Ischemic StrokeNCT03032692
Motor Task Performance Under Visual and Auditory Feedback Post Stroke: a Randomized Crossover Trial
A study testing SWORD, Exercise with biofeedback and exercise without biofeedback in people with Ischemic Stroke and Upper Extremity Paresis, run by Sword Health, SA at 3 sites in Portugal.
Trial summary
The study was designed to evaluate the impact of a novel kinematic biofeedback system - SWORD - in the motor performance of patients after stroke. The SWORD system combines inertial motion trackers and a mobile app, allowing digitization of patient motion and providing real-time audiovisual biofeedback. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ischemic Stroke, Upper Extremity Paresis
- What is being tested?
- SWORD, Exercise with biofeedback and exercise without biofeedback
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 3 sitesPortugal
- Study dates
- 1 Jun 2016to 31 Aug 2016
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- clinical symptoms and signs and CT or MRI findings compatible with a lesion in the territory of the medial cerebral artery;
- persistent motor deficit on the upper limb but not plegia with a score between 0 and 2 on item 5b of the National Institute of Health Stroke Scale (NIHSS)
- more than 2 weeks after stroke onset;
- the ability to sit comfortably for more than 10 minutes and perform two-step commands
Who cannot join
- no detectable motor deficits at baseline assessment;
- severe aphasia;
- clinical dementia or mini mental state examination (MMSE) below cutoff;
- other cognitive or psychiatric comorbidity that impaired communication or compliance with the tasks;
- severe respiratory or cardiac condition incompatible with more than 5 minutes of continuous mild exercise in a sitting position;
- pain or deformity that limited upper limb movement on the affected side.
Trial locations and contacts
3 sites in 1 country.
Portugal3 sites
CMM - Centro Médico de Aveiro
Aveiro
CMM - Murtosa
Murtosa, Aveiro District, 3870-216
CMM- Centro Médico de Viseu
Viseu, 3500-719
About this study
The study was designed to evaluate the impact of a novel kinematic biofeedback system - SWORD - in the motor performance of patients after stroke. The SWORD system combines inertial motion trackers and a mobile app, allowing digitization of patient motion and providing real-time audiovisual biofeedback.
The investigators hypothesize that the biofeedback feedback provided by the SWORD system improves patient performance, defined as an increase in the number of correct movements.
The design of the study is a cross-over randomized clinical trial. Patients will be randomized into two groups. Both will perform two separate sessions consisting of one exercise - shoulder flexion with elbow flexion at 90 degrees - for 4 minutes in both experimental settings: with and without biofeedback. Group 1 will perform the exercise with biofeedback first and without biofeedback after, with an interval >24h. Group 2 will perform the exercise in the opposite order. The SWORD system will be used to record movement data in both sessions, but the feedback was only active in one of them.
- Conditions
- Ischemic Stroke, Upper Extremity Paresis
- Being tested
- SWORD, Exercise with biofeedback, exercise without biofeedback
- Medical subject headings
- Ischemic Stroke, Paresis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SWORDDevice
Also called Stroke Wearable Operative Rehabilitation Device
Both arms will perform two separate sessions consisting of one exercise - shoulder flexion with elbow flexion at 90 degrees - for 4 minutes in two experimental conditions: with and without biofeedback. Group 1 will perform the exercise with biofeedback first and without biofeedback after; group 2 performed the exercise in the opposite order. The SWORD system will be used to record movement data in both sessions.
Exercise with biofeedbackOther
exercise without biofeedbackOther
| Study group | Role | What they receive |
|---|---|---|
| SWORD and exercise with biofeedback | Experimental | The patient will perform one repetition of the exercise shoulder flexion with elbow flexion at 90 degrees under monitoring from SWORD. The recorded parameters will be used to define: baseline and target angle; execution time; maximum postural sway. Two additional repetitions will be performed to ensure reproducibility. During the session, SWORD will be providing real-time audiovisual feedback. The patient has to start in the baseline position and fill the progress bar without violating movement or posture constraints. If the patient does not reach the goal or violates constraints he will receive a negative audio feedback, the progress bar will turn red and be reset. The patient has to return to the baseline position to restart the movement. Receives: Device: SWORD; Other: Exercise with biofeedback |
| SWORD and exercise without biofeedback | Active comparator | The patient will perform one repetition of the exercise shoulder flexion with elbow flexion at 90 degrees under monitoring from SWORD. The recorded parameters will be used to define: baseline and target angle; execution time; maximum postural sway. Two additional repetitions will be performed to ensure reproducibility. The patient will then be instructed to perform as many movements as possible during the allocated time (4 minutes), at a comfortable pace, starting at or below the baseline and trying to reach maximum flexion without significant pain or discomfort. During the session, the SWORD system will be recording the patient´s movement without providing feedback to the patient. Receives: Device: SWORD; Other: exercise without biofeedback |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of correct movements
Number of correct movements performed within the duration of each exercise session
Measured: At the end of each exercise session (4 minute duration)
Secondary outcomes (8)
Total number of repetitions
Total number of repetitions performed within the duration of each exercise session
Measured: At the end of each exercise session (4 minute duration)
Number of incorrect repetitions
Number of incorrect repetitions performed within the duration of each exercise session
Measured: At the end of each exercise session (4 minute duration)
Number of consecutive incorrect repetitions
Number of consecutive incorrect repetitions performed within the duration of each exercise session
Measured: At the end of each exercise session (4 minute duration)
Number of pauses
Number of pauses registered during each exercise session
Measured: At the end of each exercise session (4 minute duration)
Posture errors
Number of posture errors registered during each exercise session
Measured: At the end of each exercise session (4 minute duration)
Movement frequency
Movement frequency (in Hertz) during each exercise session
Measured: At the end of each exercise session (4 minute duration)
Range of motion of correct movements
Mean range of motion of the correct movements performed during each exercise session
Measured: At the end of each exercise session (4 minute duration)
Range of motion variability over time
Variability of the mean range of motion during the exercise session (for correct movements)
Measured: Between the second and first minute; between the second and third minutes; between the third and fourth minute
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2017 (estimated)
- Study start1 Jun 2016
- Primary completion31 Aug 2016
- Study completion31 Aug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sword Health, SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- CMM - Centro Médico da Murtosa, CMM - Centro Médico de Aveiro, Centro Médico de Viseu
- Responsible party
- Sponsor
- Investigators
- Fernando D Correia, MD, Principal investigator, Sword Health, SA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03032692
- Sponsor's protocol ID
- RCT-BFK01
- Status last verified
- Jun 2017
- First submitted
- 24 Jan 2017
- Last updated
- 14 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual Participant Data will not be made available to other researchers
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Motor Task Performance Under Visual and Auditory Feedback Post Stroke: a Randomized Crossover Trial
- ClinicalTrials.gov ID
- NCT03032692
- Acronym / sponsor ID
- RCT-BFK01
- Conditions
- Ischemic Stroke, Upper Extremity Paresis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Sword Health, SAIndustry (pharma, biotech, devices)
- Collaborators
- CMM - Centro Médico da Murtosa, CMM - Centro Médico de Aveiro, Centro Médico de Viseu
- Study start
- 1 Jun 2016 (actual)
- Primary completion
- 31 Aug 2016 (actual)
- Study completion
- 31 Aug 2016 (actual)
- First posted
- 26 Jan 2017 (estimated)
- 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 study was designed to evaluate the impact of a novel kinematic biofeedback system - SWORD - in the motor performance of patients after stroke. The SWORD system combines inertial motion trackers and a mobile app, allowing digitization of patient motion and providing real-time audiovisual biofeedback.
The investigators hypothesize that the biofeedback feedback provided by the SWORD system improves patient performance, defined as an increase in the number of correct movements.
The design of the study is a cross-over randomized clinical trial. Patients will be randomized into two groups. Both will perform two separate sessions consisting of one exercise - shoulder flexion with elbow flexion at 90 degrees - for 4 minutes in both experimental settings: with and without biofeedback. Group 1 will perform the exercise with biofeedback first and without biofeedback after, with an interval >24h. Group 2 will perform the exercise in the opposite order. The SWORD system will be used to record movement data in both sessions, but the feedback was only active in one of them.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SWORD and exercise with biofeedback | Experimental | Device: SWORD, Other: Exercise with biofeedbackThe patient will perform one repetition of the exercise shoulder flexion with elbow flexion at 90 degrees under monitoring from SWORD. The recorded parameters will be used to define: baseline and target angle; execution time; maximum postural sway. Two additional repetitions will be performed to ensure reproducibility. During the session, SWORD will be providing real-time audiovisual feedback. The patient has to start in the baseline position and fill the progress bar without violating movement or posture constraints. If the patient does not reach the goal or violates constraints he will receive a negative audio feedback, the progress bar will turn red and be reset. The patient has to return to the baseline position to restart the movement. |
| SWORD and exercise without biofeedback | Active comparator | Device: SWORD, Other: exercise without biofeedbackThe patient will perform one repetition of the exercise shoulder flexion with elbow flexion at 90 degrees under monitoring from SWORD. The recorded parameters will be used to define: baseline and target angle; execution time; maximum postural sway. Two additional repetitions will be performed to ensure reproducibility. The patient will then be instructed to perform as many movements as possible during the allocated time (4 minutes), at a comfortable pace, starting at or below the baseline and trying to reach maximum flexion without significant pain or discomfort. During the session, the SWORD system will be recording the patient´s movement without providing feedback to the patient. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- clinical symptoms and signs and CT or MRI findings compatible with a lesion in the territory of the medial cerebral artery;
- persistent motor deficit on the upper limb but not plegia with a score between 0 and 2 on item 5b of the National Institute of Health Stroke Scale (NIHSS)
- more than 2 weeks after stroke onset;
- the ability to sit comfortably for more than 10 minutes and perform two-step commands
Key exclusion criteria (6 listed)
- no detectable motor deficits at baseline assessment;
- severe aphasia;
- clinical dementia or mini mental state examination (MMSE) below cutoff;
- other cognitive or psychiatric comorbidity that impaired communication or compliance with the tasks;
- severe respiratory or cardiac condition incompatible with more than 5 minutes of continuous mild exercise in a sitting position;
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 |
|---|---|---|
| SWORDAlso: Stroke Wearable Operative Rehabilitation DeviceBoth arms will perform two separate sessions consisting of one exercise - shoulder flexion with elbow flexion at 90 degrees - for 4 minutes in two experimental conditions: with and without biofeedback. Group 1 will perform the exercise with biofeedback first and without biofeedback after; group 2 performed the exercise in the opposite order. The SWORD system will be used to record movement data in both sessions. | Device | SWORD and exercise with biofeedback, SWORD and exercise without biofeedback |
| Exercise with biofeedback | Other | SWORD and exercise with biofeedback |
| exercise without biofeedback | Other | SWORD and exercise without biofeedback |
Primary outcome
Number of correct movements
Time frame: At the end of each exercise session (4 minute duration)
Number of correct movements performed within the duration of each exercise session
8 secondary outcomes
Total number of repetitions
Time frame: At the end of each exercise session (4 minute duration)
Number of incorrect repetitions
Time frame: At the end of each exercise session (4 minute duration)
Number of consecutive incorrect repetitions
Time frame: At the end of each exercise session (4 minute duration)
Number of pauses
Time frame: At the end of each exercise session (4 minute duration)
Posture errors
Time frame: At the end of each exercise session (4 minute duration)
Movement frequency
Time frame: At the end of each exercise session (4 minute duration)
Range of motion of correct movements
Time frame: At the end of each exercise session (4 minute duration)
Range of motion variability over time
Time frame: Between the second and first minute; between the second and third minutes; between the third and fourth minute
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 14 Jun 2017.
- Individual participant dataSharing planned: No. Individual Participant Data will not be made available to other researchers
Related trials for Ischemic Stroke
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Acute Ischemic Stroke
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Detecting and Predicting Post-stroke Cognitive Impairment Using the Oxford Cognitive Screen
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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.
Fernando D Correia, MD principal investigator
Sword Health, SA
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SWORD, Exercise with biofeedback and exercise without biofeedback in people with Ischemic Stroke and Upper Extremity Paresis, run by Sword Health, SA at 3 sites in Portugal.
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 14 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Portugal. 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?
Number of correct movements (time frame: At the end of each exercise session (4 minute duration)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Jun 2017.