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

NCT06303336 | Completed DMC

• 1 other identifier: REC/0258 Ayesha Ashraf
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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

Conditions

Diplegic Spastic Cerebral Palsy

Keywords

NMES; Dynamic Bracing; Cerebral Palsy; lower extremity

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (3)

NMES with Dynamic Bracing

EXPERIMENTAL

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

Other: NMES with Dynamic Bracing

NMES without Dynamic Bracing

EXPERIMENTAL

Neuromuscular Electrical Stimulator targeting the lower extremity

Other: NMES without Dynamic Bracing

Dynamic Bracing Only

EXPERIMENTAL

Dynamic Bracing of lower extremity

Other: Dynamic Bracing Only

Interventions

NMES with Dynamic Bracing OTHER

The group will receive NMES along with dynamic bracing

NMES with Dynamic Bracing

NMES without Dynamic Bracing OTHER

The participants will receive NMES on the lower extremity

NMES without Dynamic Bracing

Dynamic Bracing Only OTHER

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

Dynamic Bracing Only

Eligibility Criteria

• Age: 5 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

Children Hospital

Faisalābad, Punjab Province, 54000, Pakistan

Location

MeSH Terms

Conditions

Cerebral palsy, spastic, diplegic; Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Ayesha Ashraf, MS NMPT*

  Ripha International Univerisity

  PRINCIPAL INVESTIGATOR

• Ammara Abbas, tDPT

  Riphah International University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: participants and outcome assessors will be kept blind about the intervention which the patients will be receiving
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2024
• First Posted: March 12, 2024
• Study Start: December 30, 2023
• Primary Completion: May 14, 2024
• Study Completion: May 14, 2024
• Last Updated: April 9, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)