Assistive Device for Hand Osteoarthritis

NCT02667145 | Completed DMC

• 1 other identifier: UFPernambuco2015
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

Brief Summary

Randomized clinical trial , blind for evaluators, to assess the effectiveness of a self-care program using assistive technology for treatment of hand osteoarthritis.

Conditions

Hand Osteoarthritis

Keywords

hand osteoarthritis; self care program; assistive tecnology

Outcome Measures

Primary Outcomes (1)

• Occupational Performance

  involvement of daily activities by the Canadian Occupational Performance Measure (COPM)

  4 weeks

Secondary Outcomes (3)

• Quality of life

  4 weeks

• Manual functional

  4 weeks

• Pain

  4 weeks

Study Arms (2)

Intervention

EXPERIMENTAL

Self care program focusing on the assistive device, For 4 weeks (1 to week lasting 90 minutes).

Other: Self care program focusing on the assistive device

Control group

NO INTERVENTION

receive only a brochure with orientations of joint protection.

Interventions

Self care program focusing on the assistive device OTHER

self-heed program focusing on the assistive device will consist of four weekly meetings lasting approximately 90 minutes. it will be stimulated the self-heed through knowledge of pathology and guidelines of protection articulate, and will be supplied, and trained the use of assistive devices to improve the performance of volunteers in their daily activities. Assistive devices are devices, not attached to the body, which help people with limited movements and restrictions on participation in the activities of everyday life. Example: thickening of tableware, tin openers. These volunteers will be evaluated in three stages: 1-initial assessment 2-after completion of the program and 90 days after the initial assessment. The questionnaires that will be used are: EVA; SACRAH; COPM; WHOQOL-Bref.

Intervention

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Hand OA diagnosis according to the criteria of the American College of Rheumatology (ACR )
• Be properly registered in the rheumatology clinic of Hospital das Clínicas

You may not qualify if:

• Surgical treatment or infiltration in the hands, in the last 6 months;
• Treatment of occupational therapy and / or physical therapy, or use of any TA feature (assist device or stent) in the last 6 months;
• Diagnosis of another rheumatologic disease or musculoskeletal system that compromise the hands associated.

Sponsors & Collaborators

• Daniela Salgado Amaral: lead

Study Sites (1)

Hospital das Clínicas - Universidade Federal de Pernambuco

Recife, Pernambuco, 50670-420, Brazil

Location

Related Publications (1)

• Amaral DS, Duarte ALBP, Barros SS, Cavalcanti SV, Ranzolin A, Leite VMM, Dantas AT, Oliveira ASCRC, Santos PS, Silva JCA, Marques CDL. Assistive devices: an effective strategy in non-pharmacological treatment for hand osteoarthritis-randomized clinical trial. Rheumatol Int. 2018 Mar;38(3):343-351. doi: 10.1007/s00296-017-3892-1. Epub 2017 Nov 28.

  PMID: 29185087 DERIVED

Study Officials

• Claudia DL Marques, PhD

  Universidade Federal de Pernambuco

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Terapeuta Ocupacional

Study Record Dates

• First Submitted: April 15, 2015
• First Posted: January 28, 2016
• Study Start: November 1, 2014
• Primary Completion: January 1, 2016
• Study Completion: January 1, 2016
• Last Updated: January 28, 2016

Record last verified: 2016-01

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)