A Soft Robotics Approach Towards Finger Joint Deformities in Rheumatic Diseases

Osteoarthritis Clinical Trial

Official title:

A Soft Robotics Approach Towards Finger Joint Deformities in Rheumatic Diseases

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03326817
• Other study ID #: 2017/00386
• Status: Completed
• Phase: N/A
• Start date: October 27, 2017
• Est. completion date: March 14, 2018

Study information

• Verified date: September 2017
• Source: National University Hospital, Singapore
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The study is to investigate the effect of a soft robotic glove approach providing continuous passive motion of fingers (flexion and extension) on degenerative arthritis patients. The approach may help reduce pain, maintain mobility and flexibility and to improve hand function.

Description:

The aim is to investigate the effect of soft robotic gloves in providing continuous passive motion of the fingers (finger flexion and extension) of degenerative arthritis patients, for the purpose of providing pain relief and alleviating stiffness at the finger joints. Specifically, we intend to 1) observe the changes in range of motion of the fingers using the Total Active Motion (TAM) measure; 2) observe the changes in grip strength and pinch strength; and 3) record changes in the patients' perception of performance in activities of daily living using the Canadian Occupational Performance Measure (COPM).

The hypothesis is that a soft robotics approach in providing continuous passive motion of the finger joints of degenerative arthritis patients can reduce pain, maintain mobility and flexibility of the joints, and to improve hand function. The soft robotics approach and the standard hand therapy is better than the standard hand therapy alone.

The proposed soft robotic glove is capable of providing continuous passive motion (flexion and extension) of the fingers, and in addition, it is also designed to be portable and easy to operate, with minimal supervision. It is aimed at the home therapy of degenerative arthritis patients. In this study, by using the soft robotic glove and in observing changes in finger range of motion, grip and pinch strength, as well as perception of performance in daily activities. This is important in establishing this device as a viable means to ultimately slow down the progression of degenerative arthritis, and to significantly improve the patients' abilities in carrying out activities of daily living, which had been impaired by degenerative arthritis.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: March 14, 2018
• Est. primary completion date: March 14, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 90 Years

Eligibility

Inclusion Criteria:

1. Aged 30-90 years regardless of race

2. Osteoarthritis of the hand (Consistent with ACR criteria 1990)

3. Ability to pay attention and maintain supported sitting for 45 mins continuously

4. Able to give own consent

5. Able to comprehend and follow commands (Abbreviated Mental Test >= 7)

Exclusion Criteria:

1. Inflammatory arthritis (e.g. rheumatoid arthritis), trigger fingers, carpal tunnel syndrome (by symptoms), finger contractures

2. Recent steroid injections in the wrist/hand joints within the past 3 months

3. Anti-inflammatory drugs (e.g. non-steroidal anti-inflammatory drugs or oral steroid) in the past 1 month

4. Old stroke and/or spasticity affecting the upper limbs

5. Epilepsy for the last 6 months as of the date of recruitment

6. Poor skin conditions which would hamper donning robotic gloves

7. Pregnancy

Related Conditions & MeSH terms

• Collagen Diseases
• Osteoarthritis
• Rheumatic Diseases

Intervention

Other:
• Control Group
Patients receive standard care

Device:
• Soft Robotic Glove Group
This group will receive standard care and soft robotic therapy (continuous passive motion device developed by National University of Singapore).

Locations

Country	Name	City	State
Singapore	National University Hospital	Singapore

Sponsors (2)

Lead Sponsor	Collaborator
National University Hospital, Singapore	National University, Singapore

Country where clinical trial is conducted

Singapore, 

References & Publications (3)

Kitay GS, Koren MJ, Helfet DL, Parides MK, Markenson JA. Efficacy of combined local mechanical vibrations, continuous passive motion and thermotherapy in the management of osteoarthritis of the knee. Osteoarthritis Cartilage. 2009 Oct;17(10):1269-74. doi: — View Citation

Kjeken I, Dagfinrud H, Slatkowsky-Christensen B, Mowinckel P, Uhlig T, Kvien TK, Finset A. Activity limitations and participation restrictions in women with hand osteoarthritis: patients' descriptions and associations between dimensions of functioning. An — View Citation

Salter RB, Hamilton HW, Wedge JH, Tile M, Torode IP, O'Driscoll SW, Murnaghan JJ, Saringer JH. Clinical application of basic research on continuous passive motion for disorders and injuries of synovial joints: a preliminary report of a feasibility study. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in fingers' Total Active Motion	Measure hand range of motion in which the sum of the extension at the metacarpophalangeal (MCP), proximal interphalangeal (PIP), and distal interphalangeal (DIP) joints is subtracted from the total achievable flexion of the same joints. Unit: Degree	Week 1 baseline assessment and Week 11 post intervention assessment
Primary	Change in grip and pinch strength	Measure hand strength. Unit: g/kg	Week 1 baseline assessment and Week 11 post intervention assessment
Secondary	Change in patient's Canadian Occupational Performance Measure	Identify issues of personal importance to the patient and to detect changes in a patient's self-perception of occupational performance over time.	Week 1 baseline assessment and Week 11 post intervention assessment.