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A Soft Robotics Approach Towards Finger Joint Deformities in Rheumatic Diseases

A Soft Robotics Approach Towards Finger Joint Deformities in Rheumatic Diseases

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03326817
Enrollment
8
Registered
2017-10-31
Start date
2017-10-27
Completion date
2018-03-14
Last updated
2018-07-19

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

Conditions

Osteoarthritis

Keywords

Degenerative Arthritis, Rheumatic Diseases

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.

Interventions

OTHERControl Group

Patients receive standard care

DEVICESoft Robotic Glove Group

This group will receive standard care and soft robotic therapy (continuous passive motion device developed by National University of Singapore).

Sponsors

National University of Singapore
CollaboratorOTHER
National University Hospital, Singapore
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE

Intervention model description

Comparing the control group and intervention group

Eligibility

Sex/Gender
ALL
Age
30 Years to 90 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change in fingers' Total Active MotionWeek 1 baseline assessment and Week 11 post intervention assessmentMeasure 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
Change in grip and pinch strengthWeek 1 baseline assessment and Week 11 post intervention assessmentMeasure hand strength. Unit: g/kg

Secondary

MeasureTime frameDescription
Change in patient's Canadian Occupational Performance MeasureWeek 1 baseline assessment and Week 11 post intervention assessment.Identify issues of personal importance to the patient and to detect changes in a patient's self-perception of occupational performance over time.

Countries

Singapore

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026