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Effect of foot insoles in patients with rheumatic joint disease

The effect of foot orthoses on balance in rheumatoid arthritis

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-7bs22c
Enrollment
Unknown
Registered
2017-10-31
Start date
2017-07-31
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rheumatoid arthritis, foot function, balance

Interventions

Intervention group: 45 patients with rheumatoid arthritis will receive customized insoles in ethnyl-vinyl acetate. Control group: 45 patients with rheumatoid arthritis without insoles. In the first ev
questionnaires for foot function(FFI) and functional disability (HAQ)
clinical examination of the feet (pain, callosities, ankle and finger deformities, tactile sensitivity using Semmes-Weinstein's 10g monofilament)
assessment of the number of swollen and painful joints in lower limbs
assessment of disease activity through the Clinical Disease Activity Index (CDAI)
assessment of lower limb strength through 5-time sit down-to-stand up test (SST5) and assessmento of balance using BBS (Berg Balance Scale) and TUG ("Timed up and go"). The order of application of the
Device

Sponsors

Faculdade de Ciências MédicasUniversidade Estadual de Campinas
Lead Sponsor
Faculdade de Ciências MédicasUniversidade Estadual de Campinas
Collaborator

Eligibility

Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: Patients diagnosed with RA according to the criteria of the American College of Rheumatology of 1987; older than 18 years; stable treatment in the last 3 months; possibility of attending scheduled reassessments; to be literate and able to understand the applied questionnaires and the instructions of the tests of strength and balance; use of shoes that allow the use of insoles

Exclusion criteria

Exclusion criteria: Lower limb involvement due to conditions not associated with rheumatoid arthritis; surgical procedure scheduled for the follow-up period; impairment of cutaneous integrity in the lower limbs; amputation of lower limbs; unbalanced vestibular disease; unbalanced visual disturbance; use of insoles in the last 30 days; use of walking aid for short distances

Design outcomes

Primary

MeasureTime frame
The group of patients using insoles may have improvement in the balance parameters assessed by physical tests (BBS and TUG) in 4 weeks after intervention

Secondary

MeasureTime frame
The group of patients using insoles may show improvement in the foot function assessed by foot function index (FFI) in 4 weeks after intervention

Countries

Brazil

Contacts

Public ContactJuliana Gaino

Faculdade de Ciências MédicasUniversidade Estadual de Campinas

jugaino@hotmail.com+55-19-3521-8859

Outcome results

None listed

Source: REBEC (via WHO ICTRP)