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The Effects of balance training on foot loading distribution after total knee arthroplasty

Protocol summary

Study aim
Determination of effects of balance training on foot loading distribution after total knee arthroplasty
Design
Two parallel group, Simple Randomized, Not blinded clinical trial, 30 patients.
Settings and conduct
Patients who meet the research entry criteria will refer to Razi Physiotherapy Clinic in Zarand. First, the patient's demographic and pain information will be completed to evaluate the subjective symptoms. Evaluation of foot pressure parameters before surgery, before and after intervention will be done by foot scanning device. In this study, the information collected from the foot pressure scanning device will be recorded. The baropodometric data collection tool will be a foot pressure scanner (Payatech model, PT-Scan4452F100). Then, the patients will be randomly assigned to two routine treatment groups (TENS, IR, exercise with emphasis on quadriceps muscle strengthening) and balance training group (TENS, IR, balance exercise).
Participants/Inclusion and exclusion criteria
Inclusion Criteria: A maximum time of 1 month after TKA, Unilateral arthroplasty, No physical therapy intervention/rehabilitation after hospital discharge for TKA, Age less than 80 years, No history of knee surgery within 6 months before the study. Exclusion Criteria: Patients who do not want to enter the study or cannot tolerate balance exercises will be excluded from the study.
Intervention groups
Intervention group: In this group, patients will receive balance exercises in addition to routine treatment. Balance exercises will include standing on one leg with eyes open and closed, anterior, lateral and posterior step-up exercises. Control group: In this group, patients will receive routine treatment including TENS, infrared radiation (IR) and stretching exercises.
Main outcome variables
The surface in contact with the ground in the foot, The oval area of the movement path of the center of body pressure, pain

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20180714040466N6
Registration date: 2023-10-07, 1402/07/15
Registration timing: prospective

Last update: 2023-10-07, 1402/07/15
Update count: 0
Registration date
2023-10-07, 1402/07/15
Registrant information
Name
Fateme Ghiasi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 54 3341 6708
Email address
f_ghiasi_p@zaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-10-22, 1402/07/30
Expected recruitment end date
2023-12-21, 1402/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effects of balance training on foot loading distribution after total knee arthroplasty
Public title
The Effects of balance training on foot loading distribution after total knee arthroplasty
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Maximum 1 month after arthroplasty Patients with unilateral arthroplasty No history of bone diseases, Surgery and fractures around the knee No physical therapy intervention/rehabilitation after hospital discharge Ability walking more than 10 meters Years: Range: 50- 80
Exclusion criteria:
Musculoskeletal disease in the lower limbs Unwillingness to enter the study Balance disorder: dizziness Metabolic disorder Vascular disorder in lower limb
Age
From 50 years old to 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 30
Randomization (investigator's opinion)
Randomized
Randomization description
Based on the number of patients in each group, the particular sort of treatment (routine treatment groups or balance training group) is written on a piece of paper. Each paper is placed in a sealed envelope. One envelope will be chosen randomly by the therapist at the first session of the patient treatment and the patient's treatment technique is selected based on that. If any of the patients is omitted from the study, one envelope related to the excluded patient treatment group will be replaced and they will mixed again.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Zahedan University of Medical Sciences
Street address
Dr. Hasabi Square
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Approval date
2023-08-20, 1402/05/29
Ethics committee reference number
IR.ZAUMS.REC.1402.195

Health conditions studied

1

Description of health condition studied
Total Knee Arthroplasty
ICD-10 code
Z96. 651
ICD-10 code description
Total Knee Arthroplasty

Primary outcomes

1

Description
The surface of foot contact with the ground
Timepoint
Before surgery, Baseline and at the end of the study
Method of measurement
Foot pressure scanning machine (Payatech model, PT-Scan4452F100)

2

Description
Pain Intensity
Timepoint
Before surgery, Baseline and at the end of the study
Method of measurement
Visual Analogue Scale (VAS)

3

Description
The ellipse area of ​​the movement path of the Center of Body Pressure
Timepoint
Before surgery, Baseline and at the end of the study
Method of measurement
Foot pressure scanning machine (Payatech model, PT-Scan4452F100)

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: In this group, patients will receive balance exercises in addition to routine treatment. Patients will be trained with balance exercise rehabilitation program for 30 minutes, 6 days a week and for 24 sessions. Balance exercises will include standing on one leg with eyes open and closed, anterior, lateral and posterior step-up exercises in both legs of the patient.
Category
Rehabilitation

2

Description
Control group: In this group, routine treatment will be performed instead of balance exercises. First, patients undergo TENS (Transcutaneous Electrical Nerve Stimulation) electrotherapy (for 20 minutes) along with infrared radiation (IR) (for 10 minutes), and then, stretching exercises for the hamstring muscles and strengthening exercises for the quad muscles will be done for 30 minutes.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Razi Physiotherapy Clinic
Full name of responsible person
Hosein Afzali
Street address
No.8 Alley, Bahonar St.
City
Zarand
Province
Kerman
Postal code
7761868208
Phone
+98 34 3342 2531
Email
hoseinafzali1365@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Dr.Noormohammad Bakhshani
Street address
Dr.Hessabi Blvd
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9817643463
Phone
+98 54 3329 5796
Email
public @zamus.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zahedan 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
Zahedan University of Medical Sciences
Full name of responsible person
Dr.Fateme Ghiasi
Position
Asistance professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Khatam al anbia Hosp, Jame jam Blvd
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9815733169
Phone
+98 54 3322 0501
Email
f_ghiasi_p@zamus.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Dr.Fateme Ghiasi
Position
Asistance professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Khatam al anbia Hosp, Jame jam Blvd
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9815733169
Phone
+98 54 3322 0501
Email
f_ghiasi_p@zamus.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Dr.Fateme Ghiasi
Position
Asistance professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Khatam al anbia Hosp, Jame jam Blvd Zahedan
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9815733169
Phone
+98 54 3322 0501
Email
f_ghiasi_p@zamus.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
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