Comparison of the conjunct effects of Electrical Stimulation and Whole-Body Vibration Therapy with Transcranial Direct Current Stimulation and Whole-body Vibration Therapy on Balance and Function in Spastic Cerebral Palsy Children.
To compare the conjunct effects of Electrical Stimulation and Whole-body Vibration Therapy with Transcranial Direct Current Stimulation and whole-body vibration therapy on balance and function in children with spastic cerebral palsy
Design
A double-blinded Randomized control trial with 3 groups. A total of 42 children will be recruited from a single center. The sample size was calculated using Gpower version 3.1.9.7. RandomAllocation Software Version 1.0 (as per the description of Randomization).
Settings and conduct
It will be carried out at Dimension inxtitute of Special education and sehat medical complex lahore Pakistan
Participants/Inclusion and exclusion criteria
Inclusion Crtieria
Age of 5- 15 years.
Both Genders (Boys and Girls).
Children diagnosed with Spastic Hemiplegic cerebral palsy.
Degree of Spasticity Grade 1, 1+, and 2 according to Modified Ashworth Scale
Level I and level II of Gross Motor Function Classification System.
Manual Ability Classification System level I to IV.
Eclusion criteria
The child or the guardian is not interested to carry out the study.
Failing to complete the study.
Intervention groups
There will be 3 main groups:
Group A Whole Body Vibration only
Group B Whole Body Vibration only and electrical stimulation
Group C Whole Body Vibration and Transcranial Direct Current stimulation
Main outcome variables
Joint Range of motion, Hand Grip Strength, Isometric Muscle strength test by (digital force gauge)SF-500, Centre of Gravity, and Balance test scores through Nintendo Wii-Fit, Gait parameters (walking speed, cadence(stride length and step length) using cinematography (Kinovea version 0.9.5), Timed up and go test, Manual dexterity (9 hole-peg test), Modified Ashworth Scale, Berg Balance scale and GMFM-88( Standing and sitting component)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20090301001722N29
Registration date:2023-06-15, 1402/03/25
Registration timing:registered_while_recruiting
Last update:2023-06-15, 1402/03/25
Update count:0
Registration date
2023-06-15, 1402/03/25
Registrant information
Name
Samira Karimpour
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 7753 3939
Email address
hadianrs@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-06-05, 1402/03/15
Expected recruitment end date
2023-10-15, 1402/07/23
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the conjunct effects of Electrical Stimulation and Whole-Body Vibration Therapy with Transcranial Direct Current Stimulation and Whole-body Vibration Therapy on Balance and Function in Spastic Cerebral Palsy Children.
Public title
Effects of Electrical stimulation and Whole Body vibration therapy with transcranial direct current stimulation on spactic cerebral palsy children
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age of 5- 15 years.
Both Genders (Boys and Girls).
Children diagnosed with Spastic Hemiplegic cerebral palsy.
Degree of Spasticity Grade 1, 1+, and 2 according to Modified Ashworth Scale in the following muscles (hip flexors, hip adductors, hamstrings and ankle plantar flexors).
Level I(Can walk indoors and outdoors and climb stairs without using hands for support, and II (ability to walk indoors and outdoors and climb stairs with a railing ) of Gross Motor Function Classification System.
Manual Ability Classification System level I to IV.
No history of epilepsy.
No unhealed fractures.
No visual impairments and auditory impairments.
Not taking botulinum toxin injections.
Does not have any sensory and motor loss.
Does not have cardiopulmonary problems.
Does not have recent surgery (less than 1 year).
Children who would not experience joint contractures
Children with no Muscle or tendon inflammation
Children with no Leg length discrepancy
Exclusion criteria:
The child or the guardian is not interested to carry out the study.
Failing to complete the study.
Age
From 5 years old to 15 years old
Gender
Both
Phase
N/A
Groups that have been masked
Care provider
Outcome assessor
Sample size
Target sample size:
42
Randomization (investigator's opinion)
Randomized
Randomization description
Before the process of randomization, we will screen all the participants and assign them a unique number from 1 to 42. Then the process of randomization will be carried out using Random Allocation software version 1.0 (developed by the Department of Anaesthesia, Isfahan University of Medical Sciences, Isfahan, Iran). It is a randomization software for parallel group trials. It requires the total sample size and the total number of groups. We will add a total sample size of 42 participants and 3 groups into the software with only one block. The software generates an output file that can be opened with internet explorer. The output file contains a list of number along with assigned groups. In our case, the groups will be A, B, C with 14 participants in each group. Then this sequence will be used for participant allocation in the study groups
Blinding (investigator's opinion)
Double blinded
Blinding description
The care provider will be blinded to the groups of the study (i.e. Treatment and Control Group). While the outcome assessors will be blinded to the treatment protocols and study hypothesis
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tehran University of Medical Sciences (TUMS)
Street address
School of Rehabilitation of Tehran University of Medical Sciences, Piche Shemiran,Enghelab Ave, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1417614411
Approval date
2023-05-31, 1402/03/10
Ethics committee reference number
IR.TUMS.FNM.REC.1402.041
Health conditions studied
1
Description of health condition studied
Cerbral Palsy
ICD-10 code
Cerebral P
ICD-10 code description
G80
Primary outcomes
1
Description
Range of Motion
Timepoint
Before and After the intervention for Upper and lower extremity joints
Method of measurement
Universal Goniometer
2
Description
Hand Grip Strength
Timepoint
Before and After the intervention for Upper Limb
Method of measurement
Hand Held Digital Dynamometer
3
Description
Isometric Muscle strength test
Timepoint
Before and After the intervention for lower extremity muscles
Method of measurement
digital force gauge SF-500
4
Description
Centre of Gravity, and Balance test scores
Timepoint
Before and After the intervention for lower extremity
Method of measurement
Nintendo Wii-Fit, Balance board
5
Description
Gait parameters (walking speed, cadence(stride length and step length) using cinematography
Timepoint
Before and after the intervention for the lower extremity
Method of measurement
Kinovea software version 0.9.5
6
Description
Timed up and go test
Timepoint
Before and After the intervention
Method of measurement
One Chair, Measurement Tape and Stop Watch
7
Description
Manual dexterity
Timepoint
before and after the intervention for the upper extremity
Method of measurement
9 hole and peg board
8
Description
Modified Ashworth Scale
Timepoint
before and after intervention for upper and lower extremity
Method of measurement
Modified Ashworth Scale Questionnaire
9
Description
berg balance scale
Timepoint
before and after the intervention for spastic Cerebral palsy children
Method of measurement
Berg Balance scale questioner
10
Description
Gross motor function
Timepoint
before and after the intervention for spastic crebral palsy children
Method of measurement
GMFM-88 scale ( Standing and sitting component)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1 WBV training for 20 min a day,4 days a week for 4 weeks. The children will be instructed to maintain a standing posture on the vibration platform. Children will stand barefooted with feet parallel and in slight flexion (30°). The feet will be placed at an equal distance from the center line of the device when standing. During the 20 min of therapy, every 3 minutes of vibration training and 2 minutes of rest will be repeated 4 times. The frequency of the WBV stimulation will be (12–18 Hz) and will achieve gradually increase by 1 Hz per 2 seconds, till the desired frequency is achieved.
Category
Rehabilitation
2
Description
Intervention group 2 WBV training for 20 min a day,4 days a week for 4 weeks. The children will be instructed to maintain a standing posture on the vibration platform. Children will stand barefooted with feet parallel and in slight flexion (30°). The feet will be placed at an equal distance from the center line of the device when standing. During the 20 min of therapy, every 3 minutes of vibration training and 2 minutes of rest will be repeated 4 times. The frequency of the WBV stimulation will be (12–18 Hz) and will achieve gradually increase by 1 Hz per 2 seconds, till the desired frequency is achieved. Functional Electrical stimulation with Rectangular biphasic pulses with a pulse width of 250 μs, the stimulus intensity 70 mA, and a frequency ranged from 40 Hz,4 days a week for 4 weeks will be administered on motor points of the spastic muscles mainly for the lower extremity ( quadriceps and gastrocnemius and soleus).
Category
Rehabilitation
3
Description
Intervention group 3 Transcranial Direct Current Stimulation (tDCS) will be given with 2mA intensity for 20 min a day,4 days sessions a week for 4 weeks. 5*7 cm square electrodes will be placed as Anodal tDCS, will be placed over the primary motor cortex and cathodal tDCS will be placed over the contralateral supraorbital region. It will receive the WBV training for 20 min a day,4 days a week for 4 weeks. The children will be instructed to maintain a standing posture on the vibration platform. Children will stand barefooted with feet parallel and in slight flexion (30°). The feet will be placed at an equal distance from the center line of the device when standing. During the 20 min of therapy, every 3 minutes of vibration training and 2 minutes of rest will be repeated 4 times. The frequency of the WBV stimulation will be (12–18 Hz) and will achieve gradually increase by 1 Hz per 2 seconds, till the desired frequency is achieved.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Dimensions institute of Special education and psychological services
Full name of responsible person
Dr Samia Sarmad
Street address
Head office 91, block C BOR society Johar town lahore
City
lahore
Postal code
54782
Phone
+92 300 4813195
Email
samia735@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Akbar Fotuhi
Street address
Tehran University of Medical Sciences , Qods Corner Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 81631
Email
tums_research@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr.Mohammad-Reza Hadian Rasanani
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Rehabilitation Faculty, Pich e Shemiran, Enghelab Street Tehran Tehran Iran,
City
Terhan
Province
Tehran
Postal code
1417614411
Phone
+98 21 8891 3469
Email
hadianrasan@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Mohammad Reza Hadian
Position
Professor, Faculty of Rehabilitation, TUMS
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Rehabilitation faculty, pich e shemiran, enghlab street
City
Tehran
Province
Tehran
Postal code
1148965141
Phone
+98 21 7753 6134
Fax
+98 21 7753 4133
Email
hadianrs@sina.tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Zainab Hassan
Position
PhD Candidate
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
121 E 2 JOHAR TOWN LAHORE
City
Lahore
Province
Punjab
Postal code
54782
Phone
+92 336 7936515
Email
zainabptphd@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available