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Completed

NCT Number: NCT06303336

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

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

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Key information

Age range

5 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Children Hospital

Faisalābad, Punjab Province, 54000, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

NMES with Dynamic Bracing

Other

The group will receive NMES along with dynamic bracing

NMES without Dynamic Bracing

Other

The participants will receive NMES on the lower extremity

Dynamic Bracing Only

Other

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

Primary outcomes

  1. Modified Ashworth Scale

    Time frame: baseline and 6 weeks

    The scale is used to measure spasticity minimum score is 0 and maximum score is 4

  2. Observable Movement Quality Scale

    Time frame: 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

  3. Physicians Rating Scale

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Riphah International University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Mar 12, 2024
Registry last updated
Apr 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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