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

Riphah International University

Status: Completed

Conditions: Diplegic Spastic Cerebral Palsy

Treatments: Other: Dynamic Bracing Only; Other: NMES without Dynamic Bracing; Other: NMES with Dynamic Bracing

Study type: Interventional

Funder types: Other

Identifiers

NCT06303336

REC/0258 Ayesha Ashraf

Details and patient eligibility

About

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

Full 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.

Enrollment: 42 patients

Sex: All

Ages: 5 to 12 years old

Volunteers: No Healthy Volunteers

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.

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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42 participants in 3 patient groups

NMES with Dynamic Bracing

Experimental group

Description:

The NMES targeting the hip adductors, the knee flexor muscles and the ankle \& foot muscles, along with dynamic bracing

Treatment:

Other: NMES with Dynamic Bracing

NMES without Dynamic Bracing

Experimental group

Description:

Neuromuscular Electrical Stimulator targeting the lower extremity

Treatment:

Other: NMES without Dynamic Bracing

Dynamic Bracing Only

Experimental group

Description:

Dynamic Bracing of lower extremity

Treatment:

Other: Dynamic Bracing Only