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

NCT06407323 | Active Not Recruiting DMC

• 1 other identifier: MSRSW/Batch-Fall22/704
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Cerebral Palsy

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Personalized vibration therapy powered by AI

EXPERIMENTAL

Diagnostic Test: Personalized vibration therapy powered by AI

physical therapy treatment

OTHER

Other: Physical therapy treatment

Interventions

Personalized vibration therapy powered by AI 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

Personalized vibration therapy powered by AI

Physical therapy treatment OTHER

A selected physical therapy treatment program for spastic diplegic CP.

physical therapy treatment

Eligibility Criteria

• Age: 2 Years - 9 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Superior University: lead

Study Sites (2)

Johar pain relief center

Lahore, Punjab Province, 54600, Pakistan

Location

Ali Fatima hospital

Lahore, Punjab Province, Pakistan

Location

MeSH Terms

Conditions

Cerebral Palsy

Interventions

Physical Therapy Modalities

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Therapeutics; Rehabilitation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 2, 2024
• First Posted: May 9, 2024
• Study Start: October 1, 2023
• Primary Completion: February 1, 2024
• Study Completion: September 1, 2024
• Last Updated: May 9, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

PA (2)