Comparison of audio biofeedback device with tracking patterns device for home-based rehabilitation of the osteoarthritis shoulder: A Feasibility and User Acceptance Study
Comparison of the effect of the auditory biofeedback device with the device of following treatment patterns in the rehabilitation at home of patients with shoulder arthritis.
Design
The clinical trial is in two groups, with parallel groups, one-blinded and randomized.
22 participants in two groups of 11 people participated in the study. 22 therapists will also be present to perform the exercises to rate the tools. The rand function of Excel software will be used for randomization.
Settings and conduct
This study will be single blind. Each participant will randomly receive one of the two treatment tools first, and after the evaluation of the first tool, will spend a one-week period without shoulder-related treatment. Then he receives another tool. The study will be done in Tehran and the evaluations will be done in the rehabilitation center in Tehran.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
People with arthritis of one or both shoulders according to the physician's diagnosis
• Aged 40 to 60 years
• Without a history of surgery and burns in the shoulder
• Absence of contracture and adhesion in the shoulder
• The ability to perform exercises without causing any health risks
Exclusion criteria:
unwillingness to continue
• Pain during exercises
Intervention groups
Eligible subjects will be randomly assigned by sealed envelopes to group A (will receive the biofeedback tool first) or group B (will receive the laser pattern tool first). Both groups will be treatment-free for one week after completing the three-day period, and then receive the other tool. In this way, group A will use laser movement therapy tools for three days and group B will use biofiber tools for three days.
Main outcome variables
Pain level of users
Acceptance and satisfaction of users
Therapists' satisfaction score
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210607051511N1
Registration date:2023-11-25, 1402/09/04
Registration timing:registered_while_recruiting
Last update:2023-11-25, 1402/09/04
Update count:0
Registration date
2023-11-25, 1402/09/04
Registrant information
Name
zahra jiryaei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 86 3425 5716
Email address
jiryaei.z@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-10-07, 1402/07/15
Expected recruitment end date
2024-03-05, 1402/12/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of audio biofeedback device with tracking patterns device for home-based rehabilitation of the osteoarthritis shoulder: A Feasibility and User Acceptance Study
Public title
Comparison of audio biofeedback device with tracking patterns device for home-based rehabilitation of the osteoarthritis shoulde
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
People with osteoarthritis in one or both shoulders
People without surgery or burn in shoulder
People without any scar or spastic in shoulder
Ability to do exercise without any dangerous
Exclusion criteria:
No interest to keep on studying
Feel pain and complain during exercises and washout period
Age
From 40 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
44
Randomization (investigator's opinion)
Randomized
Randomization description
Eligible subjects will be randomly assigned by sealed envelopes to group A (will receive the biofeedback tool first) or group B (will receive the laser pattern tool first). The randomization process will be done by someone unaware of the study protocol.
Blinding (investigator's opinion)
Single blinded
Blinding description
This study will be single blind. Each participant will randomly receive one of the two treatment tools using the sealed envelope method, and after the evaluation of the first tool, they will spend a one-week period without treatment related to the shoulder. Then he receives another tool. The participants will not know how the other tool works until the end of the intervention with the first tool.
Placebo
Not used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Iran university medicine science
Street address
Shahnazari alley- Madar squre- Mirdamad avenue
City
Tehran
Province
Tehran
Postal code
1545913487
Approval date
2023-07-03, 1402/04/12
Ethics committee reference number
IR.IUMS.REC.1402.348
Health conditions studied
1
Description of health condition studied
Shoulder Osteoarthritis
ICD-10 code
M19.9
ICD-10 code description
Osteoarthritis, unspecified site
Primary outcomes
1
Description
Pain is an unpleasant sensation and experience related to real or potential tissue damage that has physiological and psychological components.
Timepoint
In beginning study- after intervention A- after intervention B
Method of measurement
Visual scale of pain intensity
2
Description
Acceptance and satisfaction of users
Timepoint
In beginning study- after intervention A- after intervention B
Method of measurement
Likert scale
3
Description
Satisfaction of therapists
Timepoint
In beginning study- after intervention A- after intervention B
Method of measurement
Likert scale
Secondary outcomes
empty
Intervention groups
1
Description
The first intervention group: The auditory biofeedback device, for three days each participant uses the device and performs five specified exercises.
Category
Rehabilitation
2
Description
The second intervention group: Tracking Patterns device, for three days each participant uses the tool and performs five specified exercises.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Nahal clinic
Full name of responsible person
Zahra Jiryaei
Street address
24 unit, 2 flat, Tehranpars building, Taheri alley, 196 west street, 3rd square of tehranpars
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Iran University of Medical Sciences
Full name of responsible person
Zahra Jiryaei
Position
Ph.D Student
Latest degree
Ph.D.
Other areas of specialty/work
Orthopedics
Street address
Shahnazari alley, Mirdamad avenue
City
Tehran
Province
Tehran
Postal code
1545913487
Phone
098 021 76700796
Email
jiryaei.z@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Zahra Jiryaei
Position
Ph.D
Latest degree
Ph.D.
Other areas of specialty/work
Rehabilitation management
Street address
Unit 24, 34 No, 196 west street, 3rd tehranpars
City
tehran
Province
Tehran
Postal code
1653886591
Phone
098 021 76700796
Email
jiryaei.z@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Zahra Jiryaei
Position
Therapist
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
No. 37, 10 Meter Kamali, Davaran Avenue
City
Arak
Province
Markazi
Postal code
3816766835
Phone
+98 86 3425 5716
Email
Jiryaei.z@gmail.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
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
The data obtained from the evaluation results of the participants will be placed in the statistical analysis software and their results will be published.
When the data will become available and for how long
After study will finish and submit it to a journal
To whom data/document is available
For researcher will be available.
Under which criteria data/document could be used
final results will be available for everyone that is interested in it.
From where data/document is obtainable
To Zahra Jiryaei:
Jiryaei.z@gmail.com
What processes are involved for a request to access data/document
The applicant must first introduce him/herself by email and continue for what purpose he needs the results. After sending the email and confirming it, he/she will have access to the final data after ten days.