Unilateral Cerebral PalsyNCT06082115
Mirror Therapy Versus Task Oriented Training on Hand Function in Children With Unilateral Cerebral Palsy
A study testing Selected Physical and Occupational Therapy Program, Mirror Therapy and Task-Oriented Training in people with Unilateral Cerebral Palsy, run by Beni-Suef University.
Trial summary
The purpose of the study is to compare the effect between mirror therapy and task-oriented training on hand function in children with unilateral cerebral palsy. Read more about this study
- Who is it for?
- Ages 5 to 8 years
- Conditions the study is for
- Unilateral Cerebral Palsy
- What is being tested?
- Selected Physical and Occupational Therapy Program, Mirror Therapy and Task-Oriented Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 20 Oct 2023to 20 Jan 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 5 to 8 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children ages will be ranged from 5 to 8 years old.
- Wrist flexor spasticity ranged from grade 1 to 1+ according to Modified Aswarth scale.
- Capacity to handle objects without continuous assistance (level I or II in accordance with the Manual Ability Classification System).
- Ability to sit alone.
- Sufficient cognition to follow simple verbal instructions.
Who cannot join
- Fixed contracture or deformities in the upper limb.
- Visual or auditory defects.
- Botulinuim toxin injection in the last 6 months before the study.
- Previous surgical intervention in the upper limb.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Functional Outcome of Mirror Therapy Versus Task Oriented Training on Hand Function in Children With Unilateral Cerebral Palsy
The purpose of the study is to compare the effect between mirror therapy and task-oriented training on hand function in children with unilateral cerebral palsy.
Read the detailed description
Dysfunction in the upper limbs and hand function is one of the most common symptoms in children with cerebral palsy (CP), particularly children with unilateral CP which intern has the potential to limit the involvement of these children in life activities and cause distress and suffering for both children and their parents. Different rehabilitation intervention procedures addressing upper extremity dysfunction are essential to promote better use of disabled arms and hands in daily activities and achieving functional independence at home, in school and in the community. However, there is little evidence directed toward which intervention procedure is more effective on hand function therefore, there is need to compare between the functional outcome of mirror therapy versus task-oriented training on hand function in children with unilateral cerebral palsy.
- Conditions
- Unilateral Cerebral Palsy
- Being tested
- Selected Physical and Occupational Therapy Program, Mirror Therapy, Task-Oriented Training
- Keywords
- Mirror Therapy, Task Oriented Training, Hand Function, Unilateral Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Selected Physical and Occupational Therapy ProgramOther
The selected physical and occupational therapy program include:- A-Physical therapy program contains neurodevelopmental technique for U.L \& L.L (U.L \& L.L approximation, U.L \& L.L weight bearing exercises), stretching exercises for U.L \& L.L muscles, strengthening exercises for antispastic group of U.L \& L.L muscles, facilitation of postural reactions, facilitation of gait training and, ascending and descending stairs.
B-Occupational therapy program contains transfer cube from one hand to hand, reaching to mouth (eating lollipop), throwing and catching ball and, clapping with both hands.
Mirror TherapyOther
The mirror therapy program include tasks of manipulative and grasping skills that performed by the non-affected hand in-front of mirror while the affected hand behind the mirror. These tasks contain building towers, rolling dough, transferring cup from one place to another place, turning cards, moving keys, drawing circle and, grasps various objects with different size, shape and weight (ball, markers, pegs and brushes).
Task-Oriented TrainingOther
The task-oriented training program include tasks of manipulative and grasping skills that performed by the affected hand based on repetition practice. These tasks contain building towers, rolling dough, transferring cup from one place to another place, turning cards, moving keys, drawing circle and, grasps various objects with different size, shape and weight (ball, markers, pegs and brushes).
| Study group | Role | What they receive |
|---|---|---|
| Selected Physical and Occupational Therapy Program | Experimental | Unilateral cerebral palsy children will receive selected physical and occupational therapy program for 1 hour. The duration of treatment will be 3 times/week for 12 weeks. Receives: Other: Selected Physical and Occupational Therapy Program |
| Mirror Therapy | Experimental | Unilateral cerebral palsy children will receive selected physical and occupational therapy program for 1 hour in addition to mirror therapy for 30 minutes. The duration of treatment will be 3 times/week for 12 weeks. Receives: Other: Selected Physical and Occupational Therapy Program; Other: Mirror Therapy |
| Task Oriented Training | Experimental | Unilateral cerebral palsy children will receive selected physical and occupational therapy program for 1 hour in addition to task oriented training for 30 minutes. The duration of treatment will be 3 times/week for 12 weeks. Receives: Other: Selected Physical and Occupational Therapy Program; Other: Task-Oriented Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Grip Strength
Hand-held dynamometer will be used to measure hand grip strength. It is a valid and reliable device used to measure isometric grip strength.
Measured: Up to 12 weeks
Secondary outcomes (3)
Range of Motion
Electronic(digital) goniometer will be used for measuring wrist extension ROM. It is a valid and reliable tool used to assess wrist extension ROM
Measured: Up to 12 weeks
Upper Extremity Skills
Quality Upper Extremity Skill Test (QUEST) will be used to evaluate movement pattern and and function. It is a valid scale contains 4 domains (33 items); Dissociated movements (19 items), Grasp (6 items), Weight bearing (5 items) and Protective extension (3 items). The total testing time including administration and scoring is approximately 45 minutes.
Measured: Up to 12 weeks
Hand Dexetrity
Box and Block Test (BBT) will be used for measuring hand dexterity by using two compartment box containing 150 blocks. The test includes grasping, moving, and releasing wooden blocks from one side to the other. The score was recorded for 1 minute as the number of blocks passed over the wooden partition
Measured: Up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2023
- Study start20 Oct 2023 (estimated)
- Primary completion20 Jan 2024 (estimated)
- Study completion20 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Unilateral 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
- Selected Physical Therapy Program, Mirror Therapy, Task Oriented Training
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beni-Suef University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eman Wagdy, Beni-Suef University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06082115
- Sponsor's protocol ID
- P.T.REC/012/004452
- Status last verified
- Oct 2023
- First submitted
- 8 Oct 2023
- Last updated
- 13 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional Outcome of Mirror Therapy Versus Task Oriented Training on Hand Function in Children With Unilateral Cerebral Palsy
- ClinicalTrials.gov ID
- NCT06082115
- Acronym / sponsor ID
- P.T.REC/012/004452
- Conditions
- Unilateral Cerebral Palsy
- Keywords
- Mirror Therapy, Task Oriented Training, Hand Function, Unilateral Cerebral Palsy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Beni-Suef UniversityUniversity, hospital or other
- Study start
- 20 Oct 2023 (estimated)
- Primary completion
- 20 Jan 2024 (estimated)
- Study completion
- 20 Jan 2024 (estimated)
- First posted
- 13 Oct 2023 (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 purpose of the study is to compare the effect between mirror therapy and task-oriented training on hand function in children with unilateral cerebral palsy.
Detailed description
Dysfunction in the upper limbs and hand function is one of the most common symptoms in children with cerebral palsy (CP), particularly children with unilateral CP which intern has the potential to limit the involvement of these children in life activities and cause distress and suffering for both children and their parents. Different rehabilitation intervention procedures addressing upper extremity dysfunction are essential to promote better use of disabled arms and hands in daily activities and achieving functional independence at home, in school and in the community. However, there is little evidence directed toward which intervention procedure is more effective on hand function therefore, there is need to compare between the functional outcome of mirror therapy versus task-oriented training on hand function in children with unilateral cerebral palsy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- Selected Physical Therapy Program, Mirror Therapy, Task Oriented Training
| Arm | Type | Receives |
|---|---|---|
| Selected Physical and Occupational Therapy Program | Experimental | Other: Selected Physical and Occupational Therapy ProgramUnilateral cerebral palsy children will receive selected physical and occupational therapy program for 1 hour. The duration of treatment will be 3 times/week for 12 weeks. |
| Mirror Therapy | Experimental | Other: Selected Physical and Occupational Therapy Program, Other: Mirror TherapyUnilateral cerebral palsy children will receive selected physical and occupational therapy program for 1 hour in addition to mirror therapy for 30 minutes. The duration of treatment will be 3 times/week for 12 weeks. |
| Task Oriented Training | Experimental | Other: Selected Physical and Occupational Therapy Program, Other: Task-Oriented TrainingUnilateral cerebral palsy children will receive selected physical and occupational therapy program for 1 hour in addition to task oriented training for 30 minutes. The duration of treatment will be 3 times/week for 12 weeks. |
Who may qualify
- Ages
- 5 to 8 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Children ages will be ranged from 5 to 8 years old.
- Wrist flexor spasticity ranged from grade 1 to 1+ according to Modified Aswarth scale.
- Capacity to handle objects without continuous assistance (level I or II in accordance with the Manual Ability Classification System).
- Ability to sit alone.
- Sufficient cognition to follow simple verbal instructions.
Key exclusion criteria (4 listed)
- Fixed contracture or deformities in the upper limb.
- Visual or auditory defects.
- Botulinuim toxin injection in the last 6 months before the study.
- Previous surgical intervention in the upper limb.
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 |
|---|---|---|
| Selected Physical and Occupational Therapy ProgramThe selected physical and occupational therapy program include:- A-Physical therapy program contains neurodevelopmental technique for U.L \& L.L (U.L \& L.L approximation, U.L \& L.L weight bearing exercises), stretching exercises for U.L \& L.L muscles, strengthening exercises for antispastic group of U.L \& L.L muscles, facilitation of postural reactions, facilitation of gait training and, ascending and descending stairs. B-Occupational therapy program contains transfer cube from one hand to hand, reaching to mouth (eating lollipop), throwing and catching ball and, clapping with both hands. | Other | Mirror Therapy, Selected Physical and Occupational Therapy Program, Task Oriented Training |
| Mirror TherapyThe mirror therapy program include tasks of manipulative and grasping skills that performed by the non-affected hand in-front of mirror while the affected hand behind the mirror. These tasks contain building towers, rolling dough, transferring cup from one place to another place, turning cards, moving keys, drawing circle and, grasps various objects with different size, shape and weight (ball, markers, pegs and brushes). | Other | Mirror Therapy |
| Task-Oriented TrainingThe task-oriented training program include tasks of manipulative and grasping skills that performed by the affected hand based on repetition practice. These tasks contain building towers, rolling dough, transferring cup from one place to another place, turning cards, moving keys, drawing circle and, grasps various objects with different size, shape and weight (ball, markers, pegs and brushes). | Other | Task Oriented Training |
Primary outcome
Grip Strength
Time frame: Up to 12 weeks
Hand-held dynamometer will be used to measure hand grip strength. It is a valid and reliable device used to measure isometric grip strength.
3 secondary outcomes
Range of Motion
Time frame: Up to 12 weeks
Upper Extremity Skills
Time frame: Up to 12 weeks
Hand Dexetrity
Time frame: Up to 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2023.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Selected Physical and Occupational Therapy Program, Mirror Therapy and Task-Oriented Training in people with Unilateral Cerebral Palsy, run by Beni-Suef University.
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: status not confirmed, as of the sponsor's last update on 13 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Eman Wagdy (01008079576, Eman.wagdy@pt.bsu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Grip Strength (time frame: Up to 12 weeks). 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 13 Oct 2023.