Leap Motion Based Gamefication Exercises in the Individuals With Systemic Sclerosis

May 4, 2023 updated by: Tugba Civi Karaaslan, Istanbul University

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

Leap Motion Based Gamefication Exercises in the Individuals With Systemic Sclerosis

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

32

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Leap motion assisted rehabilitation
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.
Other: Leap motion assisted rehabilitation
Hand Therapy via leap motion sensor
Experimental: Traditional program
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.
Other: Traditional program
Hand Therapy by physiotherapist via traditional methods

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
modified Hand Mobility in Scleroderma (mHAMIS)
Time Frame: change from baseline at 5 weeks
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Finger Joint Range of Motion
Time Frame: change from baseline at 5 weeks
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
Grip Strength
Time Frame: change from baseline at 5 weeks
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
Skin Hardness
Time Frame: change from baseline at 5 weeks
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
Purdue Pegboard Test
Time Frame: change from baseline at 5 weeks
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istanbul University

Investigators

  • Principal Investigator: TUGBA CIVI KARAASLAN, PhD, Istanbul University - Cerrahpasa (IUC)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

May 30, 2023

Primary Completion (Anticipated)

May 30, 2023

Study Completion (Anticipated)

May 30, 2024

Study Registration Dates

First Submitted

April 7, 2023

First Submitted That Met QC Criteria

April 7, 2023

First Posted (Actual)

April 20, 2023

Study Record Updates

Last Update Posted (Estimate)

May 5, 2023

Last Update Submitted That Met QC Criteria

May 4, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IstanbulC3

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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