A Soft Robotics Approach Towards Finger Joint Deformities in Rheumatic Diseases

Sponsor
National University Hospital, Singapore (Other)
Overall Status
Completed
CT.gov ID
NCT03326817
Collaborator
National University, Singapore (Other)
8
1
2
4.5
1.8

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Control Group
  • Device: Soft Robotic Glove Group
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
8 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Comparing the control group and intervention groupComparing the control group and intervention group
Masking:
None (Open Label)
Primary Purpose:
Device Feasibility
Official Title:
A Soft Robotics Approach Towards Finger Joint Deformities in Rheumatic Diseases
Actual Study Start Date :
Oct 27, 2017
Actual Primary Completion Date :
Mar 14, 2018
Actual Study Completion Date :
Mar 14, 2018

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Control Group

This group will receive standard care.

Other: Control Group
Patients receive standard care

Experimental: Soft Robotic Glove Group

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

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

Outcome Measures

Primary Outcome Measures

  1. 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

  2. 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

  1. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
30 Years to 90 Years
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 National University Hospital Singapore Singapore 119074

Sponsors and Collaborators

  • National University Hospital, Singapore
  • National University, Singapore

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
National University Hospital, Singapore
ClinicalTrials.gov Identifier:
NCT03326817
Other Study ID Numbers:
  • 2017/00386
First Posted:
Oct 31, 2017
Last Update Posted:
Jul 19, 2018
Last Verified:
Sep 1, 2017
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by National University Hospital, Singapore
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 19, 2018