Clinical trial NCT05045898: Textured Insoles and Foot Massage in Individuals Diagnosed With Rheumatoid Arthritis
Official title: Effects of Textured Insoles Used in Addition to Foot Massage Application on Balance, Sensation, Foot Functions, Physical Activity and Quality of Life in Individuals Diagnosed With Rheumatoid Arthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rheumatoid Arthritis
Keywords: plantar massage
textured insoles
balance
rheumatoid arthritis
Lead sponsor: Gazi University
Sponsor class: OTHER
First posted: 2021-09-16
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Foot Function Index
timeFrame: 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.
measure: International Physical Activity Questionnaire Short Form
timeFrame: 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).
measure: Health Assessment Questionnaire
timeFrame: Before treatment. The health assessment questionnaire consists of 20 questions, each question is scored between 0-3. A high score indicates poor functional status.
measure: Plantar sensory assessment
timeFrame: Before treatment. The score of the thinnest monofilament felt will be recorded.
measure: Balance
timeFrame: 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.
measure: Foot Function Index
timeFrame: 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.
measure: International Physical Activity Questionnaire Short Form
timeFrame: 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).
measure: Health Assessment Questionnaire
timeFrame: 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.
measure: Plantar sensory assessment
timeFrame: After 6 weeks. The score of the thinnest monofilament felt will be recorded.
measure: Balance
timeFrame: 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.
measure: Foot Function Index
timeFrame: 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.
measure: International Physical Activity Questionnaire Short Form
timeFrame: 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).
measure: Health Assessment Questionnaire
timeFrame: 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.
measure: Plantar sensory assessment
timeFrame: After 14 weeks.The score of the thinnest monofilament felt will be recorded.
measure: Balance
timeFrame: 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.
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Gazi University
Study officials:
affiliation: Gazi University
name: Deran Oskay, Prof
role: PRINCIPAL_INVESTIGATOR
affiliation: Gazi University
name: Abdurrahman Tufan, Prof
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.