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

Cerebral Palsy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06407323
• Other study ID #: MSRSW/Batch-Fall22/704
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 1, 2023
• Est. completion date: September 1, 2024

Study information

• Verified date: May 2024
• Source: Superior University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 32
• Est. completion date: September 1, 2024
• Est. primary completion date: February 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 9 Years

Eligibility

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).

Related Conditions & MeSH terms

• Cerebral Palsy

Intervention

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
A selected physical therapy treatment program for spastic diplegic CP.

Locations

Country	Name	City	State
Pakistan	Ali Fatima hospital	Lahore	Punjab
Pakistan	Johar pain relief center	Lahore	Punjab

Sponsors (1)

Lead Sponsor	Collaborator
Superior University

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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