Clinical Trials Directory

Trials / Completed

CompletedNCT05045898

Textured Insoles and Foot Massage in Individuals Diagnosed With Rheumatoid Arthritis

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
20 (actual)
Sponsor
Gazi University · Academic / Other
Sex
All
Age
18 Years – 65 Years
Healthy volunteers
Accepted

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.

Conditions

Interventions

TypeNameDescription
OTHERplantar massageThe 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.
OTHERtextured insolesTextured 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.

Timeline

Start date
2022-09-01
Primary completion
2022-12-01
Completion
2023-10-01
First posted
2021-09-16
Last updated
2024-07-24

Locations

1 site across 1 country: Turkey (Türkiye)

Source: ClinicalTrials.gov record NCT05045898. Inclusion in this directory is not an endorsement.