Impact of Focal Muscle Vibration on Bio-psychosocial Outcomes in Cerebral Palsy

Cerebral Palsy Clinical Trial

Official title:

Impact of Focal Muscle Vibration on Bio-psychosocial Outcomes in Cerebral Palsy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05751135
• Other study ID #: REC-01289 KiranKhushnood
• Status: Completed
• Phase: N/A
• Start date: March 3, 2023
• Est. completion date: November 30, 2023

Study information

• Verified date: January 2024
• Source: Riphah International University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 111
• Est. completion date: November 30, 2023
• Est. primary completion date: September 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 15 Years

Eligibility

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

Related Conditions & MeSH terms

• Cerebral Palsy
• Paralysis

Intervention

Device:
• Focal muscle vibration
Focal muscle vibration will be provided by a longitudinal muscle vibrator on muscles of lower limb; hamstrings, quadriceps, illiopsoas, calf, gluteus maximus and medius. Each muscle will be targeted 3 times with 30 seconds time period and keeping 10 second interval.

Procedure:
• Stretching
Stretching of shortened lower extremity muscle
• Strengthening
Strengthening exercises for weak lower extremity muscles
• Positioning
Positioning of participant to maintain a good body posture

Locations

Country	Name	City	State
Pakistan	Al-Farabi Special Education Center For (P.H.C)	Islamabad

Sponsors (1)

Lead Sponsor	Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Functional near-infrared spectroscopy (fNIRS)	Functional near-infrared spectroscopy (fNIRS) is an optical imaging tool for noninvasive, continuous monitoring of regional blood flow and tissue oxygenation. It can measure two hemodynamic parameters, both deoxyhemoglobin (HHb) and oxyhemoglobin (HbO2), at the same time. It reflects changes in regional blood flow to areas of the brain involved in processing functional tasks.	Baseline
Primary	Functional near-infrared spectroscopy (fNIRS)	Functional near-infrared spectroscopy (fNIRS) is an optical imaging tool for noninvasive, continuous monitoring of regional blood flow and tissue oxygenation. It can measure two hemodynamic parameters, both deoxyhemoglobin (HHb) and oxyhemoglobin (HbO2), at the same time. It reflects changes in regional blood flow to areas of the brain involved in processing functional tasks.	After 4 weeks
Primary	Functional near-infrared spectroscopy (fNIRS)	Functional near-infrared spectroscopy (fNIRS) is an optical imaging tool for noninvasive, continuous monitoring of regional blood flow and tissue oxygenation. It can measure two hemodynamic parameters, both deoxyhemoglobin (HHb) and oxyhemoglobin (HbO2), at the same time. It reflects changes in regional blood flow to areas of the brain involved in processing functional tasks.	After 8 weeks
Primary	Electroencephalogram (EEG)	The EEG will be recorded from 40-scalp electrodes using the extended 10-20 system montage (Quick-Cap International). The participant will be seated comfortably in a chair with eyes closed throughout the entire recording. We will record a period of resting whole head EEG. We will use standardized low-resolution brain electromagnetic tomography (sLORETA) for the resting EEG to calculate potential changes (Spatio-spectral Analysis) in brain activity and communication post the chiropractic care intervention.	Baseline
Primary	Electroencephalogram (EEG)	The EEG will be recorded from 40-scalp electrodes using the extended 10-20 system montage (Quick-Cap International). The participant will be seated comfortably in a chair with eyes closed throughout the entire recording. We will record a period of resting whole head EEG. We will use standardized low-resolution brain electromagnetic tomography (sLORETA) for the resting EEG to calculate potential changes (Spatio-spectral Analysis) in brain activity and communication post the chiropractic care intervention.	After 4 weeks
Primary	Electroencephalogram (EEG)	The EEG will be recorded from 40-scalp electrodes using the extended 10-20 system montage (Quick-Cap International). The participant will be seated comfortably in a chair with eyes closed throughout the entire recording. We will record a period of resting whole head EEG. We will use standardized low-resolution brain electromagnetic tomography (sLORETA) for the resting EEG to calculate potential changes (Spatio-spectral Analysis) in brain activity and communication post the chiropractic care intervention.	After 8 weeks
Primary	Gross Motor Function Measure	Gross motor function measure is a standard instrument which measures the change in motor function with time in CP subjects. It assess the amount of motor task a child can perform. an 88 point tool with scoring of 0-3 for each item, with 0 = doesn't initate activity to 3= complete the activity	Baseline
Primary	Gross Motor Function Measure	Gross motor function measure is a standard instrument which measures the change in motor function with time in CP subjects. It assess the amount of motor task a child can perform. an 88 point tool with scoring of 0-3 for each item, with 0 = doesn't initate activity to 3= complete the activity	After 4 weeks
Primary	Gross Motor Function Measure	Gross motor function measure is a standard instrument which measures the change in motor function with time in CP subjects. It assess the amount of motor task a child can perform. an 88 point tool with scoring of 0-3 for each item, with 0 = doesn't initate activity to 3= complete the activity	After 8 weeks
Primary	Gross Motor Function Measure	Gross motor function measure is a standard instrument which measures the change in motor function with time in CP subjects. It assess the amount of motor task a child can perform. an 88 point tool with scoring of 0-3 for each item, with 0 = doesn't initate activity to 3= complete the activity	After 12 weeks
Primary	Modified Ashworth scale	It is standard tool for measuring the spasticity with scoring 0-5, 0=no increase in muscle tone to 5=rigid in flexion and extension	Baseline
Primary	Modified Ashworth scale	It is standard tool for measuring the spasticity with scoring 0-5, 0=no increase in muscle tone to 5=rigid in flexion and extension	After 4 weeks
Primary	Modified Ashworth scale	It is standard tool for measuring the spasticity with scoring 0-5, 0=no increase in muscle tone to 5=rigid in flexion and extension	After 8 weeks
Primary	Modified Ashworth scale	It is standard tool for measuring the spasticity with scoring 0-5, 0=no increase in muscle tone to 5=rigid in flexion and extension	After 12 weeks
Primary	Child Behavior Checklist (CBCL)	The Child Behavior Checklist (CBCL) is a checklist parents complete to detect emotional and behavioral problems in children and adolescents. There are 2 checklists; 1 for ages 1.5 to 5 years and other for 6 to 18 years of age.	Baseline
Primary	Child Behavior Checklist (CBCL)	The Child Behavior Checklist (CBCL) is a checklist parents complete to detect emotional and behavioral problems in children and adolescents. There are 2 checklists; 1 for ages 1.5 to 5 years and other for 6 to 18 years of age.	After 4 weeks
Primary	Child Behavior Checklist (CBCL)	The Child Behavior Checklist (CBCL) is a checklist parents complete to detect emotional and behavioral problems in children and adolescents. There are 2 checklists; 1 for ages 1.5 to 5 years and other for 6 to 18 years of age.	After 8 weeks
Primary	Child Behavior Checklist (CBCL)	The Child Behavior Checklist (CBCL) is a checklist parents complete to detect emotional and behavioral problems in children and adolescents. There are 2 checklists; 1 for ages 1.5 to 5 years and other for 6 to 18 years of age.	After 12 weeks
Primary	Social support questionnaire	A 6 item questionnaire designed to measure perceptions of social support and satisfaction with that social support	Baseline
Primary	Social support questionnaire	A 6 item questionnaire designed to measure perceptions of social support and satisfaction with that social support	After 4 weeks
Primary	Social support questionnaire	A 6 item questionnaire designed to measure perceptions of social support and satisfaction with that social support	After 8 weeks
Primary	Social support questionnaire	A 6 item questionnaire designed to measure perceptions of social support and satisfaction with that social support	After 12 weeks
Primary	Self perception profile	Targeting the self-perception this tool is used to determine global psychosocial function and encompasses major domains; scholastic, social, athletic competence, physical appearance, behavioral conduct and global self-worth. There are 6 domains with 36 items in total with in each item is scored on a four-point scale from 1 to 4.	Baseline
Primary	Self perception profile	Targeting the self-perception this tool is used to determine global psychosocial function and encompasses major domains; scholastic, social, athletic competence, physical appearance, behavioral conduct and global self-worth. There are 6 domains with 36 items in total with in each item is scored on a four-point scale from 1 to 4.	After 4 weeks
Primary	Self perception profile	Targeting the self-perception this tool is used to determine global psychosocial function and encompasses major domains; scholastic, social, athletic competence, physical appearance, behavioral conduct and global self-worth. There are 6 domains with 36 items in total with in each item is scored on a four-point scale from 1 to 4.	After 8 weeks
Primary	Self perception profile	Targeting the self-perception this tool is used to determine global psychosocial function and encompasses major domains; scholastic, social, athletic competence, physical appearance, behavioral conduct and global self-worth. There are 6 domains with 36 items in total with in each item is scored on a four-point scale from 1 to 4.	After 12 weeks
Primary	Perth Emotional Reactivity Scale (PERS-S)	The Perth Emotional Reactivity Scale (PERS-S) is 18 item self-report measure of trait levels of emotional reactivity, derived from original version of 30 item.	Baseline
Primary	Perth Emotional Reactivity Scale (PERS-S)	The Perth Emotional Reactivity Scale (PERS-S) is 18 item self-report measure of trait levels of emotional reactivity, derived from original version of 30 item.	After 4 weeks
Primary	Perth Emotional Reactivity Scale (PERS-S)	The Perth Emotional Reactivity Scale (PERS-S) is 18 item self-report measure of trait levels of emotional reactivity, derived from original version of 30 item.	After 8 weeks
Primary	Perth Emotional Reactivity Scale (PERS-S)	The Perth Emotional Reactivity Scale (PERS-S) is 18 item self-report measure of trait levels of emotional reactivity, derived from original version of 30 item.	After 12 weeks
Primary	Modified Caregiver Strain Index (MCSI)	The Modified Caregiver Strain Index (MCSI) is used to screen for caregiver strain with long-term family caregivers. It is short and quick with 13 questions, which measures strain related to care provision.	Baseline
Primary	Modified Caregiver Strain Index (MCSI)	The Modified Caregiver Strain Index (MCSI) is used to screen for caregiver strain with long-term family caregivers. It is short and quick with 13 questions, which measures strain related to care provision.	After 4 weeks
Primary	Modified Caregiver Strain Index (MCSI)	The Modified Caregiver Strain Index (MCSI) is used to screen for caregiver strain with long-term family caregivers. It is short and quick with 13 questions, which measures strain related to care provision.	After 8 weeks
Primary	Modified Caregiver Strain Index (MCSI)	The Modified Caregiver Strain Index (MCSI) is used to screen for caregiver strain with long-term family caregivers. It is short and quick with 13 questions, which measures strain related to care provision.	After 12 weeks
Primary	Electromyography (EMG)	EMG will identify any changes in co-contraction between the muscles; quadriceps and hamstrings.	Baseline
Primary	Electromyography (EMG)	EMG will identify any changes in co-contraction between the muscles; quadriceps and hamstrings.	After 4 weeks
Primary	Electromyography (EMG)	EMG will identify any changes in co-contraction between the muscles; quadriceps and hamstrings.	After 8 weeks
Primary	Trunk control measurement scale (TCMS)	Trunk control measurement scale will determine the level of trunk control in a child with CP. It comprises of static and dynamic sitting balance along with reaching activities which determine the equilibrium. The maximum score is 58, the higher the scores indicate better trunk control.	Baseline
Primary	Trunk control measurement scale (TCMS)	Trunk control measurement scale will determine the level of trunk control in a child with CP. It comprises of static and dynamic sitting balance along with reaching activities which determine the equilibrium. The maximum score is 58, the higher the scores indicate better trunk control.	After 4 weeks
Primary	Trunk control measurement scale (TCMS)	Trunk control measurement scale will determine the level of trunk control in a child with CP. It comprises of static and dynamic sitting balance along with reaching activities which determine the equilibrium. The maximum score is 58, the higher the scores indicate better trunk control.	After 8 weeks
Primary	Trunk control measurement scale (TCMS)	Trunk control measurement scale will determine the level of trunk control in a child with CP. It comprises of static and dynamic sitting balance along with reaching activities which determine the equilibrium. The maximum score is 58, the higher the scores indicate better trunk control.	After 12 weeks
Primary	Pediatric Balance Scale (PBS)	Pediatric Balance Scale will determine the level of balance and postural control in a child with CP. The maximum score is 56 and higher scores indicate better level of balance while score closer to zero indicate impaired balance.	Baseline
Primary	Pediatric Balance Scale (PBS)	Pediatric Balance Scale will determine the level of balance and postural control in a child with CP. The maximum score is 56 and higher scores indicate better level of balance while score closer to zero indicate impaired balance.	After 4 weeks
Primary	Pediatric Balance Scale (PBS)	Pediatric Balance Scale will determine the level of balance and postural control in a child with CP. The maximum score is 56 and higher scores indicate better level of balance while score closer to zero indicate impaired balance.	After 8 weeks
Primary	Pediatric Balance Scale (PBS)	Pediatric Balance Scale will determine the level of balance and postural control in a child with CP. The maximum score is 56 and higher scores indicate better level of balance, while score closer to zero indicate impaired balance.	After 12 weeks
Primary	Dynamometer	The dynamometer will be used to determine the strength in lower limb muscles; quadriceps, hamstrings, adductors and abductors of the CP subjects	Bassline
Primary	Dynamometer	The dynamometer will be used to determine the strength in lower limb muscles; quadriceps, hamstrings, adductors and abductors of the CP subjects	After 4 weeks
Primary	Dynamometer	The dynamometer will be used to determine the strength in lower limb muscles; quadriceps, hamstrings, adductors and abductors of the CP subjects	After 8 weeks
Primary	Dynamometer	The dynamometer will be used to determine the strength in lower limb muscles; quadriceps, hamstrings, adductors and abductors of the CP subjects	After 12 weeks
Primary	Cerebral Palsy Quality of Life (CPQOL)	Cerebral Palsy Quality of Life is tool to access the quality of life of children with CP it incorporates parental impact and family functioning along with concepts of illness, functional status, mental health, and comfort. Items are transformed to range of 0-100, the algebraic mean of item values is computer for each domain	Baseline
Primary	Cerebral Palsy Quality of Life (CPQOL)	Cerebral Palsy Quality of Life is tool to access the quality of life of children with CP it incorporates parental impact and family functioning along with concepts of illness, functional status, mental health, and comfort. Items are transformed to range of 0-100, the algebraic mean of item values is computer for each domain	After 4 weeks
Primary	Cerebral Palsy Quality of Life (CPQOL)	Cerebral Palsy Quality of Life is tool to access the quality of life of children with CP it incorporates parental impact and family functioning along with concepts of illness, functional status, mental health, and comfort. Items are transformed to range of 0-100, the algebraic mean of item values is computer for each domain	After 8 weeks
Primary	Cerebral Palsy Quality of Life (CPQOL)	Cerebral Palsy Quality of Life is tool to access the quality of life of children with CP it incorporates parental impact and family functioning along with concepts of illness, functional status, mental health, and comfort. Items are transformed to range of 0-100, the algebraic mean of item values is computer for each domain	After 12 weeks
Primary	Edinburgh Visual Gait Assessment Score	Edinburgh Visual Gait Assessment (EVGA) is an assessment tool which qualitatively asses various parameters of gait via video recordings. It uses lateral and anterior views of gait to identify the quality of gait patterns and movements.	Baseline
Primary	Edinburgh Visual Gait Assessment Score	Edinburgh Visual Gait Assessment (EVGA ) is an assessment tool which qualitatively asses various parameters of gait via video recordings. It uses lateral and anterior views of gait to identify the quality of gait patterns and movements.	After 4 weeks
Primary	Edinburgh Visual Gait Assessment Score	Edinburgh Visual Gait Assessment Score (EVGA) is an assessment tool which qualitatively asses various parameters of gait via video recordings. It uses lateral and anterior views of gait to identify the quality of gait patterns and movements.	After 8 weeks
Primary	Edinburgh Visual Gait Assessment Score	Edinburgh Visual Gait Assessment Score (EVGA) is an assessment tool which qualitatively asses various parameters of gait via video recordings. It uses lateral and anterior views of gait to identify the quality of gait patterns and movements.	After 12 weeks
Primary	Child friendly Depression Anxiety Stress Scale 21 (DASS-21)	A 21 item scale derive from DASS 42 to access the depression, anxiety and stress among children	Baseline
Primary	Child friendly Depression Anxiety Stress Scale 21 (DASS-21)	A 21 item scale derive from DASS 42 to access the depression, anxiety and stress among children	After 4 weeks
Primary	Child friendly Depression Anxiety Stress Scale 21 (DASS-21)	A 21 item scale derive from DASS 42 to access the depression, anxiety and stress among children	After 8 weeks
Primary	Child friendly Depression Anxiety Stress Scale 21 (DASS-21)	A 21 item scale derive from DASS 42 to access the depression, anxiety and stress among children	After 12 weeks
Primary	Immune Response Questionnaire (IRQ)	The Immune Function Questionnaire (IFQ) consists of 15 items that assess the frequency of various symptoms associated with poor immune function. There are 19 symptom items included on the questionnaire as signs of weakened immune system functioning: headaches, sore throat, eye infection, sinusitis, runny nose, flu, coughing, cold sores, boils, mild fever, pneumonia, bronchitis, warts/verrucas, sepsis, ear infection, diarrhea, meningitis, sudden high fever, and prolonged healing injuries. The IFQ score has been found to positively correlate with the number of visits to a General Medical Practitioner. Assessment of participants will be repeated after 6 weeks of intervention. Calculate the sum score of the 7 IFQ items. To obtain the final IFQ score, translate the "raw" IFQ scores as follows: Interpretation: 0 = very poor, 10 excellent perceived immune status	Baseline
Primary	Immune Response Questionnaire (IRQ)	The Immune Function Questionnaire (IFQ) consists of 15 items that assess the frequency of various symptoms associated with poor immune function. There are 19 symptom items included on the questionnaire as signs of weakened immune system functioning: headaches, sore throat, eye infection, sinusitis, runny nose, flu, coughing, cold sores, boils, mild fever, pneumonia, bronchitis, warts/verrucas, sepsis, ear infection, diarrhea, meningitis, sudden high fever, and prolonged healing injuries. The IFQ score has been found to positively correlate with the number of visits to a General Medical Practitioner. Assessment of participants will be repeated after 6 weeks of intervention. Calculate the sum score of the 7 IFQ items. To obtain the final IFQ score, translate the "raw" IFQ scores as follows: Interpretation: 0 = very poor, 10 excellent perceived immune status	After 4 weeks
Primary	Immune Response Questionnaire (IRQ)	The Immune Function Questionnaire (IFQ) consists of 15 items that assess the frequency of various symptoms associated with poor immune function. There are 19 symptom items included on the questionnaire as signs of weakened immune system functioning: headaches, sore throat, eye infection, sinusitis, runny nose, flu, coughing, cold sores, boils, mild fever, pneumonia, bronchitis, warts/verrucas, sepsis, ear infection, diarrhea, meningitis, sudden high fever, and prolonged healing injuries. The IFQ score has been found to positively correlate with the number of visits to a General Medical Practitioner. Assessment of participants will be repeated after 6 weeks of intervention. Calculate the sum score of the 7 IFQ items. To obtain the final IFQ score, translate the "raw" IFQ scores as follows: Interpretation: 0 = very poor, 10 excellent perceived immune status	After 8 weeks
Primary	Immune Response Questionnaire (IRQ)	The Immune Function Questionnaire (IFQ) consists of 15 items that assess the frequency of various symptoms associated with poor immune function. There are 19 symptom items included on the questionnaire as signs of weakened immune system functioning: headaches, sore throat, eye infection, sinusitis, runny nose, flu, coughing, cold sores, boils, mild fever, pneumonia, bronchitis, warts/verrucas, sepsis, ear infection, diarrhea, meningitis, sudden high fever, and prolonged healing injuries. The IFQ score has been found to positively correlate with the number of visits to a General Medical Practitioner. Assessment of participants will be repeated after 6 weeks of intervention. Calculate the sum score of the 7 IFQ items. To obtain the final IFQ score, translate the "raw" IFQ scores as follows: Interpretation: 0 = very poor, 10 excellent perceived immune status	After 12 weeks
Primary	Reaction Time	Reaction Time provides assessments of motor and mental response speeds and measures of movement time, reaction time, response accuracy, and impulsivity.; Outcome measures are divided into reaction time and movement time for both the simple and five-choice variants.; It's a six-minute test that covers latency (response speed), correct responses and errors of commission and omission.; More accurate reaction in less time inclines toward good reaction time	Baseline
Primary	Reaction Time	Reaction Time provides assessments of motor and mental response speeds and measures of movement time, reaction time, response accuracy, and impulsivity.; Outcome measures are divided into reaction time and movement time for both the simple and five-choice variants.; It's a six-minute test that covers latency (response speed), correct responses and errors of commission and omission.; More accurate reaction in less time inclines toward good reaction time	After 4 weeks
Primary	Reaction Time	Reaction Time provides assessments of motor and mental response speeds and measures of movement time, reaction time, response accuracy, and impulsivity.; Outcome measures are divided into reaction time and movement time for both the simple and five-choice variants.; It's a six-minute test that covers latency (response speed), correct responses and errors of commission and omission.; More accurate reaction in less time inclines toward good reaction time	After 8 weeks
Primary	Reaction Time	Reaction Time provides assessments of motor and mental response speeds and measures of movement time, reaction time, response accuracy, and impulsivity.; Outcome measures are divided into reaction time and movement time for both the simple and five-choice variants.; It's a six-minute test that covers latency (response speed), correct responses and errors of commission and omission.; More accurate reaction in less time inclines toward good reaction time	After 12 weeks
Primary	Heart rate variability (HRV)	Heart rate variability (HRV) will be used as an objective assessment of psychological health and stress for the participants. High HRV is a marker of an adaptable, responsive nervous system that can detect sensory stimuli and appropriately increase or decrease the heart rate based on the needs of the individual. Low HRV and low parasympathetic activity is associated with chronic pain states, poor cardiovascular health and mood disorders. Heart Rate will be monitored throughout the session. Assessment of participants will be continued throughout the intervention.	Baseline
Primary	Heart rate variability (HRV)	Heart rate variability (HRV) will be used as an objective assessment of psychological health and stress for the participants. High HRV is a marker of an adaptable, responsive nervous system that can detect sensory stimuli and appropriately increase or decrease the heart rate based on the needs of the individual. Low HRV and low parasympathetic activity is associated with chronic pain states, poor cardiovascular health and mood disorders. Heart Rate will be monitored throughout the session. Assessment of participants will be continued throughout the intervention	After 4 weeks
Primary	Heart rate variability (HRV)	Heart rate variability (HRV) will be used as an objective assessment of psychological health and stress for the participants. High HRV is a marker of an adaptable, responsive nervous system that can detect sensory stimuli and appropriately increase or decrease the heart rate based on the needs of the individual. Low HRV and low parasympathetic activity is associated with chronic pain states, poor cardiovascular health and mood disorders. Heart Rate will be monitored throughout the session. Assessment of participants will be continued throughout the intervention	After 8 weeks
Primary	Heart rate variability (HRV)	Heart rate variability (HRV) will be used as an objective assessment of psychological health and stress for the participants. High HRV is a marker of an adaptable, responsive nervous system that can detect sensory stimuli and appropriately increase or decrease the heart rate based on the needs of the individual. Low HRV and low parasympathetic activity is associated with chronic pain states, poor cardiovascular health and mood disorders. Heart Rate will be monitored throughout the session. Assessment of participants will be continued throughout the intervention	After 12 weeks
Primary	Manual Muscle Testing (MMT)	Manual muscle testing will be used to determine the strength of lower limb muscles. It has scores from 0 to 5, with 5 being the movement against maximum resistance and 0 being no contraction.	Baseline
Primary	Manual Muscle Testing (MMT)	Manual muscle testing will be used to determine the strength of lower limb muscles. It has scores from 0 to 5, with 5 being the movement against maximum resistance and 0 being no contraction.	After 4 weeks
Primary	Manual Muscle Testing (MMT)	Manual muscle testing will be used to determine the strength of lower limb muscles. It has scores from 0 to 5, with 5 being the movement against maximum resistance and 0 being no contraction.	After 8 weeks
Primary	Manual Muscle Testing (MMT)	Manual muscle testing will be used to determine the strength of lower limb muscles. It has scores from 0 to 5, with 5 being the movement against maximum resistance and 0 being no contraction.	After 12 weeks
Primary	Semi structured interview	A semi-structured interview will be conducted with parents/ caregivers of CP subjects focusing on the feedback about treatment protocols and social, psychological and physical status and needs, and any observed change in needs or status	After 8 weeks