NCT03326817

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 24, 2017

Completed
3 days until next milestone

Study Start

First participant enrolled

October 27, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 31, 2017

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 14, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 14, 2018

Completed
Last Updated

July 19, 2018

Status Verified

September 1, 2017

Enrollment Period

5 months

First QC Date

October 24, 2017

Last Update Submit

July 18, 2018

Conditions

Osteoarthritis

Keywords

Degenerative Arthritis, Rheumatic Diseases

Outcome Measures

Primary Outcomes (2)

  • 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

    Week 1 baseline assessment and Week 11 post intervention assessment

  • Change in grip and pinch strength

    Measure hand strength. Unit: g/kg

    Week 1 baseline assessment and Week 11 post intervention assessment

Secondary Outcomes (1)

  • Change in patient's Canadian Occupational Performance Measure

    Week 1 baseline assessment and Week 11 post intervention assessment.

Study Arms (2)

Control Group

ACTIVE COMPARATOR

This group will receive standard care.

Other: Control Group

Soft Robotic Glove Group

EXPERIMENTAL

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

Interventions

Control GroupOTHER

Patients receive standard care

Control Group
Soft Robotic Glove GroupDEVICE

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

Soft Robotic Glove Group

Eligibility Criteria

Age30 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National University Hospital

Singapore, 119074, Singapore

Location

Related Publications (3)

  • 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.

    PMID: 6481515RESULT

  • 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.

    PMID: 19433134RESULT

  • 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.

    PMID: 15829571RESULT

MeSH Terms

Conditions

OsteoarthritisRheumatic Diseases

Interventions

Control Groups

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesConnective Tissue DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DEVICE FEASIBILITY
Intervention Model
PARALLEL
Model Details: Comparing the control group and intervention group
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 24, 2017

First Posted

October 31, 2017

Study Start

October 27, 2017

Primary Completion

March 14, 2018

Study Completion

March 14, 2018

Last Updated

July 19, 2018

Record last verified: 2017-09

Data Sharing

IPD Sharing
Will not share

Locations

SG(1)