Cerebral PalsyNCT05659355
Effects of Constraints Induced Movement Therapy Versus Mirror Therapy in Children With Hemiplegic Cerebral Palsy
A study testing Constraint Induced Movement Therapy (CIMT) and Mirror Therapy (MT) in people with Cerebral Palsy and Hemiplegic Cerebral Palsy, run by Riphah International University at 1 site in Pakistan.
Trial summary
The aim of this study is to find Effects of constraints induced movement therapy (CIMT) versus mirror therapy (MT) on hand dexterity and grip strength in children with hemiplegic cerebral palsy. Read more about this study
- Who is it for?
- Ages 9 to 14 years
- Conditions the study is for
- Cerebral Palsy, Hemiplegic Cerebral Palsy
- What is being tested?
- Constraint Induced Movement Therapy (CIMT) and Mirror Therapy (MT)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 sitePakistan
- Study dates
- 15 Jan 2022to 15 Feb 2023
- 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 9 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children of age range 9-14 year
- Children with diagnosed hemiplegic cerebral palsy
- Children who can perform active extension of affected wrist and more than
- two fingers at an angle of more than 10 degrees
- Active abduction of affected thumb at an angle of 10 degrees
- Children who can respond to simple communication-
Who cannot join
- Children with uncontrolled seizures
- Botulinum toxin injections or orthopedic surgery in the upper or lower
- extremities within the previous 12 months or planned within the study period
- Children with depression who were unable to cooperate in treatment
- Children who are unable to perform active task training
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Constraints Induced Movement Therapy Versus Mirror Therapy on Hand Dexterity and Grip Strength in Children With Hemiplegic Cerebral Palsy
The aim of this study is to find Effects of constraints induced movement therapy (CIMT) versus mirror therapy (MT) on hand dexterity and grip strength in children with hemiplegic cerebral palsy.
Read the detailed description
Although quite number of research has been done on effects of CIMT and mirror therapy but most of the studies included stroke population. There was no literature on comparative effect of both CIMT and Mirror therapy in children with hemiplegic cerebral palsy. This study will be covering specifically cerebral palsy children to have better treatment techniques to be introduced in therapeutic programs of hemiplegic cerebral palsy children.
- Conditions
- Cerebral Palsy, Hemiplegic Cerebral Palsy
- Being tested
- Constraint Induced Movement Therapy (CIMT), Mirror Therapy (MT)
- Keywords
- cerebral palsy, constraints induced movement therapy, mirror therapy
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Constraint Induced Movement Therapy (CIMT)Other
Also called CIMT
I will apply CIMT on effected hand to observe the hand dexterity and grip strength
Mirror Therapy (MT)Other
I will apply Mirror Therapy on effected hand to obeserve the hand dexterity and grip strength
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group | Experimental | Constraint Induced Movement Therapy Receives: Other: Constraint Induced Movement Therapy (CIMT) |
| Control Group | Experimental | Mirror Therapy Receives: Other: Mirror Therapy (MT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
9 Hole pegboard test:
The 9 hole peg test is a standardized quantitative assessment used to measure finger dexterity in patients with various neurological diagnosis.
Measured: 3 months
Haptic (Tactile) Recognition Test:
it's a quantitative measure of haptic (tactile) object recognition design to test one's ability to recognize everyday objects across seven sensory attributes using 14 sets of objects. Haptic recognition of everyday objects is quite fast and highly accurate with 96% correctly named: 68% in less than 3 s and 94% within 5 sec.
Measured: 3 months
Hand Dynamometer:
Hand Dynamometer: Hand dynamometer is an evaluation tool that is used to measure isometric grip force. . Once the grip position is adjusted, the user holds the handle and squeezes the handle
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2022
- Study start15 Jan 2022
- Primary completion15 Feb 2023
- Study completion15 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shabana Ashraf, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05659355
- Sponsor's protocol ID
- REC/RCR&AHS/22/0730
- Status last verified
- Mar 2023
- First submitted
- 13 Dec 2022
- Last updated
- 3 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Constraints Induced Movement Therapy Versus Mirror Therapy on Hand Dexterity and Grip Strength in Children With Hemiplegic Cerebral Palsy
- ClinicalTrials.gov ID
- NCT05659355
- Acronym / sponsor ID
- REC/RCR&AHS/22/0730
- Conditions
- Cerebral Palsy, Hemiplegic Cerebral Palsy
- Keywords
- cerebral palsy, constraints induced movement therapy, mirror therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 15 Jan 2022 (actual)
- Primary completion
- 15 Feb 2023 (actual)
- Study completion
- 15 Feb 2023 (actual)
- First posted
- 21 Dec 2022 (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.
The aim of this study is to find Effects of constraints induced movement therapy (CIMT) versus mirror therapy (MT) on hand dexterity and grip strength in children with hemiplegic cerebral palsy.
Detailed description
Although quite number of research has been done on effects of CIMT and mirror therapy but most of the studies included stroke population. There was no literature on comparative effect of both CIMT and Mirror therapy in children with hemiplegic cerebral palsy. This study will be covering specifically cerebral palsy children to have better treatment techniques to be introduced in therapeutic programs of hemiplegic cerebral palsy children.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment Group | Experimental | Other: Constraint Induced Movement Therapy (CIMT)Constraint Induced Movement Therapy |
| Control Group | Experimental | Other: Mirror Therapy (MT)Mirror Therapy |
Who may qualify
- Ages
- 9 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Children of age range 9-14 year
- Children with diagnosed hemiplegic cerebral palsy
- Children who can perform active extension of affected wrist and more than
- two fingers at an angle of more than 10 degrees
- Active abduction of affected thumb at an angle of 10 degrees
Key exclusion criteria (5 listed)
- Children with uncontrolled seizures
- Botulinum toxin injections or orthopedic surgery in the upper or lower
- extremities within the previous 12 months or planned within the study period
- Children with depression who were unable to cooperate in treatment
- Children who are unable to perform active task training
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 Therapy (CIMT)Also: CIMTI will apply CIMT on effected hand to observe the hand dexterity and grip strength | Other | Treatment Group |
| Mirror Therapy (MT)I will apply Mirror Therapy on effected hand to obeserve the hand dexterity and grip strength | Other | Control Group |
Primary outcome
9 Hole pegboard test:
Time frame: 3 months
The 9 hole peg test is a standardized quantitative assessment used to measure finger dexterity in patients with various neurological diagnosis.
Haptic (Tactile) Recognition Test:
Time frame: 3 months
it's a quantitative measure of haptic (tactile) object recognition design to test one's ability to recognize everyday objects across seven sensory attributes using 14 sets of objects. Haptic recognition of everyday objects is quite fast and highly accurate with 96% correctly named: 68% in less than 3 s and 94% within 5 sec.
Hand Dynamometer:
Time frame: 3 months
Hand Dynamometer: Hand dynamometer is an evaluation tool that is used to measure isometric grip force. . Once the grip position is adjusted, the user holds the handle and squeezes the handle
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 3 Apr 2023.
- Individual participant dataSharing planned: No
Related trials for Cerebral Palsy
Not yet recruiting
Feasibility of a Robot-Guided Active Play Intervention for Children With Cerebral Palsy
Cerebral Palsy
Recruiting
Additional Effects on tDCS With AOT on Lower Limb Functions on Children With Diplegic CP
Diplegic Cerebral Palsy
Recruiting
Sensory Integration Therapy vs Conventional Physical Therapy in Children With Mixed Cerebral Palsy
Cerebral Palsy
Active, not recruiting
Functional Outcomes and Control Using Synchron BCI - Australia
Neurologic Disorder, Neurologic Diseases
Enrolling by invitationObservational study
Early Molecular Biomarkers for Differentiating Parkinsonian Syndromes
PARKINSON DISEASE (Disorder), Atypical Parkinsonism
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.
Shabana Ashraf 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 Constraint Induced Movement Therapy (CIMT) and Mirror Therapy (MT) in people with Cerebral Palsy and 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 6 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 3 Apr 2023. 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?
9 Hole pegboard test: (time frame: 3 months). 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?
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 3 Apr 2023.