Functional Electrical Stimulation With Mirror Therapy on Upper Limb Functions and Quality of Life in Hemiplegic Children

NCT ID: NCT07135739

Last Updated: 2025-08-22

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-01
• Study Completion Date: 2026-11-01

Brief 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. 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.

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 .

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) 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 upper limb.

5. 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.

6. 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.

7. 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.

8. 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

group (A)

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.

Group Type: ACTIVE_COMPARATOR

Physical therapy program

Intervention Type: OTHER

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.

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)

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

Group Type: EXPERIMENTAL

funcional Electrical stimulation combined with mirror therapy

Intervention Type: DEVICE

• 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 program

Intervention Type: OTHER

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.

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.

Interventions

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.

Intervention Type: DEVICE

Physical therapy program

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.

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

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.

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 10 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rabab Mustafa Abdo

OTHER

Sponsor Role: lead

Responsible Party

Rabab Mustafa Abdo

Senior physical therapist

Responsibility Role: SPONSOR_INVESTIGATOR

Central Contacts

Rabab mustafa abdo ABDO,senior physical therapist, master degree

Role: CONTACT

rabab.mostafa.abdo90@gmail.com

+2001024238293

Other Identifiers

P.T.REC/012/005699

Identifier Type: -

Identifier Source: org_study_id