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

Not Applicable

Active, not recruiting

• Conditions: Cerebral Palsy
• Interventions: Other: Physical therapy treatment; Diagnostic Test: Personalized vibration therapy powered by AI

• Registration Number: NCT06407323
• Lead Sponsor: Superior University

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.

Study Timeline

• Study Start: 2023-10-01
• Primary Completion: 2024-02-01
• Status Verified: 2024-05
• Study First Submitted: 2024-05-02
• Study First Submitted QC: 2024-05-06
• Last Update Submitted: 2024-05-06
• Study First Posted: 2024-05-09
• Last Update Posted: 2024-05-09
• Study Completion: 2024-09-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 32

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
physical therapy treatment	Physical therapy treatment	-
Personalized vibration therapy powered by AI	Personalized vibration therapy powered by AI	-

Primary Outcome Measures

Name	Time	Method
Quality of life-child Questionnaire	12 months	The first health condition-specific questionnaire created specifically to measure quality of life (QOL) in children with cerebral palsy (CP) is the Cerebral Palsy Quality of Life for Children (CP QOL-Child). For primary carers, intra-class correlation values varied from.88 to.97, while for children, they were between.91 and.98. The assessment of children with cerebral palsy (CP) using the Turkish version of the CP QOL questionnaire was found to be a valid and dependable method. b)Gross Motor Function Classification System There was 0.84 interrater reliability. The GMFCS level and motor development tests had a stronger correlation than the GMFCS level and non-motor development tests.
Modified Ashworth Scale	12 Months	It is used to assess spasticity of neurological disorder patients. For scores on the Modified Ashworth Scale, there was satisfactory inter- and intra-rater agreement. The results of the Modified Ashworth Scale showed more reliability in measuring the upper extremities than the lower. The inter-rater reliability of the ratings for the lower and upper extremities was statistically correlated with a number of study parameters

Trial Locations

Locations (2)

Ali Fatima hospital; 🇵🇰 Lahore, Punjab, Pakistan

Johar pain relief center; 🇵🇰 Lahore, Punjab, Pakistan