Effects OF NMES With and Without Dynamic Bracing on Spasticity and Movement Quality in CP
- Conditions
- Diplegic Spastic Cerebral Palsy
- Interventions
- Other: NMES without Dynamic BracingOther: NMES with Dynamic BracingOther: 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
- COMPLETED
- Sex
- All
- Target Recruitment
- 42
- 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.
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description NMES without Dynamic Bracing NMES without Dynamic Bracing Neuromuscular Electrical Stimulator targeting the lower extremity NMES with Dynamic Bracing NMES with Dynamic Bracing The NMES targeting the hip adductors, the knee flexor muscles and the ankle \& foot muscles, along with dynamic bracing Dynamic Bracing Only Dynamic Bracing Only Dynamic Bracing of lower extremity
- Primary Outcome Measures
Name Time Method Modified Ashworth Scale baseline and 6 weeks The scale is used to measure spasticity minimum score is 0 and maximum score is 4
Observable Movement Quality Scale baseline and 6 weeks it is used assess the movement quality in children Minimum Score: 0 (indicating the poorest movement quality) and maximum is 24
Physicians Rating Scale baseline and 6 weeks it is used to objectively documenting the hip, knee, ankle and foot changes in children with CP. Minimum Score: 0 (indicating no impairment or lowest severity) and Maximum score is 7
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Children Hospital
🇵🇰Faisalābad, Punjab, Pakistan