Soft Robotic Sock Intervention for Robot-assisted Ankle-foot Mobility in Post-stroke Patients
1 other identifier
interventional
90
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable stroke
Started Sep 2022
Shorter than P25 for not_applicable stroke
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 4, 2022
CompletedFirst Posted
Study publicly available on registry
August 8, 2022
CompletedStudy Start
First participant enrolled
September 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 6, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
March 6, 2023
CompletedMarch 15, 2023
August 1, 2022
6 months
August 4, 2022
March 13, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (24)
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.
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.
Post-intervention assessment at 21 days
Modified Ashworth Scale (MAS)
Vahe 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. lidated tool for measuring muscle tone and spasticity. its performed by extending t
Post-intervention assessment at 3 month follow up visit
Functional Independent Measure (FIM) - Mobility Part. 2 questionnaires (Stroke Impact Scale (SIS)
The Stroke Impact Scale is a questionnaire with 59 questions on 8 domains of health, suitable to use for patients recovering from stroke and is used to track improvements or decline through time. Each question is score on a scale of 0 to 5. Scores from each domain are added up where total scores ranges from 0 to 100, where higher scores represent better functioning and lower score represents decline in functioning in the respective domains. An upward trend in the scores represent improvements and downward trend of the scores represent a decline in the respective domains.
Baseline assessment
Functional Independent Measure (FIM) - Mobility Part. 2 questionnaires (Stroke Impact Scale (SIS)
The Stroke Impact Scale is a questionnaire with 59 questions on 8 domains of health, suitable to use for patients recovering from stroke and is used to track improvements or decline through time. Each question is score on a scale of 0 to 5. Scores from each domain are added up where total scores ranges from 0 to 100, where higher scores represent better functioning and lower score represents decline in functioning in the respective domains. An upward trend in the scores represent improvements and downward trend of the scores represent a decline in the respective domains.
Post-intervention assessment at 21 days
Functional Independent Measure (FIM) - Mobility Part. 2 questionnaires (Stroke Impact Scale (SIS)
The Functional Independent Measure (FIM) - Mobility Part. 2 questionnaires (Stroke Impact Scale (SIS) is a questionnaire with 59 questions on 8 domains of health, suitable to use for patients recovering from stroke and is used to track improvements or decline through time. Each question is score on a scale of 0 to 5. Scores from each domain are added up where total scores ranges from 0 to 100, where higher scores represent better functioning and lower score represents decline in functioning in the respective domains. An upward trend in the scores represent improvements and downward trend of the scores represent a decline in the respective domains.
Post-intervention assessment at 3 month follow up visit
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.
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.
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.
Post-intervention assessment at 3 month follow up visit
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.
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.
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.
Post-intervention assessment at 3 months follow up visit
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.
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.
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.
Post-intervention assessment at 3 months follow-up
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.
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.
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.
Post-intervention assessment at 3 months follow-up
10 meters walk test (10MWT)
To assess the walking speed in meters per second over a short distance of 10 meters. Shorter time taken to cover the 10 meters indicates better functional mobility hence a decrease in the time taken to complete the 10MWT in subsequent measurements compared to the baseline indicates improvements.
Baseline assessment
10 meters walk test (10MWT)
To assess the walking speed in meters per second over a short distance of 10 meters. Shorter time taken to cover the 10 meters indicates better functional mobility hence a decrease in the time taken to complete the 10MWT in subsequent measurements compared to the baseline indicates improvements.
Post-intervention assessment at 21 days
10 meters walk test (10MWT)
To assess the walking speed in meters per second over a short distance of 10 meters. Shorter time taken to cover the 10 meters indicates better functional mobility hence a decrease in the time taken to complete the 10MWT in subsequent measurements compared to the baseline indicates improvements.
Post-intervention assessment 3 months follow-up
functional Magnetic Resonance Imaging (fMRI)
The functional Magnetic Resonance Imaging (fMRI) is used in this study to measure the ability of the brain to form and reorganize synaptic connections (neuroplasticity), especially in response to learning or experience or following injury. The presence of new synaptic connections or neuronal pathways in the intervention group post-intervention indicates that the intervention (Venous Assistance Contracture Management (VACOM) system helps to create more neuroplasticity through the ankle-foot movements generated by the device under investigation compared to the control group.
Post-intervention assessment at 6 weeks follow-up
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.
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.
Post-intervention assessment at 21 days.
Study Arms (2)
Venous Assistance and Contracture Management System (VACOM)
EXPERIMENTALVenous Assistance and Contracture Management System (VACOM) + Inpatient rehabilitation (daily Physiotherapy therapy and Occupational therapy)
Intermittent Pneumatic Compression (IPC)
ACTIVE COMPARATORIntermittent Pneumatic Compression (IPC) which is the standard care + Inpatient rehabilitation (daily Physiotherapy therapy and Occupational therapy)
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Medically unstable.
- Known pulmonary embolism (PE) or deep vein thrombosis (DVT).
- Pre-existing lower limb deformity, irreversible contracture, amputation, and foot drop.
- Open wound or ulcer, poor skin condition over the lower limb.
- On anti-coagulation (treatment dose).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Pui Kit Tam
Singapore, 119074, Singapore
Related Publications (2)
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.
PMID: 31065466BACKGROUNDKwah 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.
PMID: 22502803BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Pui Kit Tam, MD
National University Hospital, Singapore
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- The Assessor would be blinded to the participants identity because a block randomization with a randomly varying block size will be used. \[Online\] Available from: https://www.sealedenvelope.com/simple-randomiser/v1/lists.https://www.sealedenvelope.com/simple-randomiser/v1/lists.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 4, 2022
First Posted
August 8, 2022
Study Start
September 1, 2022
Primary Completion
March 6, 2023
Study Completion
March 6, 2023
Last Updated
March 15, 2023
Record last verified: 2022-08