Leap Motion Based Gamefication Exercises in the Individuals With Systemic Sclerosis

NCT05821335 | Unknown

• 1 other identifier: IstanbulC3
• Study Type: interventional
• Target: 32
• Locations: 0 countries
• Sites: N/A

Brief Summary

Leap Motion Based Gamefication Exercises in the Individuals With Systemic Sclerosis

Conditions

Rheumatology; Scleroderma, Systemic; Video Games; Physiotherapy; Rehabilitation; Hand Rheumatism

Keywords

Scleroderma, Systemic; Hand therapy; Therapy, Computer-Assisted

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Finger Joint Range of Motion

  change from baseline at 5 weeks

• Grip Strength

  change from baseline at 5 weeks

• Skin Hardness

  change from baseline at 5 weeks

• Purdue Pegboard Test

  change from baseline at 5 weeks

Study Arms (2)

Leap motion assisted rehabilitation

EXPERIMENTAL

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

Traditional program

EXPERIMENTAL

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

Interventions

Leap motion assisted rehabilitation OTHER

Hand Therapy via leap motion sensor

Leap motion assisted rehabilitation

Traditional program OTHER

Hand Therapy by physiotherapist via traditional methods

Traditional program

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Having the ability to adapt to exercises
• Not having any diagnosed cardiac or orthopedic disease that may prevent the application of assessment methods

You may not qualify if:

• 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

Sponsors & Collaborators

• Istanbul University: lead

Related Publications (2)

• 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.

  PMID: 31010703 BACKGROUND

• 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.

  PMID: 34165263 BACKGROUND

MeSH Terms

Conditions

Scleroderma, Systemic

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases

Study Officials

• TUGBA CIVI KARAASLAN, PhD

  Istanbul University - Cerrahpasa

  PRINCIPAL INVESTIGATOR

Central Study Contacts

TUGBA CIVI KARAASLAN, PhD

CONTACT

+905343855606; tugba.civi@iuc.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Assessment and treatment will be done by different investigators.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant

Study Record Dates

• First Submitted: April 7, 2023
• First Posted: April 20, 2023
• Study Start: May 30, 2023
• Primary Completion: May 30, 2023
• Study Completion: May 30, 2024
• Last Updated: May 6, 2023

Record last verified: 2023-05