Effect of Kinect-based rehabilitation on joint range of motion in elderly patients with burns.
Impact of Kinect-based rehabilitation on pain reduction in elderly patients with burns.
Influence of Kinect-based rehabilitation on anxiety reduction in elderly patients with burns.
Design
A parallel-group, single-blind, randomized clinical trial will be conducted. Participants will be randomly assigned to intervention and control groups using Stata software (version 17) with 4-person randomization blocks. The total sample size will be 90, with 45 participants in each group.
Intervention Group: Kinect Xbox 360-based rehabilitation exercises.
Control Group: Standard rehabilitation exercises.
Settings and conduct
The study will take place in the Burn Unit of Imam Reza (AS) Hospital. The intervention group will undergo Kinect Xbox 360-based rehabilitation exercises starting 24 hours post-fluid resuscitation, twice daily for 30 to 45 minutes, for up to 5 days post-grafting.
Blinding:
Single-blind design; assessors and data analysts will not know group assignments.
Participants/Inclusion and exclusion criteria
Inclusion Criteria:
Age between 60 and 75 years.
No speech, hearing, or visual impairments.
Burns less than 25% and second-degree.
Exclusion Criteria:
Willingness to withdraw from the study.
Development of uncontrollable conditions.
Intervention groups
Intervention Group: Rehabilitation exercises using Kinect Xbox 360 will start 24 hours after fluid resuscitation and hemodynamic stabilization, occurring twice daily for 30 to 45 minutes until discharge.
Control Group: Standard traditional rehabilitation exercises will be provided.
Main outcome variables
Range of joint motion ,Intensity of pain, Severity of anxiety
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20171123037599N4
Registration date:2024-08-03, 1403/05/13
Registration timing:prospective
Last update:2024-08-03, 1403/05/13
Update count:0
Registration date
2024-08-03, 1403/05/13
Registrant information
Name
Razieh Froutan
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3881 4241
Email address
froutanr@mums.ac.ir
Recruitment status
recruiting
Funding source
Expected recruitment start date
2024-09-05, 1403/06/15
Expected recruitment end date
2025-09-06, 1404/06/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Design and Evaluation of Kinect-Based Rehabilitation on Joint Range of Motion, Pain Intensity, and Anxiety in Elderly Burn Patients"
Public title
Investigating the Effects of Kinect-Based Rehabilitation on Joint Mobility, Pain Reduction, and Anxiety in Elderly Burn Patients
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria:
No speech, hearing, or visual impairments.
No history of alcohol or drug addiction, no psychiatric disorders, and no cognitive impairments.
Burns less than 25% of body surface area and only second-degree burns on extremities.
Less than 72 hours since the occurrence of the burn.
Not self-inflicted (no self-burns).
No other injuries apart from burns.
Exclusion criteria:
Patients who are unwilling to continue participating in the study.
Patients who experience severe pain in other areas of the body.
Patients who develop unmanageable or critical conditions during the study
Age
From 60 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
Data analyser
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
This clinical trial is a randomized, single-blind, parallel-group study. Participants will be randomly assigned to the intervention and control groups using the Stata software (version 17) with 4-person random blocks. The total sample size will be 90 participants, with 45 in each group.
Intervention Group: Rehabilitation exercises based on Kinect Xbox 360.
Control Group: Standard rehabilitation exercises using traditional methods.
Initially, all eligible participants will be enrolled. Random allocation will then be performed using randomization software, and participants will be assigned to either the intervention or control group. To ensure a balanced distribution of participants across both groups, 4-person random blocks will be used.
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, a single-blind design was employed. This means that the statistical consultant responsible for data analysis was unaware of the participants' allocation to either the intervention or control groups. This approach helps ensure that the data analysis is not influenced by any preconceived notions or biases related to group assignments, thereby enhancing the validity of the results.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Mashhad University of Medical Sciences
The range of motion of the upper limbs will be measured using the program embedded in Kinect.
Timepoint
Measurements will be taken immediately after the intervention (end of the exercise program), daily, and at specific intervals thereafter, specifically at 1 week and 2 weeks after the intervention.
Method of measurement
The Kinect program uses 3D cameras and motion sensors to simulate and measure body and limb movements. This program can accurately measure the range of motion of the upper limbs and provide detailed reports on the range of movements. For measurements to be performed, the participant must be within the Kinect’s field and perform specific movements so that the program can record and analyze the range of motion.
2
Description
Measurement of anxiety related to pain in burn patients using the abbreviated Burn-Specific Pain Anxiety Scale (BSPAS) is a validated tool for assessing pain-related anxiety in burn patients.
Timepoint
Measurements will be taken at the beginning of the study (before the intervention starts), immediately after the intervention (at the end of the exercise period), and also at specified intervals thereafter, namely 1 week and 2 weeks after the end of the intervention.
Method of measurement
The Burn-Specific Pain Anxiety Scale (BSPAS) is a validated tool for measuring pain-related anxiety in burn patients. This scale consists of 6 items that assess various aspects of anxiety associated with pain. The tool is used by asking patients about their experiences and feelings related to pain, and evaluating their responses based on the specified scale.
3
Description
Pain intensity is measured using the Numeric Rating Scale (NRS). The NRS allows patients to describe the intensity of their pain by choosing a number from 0 to 10, where 0 represents no pain and 10 represents the worst possible pain.
Timepoint
Before the intervention, at the end of daily exercise sessions, and one and two weeks after the start of the rehabilitation exercises.
Method of measurement
Patients are asked to describe the intensity of their pain by selecting a number from 0 to 10. A score of 0 represents no pain, while a score of 10 represents the worst possible pain. Patients report their pain intensity by choosing a number.
Secondary outcomes
empty
Intervention groups
1
Description
In the intervention group, elderly burn patients perform exercise routines twice daily using the Kinect device. This device utilizes 3D cameras and motion sensors to simulate and measure body movements, accurately assessing the range of motion in the upper limbs. Measurements are taken immediately after the intervention, daily, and at specified intervals1 week and 2 weeks post-intervention.
Category
Rehabilitation
2
Description
In the control group, elderly burn patients perform exercise routines twice daily under the supervision of the research team, with direct instruction. The range of motion in the upper limbs is measured using a goniometer. Measurements are taken immediately after the intervention, daily, and at specified intervals of 1 week and 2 weeks post-intervention.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Hospital
Full name of responsible person
Razieh Froutan
Street address
Park Square, Ferdowsi University of Mashhad, Khwarazmi Building, Nursing Department
City
Mashhad
Province
Razavi Khorasan
Postal code
91775-1365
Phone
+98 51 3881 4241
Email
froutanr@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Razieh Froutan
Street address
Park Square, Ferdowsi University of Mashhad, Khwarazmi Building, Nursing Department
City
Mashhad
Province
Razavi Khorasan
Postal code
91775-1365
Phone
+98 51 3881 4241
Email
froutanr@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Mashhad University of Medical Sciences
Proportion provided by this source
50
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
Mashhad University of Medical Sciences
Full name of responsible person
Razieh Froutan
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Park Square, Ferdowsi University of Mashhad, Khwarazmi Building, Nursing Department
City
Mashhad
Province
Razavi Khorasan
Postal code
91775-1365
Phone
+98 51 3881 4241
Email
froutanr@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Razieh Froutan
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Park Square, Ferdowsi University of Mashhad, Khwarazmi Building, Nursing Department
City
Mashhad
Province
Razavi Khorasan
Postal code
91775-1365
Phone
+98 51 3881 4241
Email
froutanr@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Razieh Froutan
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Park Square, Ferdowsi University of Mashhad, Khwarazmi Building, Nursing Department
City
Mashhad
Province
Razavi Khorasan
Postal code
91775-1365
Phone
+98 51 3881 4241
Email
froutanr@mums.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