Ignite Creation Date:
2024-05-06 @ 4:54 PM
Last Modification Date:
2024-10-26 @ 2:18 PM
Study NCT ID:
NCT05133232
Status:
RECRUITING
Last Update Posted:
2022-12-20
First Post:
2020-08-19
Brief Title:
Effect of SynPhNe Physio-neuro Platform on Hand Motor Function Rehabilitation of Acute and Subacute Stroke Patients
Sponsor:
National University Hospital Singapore
Organization:
National University Hospital Singapore
Study Overview
Official Title:
Effect of SynPhNe Physio-neuro Platform on Hand Motor Function Rehabilitation of Acute and Subacute Stroke Patients
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Stroke is a major cause of adult long term disability and the fourth leading cause of death and affects 181000 persons in Singapore Post-stroke functional recovery of upper limb is poor with 80 of stroke survivors having some upper limb disability during the acute to subacute phase after stroke Early rehabilitation is paramount for enhancing the survival and independence of stroke patients and inadequate supervised therapy hours is closely associated with poor rehabilitation outcome However high intensity and high repetition therapies which facilitates neuroplasticity have historically had a poor uptake because it is manpower intensive and places a high demand on stroke patients many of whom cannot cope High fatigue and sustained levels of effort are also generally perceived as placing the patient at risk if done at home without trained supervision
Robotic rehabilitation system can provide high-intensity repetitive task-specific interactive treatment of the impaired upper limb and can serve as an objective and reliable means of monitoring patient progress
Stroke subjects also have a wide spectrum of disability resulting in unconscious co-contractions and compensatory muscle use Although these disability elements are widely acknowledged to be present technological tools for identifying and quantifying these are missing This technology gap affects the optimization of therapy and the patients understanding of their condition
This study aims
1 To investigate the feasibility and efficacy of using the SynPhNe device outside of conventional therapy time compared with conventional occupational therapy alone on hand motor function in acute and subacute stroke patients
2 To evaluate the feasibility of the use of SynPhNe by acute and subacute stroke patients with minimized supervision
3 To investigate subject and staff perceptions in terms of usability and benefit of the device
4 To study clinical outcomes EEG EMG and TMS changes over the course of the study
5 To compare the cost-benefit of SynPhNe therapy on inpatients with standard care
Hypotheses
1 SynPhNe therapy will have added benefit compared to conventional occupational therapy alone on hand motor function in acute and subacute stroke patients
2 SynPhNe can be used with minimal supervision by acute and subacute stroke patients so that the efficiency of rehabilitation is increased
3 SynPhNe therapy is a cost-effective inpatient rehabilitation option
Robotic rehabilitation system can provide high-intensity repetitive task-specific interactive treatment of the impaired upper limb and can serve as an objective and reliable means of monitoring patient progress
Stroke subjects also have a wide spectrum of disability resulting in unconscious co-contractions and compensatory muscle use Although these disability elements are widely acknowledged to be present technological tools for identifying and quantifying these are missing This technology gap affects the optimization of therapy and the patients understanding of their condition
This study aims
1 To investigate the feasibility and efficacy of using the SynPhNe device outside of conventional therapy time compared with conventional occupational therapy alone on hand motor function in acute and subacute stroke patients
2 To evaluate the feasibility of the use of SynPhNe by acute and subacute stroke patients with minimized supervision
3 To investigate subject and staff perceptions in terms of usability and benefit of the device
4 To study clinical outcomes EEG EMG and TMS changes over the course of the study
5 To compare the cost-benefit of SynPhNe therapy on inpatients with standard care
Hypotheses
1 SynPhNe therapy will have added benefit compared to conventional occupational therapy alone on hand motor function in acute and subacute stroke patients
2 SynPhNe can be used with minimal supervision by acute and subacute stroke patients so that the efficiency of rehabilitation is increased
3 SynPhNe therapy is a cost-effective inpatient rehabilitation option
Detailed Description:
Stroke is a major cause of adult long term disability and the fourth leading cause of death and affects 181000 persons in Singapore Post-stroke functional recovery of upper limb is poor with 80 of stroke survivors having some upper limb disability during the acute to subacute phase after stroke Early rehabilitation is paramount for enhancing the survival and independence of stroke patients and inadequate supervised therapy hours is closely associated with poor rehabilitation outcome However high intensity and high repetition therapies which facilitates neuroplasticity have historically had a poor uptake because it is manpower intensive and places a high demand on stroke patients many of whom cannot cope High fatigue and sustained levels of effort are also generally perceived as placing the patient at risk if done at home without trained supervision
Robotic rehabilitation system can provide high-intensity repetitive task-specific interactive treatment of the impaired upper limb and can serve as an objective and reliable means of monitoring patient progress However robotic rehabilitation technologies have not had the wide-ranging impact that was once expected Not only are they difficult to afford for the general population but their training options are limited with most of them allowing basic joint movements such as wrist extension finger extension and the like rather than actual everyday tasks and activity level training Those devices that provide a wider variety of everyday task training are more complex and expensive and few are designed to be used at home
Stroke subjects also have a wide spectrum of disability which includes muscle weakness lack of control cognitive deficits joint pain and deeply embedded maladaptive muscle couplings resulting in unconscious co-contractions and compensatory muscle use Although these disability elements are widely acknowledged to be present technological tools for identifying and quantifying these are missing This technology gap affects the optimization of therapy and the patients understanding of their condition In many cases patients are unable to grasp why there is no visible progress despite sincere effort leading to discouragement and an eventual drop out of therapy Conversely a therapist may conclude no further improvement is feasible and place the patient on maintenance exercises It is well known that patients may be required to follow different therapy roadmaps for hand function depending on the nature and extent of deficits This would involve not just strength training but also co-ordination organization and goal-based execution To be truly effective a rehabilitation platform must be able to deliver a wide range of tasks and activities in a guided manner while measuring incremental as well as overall performance in a quantitative manner
In this study we intend to fill the gap using SynPhNe- a physio-neuro platform It can provide an early repetitive and task-specific hand rehabilitation with less supervision using correct muscle groups and muscle synergies of stroke patients It also can engage physical and cognitive aspects of stroke patients We had previously conducted a study using the SynPhNe device in chronic stroke patients and found an average of 63 improvement in the upper extremity component of the Fugl-Meyer score p0015 and a 22 improvement in the Action Research Arm test p0003 after a 4 week intervention DSRB 201200521 Just as with conventional therapy we expect that the effect will be more pronounced in the acute to sub-acute stages of stroke when there is a greater degree of neuronal plasticity Hence we propose this study where we intend to explore the use of the SynPhNe to 1 increase the time the stroke-affected hand is used in therapeutic activity 2 improve the effectiveness of upper extremity rehabilitation 3 reduce the length of inpatients hospital stay
Specific study aims 1 To investigate the feasibility and efficacy of using the SynPhNe device outside of conventional therapy time compared with conventional occupational therapy alone on hand motor function in acute and subacute stroke patients 2 To evaluate the feasibility of the use of SynPhNe by acute and subacute stroke patients with minimized supervision 3 To investigate subject and staff perceptions in terms of usability and benefit of the device 4 To study clinical outcomes EEG EMG and TMS changes over the course of the study 5 To compare the cost-benefit of SynPhNe therapy on inpatients with standard care
Hypotheses 1 SynPhNe therapy will have added benefit compared to conventional occupational therapy alone on hand motor function in acute and subacute stroke patients 2 SynPhNe can be used with minimal supervision by acute and subacute stroke patients so that the efficiency of rehabilitation is increased 3 SynPhNe therapy is a cost-effective inpatient rehabilitation option
The study will be conducted in 2 phases
Phase 1 This will be a prospective cohort study recruiting 40 stroke subjects upon their admission to the inpatient rehabilitation unit at AH within 4 months of stroke Subjects will be given the option to participate in the active SynPhNe intervention arm or participate as controls 20 subjects will be recruited to the intervention arm and 20 to the control arm Subject drop-outs will be replaced to meet the recruitment target All subjects will continue with their conventional occupational therapy OT as per usual medical care plan The subjects in the SynPhNe arm will receive training with the device for 15-18 sessions over the course of 4 weeks in addition to conventional occupational therapy If the subject is discharged before completing the required training sessions they will be requested to complete the remaining sessions at outpatient clinic or at home being supervised remotely via Microsoft team viewer Among them the first 5 subjects will be supervised fully for all training sessions the subsequent subjects we will attempt to decrease the amount of supervision provided after the first 5 sessions according to the competence of the subjects to navigate the system independently The control group will continue with conventional occupational therapy without training with SynPhNe device Subject who drops out from the intervention group but has completed the first session for the introduction of the use of SynPhNe device will be given an option to be enrolled in the control group Both groups will undergo outcome measurements at pre-intervention post intervention and 4 weeks after intervention by staff who is blinded to the intervention allocation including
1 Clinical outcome measures for upper limb function the upper extremity of the Fugl-Meyer scale Action Research Arm Test grip strength 9-hole peg test Modified Ashworth scale
2 Hospital Anxiety and Depression Scale HADS
3 EQ5D
4 Transcranial Magnetic Stimulation TMS measures of cortical excitability for those without TMS contraindications The outcome measures for the control group is the same as above and will be done at similar timepoints ie after recruited pre after 15-18 session of conventional occupational therapy post and 4 weeks later post 4-weeks
For subjects convenience post assessment and post 4 weeks assessment are allowed to be completed within 1 week after the actual dates Subjects medical history length of inpatient rehabilitation stay FIM score at recruitment number of conventional therapy sessions and duration will be retrieved from subjects medical record The following information will also be collected in order to evaluate the application of SynPhNe device in stroke rehabilitation
1 Subject questionnaire which will include questions on usability perceptions of the device and its effectiveness
2 Caregiver strain index
The SynPhNe device training protocol will last approximately 60 minutes
The following information will be automatically collected by the SynPhNe device during the course of the training
1 Number of sessions of training with SynPhNe device duration of each session
2 EEGEMG scores during rest and various stages in the therapy protocol 3 Environment parameters temperature noise etc
Progress in ability to perform grasping picking reaching transferring and object releasing based on visual data will be recorded by video camera The video recording is necessary to correlate and verify EMG data changes in the course of different therapy actions The face and identifiers of subjects will not be captured If it is accidentally captured the video for that session will be deleted after the training session TMS measurement of corticospinal excitability was performed by a trained research staff Resting motor threshold RMT short intra-cortical inhibition SICI and short intra-cortical facilitation SICF will be measured using TMS stimulation of the primary motor cortex with subject sitting upright in a chair with back supported looking forward with both forearms resting comfortably on pillows and elbows supported at 90 degrees Motor-evoked potentials MEPs are recorded from the abductor pollicus brevis APB via surface electrodes in a belly-tendon arrangement Single- and paired-pulse TMS are delivered through a 70 mm figure-of-eight coil placed on the scalp with the handle pointing posteriorly at a 45 between the coronal and sagittal planes The optimal scalp position for activating APB was determined from initial exploration over a 1-cm grid marked on a swimming cap worn over the head RMT is defined by the lowest intensity eliciting peak-to-peak MEP amplitude of 50µV in at least 5 out of 10 trials from single-pulse TMS stimulation SICI and SICF are measured using paired-pulse stimulation with a conditioning stimulus of 80 of RMT followed by a test stimulus of 120 of RMT MEPs were recorded with different inter-stimulus intervals ISIs 2 3 6 10 15 ms
Phase 2 To assess the feasibility of the use of the SynPhNe device with minimal supervision in a home environment 10 acute or sub-acute stroke subjects who come from inpatient rehabilitation pool preparing for discharge and their caregivers will be recruited for SynPhNe training The first 5 sessions will be fully supervised by research staff either physically at the hospital or remotely via Microsoft team viewer and the caregivers of the subject will be trained on the operation of the synphne device The subsequent sessions will be assisted by the trained caregiver at home The protocol duration and frequency of the SynPhNe training will be the same as the intervention group of the Phase 1
In this cohort a caregiver facilitator questionnaire on usability and perceived effectiveness of the device will be administered in addition to the outcome measures common to all Incidental findings are findings that have potential health or reproductive importance to research participants and are discovered in the course of conducting the study but are unrelated to the purposes objectives or variables of the study There will be no incidental findings arising in this research as all outcome assessments in this study are designed for the purposes of the study- to study clinical outcomes EEG EMG and TMS changes over the course of the study Clinical outcomes include Action Research Arm Test Fugl-Meyer Assessment grip strength Modified Ashworth scale 9 hole peg test All these are measurement of upper limb motor function EEG EMG and TMS measures are for corticospinal excitability levels And the questionnaires are for evaluating the feasibility of the use of SynPhNe by stroke patients
Robotic rehabilitation system can provide high-intensity repetitive task-specific interactive treatment of the impaired upper limb and can serve as an objective and reliable means of monitoring patient progress However robotic rehabilitation technologies have not had the wide-ranging impact that was once expected Not only are they difficult to afford for the general population but their training options are limited with most of them allowing basic joint movements such as wrist extension finger extension and the like rather than actual everyday tasks and activity level training Those devices that provide a wider variety of everyday task training are more complex and expensive and few are designed to be used at home
Stroke subjects also have a wide spectrum of disability which includes muscle weakness lack of control cognitive deficits joint pain and deeply embedded maladaptive muscle couplings resulting in unconscious co-contractions and compensatory muscle use Although these disability elements are widely acknowledged to be present technological tools for identifying and quantifying these are missing This technology gap affects the optimization of therapy and the patients understanding of their condition In many cases patients are unable to grasp why there is no visible progress despite sincere effort leading to discouragement and an eventual drop out of therapy Conversely a therapist may conclude no further improvement is feasible and place the patient on maintenance exercises It is well known that patients may be required to follow different therapy roadmaps for hand function depending on the nature and extent of deficits This would involve not just strength training but also co-ordination organization and goal-based execution To be truly effective a rehabilitation platform must be able to deliver a wide range of tasks and activities in a guided manner while measuring incremental as well as overall performance in a quantitative manner
In this study we intend to fill the gap using SynPhNe- a physio-neuro platform It can provide an early repetitive and task-specific hand rehabilitation with less supervision using correct muscle groups and muscle synergies of stroke patients It also can engage physical and cognitive aspects of stroke patients We had previously conducted a study using the SynPhNe device in chronic stroke patients and found an average of 63 improvement in the upper extremity component of the Fugl-Meyer score p0015 and a 22 improvement in the Action Research Arm test p0003 after a 4 week intervention DSRB 201200521 Just as with conventional therapy we expect that the effect will be more pronounced in the acute to sub-acute stages of stroke when there is a greater degree of neuronal plasticity Hence we propose this study where we intend to explore the use of the SynPhNe to 1 increase the time the stroke-affected hand is used in therapeutic activity 2 improve the effectiveness of upper extremity rehabilitation 3 reduce the length of inpatients hospital stay
Specific study aims 1 To investigate the feasibility and efficacy of using the SynPhNe device outside of conventional therapy time compared with conventional occupational therapy alone on hand motor function in acute and subacute stroke patients 2 To evaluate the feasibility of the use of SynPhNe by acute and subacute stroke patients with minimized supervision 3 To investigate subject and staff perceptions in terms of usability and benefit of the device 4 To study clinical outcomes EEG EMG and TMS changes over the course of the study 5 To compare the cost-benefit of SynPhNe therapy on inpatients with standard care
Hypotheses 1 SynPhNe therapy will have added benefit compared to conventional occupational therapy alone on hand motor function in acute and subacute stroke patients 2 SynPhNe can be used with minimal supervision by acute and subacute stroke patients so that the efficiency of rehabilitation is increased 3 SynPhNe therapy is a cost-effective inpatient rehabilitation option
The study will be conducted in 2 phases
Phase 1 This will be a prospective cohort study recruiting 40 stroke subjects upon their admission to the inpatient rehabilitation unit at AH within 4 months of stroke Subjects will be given the option to participate in the active SynPhNe intervention arm or participate as controls 20 subjects will be recruited to the intervention arm and 20 to the control arm Subject drop-outs will be replaced to meet the recruitment target All subjects will continue with their conventional occupational therapy OT as per usual medical care plan The subjects in the SynPhNe arm will receive training with the device for 15-18 sessions over the course of 4 weeks in addition to conventional occupational therapy If the subject is discharged before completing the required training sessions they will be requested to complete the remaining sessions at outpatient clinic or at home being supervised remotely via Microsoft team viewer Among them the first 5 subjects will be supervised fully for all training sessions the subsequent subjects we will attempt to decrease the amount of supervision provided after the first 5 sessions according to the competence of the subjects to navigate the system independently The control group will continue with conventional occupational therapy without training with SynPhNe device Subject who drops out from the intervention group but has completed the first session for the introduction of the use of SynPhNe device will be given an option to be enrolled in the control group Both groups will undergo outcome measurements at pre-intervention post intervention and 4 weeks after intervention by staff who is blinded to the intervention allocation including
1 Clinical outcome measures for upper limb function the upper extremity of the Fugl-Meyer scale Action Research Arm Test grip strength 9-hole peg test Modified Ashworth scale
2 Hospital Anxiety and Depression Scale HADS
3 EQ5D
4 Transcranial Magnetic Stimulation TMS measures of cortical excitability for those without TMS contraindications The outcome measures for the control group is the same as above and will be done at similar timepoints ie after recruited pre after 15-18 session of conventional occupational therapy post and 4 weeks later post 4-weeks
For subjects convenience post assessment and post 4 weeks assessment are allowed to be completed within 1 week after the actual dates Subjects medical history length of inpatient rehabilitation stay FIM score at recruitment number of conventional therapy sessions and duration will be retrieved from subjects medical record The following information will also be collected in order to evaluate the application of SynPhNe device in stroke rehabilitation
1 Subject questionnaire which will include questions on usability perceptions of the device and its effectiveness
2 Caregiver strain index
The SynPhNe device training protocol will last approximately 60 minutes
The following information will be automatically collected by the SynPhNe device during the course of the training
1 Number of sessions of training with SynPhNe device duration of each session
2 EEGEMG scores during rest and various stages in the therapy protocol 3 Environment parameters temperature noise etc
Progress in ability to perform grasping picking reaching transferring and object releasing based on visual data will be recorded by video camera The video recording is necessary to correlate and verify EMG data changes in the course of different therapy actions The face and identifiers of subjects will not be captured If it is accidentally captured the video for that session will be deleted after the training session TMS measurement of corticospinal excitability was performed by a trained research staff Resting motor threshold RMT short intra-cortical inhibition SICI and short intra-cortical facilitation SICF will be measured using TMS stimulation of the primary motor cortex with subject sitting upright in a chair with back supported looking forward with both forearms resting comfortably on pillows and elbows supported at 90 degrees Motor-evoked potentials MEPs are recorded from the abductor pollicus brevis APB via surface electrodes in a belly-tendon arrangement Single- and paired-pulse TMS are delivered through a 70 mm figure-of-eight coil placed on the scalp with the handle pointing posteriorly at a 45 between the coronal and sagittal planes The optimal scalp position for activating APB was determined from initial exploration over a 1-cm grid marked on a swimming cap worn over the head RMT is defined by the lowest intensity eliciting peak-to-peak MEP amplitude of 50µV in at least 5 out of 10 trials from single-pulse TMS stimulation SICI and SICF are measured using paired-pulse stimulation with a conditioning stimulus of 80 of RMT followed by a test stimulus of 120 of RMT MEPs were recorded with different inter-stimulus intervals ISIs 2 3 6 10 15 ms
Phase 2 To assess the feasibility of the use of the SynPhNe device with minimal supervision in a home environment 10 acute or sub-acute stroke subjects who come from inpatient rehabilitation pool preparing for discharge and their caregivers will be recruited for SynPhNe training The first 5 sessions will be fully supervised by research staff either physically at the hospital or remotely via Microsoft team viewer and the caregivers of the subject will be trained on the operation of the synphne device The subsequent sessions will be assisted by the trained caregiver at home The protocol duration and frequency of the SynPhNe training will be the same as the intervention group of the Phase 1
In this cohort a caregiver facilitator questionnaire on usability and perceived effectiveness of the device will be administered in addition to the outcome measures common to all Incidental findings are findings that have potential health or reproductive importance to research participants and are discovered in the course of conducting the study but are unrelated to the purposes objectives or variables of the study There will be no incidental findings arising in this research as all outcome assessments in this study are designed for the purposes of the study- to study clinical outcomes EEG EMG and TMS changes over the course of the study Clinical outcomes include Action Research Arm Test Fugl-Meyer Assessment grip strength Modified Ashworth scale 9 hole peg test All these are measurement of upper limb motor function EEG EMG and TMS measures are for corticospinal excitability levels And the questionnaires are for evaluating the feasibility of the use of SynPhNe by stroke patients
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None