StrokeNCT05491109
Soft Robotic Sock Intervention for Robot-assisted Ankle-foot Mobility in Post-stroke Patients
A study testing Venous Assistance and Contracture Management System (VACOM) in people with Stroke and DVT, run by National University Hospital, Singapore at 1 site in Singapore.
Trial summary
Stroke is closely associated with high mortality among patients in hospitals and immobility leading development of deep vein thrombosis (DVT) leading to pulmonary embolism (PE) and Venous thromboembolism (VTE) and/or ankle joint contracture, which impairs mobility resulting in bedridden. Read more about this study
- Who is it for?
- Ages 21 to 99 years
- Conditions the study is for
- Stroke, DVT, Ankle Contracture
- What is being tested?
- Venous Assistance and Contracture Management System (VACOM)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteSingapore
- Study dates
- 1 Sep 2022to 31 Oct 2023
- 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 21 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Acute ischemic or haemorrhagic stroke.
- Affected Ankle Dorsi-Flexor MMT < 3.
- Modified Ashworth Scale (MAS) = 1+ (Ankle Dorsi-Flexor/Plantar Flexor).
- Not able to ambulate without assistance except during therapy time.
Who cannot join
- Medically unstable.
- Known pulmonary embolism (PE) or deep vein thrombosis (DVT).
- Pre-existing lower limb deformity, amputation, and foot drop.
- Open wound or ulcer, poor skin condition over the lower limb.
- On anti-coagulation (treatment dose).
Trial locations and contacts
1 site in 1 country.
About this study
Stroke is closely associated with high mortality among patients in hospitals and immobility leading development of deep vein thrombosis (DVT) leading to pulmonary embolism (PE) and Venous thromboembolism (VTE) and/or ankle joint contracture, which impairs mobility resulting in bedridden. Worldwide, the incidences of DVTs is 0.75-2.69 per 1000 individuals and 2-7 per 1000 for individuals aged > 70 years and accounts for 600,000-800,000 deaths yearly.
Pharmacological treatment for DVTs include anti-coagulants to prevent blood clot development and VTE but may cause haemorrhagic stroke leading to death. Non-invasive treatment such as intermittent pneumatic compression (IPC) and anti-embolism stockings may prevent DVT but not ankle joint contractures, which affects 50% of all stroke patients. Joint contractures exacerbate pedal edema and fluid retention, hamper proper joint movement and decreases ADLs and quality of life. Regular physiotherapy is vital for preventing ankle joint contracture and DVT but is labour intensive hence posing an increased workload on physiotherapists resulting in decreased physiotherapy duration.
This study will investigate the use of an automated robot-assisted ankle exercise solution (Venous Assistance and Contracture Management System, VACOM) to mimic therapist-assisted on bed passive ankle exercises to preclude the development of ankle joint contracture and facilitate venous flow in lower extremities to reduce DVT risk. The investigators hypothesize that the Venous Assistance and Contracture Management (VACOM) system can prevent ankle contracture, improve ankle range of motion (ROM) and flexibility while reducing the risk of DVT incidence among stroke patients more than using IPC alone. Additionally, through early ankle mobilization, rehabilitation can be optimized to achieve better neurological recovery.
Read the detailed description
Stroke is one of the top medical conditions resulting in high mortality among patients in hospitals, where complications related to immobility such as deep vein thrombosis (DVT) and/or ankle joint contracture can affect patients in their road to recovery. Patients may often take months or even years to fully recover their limb functions, where certain activities of daily living cannot be easily achieved prior to recovery. In the case of the affected lower limbs, immobility can affect common activities such as getting out of bed resulting in bedridden. Bedridden is also highly susceptible to the vicious cycle which developing ankle joint contracture and DVT.
In severe DVT cases, the blood clots in the deep veins can dislodge into the bloodstream and circulate in the whole body. There is a chance to occlude the arteries in the lungs, leading to pulmonary embolism (PE). Venous thromboembolism (VTE), including DVT and PE, occurs at an annual incidence rate of 0.75-2.69 per 1000 individuals worldwide; this incidence rate increased to 2-7 per 1000 for individuals aged > 70 years (ISTH Steering Committee, 2014). Among those diagnosed with DVT, 10-30% dies within 1 month of diagnosis (Beckman et al., 2010), and 600,000-800,000 people die from DVT worldwide annually (worldthrombosisday.org), which equates to approximately 1 DVT-related death per minute.
Current treatment approaches include pharmacological prophylaxis can be often used as the blood thinner to prevent blood clot development. Low-dose anticoagulation reduces the incidence of VTE, however, the benefit can be often offset by haemorrhagic complications which can lead to death, especially for patients suffering from haemorrhagic stroke (Roderick et al., 2005).
Other non-invasive treatment or mechanical prophylaxis, such as intermittent pneumatic compression (IPC) and anti-embolism stockings, have some efficacy in preventing DVT based on clinical reports (Mazzone et al., 2004; Caprini, 2010); however, these devices do not prevent ankle joint contractures as their action mechanism is related with passive compression and decompression of lower limb muscles without the actual mobilization of joints. Approximately 50% of all stroke patients develop at least one contracture within six months of stroke (Li et al. 2012). Once the ankle joint contracture developed, it can exacerbate pedal edema and fluid retention, and hamper proper joint movement, which is indispensable for regaining ambulatory function and quality of life. These patients usually have to rely on regular physiotherapy sessions that provide therapist-assisted ankle exercises to prevent ankle joint contracture and reduce the risk of DVT. However, given growing manpower constraints and a greying global population, there is an increasing workload on physiotherapists, resulting in insufficient time to complete their physiotherapy routines.
This study is important for the following reasons:
- To investigate the efficacy of the VACOM system in providing assisted ankle movement and promoting lower limbs venous return for stroke patients in the hospital rehabilitation setting.
- This study intends to 1) observe the ankle joint mobility and flexibility by using the range of motion measure, 2) monitor the presence of blood clots in lower limbs by using compression Duplex ultrasonography, 3) evaluate the functional recovery by providing early mobilization in the bed.
- To study the economic impact of the VACOM system in the current healthcare system by collecting the survey forms and statistical data.
- To examine the cost-effectiveness, such as healthcare workload reduction, the probability of the intervention being cost-effective, etc.
- To generate evidence on this innovative device and further deploy it in clinical practice.
The automated robot-assisted ankle exercise solution (Venous Assistance and Contracture Management System, VACOM) aims to mimic therapist-assisted on bed passive ankle exercises to preclude the development of ankle joint contracture and facilitate venous flow in lower extremities to reduce DVT risk.
The VACOM uses soft pneumatic extension actuators, which is capable of providing robot-assisted ankle exercises, specifically dorsiflexion-plantarflexion and inversion-eversion movements. Through these natural movements to improve blood flow and venous return and maintain ankle joint flexibility. Furthermore, it can facilitate and stimulate the neurologic recovery in walking by early mobilization.
The investigators will conduct a multi-site clinical trial on around 100 stroke patients across different hospitals and healthcare institutions in Singapore to establish the efficacy of our soft robotic system (VACOM) in preventing ankle joint contracture and reducing DVT risk. Importantly, to investigate the effect and impact of the current healthcare system on the cost-effectiveness and workload reduction for the healthcare staff.
The Investigators hypothesize that the Venous Assistance and Contracture Management (VACOM) system can improve ankle range of motion (ROM) and flexibility by preventing ankle contracture while reducing the risk of DVT incidence among stroke patients. It might have a better outcome than using IPC alone. Additionally, through early ankle mobilization, rehabilitation can be optimized to achieve better neurological recovery.
- Conditions
- Stroke, DVT, Ankle Contracture
- Being tested
- Venous Assistance and Contracture Management System (VACOM)
- Keywords
- Soft robotics, rehabilitation, Deep vein thrombosis, Stroke, Ankle contracture
- Medical subject headings
- Stroke, Venous Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Venous Assistance and Contracture Management System (VACOM)Device
Mimic therapist-assisted on bed passive ankle exercises to preclude the development of ankle joint contracture and facilitate venous flow in lower extremities to reduce DVT risk. Using soft pneumatic extension actuators, which is capable of providing robot-assisted ankle exercises, specifically dorsiflexion-plantarflexion and inversion-eversion movements. Through these natural movements to improve blood flow and venous return and maintain ankle joint flexibility. Furthermore, it can facilitate and stimulate the neurologic recovery in walking by early mobilization.
| Study group | Role | What they receive |
|---|---|---|
| Venous Assistance and Contracture Management System (VACOM) | Experimental | Venous Assistance and Contracture Management System (VACOM) + Inpatient rehabilitation (daily Physiotherapy therapy and Occupational therapy) Receives: Device: Venous Assistance and Contracture Management System (VACOM) |
| Intermittent Pneumatic Compression (IPC) | Active comparator | Intermittent Pneumatic Compression (IPC) which is the standard care + Inpatient rehabilitation (daily Physiotherapy therapy and Occupational therapy) Receives: Device: Venous Assistance and Contracture Management System (VACOM) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified Ashworth Scale (MAS)
Validated tool for measuring muscle tone and spasticity. its performed by extending the patients limb first from a position of maximal possible flexion to maximal possible extension ( the point at which the first soft resistance is met). Afterwards, the modified Ashworth scale is assessed while moving from extension to flexion. Measurements are scored on a scale of 0 to 4, where score of 0= no increase in tone, 1= slight increase in tone giving a catch when slight increase in muscle tone, manifested by the limb was moved in flexion or extension, 1+ = slight increase in muscle tone, manifested by a catch followed by minimal resistance throughout (ROM ), 2= more marked increase in tone but more marked increased in muscle tone through most limb easily flexed, 3= considerable increase in tone, passive movement difficult, 4= limb rigid in flexion or extension. Higher scores post-intervention represents improvements in participants.
Measured: Baseline assessment
Modified Ashworth Scale (MAS)
Validated tool for measuring muscle tone and spasticity. its performed by extending the patients limb first from a position of maximal possible flexion to maximal possible extension ( the point at which the first soft resistance is met). Afterwards, the modified Ashworth scale is assessed while moving from extension to flexion. Measurements are scored on a scale of 0 to 4, where score of 0= no increase in tone, 1= slight increase in tone giving a catch when slight increase in muscle tone, manifested by the limb was moved in flexion or extension, 1+ = slight increase in muscle tone, manifested by a catch followed by minimal resistance throughout (ROM ), 2= more marked increase in tone but more marked increased in muscle tone through most limb easily flexed, 3= considerable increase in tone, passive movement difficult, 4= limb rigid in flexion or extension. Higher scores post-intervention represents improvements in participants.
Measured: Post-intervention assessment at 21 days
Ankle Range of Motion (ROM)
To measure the ability of a joint ability to move in its full range of motion using a goniometer. Normal ranges of ankle: Plantar flexion: 0 degrees to 40 degrees, Dorsiflexion: 0 degrees to 20. The normal range of motion for a foot is: Inversion: 0 degrees to 30 degrees, Eversion: 0 degrees to 20 degrees. Increasing degree of difference in the angles measured compared to baseline represents improvements in the range of motion of the ankle/foot.
Measured: Baseline assessment
Ankle Range of Motion (ROM)
To measure the ability of a joint ability to move in its full range of motion using a goniometer. Normal ranges of ankle: Plantar flexion: 0 degrees to 40 degrees, Dorsiflexion: 0 degrees to 20. The normal range of motion for a foot is: Inversion: 0 degrees to 30 degrees, Eversion: 0 degrees to 20 degrees. Increasing degree of difference in the angles measured compared to baseline represents improvements in the range of motion of the ankle/foot.
Measured: Post-intervention assessment at 21 days
Medical Research Council (MRC) Scale for muscle strength
The muscle scale grades muscle power on a scale of 0 to 5 in relation to the maximum expected for that muscle. Grade 0 = No movement is observed, Grade 5 = muscle contracts normally against full resistance hence the larger the score, the better the muscle strength. Higher subsequent score trend represents improving muscle strength.
Measured: Baseline assessment
Medical Research Council (MRC) Scale for muscle strength
The muscle scale grades muscle power on a scale of 0 to 5 in relation to the maximum expected for that muscle. Grade 0 = No movement is observed, Grade 5 = muscle contracts normally against full resistance hence the larger the score, the better the muscle strength. Higher subsequent score trend represents improving muscle strength.
Measured: Post-intervention assessment at 21 days
Fugl-Meyer Assessment - Lower Extremity (FMA-LE)
Lower Extremity (FMA-LE) scale measures 17 items in 2 subscales - Lower Extremity (E) and Speed/Coordination (F) - to assess the lower limb impairment in individuals who have had stroke. Measured using a 3 point scale, where 0= cannot perform, 1= performs partially, 2= performs fully. The maximum score for the Lower Extremity Subscale is 28 points and for Speed/Coordination 6 points. The total summed score of 34 points indicates normal function. Hence the higher score trends compared to the baseline indicates improvements in the lower limb functions.
Measured: Baseline assessment
Fugl-Meyer Assessment - Lower Extremity (FMA-LE)
Lower Extremity (FMA-LE) scale measures 17 items in 2 subscales - Lower Extremity (E) and Speed/Coordination (F) - to assess the lower limb impairment in individuals who have had stroke. Measured using a 3 point scale, where 0= cannot perform, 1= performs partially, 2= performs fully. The maximum score for the Lower Extremity Subscale is 28 points and for Speed/Coordination 6 points. The total summed score of 34 points indicates normal function. Hence the higher score trends compared to the baseline indicates improvements in the lower limb functions.
Measured: Post-intervention assessment at 21 days
Functional Ambulation Categories (FAC)
The Functional Ambulation Scale is a 6 point for assessing ability to ambulate through determining the extent to which an individual requires assistance when walking, regardless of with or without assistive device. When measuring FAC, the assessor asks the subject various questions and briefly observes their walking ability to provide a rating from 0 to 5, where 0 = patient is a non-functional ambulator (cannot walk); score of 1, 2 or 3 denotes a dependent ambulator who requires assistance from another person in the form of continuous manual contact (1), continuous or intermittent manual contact (2), or verbal supervision/guarding (3), a score of 4 or 5 describes an independent ambulator who can walk freely on: level surfaces only (4) or any surface (5=maximum score). Increasing FAC scores through time indicates improvements in a person's ability to ambulate.
Measured: Baseline assessment
Functional Ambulation Categories (FAC)
The Functional Ambulation Scale is a 6 point for assessing ability to ambulate through determining the extent to which an individual requires assistance when walking, regardless of with or without assistive device. When measuring FAC, the assessor asks the subject various questions and briefly observes their walking ability to provide a rating from 0 to 5, where 0 = patient is a non-functional ambulator (cannot walk); score of 1, 2 or 3 denotes a dependent ambulator who requires assistance from another person in the form of continuous manual contact (1), continuous or intermittent manual contact (2), or verbal supervision/guarding (3), a score of 4 or 5 describes an independent ambulator who can walk freely on: level surfaces only (4) or any surface (5=maximum score). Increasing FAC scores through time indicates improvements in a person's ability to ambulate.
Measured: Post-intervention assessment at 21 days
Compression Ultrasound Sonography (U/S) for the lower limbs
To detect the presence of Deep vein thrombosis (DVT) for participants in both intervention and control group.
Measured: Baseline measurement
Compression Ultrasound Sonography (U/S) for the lower limbs
To detect the presence of Deep vein thrombosis (DVT). Post-intervention U/S results should reveal that the occurrence of new DVT in the intervention group is lower than the control group thus indicating that the intervention is efficacious in preventing DVTs.
Measured: Post-intervention assessment at 21 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2022
- Study start1 Sep 2022
- Primary completion31 Oct 2023
- Study completion31 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomised Controlled Trial, Assessor blinded. The randomization method: A block randomization with a randomly varying block size. \[Online\] Available from: https://www.sealedenvelope.com/simple-randomiser/v1/lists.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- National University Hospital, Singapore
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pui Kit Tam, MD, Principal investigator, National University Hospital, Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05491109
- Sponsor's protocol ID
- 2020/01058
- Status last verified
- Aug 2024
- First submitted
- 4 Aug 2022
- Last updated
- 10 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Low FZ, Lim JH, Kapur J, Yeow RC. Effect of a Soft Robotic Sock Device on Lower Extremity Rehabilitation Following Stroke: A Preliminary Clinical Study With Focus on Deep Vein Thrombosis Prevention. IEEE J Transl Eng Health Med. 2019 Mar 22;7:4100106. doi: 10.1109/JTEHM.2019.2894753. eCollection 2019.
PubMed 31065466Kwah LK, Herbert RD, Harvey LA, Diong J, Clarke JL, Martin JH, Clarke EC, Hoang PD, Bilston LE, Gandevia SC. Passive mechanical properties of gastrocnemius muscles of people with ankle contracture after stroke. Arch Phys Med Rehabil. 2012 Jul;93(7):1185-90. doi: 10.1016/j.apmr.2012.02.009. Epub 2012 Feb 25.
PubMed 22502803
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Soft Robotic Sock Intervention for Robot-assisted Ankle-foot Mobility in Post-stroke Patients
- ClinicalTrials.gov ID
- NCT05491109
- Acronym / sponsor ID
- 2020/01058
- Conditions
- Stroke, DVT, Ankle Contracture
- Keywords
- Soft robotics, rehabilitation, Deep vein thrombosis, Stroke, Ankle contracture
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- National University Hospital, SingaporeUniversity, hospital or other
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 31 Oct 2023 (actual)
- Study completion
- 31 Oct 2023 (actual)
- First posted
- 8 Aug 2022 (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.
Stroke is closely associated with high mortality among patients in hospitals and immobility leading development of deep vein thrombosis (DVT) leading to pulmonary embolism (PE) and Venous thromboembolism (VTE) and/or ankle joint contracture, which impairs mobility resulting in bedridden. Worldwide, the incidences of DVTs is 0.75-2.69 per 1000 individuals and 2-7 per 1000 for individuals aged > 70 years and accounts for 600,000-800,000 deaths yearly.
Pharmacological treatment for DVTs include anti-coagulants to prevent blood clot development and VTE but may cause haemorrhagic stroke leading to death. Non-invasive treatment such as intermittent pneumatic compression (IPC) and anti-embolism stockings may prevent DVT but not ankle joint contractures, which affects 50% of all stroke patients. Joint contractures exacerbate pedal edema and fluid retention, hamper proper joint movement and decreases ADLs and quality of life. Regular physiotherapy is vital for preventing ankle joint contracture and DVT but is labour intensive hence posing an increased workload on physiotherapists resulting in decreased physiotherapy duration.
This study will investigate the use of an automated robot-assisted ankle exercise solution (Venous Assistance and Contracture Management System, VACOM) to mimic therapist-assisted on bed passive ankle exercises to preclude the development of ankle joint contracture and facilitate venous flow in lower extremities to reduce DVT risk. The investigators hypothesize that the Venous Assistance and Contracture Management (VACOM) system can prevent ankle contracture, improve ankle range of motion (ROM) and flexibility while reducing the risk of DVT incidence among stroke patients more than using IPC alone. Additionally, through early ankle mobilization, rehabilitation can be optimized to achieve better neurological recovery.
Detailed description
Stroke is one of the top medical conditions resulting in high mortality among patients in hospitals, where complications related to immobility such as deep vein thrombosis (DVT) and/or ankle joint contracture can affect patients in their road to recovery. Patients may often take months or even years to fully recover their limb functions, where certain activities of daily living cannot be easily achieved prior to recovery. In the case of the affected lower limbs, immobility can affect common activities such as getting out of bed resulting in bedridden. Bedridden is also highly susceptible to the vicious cycle which developing ankle joint contracture and DVT.
In severe DVT cases, the blood clots in the deep veins can dislodge into the bloodstream and circulate in the whole body. There is a chance to occlude the arteries in the lungs, leading to pulmonary embolism (PE). Venous thromboembolism (VTE), including DVT and PE, occurs at an annual incidence rate of 0.75-2.69 per 1000 individuals worldwide; this incidence rate increased to 2-7 per 1000 for individuals aged > 70 years (ISTH Steering Committee, 2014). Among those diagnosed with DVT, 10-30% dies within 1 month of diagnosis (Beckman et al., 2010), and 600,000-800,000 people die from DVT worldwide annually (worldthrombosisday.org), which equates to approximately 1 DVT-related death per minute.
Current treatment approaches include pharmacological prophylaxis can be often used as the blood thinner to prevent blood clot development. Low-dose anticoagulation reduces the incidence of VTE, however, the benefit can be often offset by haemorrhagic complications which can lead to death, especially for patients suffering from haemorrhagic stroke (Roderick et al., 2005).
Other non-invasive treatment or mechanical prophylaxis, such as intermittent pneumatic compression (IPC) and anti-embolism stockings, have some efficacy in preventing DVT based on clinical reports (Mazzone et al., 2004; Caprini, 2010); however, these devices do not prevent ankle joint contractures as their action mechanism is related with passive compression and decompression of lower limb muscles without the actual mobilization of joints. Approximately 50% of all stroke patients develop at least one contracture within six months of stroke (Li et al. 2012). Once the ankle joint contracture developed, it can exacerbate pedal edema and fluid retention, and hamper proper joint movement, which is indispensable for regaining ambulatory function and quality of life. These patients usually have to rely on regular physiotherapy sessions that provide therapist-assisted ankle exercises to prevent ankle joint contracture and reduce the risk of DVT. However, given growing manpower constraints and a greying global population, there is an increasing workload on physiotherapists, resulting in insufficient time to complete their physiotherapy routines.
This study is important for the following reasons:
- To investigate the efficacy of the VACOM system in providing assisted ankle movement and promoting lower limbs venous return for stroke patients in the hospital rehabilitation setting.
- This study intends to 1) observe the ankle joint mobility and flexibility by using the range of motion measure, 2) monitor the presence of blood clots in lower limbs by using compression Duplex ultrasonography, 3) evaluate the functional recovery by providing early mobilization in the bed.
- To study the economic impact of the VACOM system in the current healthcare system by collecting the survey forms and statistical data.
- To examine the cost-effectiveness, such as healthcare workload reduction, the probability of the intervention being cost-effective, etc.
- To generate evidence on this innovative device and further deploy it in clinical practice.
The automated robot-assisted ankle exercise solution (Venous Assistance and Contracture Management System, VACOM) aims to mimic therapist-assisted on bed passive ankle exercises to preclude the development of ankle joint contracture and facilitate venous flow in lower extremities to reduce DVT risk.
The VACOM uses soft pneumatic extension actuators, which is capable of providing robot-assisted ankle exercises, specifically dorsiflexion-plantarflexion and inversion-eversion movements. Through these natural movements to improve blood flow and venous return and maintain ankle joint flexibility. Furthermore, it can facilitate and stimulate the neurologic recovery in walking by early mobilization.
The investigators will conduct a multi-site clinical trial on around 100 stroke patients across different hospitals and healthcare institutions in Singapore to establish the efficacy of our soft robotic system (VACOM) in preventing ankle joint contracture and reducing DVT risk. Importantly, to investigate the effect and impact of the current healthcare system on the cost-effectiveness and workload reduction for the healthcare staff.
The Investigators hypothesize that the Venous Assistance and Contracture Management (VACOM) system can improve ankle range of motion (ROM) and flexibility by preventing ankle contracture while reducing the risk of DVT incidence among stroke patients. It might have a better outcome than using IPC alone. Additionally, through early ankle mobilization, rehabilitation can be optimized to achieve better neurological recovery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomised Controlled Trial, Assessor blinded. The randomization method: A block randomization with a randomly varying block size. [Online] Available from: https://www.sealedenvelope.com/simple-randomiser/v1/lists.
| Arm | Type | Receives |
|---|---|---|
| Venous Assistance and Contracture Management System (VACOM) | Experimental | Device: Venous Assistance and Contracture Management System (VACOM)Venous Assistance and Contracture Management System (VACOM) + Inpatient rehabilitation (daily Physiotherapy therapy and Occupational therapy) |
| Intermittent Pneumatic Compression (IPC) | Active comparator | Device: Venous Assistance and Contracture Management System (VACOM)Intermittent Pneumatic Compression (IPC) which is the standard care + Inpatient rehabilitation (daily Physiotherapy therapy and Occupational therapy) |
Who may qualify
- Ages
- 21 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Acute ischemic or haemorrhagic stroke.
- Affected Ankle Dorsi-Flexor MMT < 3.
- Modified Ashworth Scale (MAS) = 1+ (Ankle Dorsi-Flexor/Plantar Flexor).
- Not able to ambulate without assistance except during therapy time.
Key exclusion criteria (5 listed)
- Medically unstable.
- Known pulmonary embolism (PE) or deep vein thrombosis (DVT).
- Pre-existing lower limb deformity, amputation, and foot drop.
- Open wound or ulcer, poor skin condition over the lower limb.
- On anti-coagulation (treatment dose).
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 |
|---|---|---|
| Venous Assistance and Contracture Management System (VACOM)Mimic therapist-assisted on bed passive ankle exercises to preclude the development of ankle joint contracture and facilitate venous flow in lower extremities to reduce DVT risk. Using soft pneumatic extension actuators, which is capable of providing robot-assisted ankle exercises, specifically dorsiflexion-plantarflexion and inversion-eversion movements. Through these natural movements to improve blood flow and venous return and maintain ankle joint flexibility. Furthermore, it can facilitate and stimulate the neurologic recovery in walking by early mobilization. | Device | Intermittent Pneumatic Compression (IPC), Venous Assistance and Contracture Management System (VACOM) |
Primary outcome
Modified Ashworth Scale (MAS)
Time frame: Baseline assessment
Validated tool for measuring muscle tone and spasticity. its performed by extending the patients limb first from a position of maximal possible flexion to maximal possible extension ( the point at which the first soft resistance is met). Afterwards, the modified Ashworth scale is assessed while moving from extension to flexion. Measurements are scored on a scale of 0 to 4, where score of 0= no increase in tone, 1= slight increase in tone giving a catch when slight increase in muscle tone, manifested by the limb was moved in flexion or extension, 1+ = slight increase in muscle tone, manifested by a catch followed by minimal resistance throughout (ROM ), 2= more marked increase in tone but more marked increased in muscle tone through most limb easily flexed, 3= considerable increase in tone, passive movement difficult, 4= limb rigid in flexion or extension. Higher scores post-intervention represents improvements in participants.
Modified Ashworth Scale (MAS)
Time frame: Post-intervention assessment at 21 days
Validated tool for measuring muscle tone and spasticity. its performed by extending the patients limb first from a position of maximal possible flexion to maximal possible extension ( the point at which the first soft resistance is met). Afterwards, the modified Ashworth scale is assessed while moving from extension to flexion. Measurements are scored on a scale of 0 to 4, where score of 0= no increase in tone, 1= slight increase in tone giving a catch when slight increase in muscle tone, manifested by the limb was moved in flexion or extension, 1+ = slight increase in muscle tone, manifested by a catch followed by minimal resistance throughout (ROM ), 2= more marked increase in tone but more marked increased in muscle tone through most limb easily flexed, 3= considerable increase in tone, passive movement difficult, 4= limb rigid in flexion or extension. Higher scores post-intervention represents improvements in participants.
Ankle Range of Motion (ROM)
Time frame: Baseline assessment
To measure the ability of a joint ability to move in its full range of motion using a goniometer. Normal ranges of ankle: Plantar flexion: 0 degrees to 40 degrees, Dorsiflexion: 0 degrees to 20. The normal range of motion for a foot is: Inversion: 0 degrees to 30 degrees, Eversion: 0 degrees to 20 degrees. Increasing degree of difference in the angles measured compared to baseline represents improvements in the range of motion of the ankle/foot.
Ankle Range of Motion (ROM)
Time frame: Post-intervention assessment at 21 days
To measure the ability of a joint ability to move in its full range of motion using a goniometer. Normal ranges of ankle: Plantar flexion: 0 degrees to 40 degrees, Dorsiflexion: 0 degrees to 20. The normal range of motion for a foot is: Inversion: 0 degrees to 30 degrees, Eversion: 0 degrees to 20 degrees. Increasing degree of difference in the angles measured compared to baseline represents improvements in the range of motion of the ankle/foot.
Medical Research Council (MRC) Scale for muscle strength
Time frame: Baseline assessment
The muscle scale grades muscle power on a scale of 0 to 5 in relation to the maximum expected for that muscle. Grade 0 = No movement is observed, Grade 5 = muscle contracts normally against full resistance hence the larger the score, the better the muscle strength. Higher subsequent score trend represents improving muscle strength.
Medical Research Council (MRC) Scale for muscle strength
Time frame: Post-intervention assessment at 21 days
The muscle scale grades muscle power on a scale of 0 to 5 in relation to the maximum expected for that muscle. Grade 0 = No movement is observed, Grade 5 = muscle contracts normally against full resistance hence the larger the score, the better the muscle strength. Higher subsequent score trend represents improving muscle strength.
Fugl-Meyer Assessment - Lower Extremity (FMA-LE)
Time frame: Baseline assessment
Lower Extremity (FMA-LE) scale measures 17 items in 2 subscales - Lower Extremity (E) and Speed/Coordination (F) - to assess the lower limb impairment in individuals who have had stroke. Measured using a 3 point scale, where 0= cannot perform, 1= performs partially, 2= performs fully. The maximum score for the Lower Extremity Subscale is 28 points and for Speed/Coordination 6 points. The total summed score of 34 points indicates normal function. Hence the higher score trends compared to the baseline indicates improvements in the lower limb functions.
Fugl-Meyer Assessment - Lower Extremity (FMA-LE)
Time frame: Post-intervention assessment at 21 days
Lower Extremity (FMA-LE) scale measures 17 items in 2 subscales - Lower Extremity (E) and Speed/Coordination (F) - to assess the lower limb impairment in individuals who have had stroke. Measured using a 3 point scale, where 0= cannot perform, 1= performs partially, 2= performs fully. The maximum score for the Lower Extremity Subscale is 28 points and for Speed/Coordination 6 points. The total summed score of 34 points indicates normal function. Hence the higher score trends compared to the baseline indicates improvements in the lower limb functions.
Functional Ambulation Categories (FAC)
Time frame: Baseline assessment
The Functional Ambulation Scale is a 6 point for assessing ability to ambulate through determining the extent to which an individual requires assistance when walking, regardless of with or without assistive device. When measuring FAC, the assessor asks the subject various questions and briefly observes their walking ability to provide a rating from 0 to 5, where 0 = patient is a non-functional ambulator (cannot walk); score of 1, 2 or 3 denotes a dependent ambulator who requires assistance from another person in the form of continuous manual contact (1), continuous or intermittent manual contact (2), or verbal supervision/guarding (3), a score of 4 or 5 describes an independent ambulator who can walk freely on: level surfaces only (4) or any surface (5=maximum score). Increasing FAC scores through time indicates improvements in a person's ability to ambulate.
Functional Ambulation Categories (FAC)
Time frame: Post-intervention assessment at 21 days
The Functional Ambulation Scale is a 6 point for assessing ability to ambulate through determining the extent to which an individual requires assistance when walking, regardless of with or without assistive device. When measuring FAC, the assessor asks the subject various questions and briefly observes their walking ability to provide a rating from 0 to 5, where 0 = patient is a non-functional ambulator (cannot walk); score of 1, 2 or 3 denotes a dependent ambulator who requires assistance from another person in the form of continuous manual contact (1), continuous or intermittent manual contact (2), or verbal supervision/guarding (3), a score of 4 or 5 describes an independent ambulator who can walk freely on: level surfaces only (4) or any surface (5=maximum score). Increasing FAC scores through time indicates improvements in a person's ability to ambulate.
Compression Ultrasound Sonography (U/S) for the lower limbs
Time frame: Baseline measurement
To detect the presence of Deep vein thrombosis (DVT) for participants in both intervention and control group.
Compression Ultrasound Sonography (U/S) for the lower limbs
Time frame: Post-intervention assessment at 21 days.
To detect the presence of Deep vein thrombosis (DVT). Post-intervention U/S results should reveal that the occurrence of new DVT in the intervention group is lower than the control group thus indicating that the intervention is efficacious in preventing DVTs.
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 10 Jun 2026.
- Background: PubMed 31065466Low FZ, Lim JH, Kapur J, Yeow RC. Effect of a Soft Robotic Sock Device on Lower Extremity Rehabilitation Following Stroke: A Preliminary Clinical Study With Focus on Deep Vein Thrombosis Prevention. IEEE J Transl Eng Health Med. 2019 Mar 22;7:4100106. doi: 10.1109/JTEHM.2019.2894753. eCollection 2019.
- Background: PubMed 22502803Kwah LK, Herbert RD, Harvey LA, Diong J, Clarke JL, Martin JH, Clarke EC, Hoang PD, Bilston LE, Gandevia SC. Passive mechanical properties of gastrocnemius muscles of people with ankle contracture after stroke. Arch Phys Med Rehabil. 2012 Jul;93(7):1185-90. doi: 10.1016/j.apmr.2012.02.009. Epub 2012 Feb 25.
Related trials for Stroke
Recruiting
Connectomic Alterations Following Acute Ischemic Stroke in the MCA Territory
Ischemic Stroke
RecruitingObservational study
Clevidipine for the Antihypertensive Treatment of Acute Intracerebral Hemorrhage
Intracerebral Hemorrhage, Stroke
Active, not recruitingPhase 4
A Study Testing How Well the Drug Extract of Ginkgo Biloba Leaves Tablets Works for People With Memory or Thinking Problems After a Stroke When Added to Standard Treatment
Ischemic Stroke Hospitalized, Impairment, Cognitive
Not yet recruitingPhase 4
Anti-inflammatory and Anti-thrombotic Therapy With colcHicine and Low Dose Rivaroxaban for Major Adverse Cardiovascular Events Reduction in Ischemic Stroke
Ischemic Stroke
RecruitingObservational study
CoMind Early Feasibility Study
Intracranial Pressure, Intracranial Pressure Changes
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.
Pui Kit Tam, MD principal investigator
National University Hospital, Singapore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Venous Assistance and Contracture Management System (VACOM) in people with Stroke and DVT, 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 4 inclusion and 5 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 10 Jun 2026. 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?
Modified Ashworth Scale (MAS) (time frame: Baseline assessment). The study lists 12 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 NCT05491109, which also lists 2 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 10 Jun 2026.