NCT07818616

Brief Summary

One of the main motor control issues in hemiplegic CP is spasticity, which affects the flexor muscles of the upper limb. This spasticity causes the limb to adopt a flexed posture, limiting the range of motion and contributing to a decreased ability to perform tasks that require precise movement and controlled muscle activation. Several studies have demonstrated that EMG biofeedback can significantly improve upper limb function in children with hemiplegic CP. Also, mirror therapy has gained recognition as an innovative and effective rehabilitation method for children with hemiplegic CP

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
3mo left

Started Sep 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress22%
Sep 2026Dec 2026

First Submitted

Initial submission to the registry

September 8, 2026

Completed
2 days until next milestone

Study Start

First participant enrolled

September 10, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 14, 2026

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2026

Expected
16 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

September 16, 2026

Status Verified

September 1, 2026

Enrollment Period

3 months

First QC Date

September 8, 2026

Last Update Submit

September 14, 2026

Conditions

Keywords

Cerebral palsyHemiplegiaMirror therapyEMG biofeedback

Outcome Measures

Primary Outcomes (3)

  • muscle activity of deltoid, elbow extensor, and wrist extensor muscles

    The Neurotrac Simplex EMG biofeedback device (model ESS102, manufactured by Verity Medical Ltd., UK) is a single-channel EMG device that has been designed to be used with a variety of applications. It acts as a diagnostic tool to measure the muscle activity, which is measured in microvolts (μV). The Neurotrac Simplex is an accurate and sensitive device that measures muscle activity down to as low as 0.2 μV and up to 2000 μV. The diverse range enables the device to measure very weak muscle activity

    The treatment period will be 3 times per week for 3 successive months

  • ROM of shoulder, elbow, and wrist joints

    A goniometer is an instrument that either measures an angle or allows an object to be rotated to a precise angular position. The baseline digital goniometer is used to measure a patient's ROM and incorporates integral absolute vertical and horizontal levels in one arm for ease of use. The device weighs 0.45 kg. The device displays 0 to 180 degrees on an LCD screen for viewing readings and has the ability to freeze angle measurements for reference. The goniometer has a durable powder-coated steel exterior with inch/cm marks screened onto its arms and is powered by one 9V battery (included). (L is length, the horizontal distance from left to right; W is width, the horizontal distance from front to back; H is height, the vertical distance from the lowest to highest point.) These ROM measurements can be taken at any joint, and they typically involve some knowledge about the anatomy of the body, particularly bony landmarks

    The treatment period will be 3 times per week for 3 successive months

  • quality of upper limb movement

    The Quality of Upper Extremity Skills Test is a descriptive, impairment-based, and evaluative measure designed to evaluate movement patterns and hand function in CP children separately for each arm. It has been validated for children who exhibit neuromotor dysfunction with spasticity. Quality of movement is assessed in four domains: dissociated movements (19 items), grasp (6 items), weight bearing (5 items), and protective extension (3 items), including 33 items. The total testing time, including administration and scoring, is approximately 45 minutes

    The treatment period will be 3 times per week for 3 successive months

Study Arms (2)

EMG Biofeedback Training

EXPERIMENTAL

Children in group A will receive 30 minutes of EMG biofeedback training. The EMG biofeedback device will be placed on the muscles of the upper extremities. First, surface electrodes will be applied at the deltoid muscle for 10 minutes; then electrodes will be applied at the triceps for 10 minutes, and then electrodes will be applied at the wrist extensors for 10 minutes to pick up the activity of the muscles and convert it to visual and auditory impulses produced from the device. In addition to the designed physical therapy program for 30 minutes

Device: Neurotrac Simplex electromyography biofeedback deviceOther: a designed physical therapy program

Mirror Therapy Training

EXPERIMENTAL

Children in group B will receive 30 minutes of mirror therapy training. Children will be seated on a chair, with the mirror positioned between the upper limbs perpendicular to the child's midline, and the reflecting side of the mirror will be adjusted to face the non-affected arm. Isolated movements of shoulder, elbow, and wrist joints by the unaffected limb will be performed in all degrees of freedom. In each direction up to 30 repetitions per session. In addition to the same designed physical therapy program for 30 minutes as group A.

Other: MirrorOther: a designed physical therapy program

Interventions

MirrorOTHER

This intervention has been assigned to 'Group B.'A mirror (20 cm × 70 cm) on a movable stand will be used to provide a mirror therapy training program for group B. It stands on mobile wheels surrounded by a frame made of wood, with the main reflective surface likely being a standard glass mirror. The affected limb will be situated in a safe and preferably comfortable position behind the mirror. The non-affected limb will be positioned in a similar position as the affected limb, which would result in facilitating the intensity of the mirror illusion. The therapist will repeatedly remind the child to focus on the movement of the unaffected limb in front of the mirror, which helped to increase the mirror illusion. Under the supervision of the physiotherapist, children observed the reflection of their unaffected limb while performing the following movement: flexion of the shoulder, elbow extension, and wrist extension.

Mirror Therapy Training

This intervention has been assigned to 'Group A.'. The Neurotrac Simplex device has been developed to enhance the understanding of muscle activity and to improve muscle conditioning. It stands upright on a flat surface, enabling the user to carry out specific exercises and at the same time view the biofeedback by way of bright LED lights on the front of the unit; the LCD screen will automatically display the average muscle readings for the session. Then using training programs in the NeuroTrac software for facilitation of the desired muscle. This software will be used in training the program for group A.

EMG Biofeedback Training

This intervention has been assigned to both groups. A designed physical therapy program for 30 minutes three times per week for three successive months 1. Active resisted exercises: A. Shoulder flexion and abduction. B. Elbow extension. C. Wrist extension. 2. Hand weight-bearing exercises: A. Quadriped position B. Side-sitting position C. Hand support standing 3. Reaching exercise with shoulder flexion, elbow and wrist extended. 4. Throwing the ball overhead by the affected hand and by both hands. 5. Protective extensor thrust from sitting on the roll and from the standing position. 6. Wheelbarrow walking (walking on hands).

EMG Biofeedback TrainingMirror Therapy Training

Eligibility Criteria

Age8 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Age ranging from 8 to 12 years
  • Spasticity grade 1+ and 2 on the Modified Ashworth Scale
  • Gross Motor Function Classification System (GMFCS) level I or II
  • Ability to follow verbal instructions

You may not qualify if:

  • Visual or hearing defects
  • Neurological conditions other than cerebral palsy
  • Previous surgical intervention of the upper limb
  • Botulinum toxin injection into the upper limb within the last 6 months prior to the study
  • Fractures of the upper limb
  • Uncontrolled convulsions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Physical Therapy, Cairo University

Giza, Giza Governorate, 12662, Egypt

Location

MeSH Terms

Conditions

Cerebral PalsyHemiplegia

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesParalysisNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Hebatallah M Kamal

    Cairo University, Egypt

    STUDY CHAIR
  • Hala R Mahmoud

    Cairo University, Egypt

    STUDY DIRECTOR
  • Walaa A Abd El-Nabie

    Cairo University, Egypt

    STUDY DIRECTOR
  • Andrew G Mourice

    Cairo University, Egypt

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Intervention, a comparative randomized study. Children in both groups will receive a designed physical therapy program. In addition, children in Group A will receive an EMG biofeedback training program, while children in Group B will receive a mirror therapy training program. The treatment session for both groups will be one hour, three times per week for three successive months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 8, 2026

First Posted

September 14, 2026

Study Start

September 10, 2026

Primary Completion (Estimated)

December 15, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

September 16, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will not share

Locations