Comparison of the effect of rehabilitation at home and outpatient physiotherapy after total knee Arthroplasty surgery on quality of life and knee function
Comparison of rehabilitation at home and outpatient physiotherapy after total knee replacement surgery
Design
This is a clinical trial study with two parallel groups, non-randomized, and open-label.
Settings and conduct
This study is conducted in Milad Hospital in Kashan. One group of knee joint replacement patients will be rehabilitated at home by a physiotherapist, and in the other group, rehabilitation measures will be performed in a physiotherapy center by the same physiotherapist.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients with end-stage osteoarthritis, patients with controlled blood pressure and diabetes, and patients whose BMI are 35 or below. Exclusion criteria: Neurological deficits, severe osteoarthritis of the opposite knee, and no willingness to participate in the study
Intervention groups
In both intervention groups, after discharge, patients will undergo two physiotherapy sessions per week for 10 weeks (20 sessions) by only one physiotherapist and based on the following physiotherapy protocols.
The physiotherapy protocol specific to the intervention group will be based on TENS and HP modalities and high-power laser therapy on the knee and in the control group with modalities focused on strengthening the hip abductors and quadriceps muscle strengthening at home by a physiotherapist (physiotherapy focused on behaviors and movements will strengthen the quadriceps and hip abductors).
Main outcome variables
Knee function
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20221005056095N1
Registration date:2022-11-19, 1401/08/28
Registration timing:registered_while_recruiting
Last update:2022-11-19, 1401/08/28
Update count:0
Registration date
2022-11-19, 1401/08/28
Registrant information
Name
Abdollah Shakiba dastgerdi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 38 3244 2169
Email address
abdollahshakiba@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-10-22, 1401/07/30
Expected recruitment end date
2023-01-20, 1401/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of rehabilitation at home and outpatient physiotherapy after total knee Arthroplasty surgery on quality of life and knee function
Public title
The effect of rehabilitation and physiotherapy after total knee Arthroplasty surgery on quality of life and knee function
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with end stage osteoarthritis
Patients with controlled blood pressure and diabetes
Patients whose BMI are 35 or below
Exclusion criteria:
Neurological deficits
Severe osteoarthritis of the opposite knee
Not willing to participate in the study
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of kashan University of Medical Sciences
Street address
15 khordad ave., kashan city
City
kashan
Province
Isfehan
Postal code
8715981151
Approval date
2022-09-05, 1401/06/14
Ethics committee reference number
IR.KAUMS.MEDNT.REC.1401.103
Health conditions studied
1
Description of health condition studied
Knee osteoarthritis
ICD-10 code
M17
ICD-10 code description
Osteoarthritis of knee
Primary outcomes
1
Description
Knee function
Timepoint
before the operation and at intervals of one month, three months and 6 months after the operation
Method of measurement
Knee Society Score
2
Description
Quality of life
Timepoint
before the operation and at intervals of one month, three months and 6 months after the operation
Method of measurement
SF-36 questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Patients seeking discharge undergo two physiotherapy sessions per week for 10 weeks (20 sessions) by only one physiotherapist and based on physiotherapy protocols specific to the intervention group according to TENS and HP modalities and high power laser therapy on It will be the knee.
Category
Rehabilitation
2
Description
Intervention group: Patients after discharge will undergo two physiotherapy sessions per week for 10 weeks (20 sessions) by only one physiotherapist and with modalities focused on strengthening the hip abductors and strengthening the quadriceps muscle at home by the physiotherapist. (Physiotherapy will focus on behaviors and movements to strengthen the quadriceps and hip abductors).
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Milad Hospital، Kashan
Full name of responsible person
Abdollah Shakiba Dastgerdi
Street address
Beheshti Hospital., Kashan City
City
Kashan
Province
Isfehan
Postal code
8715981151
Phone
+98 913 985 4783
Email
abdollahshakiba@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Gholamali Hamidi
Street address
Kashan University of Medical Sciences, Basic Sciences Research Institute
City
Kashan
Province
Isfehan
Postal code
8715988141
Phone
+98 31 5558 9399
Email
hamidi_gh@kaums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
no
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
Persons
Person responsible for general inquiries
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
abdollah shakiba dastgerdi
Position
Orthopaedic resident
Latest degree
Medical doctor
Other areas of specialty/work
Orthopedics
Street address
Kashan., Beheshti hospital
City
Kashan
Province
Isfehan
Postal code
8715981151
Phone
+98 38 3244 2169
Email
abdollahshakiba@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Abdollah Shakiba Dastgerdi
Position
Orthopedic resident
Latest degree
Medical doctor
Other areas of specialty/work
Orthopedics
Street address
Beheshti Hospital., Kashan
City
Kashan
Province
Isfehan
Postal code
8715981151
Phone
+98 38 3244 2169
Email
abdollahshakiba@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Abdollah Shakiba Dastgerdi
Position
Orthopedic resident
Latest degree
Medical doctor
Other areas of specialty/work
Orthopedics
Street address
Beheshti Hospital., Kashan
City
Kashan
Province
Isfehan
Postal code
8715981151
Phone
+98 38 3244 2169
Email
abdollahshakiba@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
All data can be shared after people have requested.
When the data will become available and for how long
The access period starts 6 months after the results are published
To whom data/document is available
The data will be available to researchers working in academic and scientific institutions
Under which criteria data/document could be used
The use of results and data is allowed only in line with scientific and research goals in line with more comprehensive studies and investigations in more diverse research fields.د