referenced test for children aged 2.5 to 15 years with neurological impairments providing measurement of four elements of upper limb movement quality: range of movement, accuracy, dexterity and fluency.
FHGT: The subject holds the dynamometer in the hand to be tested, with the arm at right angles and the elbow by the side of the body. The handle of the dynamometer is adjusted if required - the base should rest on the first metacarpal (heel of palm), while the handle should rest on middle of the four fingers. When ready the subject squeezes the dynamometer with maximum isometric effort, which is maintained for about 5 seconds. No other body movement is allowed. The subject should be strongly encouraged to give a maximum effort.
MMT: Manual Muscle Testing Grades 0-5
Measured: 6weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2024
- Study start1 Dec 2023
- Primary completion15 Mar 2024
- Study completion15 Mar 2024
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.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized Control Trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hurriya Sehar, MS*, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06294444
- Sponsor's protocol ID
- REC/RCR&AHS/23/0741
- Status last verified
- May 2024
- First submitted
- 26 Dec 2023
- Last updated
- 7 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Oliva-Sierra M, Rios-Leon M, Abuin-Porras V, Martin-Casas P. [Effectiveness of mirror therapy and action observation therapy in infantile cerebral palsy: a systematic review]. An Sist Sanit Navar. 2022 Aug 16;45(2):e1003. doi: 10.23938/ASSN.1003. Spanish.
PubMed 35972309
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of CIMT With and Without Mirror Therapy on Upper Limb Function in Children With Hemiplegic Cerebral Palsy
- ClinicalTrials.gov ID
- NCT06294444
- Acronym / sponsor ID
- REC/RCR&AHS/23/0741
- Conditions
- Hemiplegic Cerebral Palsy
- Keywords
- mCIMT, Hemiplegia, Mirror therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 15 Mar 2024 (actual)
- Study completion
- 15 Mar 2024 (actual)
- First posted
- 5 Mar 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.
Hemiplegia in infants and children is a type of Cerebral Palsy that results from damage to the part (hemisphere) of the brain that controls muscle movements. This damage may occur before, during or shortly after birth. The term hemiplegia means that the paralysis is on one vertical half of the body. The aim of this study will be the to know the effect of mCIMT with and without mirror therapy on upper limb function in children with hemiplegic cerebral palsy. A randomized control trial will be conducted at Sheikh Zayed Hospital, RYK through convenience sampling technique on 30 patients which will be allocated through simple random sampling through sealed opaque enveloped into group A and group B. Group A will be treated with mCIMT and Group B will be treated with mCIMT and mirror therapy. Outcome measure will be conducted through pain and disability questionnaire after 6 weeks. Data will be analyzed using SPSS software version 21. After assessing normality of data by Shapiro - wilk test, it will be decided either parametric or non-parametric test will be used within a group or between two groups. mCIMT with and without mirror therapy will be applied in patients with hemiplegic cerebral palsy to see the effect on upper limb function.
Detailed description
Patients who will meet the inclusion criteria will be recruited by convenience sampling technique and allocated to groups by simple randomization process by sealed opaque enveloped labeled as 0 for Group A and 1 for Group B.
After taking consent from the patients parents with hemiplegic CP of both genders will be randomized into two equal groups. Patients from physical therapy department will be assessed with CHEQ and Melbourne Assessment of the Unilateral Upper Limb Function (MAULF) and the Functional Hand Grip Test (FHGT) . At start of study, a formal educational session, lasting about 30 min will be given by physiotherapist.
Group A: This group patients will be treated with mCIMT, the forced use of the affected arm by restraining the unaffected arm, with a sling or a hand splint, during dedicated exercise sections or usual ADLs (90% of waking hours).Massed practice (eight hours of exercise) of the affected arm through a shaping method, where shaping involves a commonly operant conditioning method in which a behavioural objective (in this case 'movement') is approached in small steps of progressively increasing difficulty. The participant is rewarded with enthusiastic approval for improvement, but never blamed or punished for failure. This therapy will be given 4hrs daily for 6 weeks. The results will be based upon pre and post evaluation.
Group B: These patients will be treated with mCIMT and mirror therapy. Children were taught repetitive symmetrical upper limbs exercises: with modelling-clay in each hand to elicit bilateral thumb-finger pinch and grasping. They performed these during a 15-minute daily routine at home with mCIMT (forced use of arm and massed practice 4hrs of exercise of affected arm). This combination of therapy will be given for 6 weeks. The results will be seen through pre and post evaluation.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Randomized Control Trial
| Arm | Type | Receives |
|---|---|---|
| Constraint induced Movement Therapy | Experimental | Other: Constraint Induced Movement TherapyGroup of 15 members will be given constraint induced movement therapy for 6 weeks. |
| Mirror therapy group | Experimental | Other: Mirror therapyGroup of 15 members will be given modified constraint induced movement therapy with mirror theray for 6 weeks. |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Medically diagnosed with Hemiplegic CP
- Age ranges btween3-12 years
- Hemiplegic CP with motor disability
- No major contractures of upper limb muscle
- Both genders were included
Key exclusion criteria (5 listed)
- Functional limb
- Patients with contracture
- Patient with sensory,cognitive and perceptual disorders
- Patient with seizures
- Patient with orthopedic surgery
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 |
|---|---|---|
| Constraint Induced Movement TherapyAlso: Mirror TherapyGroup A: This group patients will be treated with mCIMT, the forced use of the affected arm by restraining the unaffected arm, with a sling or a hand splint, during dedicated exercise sections or usual ADLs (90% of waking hours).Massed practice (eight hours of exercise) of the affected arm through a shaping method, where shaping involves a commonly operant conditioning method in which a behavioural objective (in this case 'movement') is approached in small steps of progressively increasing difficulty. The participant is rewarded with enthusiastic approval for improvement, but never blamed or punished for failure. This therapy will be given 4hrs daily for 6 weeks. The results will be based upon pre and post evaluation. | Other | Constraint induced Movement Therapy |
| Mirror therapyGroup B: These patients will be treated with mCIMT and mirror therapy. Children were taught repetitive symmetrical upper limbs exercises: with modelling-clay in each hand to elicit bilateral thumb-finger pinch and grasping. They performed these during a 15-minute daily routine at home with mCIMT (forced use of arm and massed practice 4hrs of exercise of affected arm). This combination of therapy will be given for 6 weeks. The results will be seen through pre and post evaluation. | Other | Mirror therapy group |
Primary outcome
fine motor skills
Time frame: 6weeks
The Melbourne Assessment 2 (MA2): a test of quality of unilateral upper limb function. Is a criterion-referenced test for children aged 2.5 to 15 years with neurological impairments providing measurement of four elements of upper limb movement quality: range of movement, accuracy, dexterity and fluency. FHGT: The subject holds the dynamometer in the hand to be tested, with the arm at right angles and the elbow by the side of the body. The handle of the dynamometer is adjusted if required - the base should rest on the first metacarpal (heel of palm), while the handle should rest on middle of the four fingers. When ready the subject squeezes the dynamometer with maximum isometric effort, which is maintained for about 5 seconds. No other body movement is allowed. The subject should be strongly encouraged to give a maximum effort. MMT: Manual Muscle Testing Grades 0-5
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 7 May 2024.
- Background: PubMed 35972309Oliva-Sierra M, Rios-Leon M, Abuin-Porras V, Martin-Casas P. [Effectiveness of mirror therapy and action observation therapy in infantile cerebral palsy: a systematic review]. An Sist Sanit Navar. 2022 Aug 16;45(2):e1003. doi: 10.23938/ASSN.1003. Spanish.
- 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.
Hurriya Sehar, MS* principal investigator
Riphah International University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Constraint Induced Movement Therapy and Mirror therapy in people with Hemiplegic Cerebral Palsy, run by Riphah International University at 2 sites 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 7 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: finished, as of the sponsor's last update on 7 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
fine motor skills (time frame: 6weeks). 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 NCT06294444, 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 7 May 2024.