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

NCT ID: NCT06303336

Last Updated: 2025-04-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-12-30
• Study Completion Date: 2024-05-14

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.

Conditions

Diplegic Spastic Cerebral Palsy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

NMES with Dynamic Bracing

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

Group Type: EXPERIMENTAL

NMES with Dynamic Bracing

Intervention Type: OTHER

The group will receive NMES along with dynamic bracing

NMES without Dynamic Bracing

Neuromuscular Electrical Stimulator targeting the lower extremity

Group Type: EXPERIMENTAL

NMES without Dynamic Bracing

Intervention Type: OTHER

The participants will receive NMES on the lower extremity

Dynamic Bracing Only

Dynamic Bracing of lower extremity

Group Type: EXPERIMENTAL

Dynamic Bracing Only

Intervention Type: OTHER

This group will receive dynamic bracing only on the lower limb.

Interventions

NMES with Dynamic Bracing

The group will receive NMES along with dynamic bracing

Intervention Type: OTHER

NMES without Dynamic Bracing

The participants will receive NMES on the lower extremity

Intervention Type: OTHER

Dynamic Bracing Only

This group will receive dynamic bracing only on the lower limb.

Intervention Type: OTHER

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)

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Riphah International University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ayesha Ashraf, MS NMPT*

Role: PRINCIPAL_INVESTIGATOR

Ripha International Univerisity

Ammara Abbas, tDPT

Role: PRINCIPAL_INVESTIGATOR

Riphah International University

Locations

Children Hospital

Faisalābad, Punjab Province, Pakistan

Countries

Pakistan

Other Identifiers

REC/0258 Ayesha Ashraf

Identifier Type: -

Identifier Source: org_study_id