Pediatric Rehabilitation for Children With Cerebral Palsy Through PVT Using AI to Reduce Spasticity

NCT ID: NCT06407323

Last Updated: 2024-05-09

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-01
• Study Completion Date: 2024-09-01

Brief Summary

The study foucs on pediatric rehabilitation for children with cerebral palsy through personalized vibration therapy powered by artificial intelligence.

Detailed Description

Innovative approach to reduce spasticity, improved motor function, quality of life. Vibration therapy reduces spasticity by activating the body's natural stretch reflex, which in turn triggers muscular contractions. Furthermore, it has been proposed that the primary ends of the muscle spindle Ia afferent are stimulated by muscular vibration. This leads to the excitation of alpha motor neurons, subsequent contractions of motor units, ultimately producing a tonic muscle contraction. This study will modify vibration therapy by introducing Artificial intelligence to rehabilitate the patients suffering from spastic CP.

Conditions

Cerebral Palsy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Personalized vibration therapy powered by AI

Group Type: EXPERIMENTAL

Personalized vibration therapy powered by AI

Intervention Type: DIAGNOSTIC_TEST

A target frequency of either 20 Hz or 25 Hz, and amplitude 2-4 mm The whole treatment session will be around 20 minutes along with hot pack as a baseline treatment, consisted of 6 sessions per week for total 8 weeks of duration

physical therapy treatment

Group Type: OTHER

Physical therapy treatment

Intervention Type: OTHER

A selected physical therapy treatment program for spastic diplegic CP.

Interventions

Personalized vibration therapy powered by AI

A target frequency of either 20 Hz or 25 Hz, and amplitude 2-4 mm The whole treatment session will be around 20 minutes along with hot pack as a baseline treatment, consisted of 6 sessions per week for total 8 weeks of duration

Intervention Type: DIAGNOSTIC_TEST

Physical therapy treatment

A selected physical therapy treatment program for spastic diplegic CP.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Diagnosed spastic CP as per neurologist report, GMFCS level I-III
• Ability to safely withstand intensity of vibrating device.
• have no planned surgery within 5 months before/after entering the study

Exclusion Criteria

• A bone fracture within 12 weeks of enrollment.
• History of using anabolic agents, glucocorticoids (excluding inhaled), or growth hormone (regardless of dose) for at least 1 month, within the 3 months prior to enrollment.
• History of botulinum toxin injection into the lower limb(s) within the 3 months before enrollment.
• History of an illness or findings on physical examination that might prevent the child from completing the study (e.g., acute thrombosis, tendinitis).

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 9 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Superior University

OTHER

Sponsor Role: lead

Responsible Party

Muhammad Naveed Babur

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Johar pain relief center

Lahore, Punjab Province, Pakistan

Ali Fatima hospital

Lahore, Punjab Province, Pakistan

Countries

Pakistan

Other Identifiers

MSRSW/Batch-Fall22/704

Identifier Type: -

Identifier Source: org_study_id