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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06303336
Enrollment
42
Registered
2024-03-12
Start date
2023-12-30
Completion date
2024-05-14
Last updated
2025-04-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diplegic Spastic Cerebral Palsy

Keywords

NMES, Dynamic Bracing, Cerebral Palsy, lower extremity

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.

Interventions

OTHERNMES with Dynamic Bracing

The group will receive NMES along with dynamic bracing

OTHERNMES without Dynamic Bracing

The participants will receive NMES on the lower extremity

OTHERDynamic Bracing Only

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

Sponsors

Riphah International University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Masking description

participants and outcome assessors will be kept blind about the intervention which the patients will be receiving

Eligibility

Sex/Gender
ALL
Age
5 Years to 12 Years
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Physicians Rating Scalebaseline and 6 weeksit 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
Modified Ashworth Scalebaseline and 6 weeksThe scale is used to measure spasticity minimum score is 0 and maximum score is 4
Observable Movement Quality Scalebaseline and 6 weeksit is used assess the movement quality in children Minimum Score: 0 (indicating the poorest movement quality) and maximum is 24

Countries

Pakistan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026