Clinical trial NCT05751135: Impact of Focal Muscle Vibration on Bio-psychosocial Outcomes in Cerebral Palsy
Official title: Impact of Focal Muscle Vibration on Bio-psychosocial Outcomes in Cerebral Palsy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebral Palsy
Keywords: Cerebral palsy
Focal muscle vibration
Biopsychosocial
Functional near-infrared spectroscopy
Electroencephalography
Emotional reactivity
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2023-03-02
Enrollment: 111
Sex: ALL
Minimum age (years): 3
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 3 parallel group mixed methods
Primary purpose: TREATMENT

Brief summary: This study aims to determine the effects of focal muscle vibration on bio-psychosocial outcomes in subjects with cerebral palsy. Mixed methods will be used and the study will be conducted in 2 phases; 1st phase is determining the effects of intervention, whereas second step is prediction of outcomes. A qualitative gait analysis will also be done.

Detailed description: The literature suggests the positive effects of focal muscle vibration on various motor components of cerebral palsy. Although there is a gap regarding it's effects with perspective of bio-psychosocial model, which will be the main focus of this study. The study will look for the effects of focal muscle vibration on biological, psychological and social aspects of subjects with cerebral palsy (CP). The intervention in form of focal muscle vibration and standard physical therapy will be provided for 12 weeks and the subjects will then be followed for 4 weeks to look for retention effects, and till 24 weeks for prediction of outcomes.

Eligibility criteria: Inclusion Criteria:

* Diagnosed spastic diplegic cerebral palsy cases with following characteristics;
* Gross motor function classification scale levels II-IV
* Receiving standard physical therapy care

Exclusion Criteria:

* Severe cognitive, visual and hearing impairments.
* History of metabolic diseases.
* History of recent fractures.
* Children with severe musculo-skeletal anomalies

Primary outcomes:
measure: Functional near-infrared spectroscopy (fNIRS)
timeFrame: Baseline
measure: Functional near-infrared spectroscopy (fNIRS)
timeFrame: After 4 weeks
measure: Functional near-infrared spectroscopy (fNIRS)
timeFrame: After 8 weeks
measure: Electroencephalogram (EEG)
timeFrame: Baseline
measure: Electroencephalogram (EEG)
timeFrame: After 4 weeks
measure: Electroencephalogram (EEG)
timeFrame: After 8 weeks
measure: Gross Motor Function Measure
timeFrame: Baseline
measure: Gross Motor Function Measure
timeFrame: After 4 weeks
measure: Gross Motor Function Measure
timeFrame: After 8 weeks
measure: Gross Motor Function Measure
timeFrame: After 12 weeks
measure: Modified Ashworth scale
timeFrame: Baseline
measure: Modified Ashworth scale
timeFrame: After 4 weeks
measure: Modified Ashworth scale
timeFrame: After 8 weeks
measure: Modified Ashworth scale
timeFrame: After 12 weeks
measure: Child Behavior Checklist (CBCL)
timeFrame: Baseline
measure: Child Behavior Checklist (CBCL)
timeFrame: After 4 weeks
measure: Child Behavior Checklist (CBCL)
timeFrame: After 8 weeks
measure: Child Behavior Checklist (CBCL)
timeFrame: After 12 weeks
measure: Social support questionnaire
timeFrame: Baseline
measure: Social support questionnaire
timeFrame: After 4 weeks
measure: Social support questionnaire
timeFrame: After 8 weeks
measure: Social support questionnaire
timeFrame: After 12 weeks
measure: Self perception profile
timeFrame: Baseline
measure: Self perception profile
timeFrame: After 4 weeks
measure: Self perception profile
timeFrame: After 8 weeks
measure: Self perception profile
timeFrame: After 12 weeks
measure: Perth Emotional Reactivity Scale (PERS-S)
timeFrame: Baseline
measure: Perth Emotional Reactivity Scale (PERS-S)
timeFrame: After 4 weeks
measure: Perth Emotional Reactivity Scale (PERS-S)
timeFrame: After 8 weeks
measure: Perth Emotional Reactivity Scale (PERS-S)
timeFrame: After 12 weeks
measure: Modified Caregiver Strain Index (MCSI)
timeFrame: Baseline
measure: Modified Caregiver Strain Index (MCSI)
timeFrame: After 4 weeks
measure: Modified Caregiver Strain Index (MCSI)
timeFrame: After 8 weeks
measure: Modified Caregiver Strain Index (MCSI)
timeFrame: After 12 weeks
measure: Electromyography (EMG)
timeFrame: Baseline
measure: Electromyography (EMG)
timeFrame: After 4 weeks
measure: Electromyography (EMG)
timeFrame: After 8 weeks
measure: Trunk control measurement scale (TCMS)
timeFrame: Baseline
measure: Trunk control measurement scale (TCMS)
timeFrame: After 4 weeks
measure: Trunk control measurement scale (TCMS)
timeFrame: After 8 weeks
measure: Trunk control measurement scale (TCMS)
timeFrame: After 12 weeks
measure: Pediatric Balance Scale (PBS)
timeFrame: Baseline
measure: Pediatric Balance Scale (PBS)
timeFrame: After 4 weeks
measure: Pediatric Balance Scale (PBS)
timeFrame: After 8 weeks
measure: Pediatric Balance Scale (PBS)
timeFrame: After 12 weeks
measure: Dynamometer
timeFrame: Bassline
measure: Dynamometer
timeFrame: After 4 weeks
measure: Dynamometer
timeFrame: After 8 weeks
measure: Dynamometer
timeFrame: After 12 weeks
measure: Cerebral Palsy Quality of Life (CPQOL)
timeFrame: Baseline
measure: Cerebral Palsy Quality of Life (CPQOL)
timeFrame: After 4 weeks
measure: Cerebral Palsy Quality of Life (CPQOL)
timeFrame: After 8 weeks
measure: Cerebral Palsy Quality of Life (CPQOL)
timeFrame: After 12 weeks
measure: Edinburgh Visual Gait Assessment Score
timeFrame: Baseline
measure: Edinburgh Visual Gait Assessment Score
timeFrame: After 4 weeks
measure: Edinburgh Visual Gait Assessment Score
timeFrame: After 8 weeks
measure: Edinburgh Visual Gait Assessment Score
timeFrame: After 12 weeks
measure: Child friendly Depression Anxiety Stress Scale 21 (DASS-21)
timeFrame: Baseline
measure: Child friendly Depression Anxiety Stress Scale 21 (DASS-21)
timeFrame: After 4 weeks
measure: Child friendly Depression Anxiety Stress Scale 21 (DASS-21)
timeFrame: After 8 weeks
measure: Child friendly Depression Anxiety Stress Scale 21 (DASS-21)
timeFrame: After 12 weeks
measure: Immune Response Questionnaire (IRQ)
timeFrame: Baseline
measure: Immune Response Questionnaire (IRQ)
timeFrame: After 4 weeks
measure: Immune Response Questionnaire (IRQ)
timeFrame: After 8 weeks
measure: Immune Response Questionnaire (IRQ)
timeFrame: After 12 weeks
measure: Reaction Time
timeFrame: Baseline
measure: Reaction Time
timeFrame: After 4 weeks
measure: Reaction Time
timeFrame: After 8 weeks
measure: Reaction Time
timeFrame: After 12 weeks
measure: Heart rate variability (HRV)
timeFrame: Baseline
measure: Heart rate variability (HRV)
timeFrame: After 4 weeks
measure: Heart rate variability (HRV)
timeFrame: After 8 weeks
measure: Heart rate variability (HRV)
timeFrame: After 12 weeks
measure: Manual Muscle Testing (MMT)
timeFrame: Baseline
measure: Manual Muscle Testing (MMT)
timeFrame: After 4 weeks
measure: Manual Muscle Testing (MMT)
timeFrame: After 8 weeks
measure: Manual Muscle Testing (MMT)
timeFrame: After 12 weeks
measure: Semi structured interview
timeFrame: After 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Islamabad
country: Pakistan
facility: Al-Farabi Special Education Center For (P.H.C)
Study officials:
affiliation: Riphah International University
name: Imran Amjad, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Riphah International University
name: Kiran Khushnood, MSNMPT
role: PRINCIPAL_INVESTIGATOR
References: