NCT03068338

Brief Summary

The research team's aim is to investigate the effects of the team's soft robotic socks in providing assisted ankle dorsiflexion-plantarflexion and promoting venous blood flow in stroke patients. Specifically, the investigators intend to 1) observe the development of joint contracture in terms of the range of motion of the ankle joint given the use of the device 2) monitor the presence of blood clots in the deep veins using compression Duplex ultrasonography given the use of the sock device. The investigators hypothesize that a soft robotics approach can provide compliant actuation to simulate natural ankle dorsiflexion and plantarflexion, which will consequently promote blood circulation in the lower leg of stroke patients who have not previously developed ankle joint contracture. This will prevent the occurrence of DVT and movement in the ankle joint will alleviate stiffness. This robotic sock intervention is to prevent the development of ankle joint contracture so established ankle contractures will be excluded from this study.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
17

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 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

Study Start

First participant enrolled

February 16, 2017

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

February 26, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 1, 2017

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 6, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 6, 2017

Completed
Last Updated

July 20, 2018

Status Verified

March 1, 2017

Enrollment Period

10 months

First QC Date

February 26, 2017

Last Update Submit

July 18, 2018

Conditions

Deep Vein ThrombosisAnkle Joint Contracture

Outcome Measures

Primary Outcomes (2)

  • Presence of DVT

    The primary outcome is a presence of DVT detected on a screening compression duplex ultrasonography

    4 weeks

  • Ankle range of motion

    Measurement of the range of motion of the ankle joint to determine the effect on joint contracture

    4 weeks

Study Arms (2)

Conventional therapy

ACTIVE COMPARATOR

Intermittent pneumatic compression devices are used for prevention of DVT.

Device: Intermittent pneumatic compression

Robotic Sock

EXPERIMENTAL

Soft robotic actuator used in a sock design technology to perform plantarflexion and dorsiflexion of the foot about the ankle joint.

Device: Robotic Sock

Interventions

Robotic SockDEVICE

Soft robotic actuator used in a sock design technology to perform plantarflexion and dorsiflexion of the foot about the ankle joint.

Robotic Sock
Intermittent pneumatic compressionDEVICE

Conventional device used by hospitals

Conventional therapy

Eligibility Criteria

Age30 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \- Ischemic or haemorrhagic stroke patients with severe lower limb weakness (MRC scale \<3) in flexors and extensors of knee and ankle

You may not qualify if:

  • Medically unstable patients
  • Queried pulmonary embolism (PE) / deep vein thrombosis (DVT) cases
  • Limited range of motion in ankle and foot including equinus or club foot deformity
  • Lower limb dermatitis, ulcer or open wound
  • Severe spasticity of ankle (modified Ashworth scale \>2)
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National University Hospital

Singapore, 119074, Singapore

Location

Related Publications (4)

  • Beckman MG, Hooper WC, Critchley SE, Ortel TL. Venous thromboembolism: a public health concern. Am J Prev Med. 2010 Apr;38(4 Suppl):S495-501. doi: 10.1016/j.amepre.2009.12.017.

    PMID: 20331949BACKGROUND

  • Roderick P, Ferris G, Wilson K, Halls H, Jackson D, Collins R, Baigent C. Towards evidence-based guidelines for the prevention of venous thromboembolism: systematic reviews of mechanical methods, oral anticoagulation, dextran and regional anaesthesia as thromboprophylaxis. Health Technol Assess. 2005 Dec;9(49):iii-iv, ix-x, 1-78. doi: 10.3310/hta9490.

    PMID: 16336844BACKGROUND

  • Mazzone C, Chiodo GF, Sandercock P, Miccio M, Salvi R. Physical methods for preventing deep vein thrombosis in stroke. Cochrane Database Syst Rev. 2004 Oct 18;(4):CD001922. doi: 10.1002/14651858.CD001922.pub2.

    PMID: 15495020BACKGROUND

  • Spyropoulos AC, Lin J. Direct medical costs of venous thromboembolism and subsequent hospital readmission rates: an administrative claims analysis from 30 managed care organizations. J Manag Care Pharm. 2007 Jul-Aug;13(6):475-86. doi: 10.18553/jmcp.2007.13.6.475.

    PMID: 17672809BACKGROUND

MeSH Terms

Conditions

Venous Thrombosis

Interventions

Intermittent Pneumatic Compression Devices

Condition Hierarchy (Ancestors)

ThrombosisEmbolism and ThrombosisVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Equipment and Supplies

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
DEVICE FEASIBILITY
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 26, 2017

First Posted

March 1, 2017

Study Start

February 16, 2017

Primary Completion

December 6, 2017

Study Completion

December 6, 2017

Last Updated

July 20, 2018

Record last verified: 2017-03

Locations

SG(1)