Textured Insoles and Foot Massage in Individuals Diagnosed With Rheumatoid Arthritis

Not Applicable

Completed

• Conditions: Rheumatoid Arthritis
• Interventions: Other: plantar massage; Other: textured insoles

• Registration Number: NCT05045898
• Lead Sponsor: Gazi University

Brief Summary

The aim of this study is to determine and compare the effects of using textured insoles and plantar massage on balance in patients with rheumatoid arthritis. Patients diagnosed with rheumatoid arthritis will be divided into two groups. In the first group the patients will be given plantar massage; in the second group, both plantar massage will be applied and the patients will use textured insoles in their indoor and outdoor activities. Plantar massage will be applied by the physiotherapist 3 days a week for 6 weeks; textured insoles will also be used for 6 weeks. All patients will be asked to complete the questionnaires, which assessed foot functionality, physical activity levels and quality of life. After each patients completed the questionnaire, the physiotherapist will perform plantar sensory and balance assessment. All assessments will be made before, after and 8 weeks after treatment.

Detailed Description

In the solution of balance problems in rheumatoid arthritis (RA), successful results can be obtained with the correct sensory inputs from the sole of the foot. Even after 5 minutes of application with plantar massage, which is one of these methods, it has been observed that there is an improvement in balance reactions. Textured insoles are also one of the methods used to improve balance with the right sensory input. Both methods increase cutaneous receptor activity and ankle proprioception by providing increased afferent information; As a result of these effects, postural sway decreases, balance can be achieved on a narrower support surface, and postural control increases. Although the positive effects of plantar massage and textured insoles on balance are known, there are no studies in which these methods are used in RA patients. In our study, we aimed to determine and compare the effects of plantar massage, which provides short-term afferent input, and the use of textured insoles, which provide long-term afferent input, on balance in RA patients. For these purposes, plantar massage will be applied to one group, and plantar massage will be applied to the other group and textured insoles will be used. In this way, the effects on the balance will be observed and compared.

Study Timeline

• Study First Submitted: 2021-09-07
• Study First Submitted QC: 2021-09-07
• Study First Posted: 2021-09-16
• Study Start: 2022-09-01
• Primary Completion: 2022-12-01
• Study Completion: 2023-10-01
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-22
• Last Update Posted: 2024-07-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• 18-65 years old
• Being diagnosed according to the American College of Rheumatology (ACR)/EULAR 2010 rheumatoid arthritis diagnostic criteria

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Exclusion Criteria

• Having an orthopedic or neurological disease that may cause balance and sensory impairment
• Using drugs that may cause balance and sensory disorders
• Having undergone lower extremity surgery
• Having a neurological problem that may cause hearing or vision impairment
• Having a communication problem
• Having a history of major psychiatric illness

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	plantar massage	plantar massage
Intervention group	plantar massage	plantar massage and textured insoles
Intervention group	textured insoles	plantar massage and textured insoles

Primary Outcome Measures

Name	Time	Method
Foot Function Index	After 14 weeks. The activity limitation subscale includes 5 items and evaluates activity limitations due to foot problems. Each item is scored between 0 and 10. A high score indicates a high degree of disability.	The feet are flexible structures of bones, joints, muscles, and soft tissues that let us stand upright and perform activities like walking, running, and jumping. Foot functions will be evaluated with the Foot Function Index.
International Physical Activity Questionnaire Short Form	After 14 weeks. After scoring, physical activity levels are classified as physically inactive (inactive), low physical activity level (minimally active), and adequate physical activity level (very active).	Physical activity refers to all movement including during leisure time, for transport to get to and from places, or as part of a person's work. The physical activity levels of the patients will be evaluated with the International Physical Activity Questionnaire Short Form.
Health Assessment Questionnaire	After 14 weeks. The health assessment questionnaire consists of 20 questions, each question is scored between 0-3. A high score indicates poor functional status.	Health-related quality of life (HRQOL) is an individual's or a group's perceived physical and mental health over time. health-related quality of life will be assessed by Health Assessment Questionnaire.
Balance	After 14 weeks. With the tests, the ability of the patients to maintain the center of balance, to move the center of gravity between the support surfaces of the body and to control it will be evaluated.	A state of equilibrium or parity characterized by cancellation of all forces by equal opposing forces. balance assessment will be done by the physiotherapist with the Biodex Balance System.
Plantar sensory assessment	After 14 weeks.The score of the thinnest monofilament felt will be recorded.	Light touch-pressure and functional sense assessment. plantar sense will be performed by a physiotherapist with Semmes-Weinstein monofilament test and two-point discriminator.

Trial Locations

Locations (1)

Gazi University; 🇹🇷 Ankara, Turkey