Clinical trial NCT06385574: Technological Based Rehabilitation on Individuals With Rheumatic Disease
Official title: The Effects of Technological Based Rehabilitation on Individuals With Rheumatic Disease With Hand Involvement
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Rheumatic Diseases
Hand Rheumatism
Virtual Reality Therapy
Keywords: rheumatic diseases
hand exercises
leap motion
functionality
Lead sponsor: Akdeniz University
Sponsor class: OTHER
First posted: 2024-04-26
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Hand grip strength measurement
timeFrame: 8 weeks
measure: Jebsen Hand Function Test (JHFT)
timeFrame: 8 weeks
measure: Nine Hole Peg Test (NHPT)
timeFrame: 8 weeks
measure: Duruoz Hand Index (DHI)
timeFrame: 8 weeks
measure: Michigan Hand Outcome questionnaire (MHQ)
timeFrame: 8 weeks
Secondary outcomes:
measure: Disease Activity Score 28 (DAS 28)
timeFrame: 8 weeks
measure: Hand fine grip strength measurement
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Antalya
country: Turkey
facility: Sebahat Yaprak Cetin
state: Konyaaltı
Study officials:
affiliation: Akdeniz University
name: Sebahat Yaprak Cetin, PhD
role: PRINCIPAL_INVESTIGATOR
References: