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Effects OF NMES With and Without Dynamic Bracing on Spasticity and Movement Quality in CP

Not Applicable
Recruiting
Conditions
Diplegic Spastic Cerebral Palsy
Interventions
Other: NMES without Dynamic Bracing
Other: NMES with Dynamic Bracing
Other: Dynamic Bracing Only
Registration Number
NCT06303336
Lead Sponsor
Riphah International University
Brief Summary

The study aims at comparing Neuromuscular electrical Stimulation with and without dynamic bracing on spasticity and movement quality of lower limb in Children with Cerebral Palsy

Detailed Description

Cerebral palsy (CP) is a lifelong motor impairment caused by an early brain injury and affects 2-3 per 1,000 live births. It is a complex medical condition that negatively impacts cognition, language, sensations, movement, and gait patterns. It is normally carried out using a comprehensive approach that incorporates numerous approaches targeted at minimizing symptoms and improving functional outcomes.

NMES (Neuromuscular and Muscular Electrical Stimulation) is an instrument that provides electrical impulses to nerves, causing muscles to contract, while dynamic bracing use muscle power to pre-compress soft tissue to produce the high forces required to control specific pathological diseases.

The hip adductors, the knee flexor muscles, and the ankle and foot muscles (gastrocnemius and soleus may experience increased tone, causing the ankles to be held in a plantar-flexed (pointed downward) position) are targeted with NMES in the lower extremity to reduce the spasticity \& improve the quality of movement in CP children. Investigating how combining NMES with dynamic bracing benefits lumbar disc bulge patients adds to the growing body of evidence supporting multimodal treatment.

Recruitment & Eligibility

Status
RECRUITING
Sex
All
Target Recruitment
42
Inclusion Criteria
  • Age between 5 to 12 years.
  • Able to walk with or without an assistive device. Classification as level I-II on the Gross Motor Functional Classification System (GMFCS).
  • Able to stand with or without support for 1 minute.
  • Classification as levels I-III on the Manual Ability Classification System (MACS); and the ability to follow and accept verbal instructions.
  • Muscle tone scored ≥2, according to Modified Ashworth Scale.
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Exclusion Criteria
  • Orthopedic Surgical intervention (e.g. tendon lengthening in lower limb) within the previous 12 months
  • Treatment with botulinum toxin in the calf muscles within the previous 6 months
  • Presence of structural deformities at the lower limbs and trunk, or instability in the ankle joint, which could compromise the child's safety and performance of the motor task
  • Severe affective or psychiatric impairments;
  • Serious vision or hearing problems
  • Any neurological impairment (epilepsy or any other disease that would interfere with physical activity)
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Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
NMES without Dynamic BracingNMES without Dynamic BracingNeuromuscular Electrical Stimulator targeting the lower extremity
NMES with Dynamic BracingNMES with Dynamic BracingThe NMES targeting the hip adductors, the knee flexor muscles and the ankle \& foot muscles, along with dynamic bracing
Dynamic Bracing OnlyDynamic Bracing OnlyDynamic Bracing of lower extremity
Primary Outcome Measures
NameTimeMethod
Modified Ashworth Scale6 weeks

The scale is used to measure spasticity

Observable Movement Quality Scale6 weeks

it is used assess the movement quality in children

Physicians Rating Scale6 weeks

it is used to objectively documenting the hip, knee, ankle and foot changes in children with CP.

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Children Hospital

🇵🇰

Faisalābad, Punjab, Pakistan

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