Hemiplegic Cerebral PalsyNCT05396053
Mirror Therapy Versus CIMT on Hand Function in Cerebral Palsy
A study testing Physical therapy exercises, Mirror therapy and Constraint Induced Movement Therapy in people with Hemiplegic Cerebral Palsy and Mirror Hands, run by Batterjee Medical College at 2 sites in Saudi Arabia.
Trial summary
The aim is to investigate the effect of mirror therapy on hand functions in children with hemiplegic cerebral palsy. Read more about this study
- Who is it for?
- Ages 5 to 9 years
- Conditions the study is for
- Hemiplegic Cerebral Palsy, Mirror Hands
- What is being tested?
- Physical therapy exercises, Mirror therapy and Constraint Induced Movement Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 2 sitesSaudi Arabia
- Study dates
- 26 May 2022to 10 Oct 2022
- 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 5 to 9 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Spasticity grade 1 or 1+ based on the modified Ashworth scale
- Able to understand and follow instructions
Who cannot join
- Cognitive impairment
- Orthopedic dysfunction
- Impairment in visual acuity
- Children who are unable to pay attention during the treatment period
Trial locations and contacts
2 sites in 1 country.
Saudi Arabia2 sites
Batterjee Medical College
Jeddah
Local physical rehabilitation centers
Jeddah
About this study
Official title: Mirror Therapy Versus CIMT Improves Hand Strength and Function in Children With Unilateral Cerebral Palsy
The aim is to investigate the effect of mirror therapy on hand functions in children with hemiplegic cerebral palsy.
Read the detailed description
Hemiplegic cerebral palsy (HCP) is a form of paralysis that affects motor performance and muscle tone on one side of the body. Spastic hemiplegia CP is the second form of cerebral palsy in premature infants, affecting one side of the body's limbs. Hand and upper limb dysfunction cause problems in half of the children with cerebral palsy. Mirror therapy is a growingly recognized new treatment option for hemiplegic cerebral palsy. While upper extremity involvement in hemiplegic CP and the residual effects are more severe, there is limited evidence of the efficacy of mirror treatment in children with hemiplegic CP
- Conditions
- Hemiplegic Cerebral Palsy, Mirror Hands
- Being tested
- Physical therapy exercises, Mirror therapy, Constraint Induced Movement Therapy
- Keywords
- Mirror therapy, Hand function, Grip strength
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical therapy exercisesOther
Three times a week for 12 weeks.
Mirror therapyOther
Three times a week for 12 weeks.
Constraint Induced Movement TherapyOther
Three times a week for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | A traditional physical therapy program Receives: Other: Physical therapy exercises |
| Study 1 | Experimental | Mirror therapy plus traditional physical therapy program Receives: Other: Physical therapy exercises; Other: Mirror therapy |
| Study 2 | Experimental | Constraint-induced movement therapy plus traditional Receives: Other: Physical therapy exercises; Other: Constraint Induced Movement Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hand grip strength
Change of hand strength by using Hand Dynamometer
Measured: 12 weeks
Hand function
Change of hand function skills by using Box and block test
Measured: 12 weeks
Fine Motor skills
Change of fine motor skills score by using Peabody
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2022
- Study start26 May 2022
- Primary completion15 Aug 2022
- Study completion10 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemiplegic 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
- Study (2 groups) and control
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Batterjee Medical College
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed A. Abdel Ghafar, Batterjee Medical College
- Investigators
- Mohamed A Abdel Ghafar, Ph.D, Principal investigator, Batterjee Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05396053
- Sponsor's protocol ID
- Mirror Therapy
- Status last verified
- Jan 2024
- First submitted
- 25 May 2022
- Last updated
- 9 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mirror Therapy Versus CIMT Improves Hand Strength and Function in Children With Unilateral Cerebral Palsy
- ClinicalTrials.gov ID
- NCT05396053
- Acronym / sponsor ID
- Mirror Therapy
- Conditions
- Hemiplegic Cerebral Palsy, Mirror Hands
- Keywords
- Mirror therapy, Hand function, Grip strength
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Batterjee Medical CollegeUniversity, hospital or other
- Study start
- 26 May 2022 (actual)
- Primary completion
- 15 Aug 2022 (actual)
- Study completion
- 10 Oct 2022 (actual)
- First posted
- 31 May 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 is to investigate the effect of mirror therapy on hand functions in children with hemiplegic cerebral palsy.
Detailed description
Hemiplegic cerebral palsy (HCP) is a form of paralysis that affects motor performance and muscle tone on one side of the body. Spastic hemiplegia CP is the second form of cerebral palsy in premature infants, affecting one side of the body's limbs. Hand and upper limb dysfunction cause problems in half of the children with cerebral palsy. Mirror therapy is a growingly recognized new treatment option for hemiplegic cerebral palsy. While upper extremity involvement in hemiplegic CP and the residual effects are more severe, there is limited evidence of the efficacy of mirror treatment in children with hemiplegic CP
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- Study (2 groups) and control
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Other: Physical therapy exercisesA traditional physical therapy program |
| Study 1 | Experimental | Other: Physical therapy exercises, Other: Mirror therapyMirror therapy plus traditional physical therapy program |
| Study 2 | Experimental | Other: Physical therapy exercises, Other: Constraint Induced Movement TherapyConstraint-induced movement therapy plus traditional |
Who may qualify
- Ages
- 5 to 9 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Spasticity grade 1 or 1+ based on the modified Ashworth scale
- Able to understand and follow instructions
Key exclusion criteria (4 listed)
- Cognitive impairment
- Orthopedic dysfunction
- Impairment in visual acuity
- Children who are unable to pay attention during the treatment period
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 |
|---|---|---|
| Physical therapy exercisesThree times a week for 12 weeks. | Other | Control, Study 1, Study 2 |
| Mirror therapyThree times a week for 12 weeks. | Other | Study 1 |
| Constraint Induced Movement TherapyThree times a week for 12 weeks. | Other | Study 2 |
Primary outcome
Hand grip strength
Time frame: 12 weeks
Change of hand strength by using Hand Dynamometer
Hand function
Time frame: 12 weeks
Change of hand function skills by using Box and block test
Fine Motor skills
Time frame: 12 weeks
Change of fine motor skills score by using Peabody
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 9 Jan 2024.
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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.
Mohamed A Abdel Ghafar, Ph.D principal investigator
Batterjee Medical College
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical therapy exercises, Mirror therapy and Constraint Induced Movement Therapy in people with Hemiplegic Cerebral Palsy and Mirror Hands, run by Batterjee Medical College at 2 sites in Saudi Arabia.
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 2 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 9 Jan 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 Saudi Arabia. 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?
Hand grip strength (time frame: 12 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?
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 9 Jan 2024.