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

Effects of Neuromuscular Electrical Stimulation With and Without Dynamic Bracing on Lower Extremity Spasticity and Quality of Movement in Children With Cerebral Palsy

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

Study Overview

• Status: Completed
• Conditions: Diplegic Spastic Cerebral Palsy
• Intervention / Treatment: Other: NMES with Dynamic Bracing; Other: NMES without Dynamic Bracing; Other: Dynamic Bracing Only

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.

• Study Type: Interventional
• Enrollment (Actual): 42
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Pakistan
  • Punjab
    • Faisalābad, Punjab, Pakistan, 54000
      • Children Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: NMES with Dynamic Bracing; The NMES targeting the hip adductors, the knee flexor muscles and the ankle & foot muscles, along with dynamic bracing	Other: NMES with Dynamic Bracing; The group will receive NMES along with dynamic bracing
Experimental: NMES without Dynamic Bracing; Neuromuscular Electrical Stimulator targeting the lower extremity	Other: NMES without Dynamic Bracing; The participants will receive NMES on the lower extremity
Experimental: Dynamic Bracing Only; Dynamic Bracing of lower extremity	Other: Dynamic Bracing Only; This group will receive dynamic bracing only on the lower limb.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Modified Ashworth Scale	The scale is used to measure spasticity minimum score is 0 and maximum score is 4	baseline and 6 weeks
Observable Movement Quality Scale	it is used assess the movement quality in children Minimum Score: 0 (indicating the poorest movement quality) and maximum is 24	baseline and 6 weeks
Physicians Rating Scale	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	baseline and 6 weeks

Collaborators and Investigators

• Sponsor: Riphah International University
• Investigators: Principal Investigator: Ammara Abbas, tDPT, Riphah International University; Principal Investigator: Ayesha Ashraf, MS NMPT*, Ripha International Univerisity

Study record dates

Study Major Dates

• Study Start (Actual): December 30, 2023
• Primary Completion (Actual): May 14, 2024
• Study Completion (Actual): May 14, 2024

Study Registration Dates

• First Submitted: March 4, 2024
• First Submitted That Met QC Criteria: March 4, 2024
• First Posted (Actual): March 12, 2024

Study Record Updates

• Last Update Posted (Actual): April 9, 2025
• Last Update Submitted That Met QC Criteria: April 7, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: Cerebral Palsy; lower extremity; NMES; Dynamic Bracing
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Damage, Chronic; Cerebral Palsy
• Other Study ID Numbers: REC/0258 Ayesha Ashraf

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No