Upper Limb ParesisFESMTNCT07135739
Functional Electrical Stimulation With Mirror Therapy on Upper Limb Functions and Quality of Life in Hemiplegic Children
A study testing funcional Electrical stimulation combined with mirror therapy and Physical therapy program in people with Upper Limb Paresis and Spastic Hemiplegia, run by Rabab Mustafa Abdo.
Trial summary
The goal of this clinical trial is to To investigate the combined effect of functional electrical stimulation and mirror therapy on:Quality of life and UL function in children with hemiplegia,Their age will be ranged from 5 to 10 years. Read more about this study
- Who is it for?
- Ages 5 to 10 years
- Conditions the study is for
- Upper Limb Paresis, Spastic Hemiplegia
- What is being tested?
- funcional Electrical stimulation combined with mirror therapy and Physical therapy program
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2025to 1 Nov 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 5 to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Their age will range from 5 to 10 years.
- Spasticity grade range from 1+ to 2, according to Modified Ashworth Scale (
- They will be able to follow instructions.
Who cannot join
- Children will be excluded if they have any of the following criteria:
- Loss of sensation
- The presence of visual impairments.
- Musculoskeletal problems or fixed deformities in the upper extremities.
- Seizures.
- Surgical interference in upper limbs.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Rabab mustafa abdo ABDO,senior physical therapist, master degree contact
About this study
Official title: Effect of Functional Electrical Stimulation With Mirror Therapy on Upper Limb Functions and Quality of Life in Hemiplegic Children
The goal of this clinical trial is to To investigate the combined effect of functional electrical stimulation and mirror therapy on:Quality of life and UL function in children with hemiplegia,Their age will be ranged from 5 to 10 years. The main question[s] it aims to answer [is/are]:Does the combination of functional electrical stimulation and mirror therapy have effects on upper limb function and Quality of life in children with hemiplegia? They will be randomly assigned into two groups, control group (A) will receive physical therapy program and study group(B) will receive same physical therapy program as control group (A) in addition FES combined with mirror therapy.
Read the detailed description
The program will be applied to all children in both groups (A and B). The exercise session for one hour for each child in both groups, conducted 3times/ week for 3 successive months.
- Flexibility exercises for shorted muscles and spastic muscles.
- Strengthening training focusing on the trunk lower limb and upper limb muscles for weak muscles.
- Postural control exercise in different positions and different surfaces
- General endurance training .
- Exercises to facilitate hand function including basic reaching grasping, carrying, release and the more complex skills of in-hand manipulation and bilateral hand use were conducted.
Group (B) will receive the same physical therapy program as group (A) in addition to combined FES (wrist extensors) and mirror therapy while doing specific exercises (including, grasping and release) conducted 3 times / week for 3 successive months.
- The treatment will be explained to every child and his/her parent emphasizing its benefits.
- Subjects were treated with a combination therapy of task specific mirror therapy and functional electrical stimulation, consisting of two tasks, for a total duration of thirty minutes.
- The subject was positioned on a height adjustable table with the mirror placed in front of the midline.
- The positive electrode and negative electrode of the muscle stimulator were placed over the muscle belly of the wrist extensors on forearm over the motor point of extensor digitorum communis/ extensor carpi radialis brevis/ extensor carpi radialis longus (between one-third and half-way from the proximal end of the dorsal forearm) of the affected upper limb.
- The subject was then instructed to observe the mirror reflection for one to two minutes, trying to visualize the mirror image as the affected limb.
- Once the subject got engaged with the mirrored limb they were asked to perform slow, easy to achieve simultaneous bilateral movements (perceived bilateral movements) while continuing to look at the reflected image, with the affected limb performing synchronously with the duty cycle of electrical stimulation.
- The exercises that performed were active wrist extension and fingers extension in mid-prone and pronated forearm, task specific grasping and releasing of a half-litre bottlereleasing cube and placing cubes. Exercises to facilitate hand function including basic reaching, grasping, carrying, release) if the patient could produce an activity in the muscles above the threshold, music broadcasts from the machine.
- The other half an hour of the session the child will do the rest of exercises described for group (A).
- Conditions
- Upper Limb Paresis, Spastic Hemiplegia
- Being tested
- funcional Electrical stimulation combined with mirror therapy, Physical therapy program
- Keywords
- hemiplegic cerebral palsy, functional electrical stimulation, mirror therapy
- Medical subject headings
- Paresis, Hemiplegia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
funcional Electrical stimulation combined with mirror therapyDevice
- Subjects were treated with a combination therapy of task specific mirror therapy and functional electrical stimulation, consisting of two tasks, for a total duration of thirty minutes.
- The subject was positioned on a height adjustable table with the mirror placed in front of the mid line.
- The positive electrode and negative electrode of the muscle simulator were placed over the muscle belly of the wrist extensors on forearm over the motor (between one-third and half-way from the proximal end of the dorsal forearm) of the affected upper limb.
- The subject was then instructed to observe the mirror reflection for one to two minutes, trying to visualize the mirror image as the affected limb, asked to perform slow, easy to achieve simultaneous bilateral movements (perceived bilateral movements) while continuing to look at ,with the affected limb performing synchronously with the duty cycle of electrical stimulation.
Physical therapy programOther
The program will be applied to all children in both groups (A and B). The exercise session for one hour for each child in both groups, conducted 3times/ week for 3 successive months.
- Flexibility exercises for shorted muscles and spastic muscles.
- Strengthening training focusing on the trunk lower limb and upper limb muscles for weak muscles.
- Postural control exercise in different positions and different surfaces
- General endurance training (Sherief et al., 2020).
- Exercises to facilitate hand function including basic reaching grasping, carrying, release and the more complex skills of in-hand manipulation and bilateral hand use were conducted.
| Study group | Role | What they receive |
|---|---|---|
| group (A) | Active comparator | control group (A) will receive physical therapy program The exercise session for one hour for each child in both groups, conducted 3times/ week for 3 successive months.
1. Flexibility exercises for shorted muscles and spastic muscles.
2. Strengthening training focusing on the trunk lower limb and upper limb muscles for weak muscles.
3. Postural control exercise in different positions and different surfaces
4. General endurance training (Sherief et al., 2020).
5. Exercises to facilitate hand function including basic reaching grasping, carrying, release and the more complex skills of in-hand manipulation and bilateral hand use were conducted. Receives: Other: Physical therapy program |
| Group (B) | Experimental | Group (B) will receive the same physical therapy program as group (A) in addition to combined FES (wrist extensors) and mirror therapy while doing specific exercises (including, grasping and release) conducted 3 times / week for 3 successive months.
1. The treatment will be explained to every child and his/her parent emphasizing its benefits.
2. Subjects were treated with a combination therapy of task specific mirror therapy and functional electrical stimulation, consisting of two tasks, for a total duration of thirty minutes.
3. The subject was positioned on a height adjustable table with the mirror placed in front of the midline.
4. The positive electrode and negative electrode of the muscle stimulator were placed over the muscle belly of the wrist extensors on forearm over the motor point of extensor digitorum communis/ extensor carpi radialis brevis/ extensor carpi radialis longus (between one-third and half-way from the proximal end of the dorsal forearm) of the affected upp Receives: Device: funcional Electrical stimulation combined with mirror therapy; Other: Physical therapy program |
What is being measured
The primary outcome is the main question the study is designed to answer.
functional ability
functional ability is assesed by The Pediatric Evaluation of Disability Inventory (PEDI) is an interview-based tool that assesses functional abilities, level of independence and extent of modification needed for a child to carry out functional activities. Originally published in 1992 by Haley et al., it has been translated into multiple languages and developed into a computer-adaptive test called Pediatric Evaluation of Disability Inventory-Computer Adaptive Test (PEDI-CAT).
It is scored on a four-point scale:
0 - unable to perform the task
- - can perform the task with assistance
- - can perform the task independently but with some difficulty
- - can perform the task independently and without difficulty
Measured: 3 successive months.
Quality of Life(Qol)
Quality of life will be assessed by The Pediatric Quality of Life Inventory (PedsQL
The PedsQL 4.0 Generic Core Scales instrument is the last version of PedsQL contain 23-items, including formats for typically developing children and adolescents 2 to 18 years old, and consists of the following:
Physical functioning (8 items). Emotional functioning (5 items). Social functioning (5 items). School functioning (5 items).
Each item of the instrument is scored on a 5-point scale from 0- 4 for ages 8-18, (0 = never a problem, 1 = almost never a problem, 2 = sometimes a problem, 3 = often a problem, 4 = almost always a problem) ad 3-point scale for young child self-reporting (ages 5- 7) as following (0 = not at all a problem, 2 = sometimes a problem, 4 = a lot of a problem) the large score means worst symptoms , scores are linearly transformed to a 0-100 scale (0 = 100, 1 = 75, 2 = 50, 3 = 25, 4 = 0) in which high score means better condition.
Measured: 3 months
Range of motion
A goniometer will be used to evaluate active range of motion of wrist extension. The child will sit on chair and the examiner palpates the relevant bony landmarks and aligns the goniometer and the child moves the joint through the available range of motion.
, the ROM will be measured as follow: Wristn extension: Centre the fulcrum of the goniometer over the lateral aspect of the wrist over the triquetrum and align the stabilized arm with the lateral midline of the ulna using the olecranon process and ulna styloid for reference. Align the moving arm of the goniometer with the lateral midline of the fifth metacarpal.
Measured: 3 months
hand grip strength
Children will sit on chair with neutral shoulder adduction and rotation, 90° flexion of the elbow, forearm and wrist in neutral on arm rest and ask to carry out the movement with maximum strength while the examiner held the device. During the assessment of strength, all the children will advise to grip the dynamometer with thumb facing the fingers and fingers alongside each other and try to do their effort to assess hand grip strength
Measured: 3 months
hand function
The Quality of Upper Extremity Skills Test (QUEST) is an outcome measure designed to evaluate movement patterns and hand function in children with CP. The QUEST is both reliable and valid. The QUEST was developed specifically for children with spastic CP in order to provide one of several outcome measures for a clinical trial on upper limb casting
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 posted22 Aug 2025
- Study start1 Sep 2025 (estimated)
- Primary completion1 Dec 2025 (estimated)
- Study completion1 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Upper Limb ParesisStudies 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
- They will be randomly assigned into two groups, control group (A) will receive physical therapy program and study group(B) will receive same physical therapy program as control group (A) in addition FES combined with mirror therapy.
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rabab Mustafa Abdo
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Rabab Mustafa Abdo, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07135739
- Sponsor's protocol ID
- P.T.REC/012/005699
- Acronym
- FESMT
- Status last verified
- Aug 2025
- First submitted
- 6 Jul 2025
- Last updated
- 22 Aug 2025
- Results posted
- No
- Data monitoring committee
- 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 22 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Functional Electrical Stimulation With Mirror Therapy on Upper Limb Functions and Quality of Life in Hemiplegic Children
- ClinicalTrials.gov ID
- NCT07135739
- Acronym / sponsor ID
- FESMT / P.T.REC/012/005699
- Conditions
- Upper Limb Paresis, Spastic Hemiplegia
- Keywords
- hemiplegic cerebral palsy, functional electrical stimulation, mirror therapy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Rabab Mustafa AbdoUniversity, hospital or other
- Study start
- 1 Sep 2025 (estimated)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 1 Nov 2026 (estimated)
- First posted
- 22 Aug 2025 (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 goal of this clinical trial is to To investigate the combined effect of functional electrical stimulation and mirror therapy on:Quality of life and UL function in children with hemiplegia,Their age will be ranged from 5 to 10 years. The main question[s] it aims to answer [is/are]:Does the combination of functional electrical stimulation and mirror therapy have effects on upper limb function and Quality of life in children with hemiplegia? They will be randomly assigned into two groups, control group (A) will receive physical therapy program and study group(B) will receive same physical therapy program as control group (A) in addition FES combined with mirror therapy.
Detailed description
The program will be applied to all children in both groups (A and B). The exercise session for one hour for each child in both groups, conducted 3times/ week for 3 successive months.
- Flexibility exercises for shorted muscles and spastic muscles.
- Strengthening training focusing on the trunk lower limb and upper limb muscles for weak muscles.
- Postural control exercise in different positions and different surfaces
- General endurance training .
- Exercises to facilitate hand function including basic reaching grasping, carrying, release and the more complex skills of in-hand manipulation and bilateral hand use were conducted.
Group (B) will receive the same physical therapy program as group (A) in addition to combined FES (wrist extensors) and mirror therapy while doing specific exercises (including, grasping and release) conducted 3 times / week for 3 successive months.
- The treatment will be explained to every child and his/her parent emphasizing its benefits.
- Subjects were treated with a combination therapy of task specific mirror therapy and functional electrical stimulation, consisting of two tasks, for a total duration of thirty minutes.
- The subject was positioned on a height adjustable table with the mirror placed in front of the midline.
- The positive electrode and negative electrode of the muscle stimulator were placed over the muscle belly of the wrist extensors on forearm over the motor point of extensor digitorum communis/ extensor carpi radialis brevis/ extensor carpi radialis longus (between one-third and half-way from the proximal end of the dorsal forearm) of the affected upper limb.
- The subject was then instructed to observe the mirror reflection for one to two minutes, trying to visualize the mirror image as the affected limb.
- Once the subject got engaged with the mirrored limb they were asked to perform slow, easy to achieve simultaneous bilateral movements (perceived bilateral movements) while continuing to look at the reflected image, with the affected limb performing synchronously with the duty cycle of electrical stimulation.
- The exercises that performed were active wrist extension and fingers extension in mid-prone and pronated forearm, task specific grasping and releasing of a half-litre bottlereleasing cube and placing cubes. Exercises to facilitate hand function including basic reaching, grasping, carrying, release) if the patient could produce an activity in the muscles above the threshold, music broadcasts from the machine.
- The other half an hour of the session the child will do the rest of exercises described for group (A).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- They will be randomly assigned into two groups, control group (A) will receive physical therapy program and study group(B) will receive same physical therapy program as control group (A) in addition FES combined with mirror therapy.
| Arm | Type | Receives |
|---|---|---|
| group (A) | Active comparator | Other: Physical therapy programcontrol group (A) will receive physical therapy program The exercise session for one hour for each child in both groups, conducted 3times/ week for 3 successive months. 1. Flexibility exercises for shorted muscles and spastic muscles. 2. Strengthening training focusing on the trunk lower limb and upper limb muscles for weak muscles. 3. Postural control exercise in different positions and different surfaces 4. General endurance training (Sherief et al., 2020). 5. Exercises to facilitate hand function including basic reaching grasping, carrying, release and the more complex skills of in-hand manipulation and bilateral hand use were conducted. |
| Group (B) | Experimental | Device: funcional Electrical stimulation combined with mirror therapy, Other: Physical therapy programGroup (B) will receive the same physical therapy program as group (A) in addition to combined FES (wrist extensors) and mirror therapy while doing specific exercises (including, grasping and release) conducted 3 times / week for 3 successive months. 1. The treatment will be explained to every child and his/her parent emphasizing its benefits. 2. Subjects were treated with a combination therapy of task specific mirror therapy and functional electrical stimulation, consisting of two tasks, for a total duration of thirty minutes. 3. The subject was positioned on a height adjustable table with the mirror placed in front of the midline. 4. The positive electrode and negative electrode of the muscle stimulator were placed over the muscle belly of the wrist extensors on forearm over the motor point of extensor digitorum communis/ extensor carpi radialis brevis/ extensor carpi radialis longus (between one-third and half-way from the proximal end of the dorsal forearm) of the affected upp |
Who may qualify
- Ages
- 5 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Their age will range from 5 to 10 years.
- Spasticity grade range from 1+ to 2, according to Modified Ashworth Scale (
- They will be able to follow instructions.
Key exclusion criteria (6 listed)
- Loss of sensation
- The presence of visual impairments.
- Musculoskeletal problems or fixed deformities in the upper extremities.
- Seizures.
- Surgical interference in upper limbs.
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 |
|---|---|---|
| funcional Electrical stimulation combined with mirror therapy* Subjects were treated with a combination therapy of task specific mirror therapy and functional electrical stimulation, consisting of two tasks, for a total duration of thirty minutes. * The subject was positioned on a height adjustable table with the mirror placed in front of the mid line. * The positive electrode and negative electrode of the muscle simulator were placed over the muscle belly of the wrist extensors on forearm over the motor (between one-third and half-way from the proximal end of the dorsal forearm) of the affected upper limb. * The subject was then instructed to observe the mirror reflection for one to two minutes, trying to visualize the mirror image as the affected limb, asked to perform slow, easy to achieve simultaneous bilateral movements (perceived bilateral movements) while continuing to look at ,with the affected limb performing synchronously with the duty cycle of electrical stimulation. | Device | Group (B) |
| Physical therapy programThe program will be applied to all children in both groups (A and B). The exercise session for one hour for each child in both groups, conducted 3times/ week for 3 successive months. 1. Flexibility exercises for shorted muscles and spastic muscles. 2. Strengthening training focusing on the trunk lower limb and upper limb muscles for weak muscles. 3. Postural control exercise in different positions and different surfaces 4. General endurance training (Sherief et al., 2020). 5. Exercises to facilitate hand function including basic reaching grasping, carrying, release and the more complex skills of in-hand manipulation and bilateral hand use were conducted. | Other | Group (B), group (A) |
Primary outcome
functional ability
Time frame: 3 successive months.
functional ability is assesed by The Pediatric Evaluation of Disability Inventory (PEDI) is an interview-based tool that assesses functional abilities, level of independence and extent of modification needed for a child to carry out functional activities. Originally published in 1992 by Haley et al., it has been translated into multiple languages and developed into a computer-adaptive test called Pediatric Evaluation of Disability Inventory-Computer Adaptive Test (PEDI-CAT). It is scored on a four-point scale: 0 - unable to perform the task 1. - can perform the task with assistance 2. - can perform the task independently but with some difficulty 3. - can perform the task independently and without difficulty
Quality of Life(Qol)
Time frame: 3 months
Quality of life will be assessed by The Pediatric Quality of Life Inventory (PedsQL The PedsQL 4.0 Generic Core Scales instrument is the last version of PedsQL contain 23-items, including formats for typically developing children and adolescents 2 to 18 years old, and consists of the following: Physical functioning (8 items). Emotional functioning (5 items). Social functioning (5 items). School functioning (5 items). Each item of the instrument is scored on a 5-point scale from 0- 4 for ages 8-18, (0 = never a problem, 1 = almost never a problem, 2 = sometimes a problem, 3 = often a problem, 4 = almost always a problem) ad 3-point scale for young child self-reporting (ages 5- 7) as following (0 = not at all a problem, 2 = sometimes a problem, 4 = a lot of a problem) the large score means worst symptoms , scores are linearly transformed to a 0-100 scale (0 = 100, 1 = 75, 2 = 50, 3 = 25, 4 = 0) in which high score means better condition.
Range of motion
Time frame: 3 months
A goniometer will be used to evaluate active range of motion of wrist extension. The child will sit on chair and the examiner palpates the relevant bony landmarks and aligns the goniometer and the child moves the joint through the available range of motion. , the ROM will be measured as follow: Wristn extension: Centre the fulcrum of the goniometer over the lateral aspect of the wrist over the triquetrum and align the stabilized arm with the lateral midline of the ulna using the olecranon process and ulna styloid for reference. Align the moving arm of the goniometer with the lateral midline of the fifth metacarpal.
hand grip strength
Time frame: 3 months
Children will sit on chair with neutral shoulder adduction and rotation, 90° flexion of the elbow, forearm and wrist in neutral on arm rest and ask to carry out the movement with maximum strength while the examiner held the device. During the assessment of strength, all the children will advise to grip the dynamometer with thumb facing the fingers and fingers alongside each other and try to do their effort to assess hand grip strength
hand function
Time frame: 3 months
The Quality of Upper Extremity Skills Test (QUEST) is an outcome measure designed to evaluate movement patterns and hand function in children with CP. The QUEST is both reliable and valid. The QUEST was developed specifically for children with spastic CP in order to provide one of several outcome measures for a clinical trial on upper limb casting
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 22 Aug 2025.
- 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.
Rabab mustafa abdo ABDO,senior physical therapist, master degree contact
Questions about this trial
What is this clinical trial studying?
A study testing funcional Electrical stimulation combined with mirror therapy and Physical therapy program in people with Upper Limb Paresis and Spastic Hemiplegia, run by Rabab Mustafa Abdo.
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 3 inclusion and 6 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: opening soon, as of the sponsor's last update on 22 Aug 2025. 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?
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?
Contact Rabab mustafa abdo ABDO,senior physical therapist, master degree (+2001024238293, rabab.mostafa.abdo90@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
functional ability (time frame: 3 successive months.). The study lists 5 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 22 Aug 2025.