To find out the efficacy of Deep Cross-Friction Massage versus Reciprocal Inhibition on spasticity in cerebral palsy patients
Design
A Randomized, blinded clinical trial with parallel group design of 30 patients
Settings and conduct
The settings in which this study going to conduct is Pakistan Society for Rehabilitation of differently disabled and rising sun institute
Participants/Inclusion and exclusion criteria
Inclusion criteria:
• Cerebral palsy patients both male and female.(Zhang and Xiong., 2021)
• Age between 2 and 10 years.(Mahmood and Habibullah., 2020)
• Muscle tone between I-IV (according to newly revised Ashworth scale)(Zhang and Xiong ., 2021)
Exclusion criteria:
• Organized diseases involving other organs such as heart, liver, and kidney.
• Exclusion of leukodystrophy, infantile spinal muscular atrophy, genetic metabolic diseases such as phenylketonuria, congenital cretinism, and congenital hydrocephalus.
Intervention groups
• Techniques will be administered in two groups.
• Group A for reciprocal inhibition and Group B for deep cross-friction massage.
• Baseline treatment will include hot pack for 15 minutes and TENS for 20 minutes having intensity between 35 and 50 Hz.
• Techniques will be applied for 3 days a week and a single session duration will be 20 minutes.
• Total duration will be 4 weeks.
Main outcome variables
Spasticity
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210326050770N1
Registration date:2023-04-27, 1402/02/07
Registration timing:prospective
Last update:2023-04-27, 1402/02/07
Update count:0
Registration date
2023-04-27, 1402/02/07
Registrant information
Name
Mohammad Abbas Jamil
Name of organization / entity
Rashid latif medical college
Country
Pakistan
Phone
+92 49 4510915
Email address
m.abbas@rlmc.edu.pk
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-04-30, 1402/02/10
Expected recruitment end date
2023-07-30, 1402/05/08
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Deep cross-friction message and Reciprocal inhibition among patients having spastic cerebral palsy
Public title
Effect of Deep cross-friction message and Reciprocal inhibition among patients having spastic cerebral palsy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Cerebral palsy patients both male and female.(Zhang and Xiong., 2021)
Age between 2 and 10 years.(Mahmood and Habibullah., 2020)
Muscle tone between I-IV (according to newly revised Ashworth scale)(Zhang and Xiong2021)
Exclusion criteria:
Organized diseases involving other organs such as heart, liver, and kidney.
Exclusion of leukodystrophy, infantile spinal muscular atrophy, genetic metabolic diseases such as phenylketonuria, congenital cretinism, and congenital hydrocephalus.
Age
From 2 years old to 10 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Allocation of patients in two equal groups by lottery method will be through random assignment. Patients were allocated into two groups i.e.; Group A and Group B, by lottery method. Lottery method is a type of simple random sampling. In this method, each participant of the trial is assigned a unique number. 60 cards were placed in a basket and thoroughly mixed. The slips are taken out randomly without looking at them and are placed into two sets. Total of 30 cards were taken out, 15 participants in each group.
Blinding (investigator's opinion)
Single blinded
Blinding description
The blinding is achieved by concealment in which the treatment allocation for each patient is not revealed to the patient. This is done to avoid biasness
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Institutional Board of Rashid Latif Medical College
Street address
35-Km Ferozepur road Lahore
City
Lahore
Postal code
54600
Approval date
2022-09-02, 1401/06/11
Ethics committee reference number
IRB/2022/040
Health conditions studied
1
Description of health condition studied
Spastic Cerebral Palsy
ICD-10 code
G80
ICD-10 code description
Cerebral palsy
Primary outcomes
1
Description
Spasticity
Timepoint
4 weeks
Method of measurement
Modified Ashworth scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group:
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Pakistan Society for Rehabilitation of Differently Abled
Full name of responsible person
Tanzeela Javeed
Street address
35-Km Ferozepur road Lahore
City
Lahore
Postal code
54600
Phone
+92 306 8122856
Email
tanzeela.javeed.256@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Rashid Latif Medical College
Full name of responsible person
Abbas Jamil
Street address
35-Km Ferozepur road Lahore
City
Lahore
Postal code
54600
Phone
+92 336 4204167
Email
m.abbas@rlmc.edu.pk
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Rashid Latif Medical College
Proportion provided by this source
100
Public or private sector
Private
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
Rashid Latif Medical College
Full name of responsible person
Tanzeela Javeed
Position
Physiotherapist
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
35-Km Ferozepur road Lahore
City
Lahore
Province
Punjab
Postal code
54600
Phone
+92 306 8122856
Email
tanzeela.javeed.256@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Rashid Latif Medical College
Full name of responsible person
Abbas Jamil
Position
Assistant Professor
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
35-Km Ferozepur road Lahore
City
Lahore
Province
Punjab
Postal code
54600
Phone
+92 336 4204167
Email
m.abbas@rlmc.edu.pk
Person responsible for updating data
Contact
Name of organization / entity
Rashid Latif Medical College
Full name of responsible person
Abbas Jamil
Position
Assistant Professor
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
35-Km Ferozepur road Lahore
City
Lahore
Province
Punjab
Postal code
54600
Phone
+92 336 4204167
Email
m.abbas@rlmc.edu.pk
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