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

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.

Study Overview

• Status: Completed
• Conditions: Cerebral Palsy
• Intervention / Treatment: Device: Focal muscle vibration; Procedure: Stretching; Procedure: Strengthening; Procedure: Positioning

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.

• Study Type: Interventional
• Enrollment (Actual): 111
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Pakistan
  • Islamabad, Pakistan, 44000
    • Al-Farabi Special Education Center For (P.H.C)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 15 years (Child)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Focal muscle vibration group 1; Focal muscle vibration with frequency of 80 Hz will be provided 3 days along with stretching, strengthening and positioning for 8 weeks	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; Procedure: Strengthening; Strengthening exercises for weak lower extremity muscles; Procedure: Positioning; Positioning of participant to maintain a good body posture
Experimental: Focal muscle vibration group 2; Focal muscle vibration with frequency of 100 Hz will be provided 3 days a week along with stretching, strengthening and positioning for 8 weeks.	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; Procedure: Strengthening; Strengthening exercises for weak lower extremity muscles; Procedure: Positioning; Positioning of participant to maintain a good body posture
Active Comparator: Control group; Stretching, strengthening and positioning in 3 sessions a week for 8 weeks	Procedure: Stretching; Stretching of shortened lower extremity muscle; Procedure: Strengthening; Strengthening exercises for weak lower extremity muscles; Procedure: Positioning; Positioning of participant to maintain a good body posture

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
Social support questionnaire	A 6 item questionnaire designed to measure perceptions of social support and satisfaction with that social support	Baseline
Social support questionnaire	A 6 item questionnaire designed to measure perceptions of social support and satisfaction with that social support	After 4 weeks
Social support questionnaire	A 6 item questionnaire designed to measure perceptions of social support and satisfaction with that social support	After 8 weeks
Social support questionnaire	A 6 item questionnaire designed to measure perceptions of social support and satisfaction with that social support	After 12 weeks
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
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
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
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
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
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
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
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
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
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
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
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
Electromyography (EMG)	EMG will identify any changes in co-contraction between the muscles; quadriceps and hamstrings.	Baseline
Electromyography (EMG)	EMG will identify any changes in co-contraction between the muscles; quadriceps and hamstrings.	After 4 weeks
Electromyography (EMG)	EMG will identify any changes in co-contraction between the muscles; quadriceps and hamstrings.	After 8 weeks
Dynamometer	The dynamometer will be used to determine the strength in lower limb muscles; quadriceps, hamstrings, adductors and abductors of the CP subjects	Bassline
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Riphah International University
• Investigators: Principal Investigator: Kiran Khushnood, MSNMPT, Riphah International University; Principal Investigator: Imran Amjad, Phd, Riphah International University

Study record dates

Study Major Dates

• Study Start (Actual): March 3, 2023
• Primary Completion (Actual): September 30, 2023
• Study Completion (Actual): November 30, 2023

Study Registration Dates

• First Submitted: February 20, 2023
• First Submitted That Met QC Criteria: February 20, 2023
• First Posted (Actual): March 2, 2023

Study Record Updates

• Last Update Posted (Actual): January 30, 2024
• Last Update Submitted That Met QC Criteria: January 28, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Cerebral palsy; Electroencephalography; Functional near-infrared spectroscopy; Biopsychosocial; Emotional reactivity; Focal muscle vibration
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Brain Damage, Chronic; Cerebral Palsy; Paralysis
• Other Study ID Numbers: REC-01289 KiranKhushnood

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