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Cerebral Palsy (CP)NCT07631390

Impact of Task-Specific Electrical Stimulation on Upper Limb Functional Motor Skills in Children With Spastic Quadriplegia

A study testing The Chattanooga Continuum™ and Designed Physical therapy program in people with Cerebral Palsy (CP) and Spastic Quadriplegia, run by Kafrelsheikh University at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

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 4 to 7 years, men only
What is being tested?
The Chattanooga Continuum™ and Designed Physical therapy program
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteEgypt
Study dates
1 May 2025to 10 Mar 2026
Phase
Interventional
Are there results?
None posted in the registry

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 4 to 7 years
  • Men only
  • No healthy volunteers
  • Child

Who may be able to join

  • Their age will be ranged from 4 to 7 years.
  • Their grade of spasticity will be from 1+ to 2 according to Modified Ashworth scale
  • They will be on Level III and IV according to Gross Motor Functional Classification System (GMFCS).
  • Parents/legals representatives consenting to their child's participation
  • 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.

Egypt1 site
  • Aalaa Ahmed Farrag

    Alexandria, Egypt, 21515

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) . 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) .

Read the detailed description

Cerebral palsy (CP) encompasses a clinically diverse group of permanent but non-progressive disorders of posture and movement caused by disturbances in the developing brain (Rosenbaum et al., 2007). Spastic quadriplegia, also known as spastic tetraplegia, is a major subtype of spastic CP, characterized by significant impairment in motor function involving all four limbs and the trunk. Unlike spastic hemiplegia, which affects one side of the body, or spastic diplegia, which predominantly involves the lower limbs, spastic quadriplegia is defined by the bilateral and symmetric involvement of upper and lower extremities-often with the upper limbs being as severely, or more severely, affected than the lower extremities (Beckung et al., 2007; Palisano et al., 2009). Spastic quadriplegia is considered the most severe form of CP. Epidemiological data indicate that this subtype accounts for approximately 20-30% of all children with CP, with some variability by region and study population (Beckung et al., 2007). The condition affects both males and females and is not limited to any particular ethnic or socioeconomic group. 2. Etiology and Pathophysiology The etiology of spastic quadriplegia is multifactorial, primarily involving prenatal, perinatal, or early postnatal injury to the developing brain. The most common causes include:

  • Prenatal factors: Intrauterine infections, genetic abnormalities, placental insufficiency, and exposure to toxins.
  • Perinatal factors: Birth asphyxia, prematurity, intracranial hemorrhage, and periventricular leukomalacia (PVL).
  • Postnatal factors: Neonatal stroke, traumatic brain injury, severe infections (e.g., meningitis, encephalitis). Brain imaging in children with spastic quadriplegia frequently reveals extensive lesions, often affecting both cortical and subcortical structures, periventricular white matter, and the basal ganglia. Lesions are typically bilateral and may include multicystic encephalomalacia or severe PVL (Rosenbaum et al., 2007; Novak et al., 2013). The widespread nature of 24 the injury explains the symmetric involvement of all limbs and the profound motor deficits observed in this population. The pathophysiology underlying spasticity includes disruption of descending inhibitory pathways, particularly those modulating the stretch reflex, resulting in increased muscle tone, hyperreflexia, and reduced reciprocal inhibition (Damiano, 2006). 3. Clinical Features The hallmark of spastic quadriplegia is the presence of bilateral spasticity affecting both upper and lower limbs, with notable involvement of the trunk and orofacial muscles in many cases. Clinical manifestations include:
  • Severe motor impairment: Marked spasticity, muscle weakness, and decreased selective voluntary motor control in all extremities (Beckung et al., 2007).
  • Joint contractures and deformities: Chronic spasticity often leads to fixed contractures, particularly at the shoulders, elbows, wrists, hips, knees, and ankles.
  • Postural instability: Poor trunk and head control, often resulting in scoliosis, pelvic obliquity, and difficulties with sitting balance.
  • Abnormal movement patterns: Persistence of primitive reflexes, synergistic patterns, and lack of dissociated movements.
  • Oromotor and bulbar involvement: Dysarthria, drooling, and feeding difficulties are common due to spasticity of facial and bulbar muscles.
  • Associated impairments: Cognitive impairment, epilepsy, sensory deficits (visual and auditory), and behavioral problems occur at higher rates in this population (Palisano et al., 2009; Novak et al., 2013). 4.Upper Limb Function in Spastic Quadriplegia Impairment of upper limb function is a cardinal feature and a primary determinant of disability in spastic quadriplegia. Key features include:
  • Spasticity and weakness: Typically most pronounced in the flexor muscles of the upper limbs (shoulder adductors, elbow flexors, wrist and finger flexors).
  • Impaired selective motor control: Difficulty isolating joint movements leads to mass grasp and release patterns, limiting dexterity and functional hand use (DeMatteo et al., 1992).
  • Contractures: Especially common at the elbows and wrists, further limiting range of motion and functional reach.
  • Poor postural control: Inadequate trunk stability compromises the ability to use the arms for support or manipulation.
  • Functional impact: Profound limitations in reaching, grasping, releasing, weight-bearing, and manipulating objects undermine the ability to perform self-care, use assistive devices, participate in play and education, and interact socially (Palisano et al., 2009). Task-Specific Electrical Stimulation (TASES) Task-specific electrical stimulation (TASES) represents a significant evolution in the application of neurostimulation in neurorehabilitation. Unlike traditional NMES or FES, which may be applied passively or in a cyclic fashion, TASES is explicitly synchronized with active, goal directed motor tasks to maximize the interplay between voluntary effort and afferent feedback (Gordon et al., 2013; Daly et al., 2006). This approach is rooted in the principles of motor learning and neuroplasticity, which posit that the repetition of meaningful, contextually relevant tasks fosters more robust and lasting changes in the central nervous system than passive exercise alone (Kleim \& Jones, 2008; Nudo, 2006). Principles and Mechanisms The primary premise of TASES is that coupling electrical stimulation with volitional, task-driven movement enhances motor output by:
  • Increasing sensory feedback during task execution, thereby strengthening sensorimotor integration
  • Facilitating the recruitment of motor units that might otherwise be difficult to activate voluntarily, especially in paretic or spastic muscles
  • Reinforcing the temporal and spatial patterns of muscle activation required for functional tasks 40 By delivering stimulation at key points during a task (for example, during the weight-bearing phase of a push-up or during wrist extension as the hand contacts a support surface), TASES can help children with severe motor impairments more effectively engage muscles critical for upper limb function (Gordon et al., 2013; Daly et al., 2006). Mechanisms Underlying Functional Improvements Understanding the mechanisms by which electrical stimulation, and specifically task-specific electrical stimulation (TASES), improves upper limb function in children with spastic quadriplegia is essential for optimizing therapy and advancing clinical practice. The effects of ES are multifaceted, involving changes at the muscular, neural, and behavioral levels.
Being tested
The Chattanooga Continuum™, Designed Physical therapy program
Medical subject headings
Cerebral Palsy, Quadriplegia

What participants receive

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

  • The Chattanooga Continuum™Device

    The Chattanooga Continuum™ (fig.2) is a portable 2 channel stimulator used by therapists in clinics and patients at home to provide electrical stimulation treatments in pain management (TENS) and neuromuscular stimulation (NMES). By combining TENS with NMES, users can simultaneously help manage pain and enhance exercise,3 thereby shortcutting the traditional muscle recovery cycle. Factor in a choice of program options including customizable waveforms,and you have a highly versatile and user-friendly rehabilitation tool that can help deliver optimal therapeutic outcomes. The Continuum Kit includes a transportation pouch and hand switch.

  • 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 NCT07631390
Study groupRoleWhat they receive
Study groupExperimentalTask-specific electrical stimulation, was delivered using the NMES (Neuromuscular Electrical Stimulation) mode on the Chattanooga ContinuumTM Portable two channel electrical stimulator. • This device is commonly used for muscle re-education, strengthening and functional rehabilitation. Every kid received three sessions per week for two months; each session lasted one hour, half an hour was for the designed physiotherapy program (as in the control group), and last 20 minutes was for the TASES application during the weight bearing exercises including push up exercise, prone on hands exercise, quadruped with weight shifting, in addition to transition activities as side sitting to quadruped exercise.
Receives: Device: The Chattanooga Continuum™; Other: Designed Physical therapy program
Control groupActive comparatorEvery kid received three sessions per week for two months; each session lasted one hour of designed physiotherapy program which included upper limb weight bearing exercises
Receives: 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 functional motor skills

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

    Measured: 2 months after treatment

Timeline

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

  1. First posted8 Jun 2026
  2. Study start1 May 2025
  3. Primary completion1 Mar 2026
  4. Study completion10 Mar 2026

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
Thirty children with spastic quadriplegic cerebral palsy after referred by pediatrician were randomly allocated into two equal groups: a control group (Group A) and a study group (Group B). The control group received a standardized physical therapy program, while the study group received the same program plus TASES.
Masking
None (open label)
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07631390
Sponsor's protocol ID
KFSIRB200-1060
Status last verified
Jun 2026
First submitted
1 Jun 2026
Last updated
8 Jun 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing The Chattanooga Continuum™ and Designed Physical therapy program in people with Cerebral Palsy (CP) and Spastic Quadriplegia, 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 5 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: finished, as of the sponsor's last update on 8 Jun 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Improved upper limb functional motor skills (time frame: 2 months after 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 8 Jun 2026.

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