Leap Motion Based Gamefication Exercises in the Individuals With Systemic Sclerosis

Rehabilitation Clinical Trial

Official title:

The Development and Investigation of Effectiveness of Leap Motion Based Gamefication Exercises in Hand Rehabilitation of the Individuals With Systemic Sclerosis

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05821335
• Other study ID #: IstanbulC3
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 30, 2023
• Est. completion date: May 30, 2024

Study information

• Verified date: May 2023
• Source: Istanbul University
• Contact: TUGBA CIVI KARAASLAN, PhD
• Phone: +905343855606
• Email: tugba.civi[@]iuc.edu.tr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Leap Motion Based Gamefication Exercises in the Individuals With Systemic Sclerosis

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 32
• Est. completion date: May 30, 2024
• Est. primary completion date: May 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Hand Rheumatism
• Physiotherapy
• Rehabilitation
• Rheumatic Diseases
• Rheumatology
• Scleroderma, Diffuse
• Scleroderma, Systemic
• Video Games

Intervention

Other:
• Leap motion assisted rehabilitation
Hand Therapy via leap motion sensor
• Traditional program
Hand Therapy by physiotherapist via traditional methods

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul University

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	change from baseline at 5 weeks
Secondary	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.	change from baseline at 5 weeks
Secondary	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).	change from baseline at 5 weeks
Secondary	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.	change from baseline at 5 weeks
Secondary	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.	change from baseline at 5 weeks