A Soft Robotics Approach Towards Finger Joint Deformities in Rheumatic Diseases

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03326817
• Date of registration: 24/10/2017
• Prospective Registration: Yes
• Primary sponsor: National University Hospital, Singapore
• Public title: A Soft Robotics Approach Towards Finger Joint Deformities in Rheumatic Diseases
• Scientific title: A Soft Robotics Approach Towards Finger Joint Deformities in Rheumatic Diseases
• Date of first enrolment: October 27, 2017
• Target sample size: 8
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03326817
• Study type: Interventional
• Study design: Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Device Feasibility. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

Singapore

Key inclusion & exclusion 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



Age minimum: 30 Years
Age maximum: 90 Years
Gender: All

Health Condition(s) or Problem(s) studied

Osteoarthritis

Intervention(s)

Device: Soft Robotic Glove Group

Other: Control Group

Primary Outcome(s)

Change in fingers' Total Active Motion [Time Frame: Week 1 baseline assessment and Week 11 post intervention assessment]

Change in grip and pinch strength [Time Frame: Week 1 baseline assessment and Week 11 post intervention assessment]

Secondary Outcome(s)

Change in patient's Canadian Occupational Performance Measure [Time Frame: Week 1 baseline assessment and Week 11 post intervention assessment.]

Secondary ID(s)

2017/00386

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

National University, Singapore