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

Pediatric Rehabilitation for Children With Cerebral Palsy Through Personalized Vibration Therapy Powered By Artificial Intelligence: An Innovative Approach to Reduce Spasticity and Improved Motor Function and Quality Of Life

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

Study Overview

• Status: Active, not recruiting
• Conditions: Cerebral Palsy
• Intervention / Treatment: Diagnostic test: Personalized vibration therapy powered by AI; Other: Physical therapy treatment

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 Type: Interventional
• Enrollment (Actual): 32
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Pakistan
  • Punjab
    • Lahore, Punjab, Pakistan, 54600
      • Johar pain relief center
    • Lahore, Punjab, Pakistan
      • Ali Fatima hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Personalized vibration therapy powered by AI	Diagnostic test: 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
Other: physical therapy treatment	Other: Physical therapy treatment; A selected physical therapy treatment program for spastic diplegic CP.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Modified Ashworth Scale	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	12 Months
Quality of life-child Questionnaire	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.	12 months

Collaborators and Investigators

• Sponsor: Superior University

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2023
• Primary Completion (Actual): February 1, 2024
• Study Completion (Estimated): September 1, 2024

Study Registration Dates

• First Submitted: May 2, 2024
• First Submitted That Met QC Criteria: May 6, 2024
• First Posted (Actual): May 9, 2024

Study Record Updates

• Last Update Posted (Actual): May 9, 2024
• Last Update Submitted That Met QC Criteria: May 6, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Damage, Chronic; Cerebral Palsy
• Other Study ID Numbers: MSRSW/Batch-Fall22/704

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No