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Cerebral Palsy (CP)NCT06925425

Effect of Task Specific Electrical Stimulation on Upper Limb Gross Motor Skills in Children With Spastic Quadriplegia

A study testing Task specific electrical stimulation ( TASES ) and Designed Physical therapy program in people with Cerebral Palsy (CP) and Spastic Cerebral Palsy, run by Kafrelsheikh University at 1 site in Egypt.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

Cerebral palsy is a non-progressive lesion of the brain occurring before 2 years of age resulting in disorders of posture and movement.( Ostensjo S, 2004)( Keles MN, 2018). Although non- progressive, motor impairments develop as the child grows leading to activity and participation restriction. Read more about this study

Who is it for?
Ages 2 to 6 years
What is being tested?
Task specific electrical stimulation ( TASES ) and Designed Physical therapy program
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteEgypt
Study dates
1 May 2025to 29 Mar 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 2 to 6 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • Their age will be ranged from 2 to 6 years. Their grade of spasticity will be from 1+ to 2 according to Modified Ashworth scale (Baunsgaard etal., 2016). (APPENDIX II).
  • They will be on Level III and IV according to Gross Motor Functional Classification System (GMFCS) (Palisano et al., 2008).(APPENDIX III).
  • Parents/legals representatives consenting to their child's participation 5 - Diagnosed with Spastic Quadriplegic cerebral palsy

Who cannot join

  • Previous neurological or orthopedic surgery in the upperextremities.
  • Fixed deformity in the joints of upper limb. 3- Severe hearing and visual defect.
  • 4-Irregular attendance at assessments or therapy sessions

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Mohamed Bedair Ibrahim, Professor of Physical Therapy contact

+2 01223800014

aalaasoliman110@gmail.com

Nesma Elsayed Barakat, Lecturer of Physical Therapy contact

+2 01552290325

aalaasoliman110@gmail.com

Egypt1 site, 1 recruiting
  • Aalaa Ahmed Farrag

    Alexandria, Egypt, 21515

    Aalaa Ahmed

    Aalaa Ahmed Farrag, Bachelor, +2 1094949313, aalaasoliman110@gmail.com

    Recruiting

Other trials in Egypt

About this study

Cerebral palsy is a non-progressive lesion of the brain occurring before 2 years of age resulting in disorders of posture and movement.( Ostensjo S, 2004)( Keles MN, 2018). Although non- progressive, motor impairments develop as the child grows leading to activity and participation restriction.

For children with CP, body function and structure impairments include changes in muscle tone and strength that affect the ability to control movement, specifically in regard to postural responses, selective control, regulation of activity, ability to learn unique movements, and inappropriate sequencing.(Ross SA,2007)( Ostensjo S, 2004) .

Read more

Lack of proper loading and maladaptive muscle pulls over time causes the skeletal system to adapt to positions of malalignment, malformation, and overall bone weakness (Beckung E, 2007) (Elbasan B, 2018).

These changes lead to delays in the natural progression of gross motor skills. As the child falls behind in motor function, they also fall behind in cognitive stimulation and development.( Akaya KU, 2018) . Understanding the anatomical and physiological implications that CP has on the developing child is necessary for physical therapists to treat this population, especially when utilizing electrical stimulation.

Spastic quadriplegia Is a type of cerebral palsy that affects all four limbs and typically involves significant motor impairment. It results from brain damage that occurs before, during, or shortly after birth, affecting the areas of the brain responsible for movement and coordination.

Electrical stimulation is a mode of physical therapy that can be utilized in the treatment of various nerve and muscle injuries, in addition to patients with acute and chronic pain. It involves an electrical pulse applied to a muscle or nerve that activates excitable tissue utilizing internal or external electrodes to build muscle strength, reduce pain, as well as create or support limb movement (Kerr C, 2007).

Task-specific electrical stimulation (TASES) is a therapeutic technique used primarily in rehabilitation settings to enhance motor function. The primary aim of TASES is to facilitate movement and improve motor learning by applying electrical stimulation to specific muscles during targeted tasks.

Read the detailed description

Cerebral palsy is a group of non-progressive motor disorders; it commonly appears in early childhood and affects muscle tone, posture, and movement. (Salazar AP, 2019) The most common cause of physical disability in developed countries and one of the most common causes of acquired physical disability in children is cerebral palsy (Surveillance of cerebral palsy in Europe, 2000). between 1.5 and 4 per 1000 live births, on average (Smithers-Sheedy H, 2016).An estimated 17 million people live with cerebral palsy worldwide, and at least 80 percent of them will survive into their sixth decade ( Blair E, 2019).

This definition acknowledged that there are numerous etiologies for cerebral palsy and that, although the movement and posture disorders are permanent, the motor impairments are frequently progressive.

Classification in CP uses different descriptors and may assess different aspects of the clinical manifestation such as topography of affected limbs, severity of movement impairment, or upper limb manual ability. For instance, regarding topographical classification, unilateral involve- ment of an arm and leg is termed hemiplegia, predomi- nant lower limb involvement is termed diplegia, and involvement of all limbs is termed quadriplegia (Shevell MI, 2010) (Stanley FJ,2000).

Tone abnormalities result from the area of the central nervous system that is damaged. Damage at the vestibulospinal and rubrospinal pathways of the spinal cord and associated central cortex of the brain, accounting for 80% of cases, results in spasticity, at the basal ganglia results in dyskinesia, at the cerebellum results in ataxia, or a mix of any of these.( Goodman CC, 2015) Damage to the cortex, can result in the topography presentations of monoplegia, hemiplegia, diplegia, or quadriplegia, and at the basal ganglia athetoid. ( Ko, N.2022)

Spastic quadriplegia is a type of cerebral palsy characterized by increased muscle tone and stiffness affecting all four limbs, often resulting in significant motor impairment. (Smith J, 2023)

Key Features:

  1. Motor Impairment: Individuals may have severe limitations in movement and muscle control, impacting their ability to walk or use their hands.
  2. Muscle Tone: Muscle tone can vary, leading to stiffness (spasticity) or weakness. This can affect posture and mobility.
  3. Associated Conditions: Many individuals with quadriplegic cerebral palsy may also experience other challenges, such as intellectual disabilities, seizures, or sensory impairments. (Rosenbaum P, 2007)

Upper limb problems in individuals with spastic quadriplegia can vary widely, but some common issues include:

  1. Muscle Tone and Spasticity: Muscles in the arms may be excessively tight, leading to difficulty in movement. This spasticity can cause awkward positioning of the hands and arms.
  2. Limited Range of Motion: Joint stiffness, particularly in the shoulders, elbows, and wrists, can restrict the range of motion. This can make it challenging to perform everyday tasks.
  3. Weakness: While spasticity affects muscle tone, many individuals also experience muscle weakness, which can impact the ability to grasp, lift, or manipulate objects.
  4. Postural Issues: Poor posture can further complicate upper limb function. Malalignment of the shoulders or spine can affect how well the arms can be used.
  5. Fine Motor Skills: Difficulties with fine motor skills can impede activities such as writing, using utensils, or buttoning clothing.
  6. Sensory Issues: Some individuals may also have sensory processing issues, making it hard to feel objects or differentiate between textures.
  7. Contractures: Over time, muscle tightness can lead to contractures, where joints become permanently bent, further limiting function.
  8. Pain and Discomfort: Spasticity and muscle imbalances can lead to discomfort or pain in the upper limbs. (Smith J, 2023) Upper limb gross motor skills involve the use of larger muscle groups to perform movements that require coordination and balance, such as reaching, lifting, and throwing. In individuals with spastic CP, these skills can be impaired in several ways.

Key Impacts on Upper Limb Gross Motor Skills :

  1. Spasticity: Muscle Tone: Increased muscle tone leads to stiffness, making it difficult to initiate and control movements. This can result in awkward postures, such as flexed elbows or wrists. Movement Patterns: Movements may become jerky or uncoordinated, making activities like reaching or throwing difficult.
  2. Limited Range of Motion: Joint Stiffness: Tightness in muscles and tendons can restrict the range of motion in the shoulders, elbows, and wrists, affecting the ability to perform full movements. Contractures: Over time, muscle tightness can lead to permanent shortening (contractures), further limiting function.
  3. Poor Coordination and Control: Proprioception: Difficulty in sensing body position can impact the ability to coordinate arm and hand movements effectively.
  4. Balance Issues: Poor balance can affect the stability required to use the arms for gross motor tasks, such as throwing a ball or climbing.
  5. Postural Control:

Core Stability: Good upper limb function often depends on a stable trunk. Weak core muscles can make it harder to control arm movements during activities.

Alignment: Abnormal postures can affect how the arms are used, leading to compensatory strategies that are less effective. (Smith J, 2023)

Upper limb and gross motor skills and postural mechanisms:

  1. Establish head control (stability and movement) for hand/eye coordination.
  2. Establish postural stability and weight shift of head, shoulder girdle, trunk and pelvis in many gross motor activities in prone, supine, sitting, standing and stepping, which are also necessary for hand function. This allows arm and hand function in postures other than in lying.
  3. Develop rising reactions. Hands and arms are used to help in the change of various postures or the assumption of posture in gross motor development. A child also needs to assume a position in which he will carry out his chosen task in various environments.
  4. Develop saving reactions in the arms. The up- per limbs are thrown into various patterns in- volving active contractions of the muscles in synergies (patterns) to save and prop the child as he falls off balance.
  5. Some of the arm synergies trained for gross motor function are also used in voluntary reach. (Levitt S. 2010)

Task-Specific Electrical Stimulation (TASES) Definition TASES involves applying electrical stimulation to muscles during the performance of specific tasks or movements. The goal is to improve motor function, enhance muscle activation, and facilitate motor learning.

Mechanism

  • Electrical Stimulation: Electrodes are placed on the skin over the targeted muscles. Electrical impulses stimulate muscle contractions.
  • Task-Specific Context: The stimulation is synchronized with task performance, meaning the muscles are activated when the patient is attempting to perform a specific movement, like reaching or grasping. (Cramer SC 2012)

Benefits:

  • Motor Learning: By pairing electrical stimulation with functional tasks, TASES helps reinforce neural pathways associated with those movements.
  • Strengthening: It can improve muscle strength and endurance in targeted areas.
  • Improved Coordination: Helps enhance the coordination and timing of muscle contractions.
  • Functional Independence: Aims to increase the ability of individuals to perform daily activities more independently. (Dario C,2016)

Key Components of TSES:

  1. Targeted Muscle Activation: TSES involves applying electrical stimulation to muscles that are involved in specific tasks, such as grasping, walking, or reaching. This helps to activate muscles that may not be functioning optimally due to injury.
  2. Task-Specific Training: The stimulation is synchronized with the performance of specific tasks. This can help reinforce neural pathways associated with those movements, promoting better motor control and learning.
  3. Neuroplasticity: By pairing electrical stimulation with motor tasks, TSES can enhance neuroplasticity, the brain's ability to reorganize itself and form new neural connections. This is crucial for recovery in post-stroke rehabilitation.
  4. Functional Outcomes: Research has shown that TSES can improve functional outcomes, such as increased strength, improved coordination, and greater independence in daily activities.
  5. Customization: TSES protocols can be tailored to individual patients, considering factors like the specific muscles involved, the type of injury, and the rehabilitation goals. (Smith J, 2023)

Children's gross motor function has a direct impact on quality of life metrics like participation and activity (Palisano RJ, 2009). Children with cerebral palsy (CP) frequently experience difficulties with their gross motor skills (Rosenbaum PL, 2002).

Maximizing functional abilities is a key objective of treatment for these children. Because of limited research area to evaluate the relation between gross motor skills with the upper limb muscles strength therefore, the aim of the current study is to investigate this relation.

It is commonly recognized that the two main issues seen in children with CP are a delayed development of gross motor function and a decline in postural control. As a result, children with spastic cerebral palsy are unable to carry out a number of daily tasks, such as standing, sitting, and walking. For many functional activities, the ability to sit is crucial because it makes transfers easier and permits independent upper limb manipulation of objects. (Beckung E, 2007) (Akaya KU, 2018).

Being tested
Task specific electrical stimulation ( TASES ), Designed Physical therapy program
Keywords
TASES, Cerebral palsy, Gross motor skills, Upper limb, Task specific electrical stimulation
Medical subject headings
Cerebral Palsy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Task specific electrical stimulation ( TASES )Other

    Each child in group B receive the designed program plus the task specific electrical stimulation (TASES) for 20 minutes during the weight bearing exercises as push up , prone on hands on wedge and quadruped with weight shifting.

    The electrical stimulation is applied with the following parameters. Pulse frequency 25-50 HZ, pulse duration 300 micro second, intensity to display a visible muscle contraction, for 20 minutes.

    First channel, one electrode will be placed at the middle of triceps muscle, the second electrode will be placed more distal towards the elbow joint itself (about 3 cm above the olecranon process).

    Second channel, one electrode will be placed over finger and wrist extensors motor point to allow activation of fingers and wrist extensors. The other electrode will be placed over the tendonous portion of the forearm between motor points of extensor carpi radialis and extensor carpi ulnaris muscles.

  • Designed Physical therapy programOther

    The program used a combination of open-and closed-chain exercises. Exercises for facilitating transitions as supine to sit with hand weight bearing , side lying to side sit , side sitting to quadruped, weight bearing exercises as prone on hands on wedge , quadruped with weight shifting and push up exercise for one hour.

Study groups in NCT06925425
Study groupRoleWhat they receive
Group (A)ExperimentalNot described
Receives: Other: Designed Physical therapy program
Group (B)ExperimentalNot described
Receives: Other: Task specific electrical stimulation ( TASES ); Other: Designed Physical therapy program

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Improved upper limb gross motor skills

    The Quality of Upper Extremity Skills Test (QUEST) is used by assessment of the weight bearing domain .

    Measured: after 3 months of treatment

Secondary outcomes (1)
  1. Improvement in joints range of motion

    Electronic Digital Goniometer will be used in this study to measure ROM of wrist and elbow extension .

    Measured: after 3 months of treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Apr 2025
  2. Study start1 May 2025
  3. Primary completion1 Mar 2026
  4. Study completion29 Mar 2026 (estimated)

Resources

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
Intervention study model Parallel assignment. The study will include thirty children with spastic quadriplegic CP of both sex. Their age will range from two to six years meeting the inclusion criteria will be randomly assigned to two experimental groups : First experimental group: children in this group will receive a designed physical therapy program, attending three sessions per week for three consecutive months. The duration of the session was one hour of the designed physical therapy program. Second experimental group: children in this group will receive the designed program plus the task specific electrical stimulation (TASES) for 20 minutes during the weight bearing exercises as push up , prone on hands on wedge and quadruped with weight shifting.
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06925425
Sponsor's protocol ID
KFSIRB200-420
Status last verified
Mar 2026
First submitted
6 Apr 2025
Last updated
1 Apr 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing Task specific electrical stimulation ( TASES ) and Designed Physical therapy program in people with Cerebral Palsy (CP) and Spastic Cerebral Palsy, run by Kafrelsheikh 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 3 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 1 Apr 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?

Contact Mohamed Bedair Ibrahim, Professor of Physical Therapy (+2 01223800014, aalaasoliman110@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Improved upper limb gross motor skills (time frame: after 3 months of treatment). 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 1 Apr 2026.

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