StrokeActSensNCT04490655
Active Somatosensory Exercise for Chronic Stroke
A study testing Active somatosensory training and Motor-based training in people with Stroke, run by Nanyang Technological University at 2 sites in Singapore.
Trial summary
The current work aims to examine whether the proposed rehabilitation training or exercise will eventually yield improvements in both motor and somatosensory aspects at one goal. Here, the word 'somatosensory' refers to bodily sensations associated with proprioception or kinesthesia, not the sensation of touch, pain… Read more about this study
- Who is it for?
- Ages 21 to 75 years
- Conditions the study is for
- Stroke
- What is being tested?
- Active somatosensory training and Motor-based training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 2 sitesSingapore
- Study dates
- 1 Mar 2021to 31 May 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- First-time ischemic or haemorrhagic stroke survivors;
- Patients of at least 6-month post-stroke;
- Patients with severe to moderate sensory impairment as assessed by Erasmus Nottingham Sensory Assessment (≤ 6/8);
- Patients with arm motor impairment, shoulder abduction and elbow extension Medical Research Council (MRC) motor power grade 3-5;
Who cannot join
- Patients with bilateral impairment;
- Patients with high upper-limb spasticity (Ashworth scale > 2);
- Patients with unilateral neglect as assessed by Star Cancellation Test (score < 44);
- Patients with cognitive impairment as assessed by a 2-step instructions from the modified Mini Mental State Examination;
- Patients with a known history of mental disorders;
- Patients with the inability to perform upper arm activity due to excessive pain
Trial locations and contacts
2 sites in 1 country.
Singapore2 sites
St Luke's Hospital
Bukit Batok New Town
AWWA Day Rehab Centre
Singapore
About this study
Official title: Effectiveness of Robotic-based ACTive somatoSENSory (Act.Sens) Retraining on Upper Limb Functions: Protocol for a Pilot Randomised Controlled Trial With Community-dwelling Stroke Survivors
The current work aims to examine whether the proposed rehabilitation training or exercise will eventually yield improvements in both motor and somatosensory aspects at one goal. Here, the word 'somatosensory' refers to bodily sensations associated with proprioception or kinesthesia, not the sensation of touch, pain, and temperature. The study focuses on upper limb retraining for community-dwelling stroke survivors using a robotic device. At the end of training, both movement accuracy and somatosensory acuity in chronic stroke survivors are presumed to improve, and such paradigm is expected to provide reliable benefits as compared to conventional intervention alone.
Read the detailed description
Long-term disability is common sequela among people with stroke. On top of motor impairment, many stroke survivors suffer from somatosensory impairment of their paretic arm, leading to their inability to perform activities of daily living using upper limb. In this respect, recent research on motor recovery following stroke has begun to place more emphasis on the inclusion of somatosensory retraining in stroke rehabilitation program. Although evidence is still scarce, training paradigms that simultaneously combine both somatosensory and motor aspects are considered useful for motor recovery in stroke survivors. Principally, studies focusing on such form of training paradigm sought to employ robotic technologies to assist in the retraining of both motor and somatosensory function in stroke survivors. Robotic technologies have gained popularity recently for assessing somatosensory function in clinical setting due to its objective quantification of patients' performance and high inter-rater reliability. Thus, with the purpose of improving both motor and somatosensory functions in chronic stroke survivors, this proposed study will provide an intensive robotic-based behavioral training intervention to chronic stroke survivors from the community. The intervention will require active participation of the patients through an exploratory strategy.
- Conditions
- Stroke
- Being tested
- Active somatosensory training, Motor-based training
- Keywords
- Somatosensory, Proprioception, Kinesthesia, Rehabilitation robotics, Positive reinforcement, Upper limb retraining
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active somatosensory trainingBehavioural
Patients in the experimental group will be required to move the robotic handle using their paretic arm from the start position to a visual target shown on screen. However, patients' paretic arm will be occluded from vision throughout the training session. They will make the reaching movement by depending on their proprioception of the arm position in space, without relying too much on the vision of their arm. Haptic guidance will be provided as somatosensory cues while participants are actively moving. Positive reinforcement will also be given for each successful movement that reaches the target in the form of a pleasant audio tone, visual feedback, and a running score. Assessment will be performed before and after the completion of the whole 15 training sessions.
Motor-based trainingBehavioural
Patients in the control group will also be required to propel the robotic handle using their paretic arm to a target location. This training covers the same centre-out reaching movements but without any emphasis on proprioception, where the view of the paretic arm will not be occluded. However, no haptic guidance will be provided during the reaching movement. Positive reinforcement will still be given to inform the participants of their trial outcomes. Assessment will be performed before and after the completion of the whole 15 training sessions.
| Study group | Role | What they receive |
|---|---|---|
| Active somatosensory training group | Experimental | Chronic stroke patients will be randomized to receive 15 sessions of robotic-based training intervention that focuses on the retraining of both motor and somatosensory functions, for a maximum of one hour per session. Receives: Behavioral: Active somatosensory training |
| Motor-based training group | Active comparator | Chronic stroke patients will be randomized to receive 15 sessions of robotic-based training intervention that is purely motor based, for a maximum of one hour per session. Receives: Behavioral: Motor-based training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in motor behavioral scores
A robotic-based assessment to evaluate the movement accuracy of patients' paretic arm. This will be analyzed through their ability to propel the robotic handle to a target location as straight and as fast as possible. Key kinematic parameters such as endpoint deviation (cm) and movement smoothness will be computed where larger numbers indicate worse performance.
Measured: Baseline, Post Day 1, Post Day 30 (where the last two sessions will be conducted 1 day and 30 days after the last intervention).
Change in somatosensory acuity
A robotic-based assessment to measure performance in proprioception/kinesthesia of patients' paretic arm. This will be analysed through their ability to first passively sense where the arm is being moved to and later on to reproduce the movement made by the robot. Key kinematic parameters such as endpoint deviation (cm) will be computed where a larger number indicate worse performance.
Measured: Baseline, Post Day 1, Post Day 30 (where the last two sessions will be conducted 1 day and 30 days after the last intervention).
Secondary outcomes (3)
Change in Fugl-Meyer Assessment for Upper Extremity (FMA-UE)
Patients' paretic arm movement ability will be evaluated across different categories of reflex, movement, and coordination. For each category, a larger number signifies better performance.
Measured: Baseline, Post Day 1, Post Day 30 (where the last two sessions will be conducted 1 day and 30 days after the last intervention).
Change in streamlined Wolf Motor Function Test (WMFT)
Patients' paretic arm performance will be measured by six timed tasks. For each category, a larger number signifies better performance.
Measured: Baseline, Post Day 1, Post Day 30 (where the last two sessions will be conducted 1 day and 30 days after the last intervention).
Change in Erasmus-MC version of the Nottingham Sensory Assessment (EmNSA)
Tactile sensations, sharp-blunt discrimination and proprioception of patients' paretic arm will be assessed. For each category, a larger number signifies better performance.
Measured: Baseline, Post Day 1, Post Day 30 (where the last two sessions will be conducted 1 day and 30 days after the last intervention).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2020
- Study start1 Mar 2021
- Primary completion31 May 2023
- Study completion31 May 2023
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 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nanyang Technological University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ananda Sidarta, Nanyang Technological University
- Investigators
- Ananda Sidarta, PhD, Principal investigator, Research Fellow
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04490655
- Sponsor's protocol ID
- NTU-IRB-2019-10-022
- Acronym
- ActSens
- Status last verified
- Oct 2023
- First submitted
- 26 Jul 2020
- Last updated
- 18 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All patient-related information, and data generated by the robotic system will be maintained on a secure server owned by the university. Access to research records will be limited to primary research team members. Data monitoring will comply with the university policy, guidelines, and data management plan (DMP) approved for the study.
Publications
Bernardi NF, Darainy M, Ostry DJ. Somatosensory Contribution to the Initial Stages of Human Motor Learning. J Neurosci. 2015 Oct 21;35(42):14316-26. doi: 10.1523/JNEUROSCI.1344-15.2015.
PubMed 26490869Sidarta A, Vahdat S, Bernardi NF, Ostry DJ. Somatic and Reinforcement-Based Plasticity in the Initial Stages of Human Motor Learning. J Neurosci. 2016 Nov 16;36(46):11682-11692. doi: 10.1523/JNEUROSCI.1767-16.2016.
PubMed 27852776Goble DJ. Proprioceptive acuity assessment via joint position matching: from basic science to general practice. Phys Ther. 2010 Aug;90(8):1176-84. doi: 10.2522/ptj.20090399. Epub 2010 Jun 3.
PubMed 20522675Sidarta A, Lim YC, Kuah CWK, Loh YJ, Ang WT. Robotic-based ACTive somatoSENSory (Act.Sens) retraining on upper limb functions with chronic stroke survivors: study protocol for a pilot randomised controlled trial. Pilot Feasibility Stud. 2021 Nov 15;7(1):207. doi: 10.1186/s40814-021-00948-3.
PubMed 34782024
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Robotic-based ACTive somatoSENSory (Act.Sens) Retraining on Upper Limb Functions: Protocol for a Pilot Randomised Controlled Trial With Community-dwelling Stroke Survivors
- ClinicalTrials.gov ID
- NCT04490655
- Acronym / sponsor ID
- ActSens / NTU-IRB-2019-10-022
- Conditions
- Stroke
- Keywords
- Somatosensory, Proprioception, Kinesthesia, Rehabilitation robotics, Positive reinforcement, Upper limb retraining
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Nanyang Technological UniversityUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 31 May 2023 (actual)
- Study completion
- 31 May 2023 (actual)
- First posted
- 29 Jul 2020 (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 current work aims to examine whether the proposed rehabilitation training or exercise will eventually yield improvements in both motor and somatosensory aspects at one goal. Here, the word 'somatosensory' refers to bodily sensations associated with proprioception or kinesthesia, not the sensation of touch, pain, and temperature. The study focuses on upper limb retraining for community-dwelling stroke survivors using a robotic device. At the end of training, both movement accuracy and somatosensory acuity in chronic stroke survivors are presumed to improve, and such paradigm is expected to provide reliable benefits as compared to conventional intervention alone.
Detailed description
Long-term disability is common sequela among people with stroke. On top of motor impairment, many stroke survivors suffer from somatosensory impairment of their paretic arm, leading to their inability to perform activities of daily living using upper limb. In this respect, recent research on motor recovery following stroke has begun to place more emphasis on the inclusion of somatosensory retraining in stroke rehabilitation program. Although evidence is still scarce, training paradigms that simultaneously combine both somatosensory and motor aspects are considered useful for motor recovery in stroke survivors. Principally, studies focusing on such form of training paradigm sought to employ robotic technologies to assist in the retraining of both motor and somatosensory function in stroke survivors. Robotic technologies have gained popularity recently for assessing somatosensory function in clinical setting due to its objective quantification of patients' performance and high inter-rater reliability. Thus, with the purpose of improving both motor and somatosensory functions in chronic stroke survivors, this proposed study will provide an intensive robotic-based behavioral training intervention to chronic stroke survivors from the community. The intervention will require active participation of the patients through an exploratory strategy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active somatosensory training group | Experimental | Behavioral: Active somatosensory trainingChronic stroke patients will be randomized to receive 15 sessions of robotic-based training intervention that focuses on the retraining of both motor and somatosensory functions, for a maximum of one hour per session. |
| Motor-based training group | Active comparator | Behavioral: Motor-based trainingChronic stroke patients will be randomized to receive 15 sessions of robotic-based training intervention that is purely motor based, for a maximum of one hour per session. |
Who may qualify
- Ages
- 21 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- First-time ischemic or haemorrhagic stroke survivors;
- Patients of at least 6-month post-stroke;
- Patients with severe to moderate sensory impairment as assessed by Erasmus Nottingham Sensory Assessment (≤ 6/8);
- Patients with arm motor impairment, shoulder abduction and elbow extension Medical Research Council (MRC) motor power grade 3-5;
Key exclusion criteria (6 listed)
- Patients with bilateral impairment;
- Patients with high upper-limb spasticity (Ashworth scale > 2);
- Patients with unilateral neglect as assessed by Star Cancellation Test (score < 44);
- Patients with cognitive impairment as assessed by a 2-step instructions from the modified Mini Mental State Examination;
- Patients with a known history of mental disorders;
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 |
|---|---|---|
| Active somatosensory trainingPatients in the experimental group will be required to move the robotic handle using their paretic arm from the start position to a visual target shown on screen. However, patients' paretic arm will be occluded from vision throughout the training session. They will make the reaching movement by depending on their proprioception of the arm position in space, without relying too much on the vision of their arm. Haptic guidance will be provided as somatosensory cues while participants are actively moving. Positive reinforcement will also be given for each successful movement that reaches the target in the form of a pleasant audio tone, visual feedback, and a running score. Assessment will be performed before and after the completion of the whole 15 training sessions. | Behavioural | Active somatosensory training group |
| Motor-based trainingPatients in the control group will also be required to propel the robotic handle using their paretic arm to a target location. This training covers the same centre-out reaching movements but without any emphasis on proprioception, where the view of the paretic arm will not be occluded. However, no haptic guidance will be provided during the reaching movement. Positive reinforcement will still be given to inform the participants of their trial outcomes. Assessment will be performed before and after the completion of the whole 15 training sessions. | Behavioural | Motor-based training group |
Primary outcome
Change in motor behavioral scores
Time frame: Baseline, Post Day 1, Post Day 30 (where the last two sessions will be conducted 1 day and 30 days after the last intervention).
A robotic-based assessment to evaluate the movement accuracy of patients' paretic arm. This will be analyzed through their ability to propel the robotic handle to a target location as straight and as fast as possible. Key kinematic parameters such as endpoint deviation (cm) and movement smoothness will be computed where larger numbers indicate worse performance.
Change in somatosensory acuity
Time frame: Baseline, Post Day 1, Post Day 30 (where the last two sessions will be conducted 1 day and 30 days after the last intervention).
A robotic-based assessment to measure performance in proprioception/kinesthesia of patients' paretic arm. This will be analysed through their ability to first passively sense where the arm is being moved to and later on to reproduce the movement made by the robot. Key kinematic parameters such as endpoint deviation (cm) will be computed where a larger number indicate worse performance.
3 secondary outcomes
Change in Fugl-Meyer Assessment for Upper Extremity (FMA-UE)
Time frame: Baseline, Post Day 1, Post Day 30 (where the last two sessions will be conducted 1 day and 30 days after the last intervention).
Change in streamlined Wolf Motor Function Test (WMFT)
Time frame: Baseline, Post Day 1, Post Day 30 (where the last two sessions will be conducted 1 day and 30 days after the last intervention).
Change in Erasmus-MC version of the Nottingham Sensory Assessment (EmNSA)
Time frame: Baseline, Post Day 1, Post Day 30 (where the last two sessions will be conducted 1 day and 30 days after the last intervention).
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 18 Oct 2023.
- Background: PubMed 26490869Bernardi NF, Darainy M, Ostry DJ. Somatosensory Contribution to the Initial Stages of Human Motor Learning. J Neurosci. 2015 Oct 21;35(42):14316-26. doi: 10.1523/JNEUROSCI.1344-15.2015.
- Background: PubMed 27852776Sidarta A, Vahdat S, Bernardi NF, Ostry DJ. Somatic and Reinforcement-Based Plasticity in the Initial Stages of Human Motor Learning. J Neurosci. 2016 Nov 16;36(46):11682-11692. doi: 10.1523/JNEUROSCI.1767-16.2016.
- Background: PubMed 20522675Goble DJ. Proprioceptive acuity assessment via joint position matching: from basic science to general practice. Phys Ther. 2010 Aug;90(8):1176-84. doi: 10.2522/ptj.20090399. Epub 2010 Jun 3.
- Derived from this study: PubMed 34782024Sidarta A, Lim YC, Kuah CWK, Loh YJ, Ang WT. Robotic-based ACTive somatoSENSory (Act.Sens) retraining on upper limb functions with chronic stroke survivors: study protocol for a pilot randomised controlled trial. Pilot Feasibility Stud. 2021 Nov 15;7(1):207. doi: 10.1186/s40814-021-00948-3.
- Individual participant dataSharing planned: Yes. All patient-related information, and data generated by the robotic system will be maintained on a secure server owned by the university. Access to research records will be limited to primary research team members. Data monitoring will comply with the university policy, guidelines, and data management plan (DMP) approved for the study.
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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.
Ananda Sidarta, PhD principal investigator
Research Fellow
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active somatosensory training and Motor-based training in people with Stroke, run by Nanyang Technological University at 2 sites 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 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 18 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Change in motor behavioral scores (time frame: Baseline, Post Day 1, Post Day 30 (where the last two sessions will be conducted 1 day and 30 days after the last intervention).). 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 NCT04490655, 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 18 Oct 2023; AzTrials last refreshed its copy on 28 Oct 2026.