Clinical trial NCT06303336: Effects OF NMES With and Without Dynamic Bracing on Spasticity and Movement Quality in CP
Official title: Effects of Neuromuscular Electrical Stimulation With and Without Dynamic Bracing on Lower Extremity Spasticity and Quality of Movement in Children With Cerebral Palsy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diplegic Spastic Cerebral Palsy
Keywords: NMES
Dynamic Bracing
Cerebral Palsy
lower extremity
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2024-03-12
Enrollment: 42
Sex: ALL
Minimum age (years): 5
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Modified Ashworth Scale
timeFrame: baseline and 6 weeks
measure: Observable Movement Quality Scale
timeFrame: baseline and 6 weeks
measure: Physicians Rating Scale
timeFrame: baseline and 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Faisalābad
country: Pakistan
facility: Children Hospital
state: Punjab
Study officials:
affiliation: Ripha International Univerisity
name: Ayesha Ashraf, MS NMPT*
role: PRINCIPAL_INVESTIGATOR
affiliation: Riphah International University
name: Ammara Abbas, tDPT
role: PRINCIPAL_INVESTIGATOR
References: