A Soft Robotics Approach Towards Finger Joint Deformities in Rheumatic Diseases
Primary Purpose
Osteoarthritis
Status
Completed
Phase
Not Applicable
Locations
Singapore
Study Type
Interventional
Intervention
Control Group
Soft Robotic Glove Group
Sponsored by
About this trial
This is an interventional device feasibility trial for Osteoarthritis focused on measuring Degenerative Arthritis, Rheumatic Diseases
Eligibility Criteria
Inclusion Criteria:
- Aged 30-90 years regardless of race
- Osteoarthritis of the hand (Consistent with ACR criteria 1990)
- Ability to pay attention and maintain supported sitting for 45 mins continuously
- Able to give own consent
- Able to comprehend and follow commands (Abbreviated Mental Test >= 7)
Exclusion Criteria:
- Inflammatory arthritis (e.g. rheumatoid arthritis), trigger fingers, carpal tunnel syndrome (by symptoms), finger contractures
- Recent steroid injections in the wrist/hand joints within the past 3 months
- Anti-inflammatory drugs (e.g. non-steroidal anti-inflammatory drugs or oral steroid) in the past 1 month
- Old stroke and/or spasticity affecting the upper limbs
- Epilepsy for the last 6 months as of the date of recruitment
- Poor skin conditions which would hamper donning robotic gloves
- Pregnancy
Sites / Locations
- National University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Control Group
Soft Robotic Glove Group
Arm Description
This group will receive standard care.
This group will receive standard care and soft robotic therapy (continuous passive motion device developed by National University of Singapore).
Outcomes
Primary Outcome Measures
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
Change in grip and pinch strength
Measure hand strength. Unit: g/kg
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT03326817
First Posted
October 24, 2017
Last Updated
July 18, 2018
Sponsor
National University Hospital, Singapore
Collaborators
National University of Singapore
1. Study Identification
Unique Protocol Identification Number
NCT03326817
Brief Title
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
2. Study Status
Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
October 27, 2017 (Actual)
Primary Completion Date
March 14, 2018 (Actual)
Study Completion Date
March 14, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National University Hospital, Singapore
Collaborators
National University of Singapore
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis
Keywords
Degenerative Arthritis, Rheumatic Diseases
7. Study Design
Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Comparing the control group and intervention group
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
8 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
This group will receive standard care.
Arm Title
Soft Robotic Glove Group
Arm Type
Experimental
Arm Description
This group will receive standard care and soft robotic therapy (continuous passive motion device developed by National University of Singapore).
Intervention Type
Other
Intervention Name(s)
Control Group
Intervention Description
Patients receive standard care
Intervention Type
Device
Intervention Name(s)
Soft Robotic Glove Group
Intervention Description
This group will receive standard care and soft robotic therapy (continuous passive motion device developed by National University of Singapore).
Primary Outcome Measure Information:
Title
Change in fingers' Total Active Motion
Description
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
Time Frame
Week 1 baseline assessment and Week 11 post intervention assessment
Title
Change in grip and pinch strength
Description
Measure hand strength. Unit: g/kg
Time Frame
Week 1 baseline assessment and Week 11 post intervention assessment
Secondary Outcome Measure Information:
Title
Change in patient's Canadian Occupational Performance Measure
Description
Identify issues of personal importance to the patient and to detect changes in a patient's self-perception of occupational performance over time.
Time Frame
Week 1 baseline assessment and Week 11 post intervention assessment.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Aged 30-90 years regardless of race
Osteoarthritis of the hand (Consistent with ACR criteria 1990)
Ability to pay attention and maintain supported sitting for 45 mins continuously
Able to give own consent
Able to comprehend and follow commands (Abbreviated Mental Test >= 7)
Exclusion Criteria:
Inflammatory arthritis (e.g. rheumatoid arthritis), trigger fingers, carpal tunnel syndrome (by symptoms), finger contractures
Recent steroid injections in the wrist/hand joints within the past 3 months
Anti-inflammatory drugs (e.g. non-steroidal anti-inflammatory drugs or oral steroid) in the past 1 month
Old stroke and/or spasticity affecting the upper limbs
Epilepsy for the last 6 months as of the date of recruitment
Poor skin conditions which would hamper donning robotic gloves
Pregnancy
Facility Information:
Facility Name
National University Hospital
City
Singapore
ZIP/Postal Code
119074
Country
Singapore
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
6481515
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.
Results Reference
result
PubMed Identifier
19433134
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.
Results Reference
result
PubMed Identifier
15829571
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.
Results Reference
result
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A Soft Robotics Approach Towards Finger Joint Deformities in Rheumatic Diseases
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