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

Official title

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

Overview

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).

Interventions

• Device 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 e
• Other 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 facil

Primary outcome measures

• functional ability [Time frame: 3 successive months.]
• Quality of Life(Qol) [Time frame: 3 months]
• Range of motion [Time frame: 3 months]
• hand grip strength [Time frame: 3 months]
• hand function [Time frame: 3 months]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07135739 · P.T.REC/012/005699

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗