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The Effect of Plantar Massage and Textured Insoles on Balance in Rheumatoid Arthritis

Primary Purpose

Rheumatoid Arthritis

Status
Active
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
plantar massage
textured insoles
Sponsored by
Gazi University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rheumatoid Arthritis focused on measuring plantar massage, textured insoles, balance, rheumatoid arthritis

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

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

Sites / Locations

  • Gazi University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Control group

Intervention group

Arm Description

plantar massage

plantar massage and textured insoles

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
September 7, 2021
Last Updated
February 22, 2023
Sponsor
Gazi University
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1. Study Identification

Unique Protocol Identification Number
NCT05045898
Brief Title
The Effect of Plantar Massage and Textured Insoles on Balance in Rheumatoid Arthritis
Official Title
The Effect of Plantar Massage and Textured Insoles on Balance in Rheumatoid Arthritis
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 1, 2022 (Actual)
Primary Completion Date
December 1, 2022 (Actual)
Study Completion Date
October 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Gazi University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis
Keywords
plantar massage, textured insoles, balance, rheumatoid arthritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
Experimental
Arm Description
plantar massage
Arm Title
Intervention group
Arm Type
Experimental
Arm Description
plantar massage and textured insoles
Intervention Type
Other
Intervention Name(s)
plantar massage
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
textured insoles
Intervention Description
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.
Primary Outcome Measure Information:
Title
Foot Function Index
Description
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.
Time Frame
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.
Title
International Physical Activity Questionnaire Short Form
Description
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.
Time Frame
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).
Title
Health Assessment Questionnaire
Description
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.
Time Frame
Before treatment. The health assessment questionnaire consists of 20 questions, each question is scored between 0-3. A high score indicates poor functional status.
Title
Plantar sensory assessment
Description
Light touch-pressure and functional sense assessment. plantar sense will be performed by a physiotherapist with Semmes-Weinstein monofilament test and two-point discriminator.
Time Frame
Before treatment. The score of the thinnest monofilament felt will be recorded.
Title
Balance
Description
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.
Time Frame
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.
Title
Foot Function Index
Description
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.
Time Frame
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.
Title
International Physical Activity Questionnaire Short Form
Description
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.
Time Frame
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).
Title
Health Assessment Questionnaire
Description
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.
Time Frame
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.
Title
Plantar sensory assessment
Description
Light touch-pressure and functional sense assessment. plantar sense will be performed by a physiotherapist with Semmes-Weinstein monofilament test and two-point discriminator.
Time Frame
After 6 weeks. The score of the thinnest monofilament felt will be recorded.
Title
Balance
Description
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.
Time Frame
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.
Title
Foot Function Index
Description
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.
Time Frame
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.
Title
International Physical Activity Questionnaire Short Form
Description
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.
Time Frame
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).
Title
Health Assessment Questionnaire
Description
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.
Time Frame
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.
Title
Plantar sensory assessment
Description
Light touch-pressure and functional sense assessment. plantar sense will be performed by a physiotherapist with Semmes-Weinstein monofilament test and two-point discriminator.
Time Frame
After 14 weeks.The score of the thinnest monofilament felt will be recorded.
Title
Balance
Description
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.
Time Frame
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 18-65 years old Being diagnosed according to the American College of Rheumatology (ACR)/EULAR 2010 rheumatoid arthritis diagnostic criteria 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Deran Oskay, Prof
Organizational Affiliation
Gazi University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Abdurrahman Tufan, Prof
Organizational Affiliation
Gazi University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Gazi University
City
Ankara
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
24349486
Citation
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.
Results Reference
background
PubMed Identifier
28535097
Citation
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.
Results Reference
background
PubMed Identifier
12663362
Citation
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.
Results Reference
background

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The Effect of Plantar Massage and Textured Insoles on Balance in Rheumatoid Arthritis

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