Technological Based Rehabilitation on Individuals With Rheumatic Disease

NCT ID: NCT06385574

Last Updated: 2024-06-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-15

Study Completion Date

2024-06-20

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Rheumatic Diseases Hand Rheumatism Virtual Reality Therapy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors
Investigator and outcome assessors do not know which patient is in which group.

Study Groups

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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.

Group Type EXPERIMENTAL

Virtual reality therapy

Intervention Type OTHER

Conventional hand therapy

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.

Group Type EXPERIMENTAL

Virtual reality therapy

Intervention Type OTHER

Conventional hand therapy

Control group

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Virtual reality therapy

Conventional hand therapy

Intervention Type OTHER

Other Intervention Names

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Hand exercises

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Akdeniz University

OTHER

Sponsor Role lead

Responsible Party

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Sebahat Yaprak Cetin, PT

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sebahat Yaprak Cetin, PhD

Role: PRINCIPAL_INVESTIGATOR

Akdeniz University

Locations

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Sebahat Yaprak Cetin

Antalya, Konyaaltı, Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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İshak Isik, MD

Role: CONTACT

+90 242 249 00 00 ext. 4217

Facility Contacts

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Sebahat Yaprak Cetin, PhD

Role: primary

Other Identifiers

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2023-088

Identifier Type: -

Identifier Source: org_study_id

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