Deep Vein ThrombosisNCT03068338
Robotic Sock Technology for Prevention of Deep Vein Thrombosis and Joint Contracture
A study testing Robotic Sock and Intermittent pneumatic compression in people with Deep Vein Thrombosis and Ankle Joint Contracture, run by National University Hospital, Singapore at 1 site in Singapore.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 100 years
- Conditions the study is for
- Deep Vein Thrombosis, Ankle Joint Contracture
- What is being tested?
- Robotic Sock and Intermittent pneumatic compression
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteSingapore
- Study dates
- 16 Feb 2017to 6 Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ischemic or haemorrhagic stroke patients with severe lower limb weakness (MRC scale <3) in flexors and extensors of knee and ankle
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
The investigator's proposed robotic sock solution is capable of providing programmable robot-assisted ankle exercises to chronic bedridden patients, thereby improving venous blood flow, and preventing DVT and ankle joint contractures. Compared to conventional mechanical prophylaxis such as the intermittent pneumatic compression devices, the robotic sock is likely to cost almost five times less, and potentially generate patient/hospital savings of up to $2750 per patient. The use of the robotic sock will also raise therapist productivity through automating the therapy exercises of the bedridden patients, and this could potentially save the therapists at least 6 workhours per day. The use of the robotic sock in hospitals, nursing homes and patients' own homes will likely reduce healthcare costs and prevent side effects, as compared to conventional DVT prophylaxis approaches. In addition, it will add new values and benefits to public healthcare by eliminating additional treatment costs arising from DVT-related complications, increasing therapists' productivity (especially given growing manpower constraints and greying population), optimizing therapy time, and ultimately saving precious lives.
Among those diagnosed with DVT, 10-30% dies within 1 month of diagnosis (Beckman et al., 2010), and worldwide 600,000-800,000 people die annually (worldthrombosisday.org). This research seeks to lower DVT risk through a safe non-drug-based approach by continuously moving the ankle joint into dorsiflexion-plantarflexion using soft robotics. Current alternatives to prevent DVT include pharmacological prophylaxis such as anticoagulant drugs, mechanical prophylaxis such as intermittent pneumatic compression devices and compression stockings, and the basic therapist-assisted exercises to prevent ankle joint contractures. Pharmacological prophylaxis can improve venous blood flow and prevent DVT, but run the risk of detrimental side effects like excessive bleeding. Mechanical prophylaxis can provide passive or automated stimulation to the calf tissue, but have been reported to deliver limited efficacy in improving venous blood flow and preventing DVT. Considering the data from the United States and United Kingdom, the annual spending incurred due to direct and indirect costs resulting from DVT is approximated to be US$2-10 billion and this ranges from US$7,594-US$16,644 per patient (Spyropoulos and Lin, 2007). Therefore, by implementing the robotic sock device, the investigators hope to enable clinicians to focus on treating patients towards stroke recovery without worrying about other complications.
Joint contractures, usually defined as limited passive range of joint motion are common in people with neurological conditions such as stroke or spinal cord injury. The risk factors for joint contractures are not well understood; however, immobility seems to be the most important factors. Joint contractures, especially in the ankle joints, may impede the ability to walk and cause loss of balance, high risk of falls and restricted participation in social activities. The frequency of ankle contractures in hospitalized patients varies with prevalence rates ranging from 24 % to 44 %.
- Conditions
- Deep Vein Thrombosis, Ankle Joint Contracture
- Being tested
- Robotic Sock, Intermittent pneumatic compression
- Medical subject headings
- Venous Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robotic SockDevice
Soft robotic actuator used in a sock design technology to perform plantarflexion and dorsiflexion of the foot about the ankle joint.
Intermittent pneumatic compressionDevice
Conventional device used by hospitals
| Study group | Role | What they receive |
|---|---|---|
| Conventional therapy | Active comparator | Intermittent pneumatic compression devices are used for prevention of DVT. Receives: 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. Receives: Device: Robotic Sock |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of DVT
The primary outcome is a presence of DVT detected on a screening compression duplex ultrasonography
Measured: 4 weeks
Ankle range of motion
Measurement of the range of motion of the ankle joint to determine the effect on joint contracture
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2017
- Study start16 Feb 2017
- Primary completion6 Dec 2017
- Study completion6 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Deep Vein ThrombosisStudies of the same condition, open and under way.
- More trials run by National University Hospital, SingaporeThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- National University Hospital, Singapore
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03068338
- Sponsor's protocol ID
- RSDVT001
- Status last verified
- Mar 2017
- First submitted
- 26 Feb 2017
- Last updated
- 20 Jul 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 20331949Roderick 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.
PubMed 16336844Mazzone 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.
PubMed 15495020Spyropoulos 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.
PubMed 17672809
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Robotic Sock Technology for Prevention of Deep Vein Thrombosis and Joint Contracture
- ClinicalTrials.gov ID
- NCT03068338
- Acronym / sponsor ID
- RSDVT001
- Conditions
- Deep Vein Thrombosis, Ankle Joint Contracture
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- National University Hospital, SingaporeUniversity, hospital or other
- Study start
- 16 Feb 2017 (actual)
- Primary completion
- 6 Dec 2017 (actual)
- Study completion
- 6 Dec 2017 (actual)
- First posted
- 1 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The investigator's proposed robotic sock solution is capable of providing programmable robot-assisted ankle exercises to chronic bedridden patients, thereby improving venous blood flow, and preventing DVT and ankle joint contractures. Compared to conventional mechanical prophylaxis such as the intermittent pneumatic compression devices, the robotic sock is likely to cost almost five times less, and potentially generate patient/hospital savings of up to $2750 per patient. The use of the robotic sock will also raise therapist productivity through automating the therapy exercises of the bedridden patients, and this could potentially save the therapists at least 6 workhours per day. The use of the robotic sock in hospitals, nursing homes and patients' own homes will likely reduce healthcare costs and prevent side effects, as compared to conventional DVT prophylaxis approaches. In addition, it will add new values and benefits to public healthcare by eliminating additional treatment costs arising from DVT-related complications, increasing therapists' productivity (especially given growing manpower constraints and greying population), optimizing therapy time, and ultimately saving precious lives.
Among those diagnosed with DVT, 10-30% dies within 1 month of diagnosis (Beckman et al., 2010), and worldwide 600,000-800,000 people die annually (worldthrombosisday.org). This research seeks to lower DVT risk through a safe non-drug-based approach by continuously moving the ankle joint into dorsiflexion-plantarflexion using soft robotics. Current alternatives to prevent DVT include pharmacological prophylaxis such as anticoagulant drugs, mechanical prophylaxis such as intermittent pneumatic compression devices and compression stockings, and the basic therapist-assisted exercises to prevent ankle joint contractures. Pharmacological prophylaxis can improve venous blood flow and prevent DVT, but run the risk of detrimental side effects like excessive bleeding. Mechanical prophylaxis can provide passive or automated stimulation to the calf tissue, but have been reported to deliver limited efficacy in improving venous blood flow and preventing DVT. Considering the data from the United States and United Kingdom, the annual spending incurred due to direct and indirect costs resulting from DVT is approximated to be US$2-10 billion and this ranges from US$7,594-US$16,644 per patient (Spyropoulos and Lin, 2007). Therefore, by implementing the robotic sock device, the investigators hope to enable clinicians to focus on treating patients towards stroke recovery without worrying about other complications.
Joint contractures, usually defined as limited passive range of joint motion are common in people with neurological conditions such as stroke or spinal cord injury. The risk factors for joint contractures are not well understood; however, immobility seems to be the most important factors. Joint contractures, especially in the ankle joints, may impede the ability to walk and cause loss of balance, high risk of falls and restricted participation in social activities. The frequency of ankle contractures in hospitalized patients varies with prevalence rates ranging from 24 % to 44 %.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional therapy | Active comparator | Device: Intermittent pneumatic compressionIntermittent pneumatic compression devices are used for prevention of DVT. |
| Robotic Sock | Experimental | Device: Robotic SockSoft robotic actuator used in a sock design technology to perform plantarflexion and dorsiflexion of the foot about the ankle joint. |
Who may qualify
- Ages
- 30 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Ischemic or haemorrhagic stroke patients with severe lower limb weakness (MRC scale <3) in flexors and extensors of knee and ankle
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Robotic SockSoft robotic actuator used in a sock design technology to perform plantarflexion and dorsiflexion of the foot about the ankle joint. | Device | Robotic Sock |
| Intermittent pneumatic compressionConventional device used by hospitals | Device | Conventional therapy |
Primary outcome
Presence of DVT
Time frame: 4 weeks
The primary outcome is a presence of DVT detected on a screening compression duplex ultrasonography
Ankle range of motion
Time frame: 4 weeks
Measurement of the range of motion of the ankle joint to determine the effect on joint contracture
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2018.
- Background: PubMed 20331949Beckman 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.
- Background: PubMed 16336844Roderick 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.
- Background: PubMed 15495020Mazzone 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.
- Background: PubMed 17672809Spyropoulos 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Robotic Sock and Intermittent pneumatic compression in people with Deep Vein Thrombosis and Ankle Joint Contracture, run by National University Hospital, Singapore at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence of DVT (time frame: 4 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03068338, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2018.