Effects Of Whole Body Vibration On Lower Extremity With Diplegic Spastic Cerebral Palsy
Primary Purpose
Spastic Diplegia
Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Whole Body Viberation
Sponsored by
About this trial
This is an interventional treatment trial for Spastic Diplegia
Eligibility Criteria
Inclusion Criteria:
- Gross motor function classification level II-III
- Modified Ashworth Scale of 1-2
Exclusion Criteria:
- Auditory/ visually impaired
- Other neurological conditions e.g. spina bifida etc.
- Lower limb contractures
- Children with history of lower limb surgery in last 6 months
Sites / Locations
- Meshal School of Special Children
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Experimental Group
Control Group
Arm Description
Standing on WBV device (frequency of 40 Hz); 3 Minute vibration with 3 minute rest. Three times repetition . Total 18-minute vibrational therapy protocol. 3 days session per week
Stretching exercise (hip adductors ,plantar flexors, external rotators of hip & knee flexors). Active and passive ROMS to lower extremities. Strengthening exercises (hip and knee extensors, ankle dorsiflexes) 3 Repetitions into 3 day session per week
Outcomes
Primary Outcome Measures
Modified Ashworth Scale
the gold standard clinical tool, widely used for the measurement of the increased muscle tone and for grading the spasticity of the muscle. This scale is categorized in to 5 grades ranging from score 0 to 4. where 0 indicating normal muscular tone and 4 indicating marked spasticity of muscle. The intra class correlation coefficient for MAS is 0.92
Pediatric Balance Scale
an upgraded version of berg balance scale (inter-tester reliability of 0.997 and test-retest reliability of 0.9989) used for the assessment of the balance of school age children having mild to moderate level of developmental disorders , motor impairment or with brain lesion while performing functional activities
Secondary Outcome Measures
Manual Muscle Testing
To assess the muscle strength, in clinical settings as well as in research trials evaluation done either manually with Manual Muscle Testing (MMT) or instrumentally by using a dynamometers .Inter-rater reliability of MMT is ICC 0.79-0.92)
CP QoL
Cp QOL have two versions :Primary caregiver (for parents of 4-12 aged children), composed of 65 items and Child self-report version (for children of 9-12 years of age ), 53 items questionnaire. Cp QOL (Caregiver ) is further Categorized into seven domains, Social wellbeing and acceptance, Participation and physical health, Feelings about functioning, Emotional wellbeing and self-esteem, Pain and impact of disability, Access to services, Family health.
Full Information
NCT ID
NCT04792229
First Posted
March 7, 2021
Last Updated
September 17, 2021
Sponsor
Riphah International University
1. Study Identification
Unique Protocol Identification Number
NCT04792229
Brief Title
Effects Of Whole Body Vibration On Lower Extremity With Diplegic Spastic Cerebral Palsy
Official Title
Effects Of Whole Body Vibration On Lower Extremity With Diplegic Spastic Cerebral Palsy
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
October 16, 2020 (Actual)
Primary Completion Date
July 31, 2021 (Actual)
Study Completion Date
August 31, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study will help to determine the beneficial effects of high frequency vibration on children with diplegic cerebral palsy in improving balance ,spasticity, strength of lower limb and quality of life and a comparison between the effect of simple conventional treatment and conventional management with the usage of vibrational therapy in cp patients.
Detailed Description
A study "Effect of whole body vibration training on mobility in children with cerebral palsy "states Whole body vibrational therapy induce an improvement in independent ambulation and mobility of lower limb by strengthening of muscles along with the refinement of walking pattern ,gait speed and stride length in children with cerebral palsy. On the basis of our study a better treatment protocol can be designed for future in diplegic spastic cerebral palsy children.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spastic Diplegia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
42 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Experimental Group
Arm Type
Experimental
Arm Description
Standing on WBV device (frequency of 40 Hz); 3 Minute vibration with 3 minute rest.
Three times repetition . Total 18-minute vibrational therapy protocol. 3 days session per week
Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
Stretching exercise (hip adductors ,plantar flexors, external rotators of hip & knee flexors).
Active and passive ROMS to lower extremities. Strengthening exercises (hip and knee extensors, ankle dorsiflexes) 3 Repetitions into 3 day session per week
Intervention Type
Other
Intervention Name(s)
Whole Body Viberation
Intervention Description
WBV device (frequency of 40 Hz), 3 Minute vibration with 3 minute rest
Primary Outcome Measure Information:
Title
Modified Ashworth Scale
Description
the gold standard clinical tool, widely used for the measurement of the increased muscle tone and for grading the spasticity of the muscle. This scale is categorized in to 5 grades ranging from score 0 to 4. where 0 indicating normal muscular tone and 4 indicating marked spasticity of muscle. The intra class correlation coefficient for MAS is 0.92
Time Frame
4 weeks
Title
Pediatric Balance Scale
Description
an upgraded version of berg balance scale (inter-tester reliability of 0.997 and test-retest reliability of 0.9989) used for the assessment of the balance of school age children having mild to moderate level of developmental disorders , motor impairment or with brain lesion while performing functional activities
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Manual Muscle Testing
Description
To assess the muscle strength, in clinical settings as well as in research trials evaluation done either manually with Manual Muscle Testing (MMT) or instrumentally by using a dynamometers .Inter-rater reliability of MMT is ICC 0.79-0.92)
Time Frame
4 weeks
Title
CP QoL
Description
Cp QOL have two versions :Primary caregiver (for parents of 4-12 aged children), composed of 65 items and Child self-report version (for children of 9-12 years of age ), 53 items questionnaire. Cp QOL (Caregiver ) is further Categorized into seven domains, Social wellbeing and acceptance, Participation and physical health, Feelings about functioning, Emotional wellbeing and self-esteem, Pain and impact of disability, Access to services, Family health.
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
11 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Gross motor function classification level II-III
Modified Ashworth Scale of 1-2
Exclusion Criteria:
Auditory/ visually impaired
Other neurological conditions e.g. spina bifida etc.
Lower limb contractures
Children with history of lower limb surgery in last 6 months
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mirza Obaid Baig
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Meshal School of Special Children
City
Tarbela
State/Province
Khyber Pakhtunkhwa
Country
Pakistan
12. IPD Sharing Statement
Plan to Share IPD
No
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Effects Of Whole Body Vibration On Lower Extremity With Diplegic Spastic Cerebral Palsy
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