The comparison of physiotherapy by parents at home and physiotherapy by expert physiotherapist in patients with Duchenne muscular dystrophy: Randomized controlled trial
The comparison between physiotherapy at home and physiotherapy by expert physiotherapist in patients with Duchenne Muscular Dystrophy
Design
the randomized Clinical trials with control group, with parallel groups. The sample size was calculated 50
Settings and conduct
All children with Duchenne Muscular Dystrophy who are referred to the Neurology Clinic or Faculty of Physics or the Department of Physical Therapy at the Children's Medical Center, who approved by a specialist physician. Patients will randomly divided into two groups. The first group of physiotherapy at home is trained by the fellows and the second group will be physiotherapy by a qualified physiotherapist. In both groups, a bi-weekly physiotherapy will be conducted. The parameters evaluated will be evaluated in two groups in both laboratory and clinical categories. The clinical parameters assessed include muscle pain, number of muscle cramps per week, muscle weakness in four limbs that had upper limb based on the international brooke and limb The bottom line will be reviewed based on the NSAA benchmark. Also, the severity of muscle atrophy will be classified according to clinical judgment.
Participants/Inclusion and exclusion criteria
Inclusion criteria: patients with clinical and Duchenne muscular dystrophy biopsy diagnosis, residence in the northwest of the country, having a higher literacy level and age range 18 to 50 years, informed consent of parents for participation in the study.
Exclusion criteria: lack of housing or relocation of the North West of the country, lack of informed consent to participate or continue the study, lack of education or poor cooperation .
Intervention groups
patients with Duchenne Muscular Dystrophy
Main outcome variables
The amount of muscle pain changes
The rate of change in muscle cramp
The rate of muscle weakness
Severity of muscle atrophy
General information
Reason for update
Acronym
DMD: Duchenne muscular dystrophy ROM: Range of Motion NSSA: the north star ambulatory assessment
IRCT registration information
IRCT registration number:IRCT20131012014988N7
Registration date:2019-07-02, 1398/04/11
Registration timing:registered_while_recruiting
Last update:2019-07-02, 1398/04/11
Update count:0
Registration date
2019-07-02, 1398/04/11
Registrant information
Name
Mohammad Barzegar
Name of organization / entity
Pediatric Health Research Center,Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 3526 2265
Email address
phrc_mb@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-05-22, 1398/03/01
Expected recruitment end date
2019-11-22, 1398/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparison of physiotherapy by parents at home and physiotherapy by expert physiotherapist in patients with Duchenne muscular dystrophy: Randomized controlled trial
Public title
The Effectiveness of Physical Therapy at Home in Patients with Duchenne Muscular Dystrophy
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with Duchenne muscular dystrophy who their clinical illness was confirmed by Biopsy and genetic test .
alert parents between 18-50 years old
informed consent
live in north western in Iran
Exclusion criteria:
Patients that they dont live in North western of Iran or they Migrate
No informed consent for participation or continuation of the study,
they dont want to take part or don't have enough education.
Age
To 15 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization to divide patients into two groups by simple randomization method individually
Accidental randomization was done based on random selection software
Patients were coded and randomly divided into two groups
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
We will divide patients into two groups randomly, the first group receive physiotherapy two times per week with expert physiotherapist. The second group's parents will train by the same physiotherapist to do that at home with the same method. after 6 month followup we compare their muscle force scores and muscle cramps per week and muscle atrophy.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences
Street address
Golgasht Ave, medicine faculty
City
Tabriz
Province
East Azarbaijan
Postal code
5157610144
Approval date
2019-04-09, 1398/01/20
Ethics committee reference number
IR.TBZMED.REC.1398.011
Health conditions studied
1
Description of health condition studied
Duchenne Muscular Dystrophy
ICD-10 code
G71.0
ICD-10 code description
Muscular dystrophy
Primary outcomes
1
Description
Musculoskeletal pain (based on scores ranging from 0 to 10), the frequency of muscle cramps per week, muscle weakness in the four limbs with upper limb based on the international brooke score ( 1 to 6) and lower limbs based on the NSAA score ( 1 to 34 with 17 items)
Timepoint
These parameters will be evaluated 2 times, 1- before the treatment and 2- six months after the treatment
Method of measurement
The upper limb muscle weakness score with the Brooke system and the lower muscle weakness score will be scored based on the NSAA system. The North Star Ambulatory Assessment (NSAA) has 17 items that can be used to assess motor ability in pediatric patients with duodenal muscular dystrophy. The highest score in this system is scoring 34, which means the ability to move completely independently. Brooke's Benchmarking Questionnaire uses 10 questions to evaluate muscular ability in the upper limb of patients with Duchenne's muscular dystrophy.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Teaching Physical Therapy at Home to Parents or Patients - Physical Therapy At Home
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Tabriz Children's Hospital
Full name of responsible person
Mohammad Barzegar
Street address
Sheshgelan Ave, Tabriz Children's Hospital
City
Tabriz
Province
East Azarbaijan
Postal code
5154300633
Phone
+98 41 3337 2084
Email
phrc_mb@tbzmed.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mohammad Barzegar
Street address
Sheshgelan Ave, Tabriz children's hospital
City
Tabriz
Province
East Azarbaijan
Postal code
5154300633
Phone
+98 41 3337 2084
Email
phrc_mb@tbzmed.az.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Mohammad Barzegar
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Sheshgelan Ave, Tabriz children's hospital
City
Tabriz
Province
East Azarbaijan
Postal code
5154300633
Phone
+98 41 3337 2084
Email
phrc_mb@tbzmed.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mohammad Barzegar
Position
Professor,
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Shasghelan Ave, Tabriz Children's Hospital
City
Tabriz
Province
East Azarbaijan
Postal code
5154300633
Phone
+98 41333372084
Email
phrc_mb@tbzmed.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mohammad Barzegar
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Shasghelan Ave, Tabriz Children's Hospital
City
Tabriz
Province
East Azarbaijan
Postal code
5154300633
Phone
+98 41 3337 2084
Email
phrc_mb@tbzmed.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is 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
Not applicable
Title and more details about the data/document
Only a portion of the information, such as the original outcome information, will be shared
When the data will become available and for how long
data from this study will be available, six months after the publication of this study,
To whom data/document is available
All who apply
Under which criteria data/document could be used
There are no specific requirements to apply
From where data/document is obtainable
correspond : Mohammad Barzegar
phrc_mb@tbzmed.ac.ir
What processes are involved for a request to access data/document