A Soft Robotics Approach Towards Finger Joint Deformities in Rheumatic Diseases

Not Applicable

Completed

• Conditions: Osteoarthritis
• Interventions: Other: Control Group; Device: Soft Robotic Glove Group

• Registration Number: NCT03326817
• Lead Sponsor: National University Hospital, Singapore

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.

Study Timeline

• Status Verified: 2017-09
• Study First Submitted: 2017-10-24
• Study First Submitted QC: 2017-10-26
• Study Start: 2017-10-27
• Study First Posted: 2017-10-31
• Primary Completion: 2018-03-14
• Study Completion: 2018-03-14
• Last Update Submitted: 2018-07-18
• Last Update Posted: 2018-07-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 8

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Change in fingers' Total Active Motion	Week 1 baseline assessment and Week 11 post intervention assessment	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
Change in grip and pinch strength	Week 1 baseline assessment and Week 11 post intervention assessment	Measure hand strength. Unit: g/kg

Secondary Outcome Measures

Name	Time	Method
Change in patient's Canadian Occupational Performance Measure	Week 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.

Trial Locations

Locations (1)

National University Hospital; 🇸🇬 Singapore, Singapore