This is a clinical trial study to improve the therapeutic methods and shorten the duration of treatment in patients with distal radius fracture and determine the effectiveness of using the Continuous Passive Motion (CPM) machine on pain, range of motion and function.
Design
In this double blind study, 22 patients with a diagnosis of distal radius fractures and entry conditions who are referred to a study referring to the Rehabilitation Center Asma. Participants are randomly divided into intervention and control groups And undergo standard rehab in four weeks.
Settings and conduct
The statistical population in this study is 22 patients over 18 years of age in Tehran with a distal radius fracture that after retrieving the fixator for rehabilitation. Sampling will be done in an accessible manner, then randomly, patients will be divided into two groups of standard treatments using CPM (intervention) and standard (control) treatments with a sample size of 11 people per group.During 12 sessions (4 weeks) they will undergo standard rehab and will be re-evaluated at weeks 4.6 and 12 after rehab.
Participants/Inclusion and exclusion criteria
Criteria for inclusion in the study include people over the age of 18 who have a distal radius fracture and who has come to rehab after removing the fixation
Intervention groups
Intervention group: A group that also uses CPM devices in addition to receiving common therapeutic exercises . Control group: A group that only receives common therapeutic exercises.
Main outcome variables
Reduce pain, increase the range of motion, improve function
General information
Reason for update
Acronym
CPMDRFx
IRCT registration information
IRCT registration number:IRCT20180531039924N1
Registration date:2018-06-15, 1397/03/25
Registration timing:prospective
Last update:2018-06-15, 1397/03/25
Update count:0
Registration date
2018-06-15, 1397/03/25
Registrant information
Name
Arezoo Shirzadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2218 0037
Email address
Ar.Shirzadi@uswr.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-06-23, 1397/04/02
Expected recruitment end date
2018-10-22, 1397/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of continuous passive motion device on pain, range of motion and function in patients with distal radius fractures
Public title
Effect of Continuous Passive Motion (CPM) on distal radius fractures
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients over the age of 18 with radial distal fractures referring to rehabilitation after removing the fixation
Exclusion criteria:
Having a history of fracture in the affected wrist, which reduces the range of motion or function
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
22
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization will be done with sealed envelopes. Allocation will be concealed and Patients will be include in one of the two intervention or control groups and receive intervention from their own group.
Blinding (investigator's opinion)
Double blinded
Blinding description
participants and the assessors will be blind , but therapist cant be masked
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
University of Social Welfare and Rehabilitation Sciences
Street address
Daneshjoo Blvd, Evin, Tehran,I ran
City
Tehran
Province
Tehran
Postal code
1985713834
Approval date
2018-02-26, 1396/12/07
Ethics committee reference number
IR.USWR.REC.1396.295
Health conditions studied
1
Description of health condition studied
Distal Radius Fracture
ICD-10 code
S52.5
ICD-10 code description
Fracture of lower end of radius
Primary outcomes
1
Description
pain
Timepoint
The beginning of treatment, the fourth week, the sixth and the twelfth weeks
Method of measurement
Visual Analog Scale(VAS)
Secondary outcomes
1
Description
Rang Of Motion (ROM)
Timepoint
The beginning of treatment, the fourth week, the sixth and the twelfth weeks
Method of measurement
Goniometer
2
Description
Function
Timepoint
The beginning of treatment, the fourth week, the sixth and the twelfth weeks
Method of measurement
The Patient-Rated Wrist Hand Evaluation(PRWHE)
Intervention groups
1
Description
Control group: conservative treatment
Category
Rehabilitation
2
Description
Intervention group: conservative treatment and CPM device
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Asma rehabilitation center
Full name of responsible person
Maryam Farzad
Street address
Corner of Twelve St, Asad Abadi Street, Yousef Abad
City
Tehran
Province
Tehran
Postal code
1985713834
Phone
+98 21 2218 0037
Email
Ar.shirazdi@uswr.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
University of social welfare and rehabilitation sciences
Full name of responsible person
Department of Occupational Therapy
Street address
Daneshjoo Blvd, Evin, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1985713834
Phone
+98 21 2218 0037
Email
Ar.shirzadi@uswr.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
University of social welfare and rehabilitation 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
University of social welfare and rehabilitation sciences
Full name of responsible person
Arezoo Shirzadi
Position
Master student
Latest degree
Bachelor
Other areas of specialty/work
Occupational Therapy
Street address
Kodakyar Ave., Daneshjo Blvd.,Evin
City
Tehran
Province
Tehran
Postal code
1985713834
Phone
+98 21 2218 0037
Fax
Email
Ar.Shirzadi@uswr.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
University of social welfare and rehabilitation sciences
Full name of responsible person
Maryam Farzad
Position
PHD of Occupational Therapy
Latest degree
Ph.D.
Other areas of specialty/work
Occupational Therapy
Street address
Kodakyar Ave., Daneshjo Blvd.,Evin
City
Tehran
Province
Tehran
Postal code
1985713834
Phone
+98 21 2218 0037
Fax
Email
ma.farzad@uswr.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
University of social welfare and rehabilitation sciences
Full name of responsible person
Arezoo Shirzadi
Position
Master student
Latest degree
Bachelor
Other areas of specialty/work
Occupational Therapy
Street address
Kodakyar Ave., Daneshjo Blvd.,Evin
City
Tehran
Province
Tehran
Postal code
1985713834
Phone
+98 21 2218 0037
Fax
Email
Ar.Shirzadi@uswr.ac.ir
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