Technological Based Rehabilitation on Individuals With Rheumatic Disease

NCT06385574 | Recruiting

• 1 other identifier: 2023-088
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

Affects such as pain, swelling, tenderness, deformities, limitations, strength and function losses, skill and coordination deficiencies in the hand joints, which are frequently seen in rheumatism patients with hand involvement, are included in body structure and function disorders within the framework of International Classification of Function System. Leap Motion Controller is used in hand rehabilitation because it is small in size, low-cost, portable, non-contact, easy to use and provides visual and auditory feedback. The aim of our study is to examine the effect of technology-based rehabilitation on joint range of motion, grip strength, functionality and disease activity in adult individuals with rheumatic disease with hand involvement; and also to compare these effects with the effects of the hand rehabilitation program implemented under the guidance of a physiotherapist and the control group that continues its routine life.

Conditions

Rheumatic Diseases; Hand Rheumatism; Virtual Reality Therapy

Keywords

rheumatic diseases; hand exercises; leap motion; functionality

Outcome Measures

Primary Outcomes (5)

• Hand grip strength measurement

  Hand grip strength will be measured with a Jamar hydraulic hand dynamometer. Grip tests will be performed in the standard position recommended by the American Association of Hand Therapists. This is the standard position; The patient will be seated in a position that provides 90-20 degree flexion of the hip and knee, shoulder adduction, forearm neutral position, 90 degree flexion of the elbow, 0-30 degree extension of the wrist and 0-15 degree ulnar deviation. The measurement will be repeated three times. There will be a 15-second rest break at the end of each measurement. As a result, the average of three measurements will be recorded.

  8 weeks

• Jebsen Hand Function Test (JHFT)

  This test consists of tasks involving grasping types commonly used in daily living activities and evaluates people's speed in these tasks. Each stage of the Jebsen Taylor Hand Function Test, which consists of seven sub-steps, will be explained to the individuals in detail before the task and the individuals will be asked to try the task. Estimated time to complete 7 subtasks is 20 minutes. Individuals will complete tasks with both their dominant and non-dominant hands. The task will start with the practitioner's "start" command, and when the task is completed, the test performance will be recorded separately for the tested hand as the time to complete the task. Below is the tasks. Task 1: Stack 4 checkers, Task 2: Card flipping, Task 3: Collecting objects, Task 4: Writing,Task 5: Eating, Task 6: Moving Light Objects, Task 7: Moving Heavy Objects

  8 weeks

• Nine Hole Peg Test (NHPT)

  This device is a device consisting of a square platform and a storage box. There are 9 holes in the square-shaped area (12.7x2cm) and 9 cylinders suitable for these holes. The diameter of the holes is 0.71 cm, the diameter of the cylinders is 0.64 cm, the length is 3.2 cm, the distance between the holes is 3.2 cm, the hole depth is 1.3 cm and the size of the storage box is 13x13 cm. During the test, the patient sits at the table with the 9-hole board, and the patient is asked to quickly take the 9 cylinders from the storage box, place them in the holes in random order, and quickly remove them from the holes without taking a break and place them in the storage box. Meanwhile, time is measured in seconds with a stopwatch. The test is performed 2 times consecutively for both hands and the average of the result is taken. The total test score is calculated by taking the average of the scores for both hands.

  8 weeks

• Duruoz Hand Index (DHI)

  The test consists of 18 questions. It is a simple, useful and reliable test that is presented by separating daily life functions (kitchen, clothing, cleaning, workplace and other daily life activities), does not require additional training and equipment for the test, and takes approximately 2-3 minutes to apply. It is a simple and understandable test in which questions are answered according to a Likert scale, with a minimum score of 0 and a maximum of 90 points. A lower score indicates a better functional state.

  8 weeks

• Michigan Hand Outcome questionnaire (MHQ)

  This questionnaire is a scale consisting of six sections and 57 different items. It helps us question how well patients perform tasks they frequently perform. The patient answers the questions according to the Likert measurement method, which gives values from one to five. Each of the 6 different categories in the scale is scored uniquely. High scores indicate good functionality.

  8 weeks

Secondary Outcomes (2)

• Disease Activity Score 28 (DAS 28)

  8 weeks

• Hand fine grip strength measurement

  8 weeks

Study Arms (3)

Virtual reality therapy group

EXPERIMENTAL

Individuals in this group will be given hand exercises (wrist flexion, extension and deviations) for 45 minutes, 2 days a week for 8 weeks, using a leap motion control device and games selected in accordance with this device.

Other: Virtual reality therapy

Conventional exercise group

EXPERIMENTAL

Hand exercises (wrist flexion, extension and deviations)) will be applied to individuals in this group under the supervision of a specialist physiotherapist for 45 minutes, 2 days a week for 8 weeks.

Other: Virtual reality therapy

Control group

NO INTERVENTION

This group is waiting list. After the study, patients will do hand exercises with the leap motion controller device.

Interventions

Virtual reality therapy OTHER

Conventional hand therapy

Also known as: Hand exercises

Conventional exercise group; Virtual reality therapy group

Eligibility Criteria

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

You may qualify if:

• Having been diagnosed with a rheumatic disease that meets the latest criteria by a rheumatologist
• Involvement in hand joints (pain, swelling, tenderness)
• Being 18 years or older
• Being on stable drug treatment for the last 6 months
• Having sufficient cooperation to participate in the study
• Volunteering to participate in the study

You may not qualify if:

• Not volunteering to participate in the study
• Having difficulty in cooperating at work
• Having an additional orthopedic and/or neurological disease that will affect hand functions

Sponsors & Collaborators

• Akdeniz University: lead

Study Sites (1)

Sebahat Yaprak Cetin

Antalya, Konyaaltı, 07100, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Rheumatic Diseases

Interventions

Virtual Reality Exposure Therapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Desensitization, Psychologic; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Sebahat Yaprak Cetin, PhD

  Akdeniz University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

İshak Isik, MD

CONTACT

+90 242 249 00 00; etik.kurul.07@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Investigator and outcome assessors do not know which patient is in which group.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: There are three groups in the study. First group is leap motion interventional group, second group is hand exercises group and the third group is waiting list.

Study Record Dates

• First Submitted: April 22, 2024
• First Posted: April 26, 2024
• Study Start: March 15, 2024
• Primary Completion: June 15, 2024
• Study Completion: June 20, 2024
• Last Updated: June 10, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)