- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07631390
Impact of Task-Specific Electrical Stimulation on Upper Limb Functional Motor Skills in Children With Spastic Quadriplegia
Study Overview
Status
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Egypt
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Alexandria, Egypt, Egypt, 21515
- Aalaa Ahmed Farrag
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Study group
Task-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. |
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.
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.
|
|
Active Comparator: Control group
Every 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
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Improved upper limb functional motor skills
Time Frame: 2 months after treatment
|
The Quality of Upper Extremity Skills Test (QUEST) is used by assessment of the weight bearing domain
|
2 months after treatment
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- KFSIRB200-1060
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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