Technological Based Rehabilitation on Individuals With Rheumatic Disease

June 7, 2024 updated by: Sebahat Yaprak Cetin, PT, Akdeniz University

The Effects of Technological Based Rehabilitation on Individuals With Rheumatic Disease With Hand Involvement

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

In the study, 45 adult individuals diagnosed with rheumatic disease with hand involvement will be randomly divided into 3 groups. The first group will be given virtual reality exercises via Leap Motion Controller. Virtual reality exercises will be applied 30 minutes a day, 3 days a week for 8 weeks. To the second group, a conventional hand rehabilitation program will be applied under the supervision of a physiotherapist. The hand rehabilitation program will be applied 30 minutes a day, 3 days a week for 8 weeks. The third group will be the control group, which continues with its routine medications and is not included in any exercise program. After randomization, the individuals' joint range of motion, gross and fine grip strength, functionality, and disease activities will be evaluated. Evaluations will be made twice, at the beginning and at the end of the 8-week program. Disease Activity Score 28 (DAS 28), hand dynamometer, picnometer, Jebsen Hand Function Test, Nine Hole Peg Test, Duruoz Hand Index and Michigan Hand Outcome questionnairre will be used for evaluation.

Study Type

Interventional

Enrollment (Estimated)

45

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

Study Locations

  • Turkey
    • Konyaaltı
      • Antalya, Konyaaltı, Turkey, 07100

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 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

Exclusion Criteria:

  • 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

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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Virtual reality therapy group
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 hand therapy
Other Names:
  • Hand exercises
Experimental: Conventional exercise group
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
Conventional hand therapy
Other Names:
  • Hand exercises
No Intervention: Control group
This group is waiting list. After the study, patients will do hand exercises with the leap motion controller device.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hand grip strength measurement
Time Frame: 8 weeks
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)
Time Frame: 8 weeks

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)
Time Frame: 8 weeks
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)
Time Frame: 8 weeks
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)
Time Frame: 8 weeks
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disease Activity Score 28 (DAS 28)
Time Frame: 8 weeks

It includes swelling and tenderness in 28 joints including the proximal interphalangeal joint, metacarpophalangeal joint, wrist, elbow, shoulder and knee joints, erythrocyte sedimentation rate (ESR) value, and global evaluation of the patient (VAS 0-100 mm). The DAS 28 value is calculated using a special formula:

DAS28 = (0.56 x √ Number of Tender Joints) + (0.28 x √ Number of Swollen Joints) + (0.70 x Ln (ESR value)) + (0.014 x Patient global assessment) High score; indicates high disease activity. Values higher than 5.1 indicate high disease activity, values between 3.2<DAS28≤5.1 indicate medium disease activity, values of 2.6<DAS28≤3.2 indicate low disease activity, and values less than or equal to 2.6 indicate that the patient is in remission.
8 weeks
Hand fine grip strength measurement
Time Frame: 8 weeks

Fine grip strength measurements will be made with finger dynamometry. 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 degrees of hip and knee flexion, shoulder adduction, forearm neutral position, 90 degree flexion of the elbow, 0-30 degree extension of the wrist and 0-15 degree ulnar deviation. Three different finger grips will be evaluated. These:

1- Fingertip grip strength, 2- Lateral grip strength, 3- Three point grip strength.

Measurements 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

Collaborators and Investigators

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

Sponsor

Akdeniz University

Investigators

  • Principal Investigator: Sebahat Yaprak Cetin, PhD, Akdeniz University

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 (Actual)

March 15, 2024

Primary Completion (Estimated)

June 15, 2024

Study Completion (Estimated)

June 20, 2024

Study Registration Dates

First Submitted

April 22, 2024

First Submitted That Met QC Criteria

April 24, 2024

First Posted (Actual)

April 26, 2024

Study Record Updates

Last Update Posted (Actual)

June 10, 2024

Last Update Submitted That Met QC Criteria

June 7, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023-088

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

We will share data to the other individuals with some analyses program.

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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