Clinical trial NCT03326817: A Soft Robotics Approach Towards Finger Joint Deformities in Rheumatic Diseases
Official title: A Soft Robotics Approach Towards Finger Joint Deformities in Rheumatic Diseases
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis
Keywords: Degenerative Arthritis, Rheumatic Diseases
Lead sponsor: National University Hospital, Singapore
Sponsor class: OTHER
Collaborators: name: National University of Singapore
First posted: 2017-10-31
Enrollment: 8
Sex: ALL
Minimum age (years): 30
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Comparing the control group and intervention group
Primary purpose: DEVICE_FEASIBILITY

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in fingers' Total Active Motion
timeFrame: Week 1 baseline assessment and Week 11 post intervention assessment
measure: Change in grip and pinch strength
timeFrame: Week 1 baseline assessment and Week 11 post intervention assessment
Secondary outcomes:
measure: Change in patient's Canadian Occupational Performance Measure
timeFrame: Week 1 baseline assessment and Week 11 post intervention assessment.
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: National University Hospital
Study officials:
References:
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. J Orthop Res. 1984;1(3):325-42. doi: 10.1002/jor.1100010313.
citation: 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: 10.1016/j.joca.2009.04.015. Epub 2009 May 4.
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. Ann Rheum Dis. 2005 Nov;64(11):1633-8. doi: 10.1136/ard.2004.034900. Epub 2005 Apr 13.