Back to resultsLeap Motion Based Gamefication Exercises in the Individuals With Systemic Sclerosis
Primary Purpose
Rheumatology, Scleroderma, Systemic, Video Games
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Leap motion assisted rehabilitation
Traditional program
Sponsored by
About this trial
This is an interventional treatment trial for Rheumatology focused on measuring Scleroderma, Systemic, Hand therapy, Therapy, Computer-Assisted
Eligibility Criteria
Inclusion Criteria: Having the ability to adapt to exercises Not having any diagnosed cardiac or orthopedic disease that may prevent the application of assessment methods Exclusion Criteria: Having a diagnosis of juvenile-onset SSc Having a history of neurological disease or trauma that will affect hand functions Receiving another treatment, such as intra-articular injection, surgery, that may affect hand rehabilitation in the last 6 months Having systemic involvement that may affect the treatment process or activities of daily living
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Leap motion assisted rehabilitation
Traditional program
Arm Description
Individuals who will participate in the study will be treated 2 days a week for 5 weeks with Leap Motion sensor-supported games aimed at increasing patient-specific wrist flexion, wrist extension, ulnar and radial deviation of the wrist, flexion, extension and abduction of the fingers. Each training period will last 30 minutes.
They will be included in traditional rehabilitation training consisting of stretching exercises, strengthening exercises and functional exercises including activities of daily living for 2 days a week for 5 weeks.
Outcomes
Primary Outcome Measures
modified Hand Mobility in Scleroderma (mHAMIS)
Hand Mobility in Scleroderma is a hand function test developed for adults who have systemic sclerosis. HAMIS consists of 9 items designed to measure all movements assessed in an ordinary range of motion-measured hand test. Each item is graded on a 0-3 scale, where 0 corresponds to normal function and 3 denotes that the individual is unable to perform the item. Each hand is assessed separately. The total score of HAMIS for each hand is 370 Sandqvist and Eklund Vol. 13, No. 6, December 2000 27, which represents a high degree of dysfunction.
Secondary Outcome Measures
Finger Joint Range of Motion
The patients will be asked to close their fingers tightly and the distance between the pulp of the 2nd, 3rd, 4th, and 5th finger - distal palmar line (PP-DPD) will be measured in cm with the help of a ruler. Dominant and nondominant hand total scores will be calculated by summing the values found for the fingers of each hand separately.
Grip Strength
A hand dynamometer will be used. For measurements, patients will be asked to make a maximally voluntary grip while sitting, elbow flexed to 90 degrees, wrist in semi-pronation with thumb pointing up. Measurements on the sick and healthy hand will be made 3 times in a row, and the average values will be recorded in kilograms (kg). Finger grip will be evaluated with a pinchmeter in three different positions (lateral, palmar, fingertip).
Skin Hardness
Skin hardness will be measured with a durometer. Although the durometer is a device designed to measure non-biomaterial surface hardness, it is used clinically to evaluate sclerosis. Measurements will be made on the dorsal surface of the third finger, midphalanx, dorsum of the hand, palmar and dorsal aspects of the forearm.
Purdue Pegboard Test
Purdue Pegboard Test will be used to evaluate hand functions. This test is an objective and standardized test that is frequently used in practice to evaluate functional hand use. The test will be preferred because of its advantages in demonstrating the functional activities and ability of the hand and its ease of use. The patient will be asked to perform the test activities first with the dominant hand, then with the non-dominant hand in 30 seconds, and using both hands in 60 seconds. Scoring will be based on the number of successfully placed pins.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05821335
Brief Title
Leap Motion Based Gamefication Exercises in the Individuals With Systemic Sclerosis
Official Title
The Development and Investigation of Effectiveness of Leap Motion Based Gamefication Exercises in Hand Rehabilitation of the Individuals With Systemic Sclerosis
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
May 30, 2023 (Anticipated)
Primary Completion Date
May 30, 2023 (Anticipated)
Study Completion Date
May 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Leap Motion Based Gamefication Exercises in the Individuals With Systemic Sclerosis
Detailed Description
The aim of this project is to develop Leap Motion Sensor-assisted rehabilitation games that can be easily applied in hand rehabilitation in individuals with SSc, motivating, directing to the right exercise, providing therapeutic evaluation and feedback during the game, and comparing the effectiveness of these rehabilitation games with traditional rehabilitation applications.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatology, Scleroderma, Systemic, Video Games, Physiotherapy, Rehabilitation, Hand Rheumatism
Keywords
Scleroderma, Systemic, Hand therapy, Therapy, Computer-Assisted
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
Assessment and treatment will be done by different investigators.
Allocation
Randomized
Enrollment
32 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Leap motion assisted rehabilitation
Arm Type
Experimental
Arm Description
Individuals who will participate in the study will be treated 2 days a week for 5 weeks with Leap Motion sensor-supported games aimed at increasing patient-specific wrist flexion, wrist extension, ulnar and radial deviation of the wrist, flexion, extension and abduction of the fingers. Each training period will last 30 minutes.
Arm Title
Traditional program
Arm Type
Experimental
Arm Description
They will be included in traditional rehabilitation training consisting of stretching exercises, strengthening exercises and functional exercises including activities of daily living for 2 days a week for 5 weeks.
Intervention Type
Other
Intervention Name(s)
Leap motion assisted rehabilitation
Intervention Description
Hand Therapy via leap motion sensor
Intervention Type
Other
Intervention Name(s)
Traditional program
Intervention Description
Hand Therapy by physiotherapist via traditional methods
Primary Outcome Measure Information:
Title
modified Hand Mobility in Scleroderma (mHAMIS)
Description
Hand Mobility in Scleroderma is a hand function test developed for adults who have systemic sclerosis. HAMIS consists of 9 items designed to measure all movements assessed in an ordinary range of motion-measured hand test. Each item is graded on a 0-3 scale, where 0 corresponds to normal function and 3 denotes that the individual is unable to perform the item. Each hand is assessed separately. The total score of HAMIS for each hand is 370 Sandqvist and Eklund Vol. 13, No. 6, December 2000 27, which represents a high degree of dysfunction.
Time Frame
change from baseline at 5 weeks
Secondary Outcome Measure Information:
Title
Finger Joint Range of Motion
Description
The patients will be asked to close their fingers tightly and the distance between the pulp of the 2nd, 3rd, 4th, and 5th finger - distal palmar line (PP-DPD) will be measured in cm with the help of a ruler. Dominant and nondominant hand total scores will be calculated by summing the values found for the fingers of each hand separately.
Time Frame
change from baseline at 5 weeks
Title
Grip Strength
Description
A hand dynamometer will be used. For measurements, patients will be asked to make a maximally voluntary grip while sitting, elbow flexed to 90 degrees, wrist in semi-pronation with thumb pointing up. Measurements on the sick and healthy hand will be made 3 times in a row, and the average values will be recorded in kilograms (kg). Finger grip will be evaluated with a pinchmeter in three different positions (lateral, palmar, fingertip).
Time Frame
change from baseline at 5 weeks
Title
Skin Hardness
Description
Skin hardness will be measured with a durometer. Although the durometer is a device designed to measure non-biomaterial surface hardness, it is used clinically to evaluate sclerosis. Measurements will be made on the dorsal surface of the third finger, midphalanx, dorsum of the hand, palmar and dorsal aspects of the forearm.
Time Frame
change from baseline at 5 weeks
Title
Purdue Pegboard Test
Description
Purdue Pegboard Test will be used to evaluate hand functions. This test is an objective and standardized test that is frequently used in practice to evaluate functional hand use. The test will be preferred because of its advantages in demonstrating the functional activities and ability of the hand and its ease of use. The patient will be asked to perform the test activities first with the dominant hand, then with the non-dominant hand in 30 seconds, and using both hands in 60 seconds. Scoring will be based on the number of successfully placed pins.
Time Frame
change from baseline at 5 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Having the ability to adapt to exercises
Not having any diagnosed cardiac or orthopedic disease that may prevent the application of assessment methods
Exclusion Criteria:
Having a diagnosis of juvenile-onset SSc
Having a history of neurological disease or trauma that will affect hand functions
Receiving another treatment, such as intra-articular injection, surgery, that may affect hand rehabilitation in the last 6 months
Having systemic involvement that may affect the treatment process or activities of daily living
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
TUGBA CIVI KARAASLAN, PhD
Phone
+905343855606
Email
tugba.civi@iuc.edu.tr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
TUGBA CIVI KARAASLAN, PhD
Organizational Affiliation
Istanbul University - Cerrahpasa (IUC)
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
31010703
Citation
Tarakci E, Arman N, Tarakci D, Kasapcopur O. Leap Motion Controller-based training for upper extremity rehabilitation in children and adolescents with physical disabilities: A randomized controlled trial. J Hand Ther. 2020 Apr-Jun;33(2):220-228.e1. doi: 10.1016/j.jht.2019.03.012. Epub 2019 Apr 19.
Results Reference
background
PubMed Identifier
34165263
Citation
Murphy SL, Poole JL, Chen YT, Lescoat A, Khanna D. Rehabilitation Interventions in Systemic Sclerosis: A Systematic Review and Future Directions. Arthritis Care Res (Hoboken). 2022 Jan;74(1):59-69. doi: 10.1002/acr.24737. Epub 2021 Dec 22.
Results Reference
background
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Leap Motion Based Gamefication Exercises in the Individuals With Systemic Sclerosis
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