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

Sponsor
Riphah International University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05751135
Collaborator
(none)
96
1
3
8.9
10.7

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Focal muscle vibration
  • Procedure: Stretching
  • Procedure: Strengthening
  • Procedure: Positioning
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
96 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
3 parallel group mixed methods3 parallel group mixed methods
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Impact of Focal Muscle Vibration on Bio-psychosocial Outcomes in Cerebral Palsy
Actual Study Start Date :
Mar 3, 2023
Anticipated Primary Completion Date :
Sep 30, 2023
Anticipated Study Completion Date :
Nov 30, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Functional near-infrared spectroscopy (fNIRS) [Baseline]

    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.

  2. Functional near-infrared spectroscopy (fNIRS) [After 4 weeks]

    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.

  3. Functional near-infrared spectroscopy (fNIRS) [After 8 weeks]

    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.

  4. Electroencephalogram (EEG) [Baseline]

    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.

  5. Electroencephalogram (EEG) [After 4 weeks]

    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.

  6. Electroencephalogram (EEG) [After 8 weeks]

    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.

  7. Gross Motor Function Measure [Baseline]

    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

  8. Gross Motor Function Measure [After 4 weeks]

    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

  9. Gross Motor Function Measure [After 8 weeks]

    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

  10. Gross Motor Function Measure [After 12 weeks]

    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

  11. Modified Ashworth scale [Baseline]

    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

  12. Modified Ashworth scale [After 4 weeks]

    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

  13. Modified Ashworth scale [After 8 weeks]

    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

  14. Modified Ashworth scale [After 12 weeks]

    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

  15. Child Behavior Checklist (CBCL) [Baseline]

    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.

  16. Child Behavior Checklist (CBCL) [After 4 weeks]

    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.

  17. Child Behavior Checklist (CBCL) [After 8 weeks]

    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.

  18. Child Behavior Checklist (CBCL) [After 12 weeks]

    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.

  19. Social support questionnaire [Baseline]

    A 6 item questionnaire designed to measure perceptions of social support and satisfaction with that social support

  20. Social support questionnaire [After 4 weeks]

    A 6 item questionnaire designed to measure perceptions of social support and satisfaction with that social support

  21. Social support questionnaire [After 8 weeks]

    A 6 item questionnaire designed to measure perceptions of social support and satisfaction with that social support

  22. Social support questionnaire [After 12 weeks]

    A 6 item questionnaire designed to measure perceptions of social support and satisfaction with that social support

  23. Self perception profile [Baseline]

    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.

  24. Self perception profile [After 4 weeks]

    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.

  25. Self perception profile [After 8 weeks]

    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.

  26. Self perception profile [After 12 weeks]

    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.

  27. Perth Emotional Reactivity Scale (PERS-S) [Baseline]

    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.

  28. Perth Emotional Reactivity Scale (PERS-S) [After 4 weeks]

    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.

  29. Perth Emotional Reactivity Scale (PERS-S) [After 8 weeks]

    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.

  30. Perth Emotional Reactivity Scale (PERS-S) [After 12 weeks]

    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.

  31. Modified Caregiver Strain Index (MCSI) [Baseline]

    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.

  32. Modified Caregiver Strain Index (MCSI) [After 4 weeks]

    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.

  33. Modified Caregiver Strain Index (MCSI) [After 8 weeks]

    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.

  34. Modified Caregiver Strain Index (MCSI) [After 12 weeks]

    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.

  35. Electromyography (EMG) [Baseline]

    EMG will identify any changes in co-contraction between the muscles; quadriceps and hamstrings.

  36. Electromyography (EMG) [After 4 weeks]

    EMG will identify any changes in co-contraction between the muscles; quadriceps and hamstrings.

  37. Electromyography (EMG) [After 8 weeks]

    EMG will identify any changes in co-contraction between the muscles; quadriceps and hamstrings.

  38. Trunk control measurement scale (TCMS) [Baseline]

    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.

  39. Trunk control measurement scale (TCMS) [After 4 weeks]

    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.

  40. Trunk control measurement scale (TCMS) [After 8 weeks]

    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.

  41. Trunk control measurement scale (TCMS) [After 12 weeks]

    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.

  42. Pediatric Balance Scale (PBS) [Baseline]

    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.

  43. Pediatric Balance Scale (PBS) [After 4 weeks]

    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.

  44. Pediatric Balance Scale (PBS) [After 8 weeks]

    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.

  45. Pediatric Balance Scale (PBS) [After 12 weeks]

    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.

  46. Dynamometer [Bassline]

    The dynamometer will be used to determine the strength in lower limb muscles; quadriceps, hamstrings, adductors and abductors of the CP subjects

  47. Dynamometer [After 4 weeks]

    The dynamometer will be used to determine the strength in lower limb muscles; quadriceps, hamstrings, adductors and abductors of the CP subjects

  48. Dynamometer [After 8 weeks]

    The dynamometer will be used to determine the strength in lower limb muscles; quadriceps, hamstrings, adductors and abductors of the CP subjects

  49. Dynamometer [After 12 weeks]

    The dynamometer will be used to determine the strength in lower limb muscles; quadriceps, hamstrings, adductors and abductors of the CP subjects

  50. Cerebral Palsy Quality of Life (CPQOL) [Baseline]

    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

  51. Cerebral Palsy Quality of Life (CPQOL) [After 4 weeks]

    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

  52. Cerebral Palsy Quality of Life (CPQOL) [After 8 weeks]

    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

  53. Cerebral Palsy Quality of Life (CPQOL) [After 12 weeks]

    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

  54. Edinburgh Visual Gait Assessment Score [Baseline]

    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.

  55. Edinburgh Visual Gait Assessment Score [After 4 weeks]

    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.

  56. Edinburgh Visual Gait Assessment Score [After 8 weeks]

    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.

  57. Edinburgh Visual Gait Assessment Score [After 12 weeks]

    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.

  58. Child friendly Depression Anxiety Stress Scale 21 (DASS-21) [Baseline]

    A 21 item scale derive from DASS 42 to access the depression, anxiety and stress among children

  59. Child friendly Depression Anxiety Stress Scale 21 (DASS-21) [After 4 weeks]

    A 21 item scale derive from DASS 42 to access the depression, anxiety and stress among children

  60. Child friendly Depression Anxiety Stress Scale 21 (DASS-21) [After 8 weeks]

    A 21 item scale derive from DASS 42 to access the depression, anxiety and stress among children

  61. Child friendly Depression Anxiety Stress Scale 21 (DASS-21) [After 12 weeks]

    A 21 item scale derive from DASS 42 to access the depression, anxiety and stress among children

  62. Immune Response Questionnaire (IRQ) [Baseline]

    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

  63. Immune Response Questionnaire (IRQ) [After 4 weeks]

    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

  64. Immune Response Questionnaire (IRQ) [After 8 weeks]

    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

  65. Immune Response Questionnaire (IRQ) [After 12 weeks]

    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

  66. Reaction Time [Baseline]

    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

  67. Reaction Time [After 4 weeks]

    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

  68. Reaction Time [After 8 weeks]

    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

  69. Reaction Time [After 12 weeks]

    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

  70. Heart rate variability (HRV) [Baseline]

    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.

  71. Heart rate variability (HRV) [After 4 weeks]

    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

  72. Heart rate variability (HRV) [After 8 weeks]

    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

  73. Heart rate variability (HRV) [After 12 weeks]

    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

  74. Manual Muscle Testing (MMT) [Baseline]

    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.

  75. Manual Muscle Testing (MMT) [After 4 weeks]

    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.

  76. Manual Muscle Testing (MMT) [After 8 weeks]

    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.

  77. Manual Muscle Testing (MMT) [After 12 weeks]

    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.

  78. Semi structured interview [After 8 weeks]

    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

Eligibility Criteria

Criteria

Ages Eligible for Study:
3 Years to 15 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Al-Farabi Special Education Center For (P.H.C) Islamabad Pakistan 44000

Sponsors and Collaborators

  • Riphah International University

Investigators

  • Principal Investigator: Imran Amjad, PhD, Riphah International University
  • Principal Investigator: Kiran Khushnood, MSNMPT, Riphah International University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Riphah International University
ClinicalTrials.gov Identifier:
NCT05751135
Other Study ID Numbers:
  • REC-01289 KiranKhushnood
First Posted:
Mar 2, 2023
Last Update Posted:
Mar 9, 2023
Last Verified:
Mar 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Riphah International University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 9, 2023