Textured Insoles and Foot Massage in Individuals Diagnosed With Rheumatoid Arthritis

NCT05045898 | Completed

• 1 other identifier: 2021 - 848
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Rheumatoid Arthritis

Keywords

plantar massage; textured insoles; balance; rheumatoid arthritis

Outcome Measures

Primary Outcomes (15)

• Foot Function Index

  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.

  Before treatment.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.

• International Physical Activity Questionnaire Short Form

  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.

  Before treatment. After scoring, physical activity levels are classified as physically inactive (inactive), low physical activity level (minimally active), and adequate physical activity level (very active).

• Health Assessment Questionnaire

  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.

  Before treatment. The health assessment questionnaire consists of 20 questions, each question is scored between 0-3. A high score indicates poor functional status.

• Plantar sensory assessment

  Light touch-pressure and functional sense assessment. plantar sense will be performed by a physiotherapist with Semmes-Weinstein monofilament test and two-point discriminator.

  Before treatment. The score of the thinnest monofilament felt will be recorded.

• Balance

  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.

  Before treatment. 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.

• Foot Function Index

  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.

  After 6 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.

• International Physical Activity Questionnaire Short Form

  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.

  After 6 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).

• Health Assessment Questionnaire

  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.

  After 6 weeks. The health assessment questionnaire consists of 20 questions, each question is scored between 0-3. A high score indicates poor functional status.

• Plantar sensory assessment

  Light touch-pressure and functional sense assessment. plantar sense will be performed by a physiotherapist with Semmes-Weinstein monofilament test and two-point discriminator.

  After 6 weeks. The score of the thinnest monofilament felt will be recorded.

• Balance

  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.

  After 6 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.

• Foot Function Index

  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.

  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.

• International Physical Activity Questionnaire Short Form

  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.

  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).

• Health Assessment Questionnaire

  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.

  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.

• Plantar sensory assessment

  Light touch-pressure and functional sense assessment. plantar sense will be performed by a physiotherapist with Semmes-Weinstein monofilament test and two-point discriminator.

  After 14 weeks.The score of the thinnest monofilament felt will be recorded.

• Balance

  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.

  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.

Study Arms (2)

Control group

EXPERIMENTAL

plantar massage

Other: plantar massage

Intervention group

EXPERIMENTAL

plantar massage and textured insoles

Other: plantar massage; Other: textured insoles

Interventions

plantar massage OTHER

The patients will be given a classical massage, known as Swedish massage, consisting of euflorage and petrissage. While the patient is lying in the supine position, a classical massage will be applied to the plantar face, dorsum and toes of both feet, which will take approximately 20 minutes in total. It will last for 6 weeks, 3 days a week.

Control group; Intervention group

textured insoles OTHER

Textured insoles will be prepared in accordance with the principles stated by Waddington et al. in 2003. In the studies of Waddington et al., ethyl vinyl acetate (EVA) textured insoles with 4 hemispherical protrusions per cm² were used. The height of each hemispherical protrusion from the EVA floor is 2 mm; The height of the insoles from the ground is 3 mm. The textured insoles will be prepared by an orthotic prosthesis center by cutting the EVA layer with the above-mentioned features in accordance with the patient's shoe/home shoe insoles and placing them on the shoe/home shoe insoles. Insoles will be provided free of charge to patients. Patients will be asked to wear their shoes/house shoes with insoles while performing activities inside and outside the home for 6 weeks.

Intervention group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Gazi University: lead

Study Sites (1)

Gazi University

Ankara, Turkey (Türkiye)

Location

Related Publications (3)

• Qiu F, Cole MH, Davids KW, Hennig EM, Silburn PA, Netscher H, Kerr GK. Effects of textured insoles on balance in people with Parkinson's disease. PLoS One. 2013 Dec 12;8(12):e83309. doi: 10.1371/journal.pone.0083309. eCollection 2013.

  PMID: 24349486 BACKGROUND

• Wikstrom EA, Song K, Lea A, Brown N. Comparative Effectiveness of Plantar-Massage Techniques on Postural Control in Those With Chronic Ankle Instability. J Athl Train. 2017 May 23. doi: 10.4085/1062-6050.52.4.02. Online ahead of print.

  PMID: 28535097 BACKGROUND

• Waddington G, Adams R. Football boot insoles and sensitivity to extent of ankle inversion movement. Br J Sports Med. 2003 Apr;37(2):170-4; discussion 175. doi: 10.1136/bjsm.37.2.170.

  PMID: 12663362 BACKGROUND

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Deran Oskay, Prof

  Gazi University

  PRINCIPAL INVESTIGATOR

• Abdurrahman Tufan, Prof

  Gazi University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant

Study Record Dates

• First Submitted: September 7, 2021
• First Posted: September 16, 2021
• Study Start: September 1, 2022
• Primary Completion: December 1, 2022
• Study Completion: October 1, 2023
• Last Updated: July 24, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)