HemiplegiaNCT07654595
Digital Mirror Versus Action Observation Therapy on Upper Limb Function and Grip Strength in Children With Hemiplegia
A study testing digital mirror therapy, action observation therapy and designed occupational therapy program in people with Hemiplegia and Digital Mirror, run by Cairo University at 1 site in Egypt.
Trial summary
Statement of problem: 1. Does the digital mirror therapy has effect on upper limb function and grip strength in children with hemiplegia ? 2. Does the action observation therapy has effect on upper limb function and grip strength in children with hemiplegia ? 3. Read more about this study
- Who is it for?
- Ages 6 to 8 years
- Conditions the study is for
- Hemiplegia, Digital Mirror, Action Observation Therapy
- What is being tested?
- digital mirror therapy, action observation therapy and designed occupational therapy program
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteEgypt
- Study dates
- 2 Jun 2026to 30 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 8 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 1 Diagnosed with unilateral cerebral palsy (hemiplegia). 2- Age range from 6 to 8 years. 3- Can understand verbal commands. 4- Their gross motor classification system (GMFCS) at level II or III. 5- Their manual ability classification system(MACS) at level II or III.
Who cannot join
- 1- Any visual problem. 2- Upper limb contracture or fixed deformity. 3- Uncontrolled convulsion. 4- Surgical procedures in upper limbs. 5- Botox injection in the past 6 months.
Trial locations and contacts
1 site in 1 country.
About this study
Statement of problem:
- Does the digital mirror therapy has effect on upper limb function and grip strength in children with hemiplegia ?
- Does the action observation therapy has effect on upper limb function and grip strength in children with hemiplegia ?
- Does there is a difference between effect of digital mirror therapy and action observation therapy on upper limb function and grip strength in children with hemiplegia?
Read more
Null hypothesis:
there is no effect of digital mirror therapy on upper limb function and grip strength in children with hemiplegia. There is no effect of action observation therapy on upper limb function and grip strength in children with hemiplegia. There is no difference between effect of digital mirror therapy and Action observation therapy on upper limb function and grip strength in children with hemiplegia.
Read the detailed description
Subjects:
The study targets the children from both sexes,diagnosed with hemiplegia,Sample size estimation will be carried out to determine the recruited number of children, selected randomly from Cairo University pediatric specialized hospital, Cairo to participate in the study,
Study design:
Randomized controlled clinical trial, Children will receive intervention type randomly(3 groups), 15 children will receive digital mirror therapy,15 children will receive action observation therapy, 15 children will receive designed occupational therapy program.
Children will be assessed by Gross Motor Function Classification System (GMFCS) and Manual ability classification system (MACS) for inclusion and Quality of upper extremity skill test, Box and Block Test (BBT) and Hand held dynanmometer which reflect clinical improvement in upper limb function and grip strength before and after 3 months of receiving intervention
- Conditions
- Hemiplegia, Digital Mirror, Action Observation Therapy
- Being tested
- digital mirror therapy, action observation therapy, designed occupational therapy program
- Medical subject headings
- Hemiplegia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
digital mirror therapyOther
Child will be asked to do the same exercises mentioned in the designed occupational therapy program with the less affected upper limb and the web cam camera will record the movement, instantly transformed into mirror images of the more affected upper limb's movements presented on the screen in front of child.
action observation therapyOther
the child will be offered to tablet screen put in front of him 50 centimeters away, time for each video will last for 2 min. Then, the child will be asked to repeat the observed action in the best possible way. All the activities included in the designed occupational therapy program will be observed and imitated.
designed occupational therapy programOther
Active occupational therapy exercises for upper limb training. The three common categories of motor actions and tasks:
(a) Active range of motion(ROM) exercises for elbow extension, wrist extension, forearm supination, finger extension using rubber band and finger flexor by squeezing a stress ball ,(b) Reaching forward and object manipulation as moving beads and blocks from one cup to another one, rolling a clay ball from tip of fingers to the palm. thumb to fingers opposition and drawing using tripod grasp.
| Study group | Role | What they receive |
|---|---|---|
| digital mirror therapy | Experimental | Children are asked to perform movements of the less affected upper limb, in which those movements are captured by a webcam and then instantly transformed into mirror images of the movements presented on the screen over the paralyzed upper limb, and children can simultaneously observe the mirror images of the movements from the front and simultaneously moved the more affected arm/hand as much as possible, imagining the movements on the screen were performed by their more affected limb, same exercises as designed occupational therapy program, for 1 hour, one session per day , 3 days per week for 12weeks. Receives: Other: digital mirror therapy |
| action observation therapy | Experimental | children observed one video clip of a movement or task for 2 min and then practiced executing the same action for 3 min, which the two phases will be applied one time for each exercises, same exercises as designed occupational therapy program Receives: Other: action observation therapy |
| designed occupational therapy program | Active comparator | Active occupational therapy exercises for upper limb training. The three common categories of motor actions and tasks: (a) Active range of motion(ROM) exercises for elbow extension, wrist extension, forearm supination, finger extension using rubber band and finger flexor by squeezing a stress ball . (b) Reaching forward and object manipulation as moving beads and blocks from one cup to another one, rolling a clay ball from tip of fingers to the palm, thumb to fingers opposition and drawing using tripod grasp for 1 hour, one session per day , 3 days per week for 12weeks. Receives: Other: designed occupational therapy program |
What is being measured
The primary outcome is the main question the study is designed to answer.
assessment of upper limb function
The Quality of Upper Extremity Skills Test (QUEST) is one of the most recommended assessment tools. It aims to evaluate upper limb movement quality and capacity in children with CP, it has four domains dissociated movement, grasp, protective extension and weight bearing.
Measured: 3 months
assessment of manual dextriry
Box and block test (BBT) examines essential components of manual dexterity for developing children, such as grasping, holding, transferring, and releasing
Measured: 3 months
assessment of grip strength
Hydraulic Handheld Dynamometer will be used to assess the maximum isometric strength of the hand muscles, Grip strength is a key predictor of functional ability. Neuralplasticity, sensorimotor integration, and musculoskeletal function.
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 posted17 Jun 2026
- Study start2 Jun 2026
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemiplegiaStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alaa Abdallah Amin, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07654595
- Sponsor's protocol ID
- P.T.REC/012/006461
- Status last verified
- Jun 2026
- First submitted
- 13 Jun 2026
- Last updated
- 17 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Digital Mirror Versus Action Observation Therapy on Upper Limb Function and Grip Strength in Children With Hemiplegia
- ClinicalTrials.gov ID
- NCT07654595
- Acronym / sponsor ID
- P.T.REC/012/006461
- Conditions
- Hemiplegia, Digital Mirror, Action Observation Therapy
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 2 Jun 2026 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 17 Jun 2026 (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.
Statement of problem:
- Does the digital mirror therapy has effect on upper limb function and grip strength in children with hemiplegia ?
- Does the action observation therapy has effect on upper limb function and grip strength in children with hemiplegia ?
- Does there is a difference between effect of digital mirror therapy and action observation therapy on upper limb function and grip strength in children with hemiplegia?
Null hypothesis:
there is no effect of digital mirror therapy on upper limb function and grip strength in children with hemiplegia. There is no effect of action observation therapy on upper limb function and grip strength in children with hemiplegia. There is no difference between effect of digital mirror therapy and Action observation therapy on upper limb function and grip strength in children with hemiplegia.
Detailed description
Subjects:
The study targets the children from both sexes,diagnosed with hemiplegia,Sample size estimation will be carried out to determine the recruited number of children, selected randomly from Cairo University pediatric specialized hospital, Cairo to participate in the study,
Study design:
Randomized controlled clinical trial, Children will receive intervention type randomly(3 groups), 15 children will receive digital mirror therapy,15 children will receive action observation therapy, 15 children will receive designed occupational therapy program.
Children will be assessed by Gross Motor Function Classification System (GMFCS) and Manual ability classification system (MACS) for inclusion and Quality of upper extremity skill test, Box and Block Test (BBT) and Hand held dynanmometer which reflect clinical improvement in upper limb function and grip strength before and after 3 months of receiving intervention
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| digital mirror therapy | Experimental | Other: digital mirror therapyChildren are asked to perform movements of the less affected upper limb, in which those movements are captured by a webcam and then instantly transformed into mirror images of the movements presented on the screen over the paralyzed upper limb, and children can simultaneously observe the mirror images of the movements from the front and simultaneously moved the more affected arm/hand as much as possible, imagining the movements on the screen were performed by their more affected limb, same exercises as designed occupational therapy program, for 1 hour, one session per day , 3 days per week for 12weeks. |
| action observation therapy | Experimental | Other: action observation therapychildren observed one video clip of a movement or task for 2 min and then practiced executing the same action for 3 min, which the two phases will be applied one time for each exercises, same exercises as designed occupational therapy program |
| designed occupational therapy program | Active comparator | Other: designed occupational therapy programActive occupational therapy exercises for upper limb training. The three common categories of motor actions and tasks: (a) Active range of motion(ROM) exercises for elbow extension, wrist extension, forearm supination, finger extension using rubber band and finger flexor by squeezing a stress ball . (b) Reaching forward and object manipulation as moving beads and blocks from one cup to another one, rolling a clay ball from tip of fingers to the palm, thumb to fingers opposition and drawing using tripod grasp for 1 hour, one session per day , 3 days per week for 12weeks. |
Who may qualify
- Ages
- 6 to 8 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 1 Diagnosed with unilateral cerebral palsy (hemiplegia). 2- Age range from 6 to 8 years. 3- Can understand verbal commands. 4- Their gross motor classification system (GMFCS) at level II or III. 5- Their manual ability classification system(MACS) at level II or III.
Key exclusion criteria (1 listed)
- 1- Any visual problem. 2- Upper limb contracture or fixed deformity. 3- Uncontrolled convulsion. 4- Surgical procedures in upper limbs. 5- Botox injection in the past 6 months.
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 |
|---|---|---|
| digital mirror therapyChild will be asked to do the same exercises mentioned in the designed occupational therapy program with the less affected upper limb and the web cam camera will record the movement, instantly transformed into mirror images of the more affected upper limb's movements presented on the screen in front of child. | Other | digital mirror therapy |
| action observation therapythe child will be offered to tablet screen put in front of him 50 centimeters away, time for each video will last for 2 min. Then, the child will be asked to repeat the observed action in the best possible way. All the activities included in the designed occupational therapy program will be observed and imitated. | Other | action observation therapy |
| designed occupational therapy programActive occupational therapy exercises for upper limb training. The three common categories of motor actions and tasks: (a) Active range of motion(ROM) exercises for elbow extension, wrist extension, forearm supination, finger extension using rubber band and finger flexor by squeezing a stress ball ,(b) Reaching forward and object manipulation as moving beads and blocks from one cup to another one, rolling a clay ball from tip of fingers to the palm. thumb to fingers opposition and drawing using tripod grasp. | Other | designed occupational therapy program |
Primary outcome
assessment of upper limb function
Time frame: 3 months
The Quality of Upper Extremity Skills Test (QUEST) is one of the most recommended assessment tools. It aims to evaluate upper limb movement quality and capacity in children with CP, it has four domains dissociated movement, grasp, protective extension and weight bearing.
assessment of manual dextriry
Time frame: 3 months
Box and block test (BBT) examines essential components of manual dexterity for developing children, such as grasping, holding, transferring, and releasing
assessment of grip strength
Time frame: 3 months
Hydraulic Handheld Dynamometer will be used to assess the maximum isometric strength of the hand muscles, Grip strength is a key predictor of functional ability. Neuralplasticity, sensorimotor integration, and musculoskeletal function.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2026.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing digital mirror therapy, action observation therapy and designed occupational therapy program in people with Hemiplegia and Digital Mirror, run by Cairo University at 1 site in Egypt.
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 1 inclusion and 1 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: under way, not looking for participants, as of the sponsor's last update on 17 Jun 2026. 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 Egypt. 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?
This study is still under way. Results are not available in the source record yet.
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?
assessment of upper limb function (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 17 Jun 2026.