Chronic StrokeNCT06154031
Dyad Learning in Wrist-robotic Environment After Stroke
A study testing Dyad learning in people with Chronic Stroke, run by University of Minnesota.
Trial summary
"Robot-assisted rehabilitation is used to mitigate the devastating effects of stroke and to recover the ability to perform complex motor tasks in survivors. One common issue is that robotic devices are costly and only available to individuals in limited capacity. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Chronic Stroke
- What is being tested?
- Dyad learning
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 15 Dec 2023to 30 Aug 2024
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Cerebral stroke at least three months before the time of data collection; full or near full functional wrist range of motion, 60° of wrist extension, 55° wrist flexion, as well as full or near full functional forearm range of motion, 65° of forearm pronation and 75° of forearm supination; ability to resist minimal resistance in gravity-eliminated position in wrist flexion/extension, and forearm pronation/supination
- no known physical or neurological impairments
- the ability to communicate in English, proficiency in English.
Who cannot join
- Cognitive impairment (Mini Mental State Examination (MMSE) < 23
- markedly increased muscle tone through most of the range of motion in wrist flexion/extension and forearm pronation/supination (>1+ on modified Ashworth Scale )
- medical conditions that affect upper limb sensorimotor functions such as Parkinson's disease or peripheral neuropathy
- uncorrected visual impairment
- speech pathology that impairs the ability to communicate.
About this study
Official title: Feasibility and Effects of Dyad Learning in a Wrist-robotic Environment in Individuals With Chronic Stroke
"Robot-assisted rehabilitation is used to mitigate the devastating effects of stroke and to recover the ability to perform complex motor tasks in survivors. One common issue is that robotic devices are costly and only available to individuals in limited capacity. Increasing efficiency by reducing required physical practice time or by improving training gains is therefore crucial to improve outcomes in robot-assisted rehabilitation after stroke. We are aiming to implement dyad learning as a learning paradigm that increases motor learning within a given timeframe for individuals to overcome this issue. Dyad learning is form of sensorimotor learning where participants learn in pairs, alternating between physical and observational practice. Between trials, learners are often allowed to engage in inter-trial dialog.
Dyad learning has not been established as a tool in rehabilitation, despite its potential to either reduce required physical practice time or increase motor improvement. The general aim of this project is to determine the usability (Aim 1) and feasibility (Aim 2) of dyad learning in a wrist robot environment in individuals with chronic stroke, as well as transfer effects in two transfer task (Aim 3). Dyad learning is characterized as motor learning where learners alternate between physical and observational training. Physical practice means that a person performs the motor task themselves. Observational practice means that the learner watches someone else practice the motor task.
Read more
In particular, the specific aims are as follows:
Aim 1: To determine if a dyad learning paradigm in the wrist robot environment can be implemented in participants with chronic stroke. This aim seeks to determine the usability of dyad learning of a gamified motor task in the wrist robot environment. Successful completion of the study by participants will verify this aim.
Aim 2: To determine the effect of dyad learning to improve wrist joint motor performance within the wrist robot environment. Participants with chronic stroke will be trained in a gamified motor task using a dyad learning paradigm. Motor performance will be measured by a performance motor score, a composite score that comprises spatial and temporal variables. Improvement in the performance motor score at the end of training will verify this aim.
Aim 3: To determine if dyadic wrist motor training in the wrist robot environment leads to improvements in the performance of two untrained functional wrist movement tasks in participants with chronic stroke. This aim seeks to identify the transfer effects of dyadic learning-related motor training gains on functional motor performance. Participants will perform two untrained wrist join motor task before and after training. The motor task are line tracing and tracking tasks. Performance will be measured by calculating the root mean square error (RMSE), measuring how much the participant deviates from the line, as well as time-to-complete in seconds. A decrease in RMSE and/or in time-to-complete at the second visit compared to the first performance will verify this aim.
- Conditions
- Chronic Stroke
- Being tested
- Dyad learning
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dyad learningBehavioural
All participants will perform a gamified exercise using a dyad learning protocol. This means that all participants will practice the gamified exercise in pairs (dyads), for 60 minutes on two consecutive days.
| Study group | Role | What they receive |
|---|---|---|
| stroke survivors | Experimental | Not described Receives: Behavioral: Dyad learning |
What is being measured
The primary outcome is the main question the study is designed to answer.
Motor performance score
The gaming software records an instantaneous motor performance score (iMPS), which is a composite score combining temporal and spatial in-game kinematics at a sampling frequency of 100 Hz. Instantaneous in-game moving speed of the car in mph, distance of the car from the ideal (shortest) path in meters, as well as rotation of the car compared to the direction of the ideal path in degrees will be recorded (Figure 3). The virtual speed, as well as distance and rotational deviation will be combined into a single, composite score. The iMPS can assume values between 0 and 1, 0 reflects poor motor performance and 1 perfect performance. A minimum virtual speed of 30 mph will be required to be able to receive an MPS of 1. A maximum virtual distance of 5 meters will be allowed before performance was recorded as 0.
Measured: Day 2
Instantaneous motor performance score (iMPS)
nstantaneous in-game moving speed of the car in mph, distance of the car from the ideal (shortest) path in meters, as well as rotation of the car compared to the direction of the ideal path in degrees will be recorded. The virtual speed, as well as distance and rotational deviation will be combined into a single, composite score called iMPS using an equation.
It assumes values between 0 and 1, 0 reflects poor motor performance and 1 perfect performance. An iMPS of 0 was recorded if the car was not moving, the car was going in the opposite direction, or if the car was further than 5 meters away from the ideal path.
Measured: Day 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2023
- Study start15 Dec 2023 (estimated)
- Primary completion30 May 2024 (estimated)
- Study completion30 Aug 2024 (estimated)
Why it stopped: Technical issues with the device
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic 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
- Not applicable
- Intervention model
- Single group
- Model description
- Cross-sectional single arm pilot-feasibility study. Assessments and training will be performed at two laboratory visits. Participants will spend approximately 125-145 minutes at the laboratory on Day 1, and approximately 80 minutes on Day 2.
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Juergen Konczak, PhD, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06154031
- Sponsor's protocol ID
- dyad
- Status last verified
- Jan 2024
- First submitted
- 20 Oct 2023
- Last updated
- 30 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Effects of Dyad Learning in a Wrist-robotic Environment in Individuals With Chronic Stroke
- ClinicalTrials.gov ID
- NCT06154031
- Acronym / sponsor ID
- dyad
- Conditions
- Chronic Stroke
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Technical issues with the device
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- 15 Dec 2023 (estimated)
- Primary completion
- 30 May 2024 (estimated)
- Study completion
- 30 Aug 2024 (estimated)
- First posted
- 1 Dec 2023 (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.
"Robot-assisted rehabilitation is used to mitigate the devastating effects of stroke and to recover the ability to perform complex motor tasks in survivors. One common issue is that robotic devices are costly and only available to individuals in limited capacity. Increasing efficiency by reducing required physical practice time or by improving training gains is therefore crucial to improve outcomes in robot-assisted rehabilitation after stroke. We are aiming to implement dyad learning as a learning paradigm that increases motor learning within a given timeframe for individuals to overcome this issue. Dyad learning is form of sensorimotor learning where participants learn in pairs, alternating between physical and observational practice. Between trials, learners are often allowed to engage in inter-trial dialog.
Dyad learning has not been established as a tool in rehabilitation, despite its potential to either reduce required physical practice time or increase motor improvement. The general aim of this project is to determine the usability (Aim 1) and feasibility (Aim 2) of dyad learning in a wrist robot environment in individuals with chronic stroke, as well as transfer effects in two transfer task (Aim 3). Dyad learning is characterized as motor learning where learners alternate between physical and observational training. Physical practice means that a person performs the motor task themselves. Observational practice means that the learner watches someone else practice the motor task.
In particular, the specific aims are as follows:
Aim 1: To determine if a dyad learning paradigm in the wrist robot environment can be implemented in participants with chronic stroke. This aim seeks to determine the usability of dyad learning of a gamified motor task in the wrist robot environment. Successful completion of the study by participants will verify this aim.
Aim 2: To determine the effect of dyad learning to improve wrist joint motor performance within the wrist robot environment. Participants with chronic stroke will be trained in a gamified motor task using a dyad learning paradigm. Motor performance will be measured by a performance motor score, a composite score that comprises spatial and temporal variables. Improvement in the performance motor score at the end of training will verify this aim.
Aim 3: To determine if dyadic wrist motor training in the wrist robot environment leads to improvements in the performance of two untrained functional wrist movement tasks in participants with chronic stroke. This aim seeks to identify the transfer effects of dyadic learning-related motor training gains on functional motor performance. Participants will perform two untrained wrist join motor task before and after training. The motor task are line tracing and tracking tasks. Performance will be measured by calculating the root mean square error (RMSE), measuring how much the participant deviates from the line, as well as time-to-complete in seconds. A decrease in RMSE and/or in time-to-complete at the second visit compared to the first performance will verify this aim.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Cross-sectional single arm pilot-feasibility study. Assessments and training will be performed at two laboratory visits. Participants will spend approximately 125-145 minutes at the laboratory on Day 1, and approximately 80 minutes on Day 2.
| Arm | Type | Receives |
|---|---|---|
| stroke survivors | Experimental | Behavioral: Dyad learning |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Cerebral stroke at least three months before the time of data collection; full or near full functional wrist range of motion, 60° of wrist extension, 55° wrist flexion, as well as full or near full functional forearm range of motion, 65° of forearm pronation and 75° of forearm supination; ability to resist minimal resistance in gravity-eliminated position in wrist flexion/extension, and forearm pronation/supination
- no known physical or neurological impairments
- the ability to communicate in English, proficiency in English.
Key exclusion criteria (5 listed)
- Cognitive impairment (Mini Mental State Examination (MMSE) < 23
- markedly increased muscle tone through most of the range of motion in wrist flexion/extension and forearm pronation/supination (>1+ on modified Ashworth Scale )
- medical conditions that affect upper limb sensorimotor functions such as Parkinson's disease or peripheral neuropathy
- uncorrected visual impairment
- speech pathology that impairs the ability to communicate.
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 |
|---|---|---|
| Dyad learningAll participants will perform a gamified exercise using a dyad learning protocol. This means that all participants will practice the gamified exercise in pairs (dyads), for 60 minutes on two consecutive days. | Behavioural | stroke survivors |
Primary outcome
Motor performance score
Time frame: Day 2
The gaming software records an instantaneous motor performance score (iMPS), which is a composite score combining temporal and spatial in-game kinematics at a sampling frequency of 100 Hz. Instantaneous in-game moving speed of the car in mph, distance of the car from the ideal (shortest) path in meters, as well as rotation of the car compared to the direction of the ideal path in degrees will be recorded (Figure 3). The virtual speed, as well as distance and rotational deviation will be combined into a single, composite score. The iMPS can assume values between 0 and 1, 0 reflects poor motor performance and 1 perfect performance. A minimum virtual speed of 30 mph will be required to be able to receive an MPS of 1. A maximum virtual distance of 5 meters will be allowed before performance was recorded as 0.
Instantaneous motor performance score (iMPS)
Time frame: Day 2
nstantaneous in-game moving speed of the car in mph, distance of the car from the ideal (shortest) path in meters, as well as rotation of the car compared to the direction of the ideal path in degrees will be recorded. The virtual speed, as well as distance and rotational deviation will be combined into a single, composite score called iMPS using an equation. It assumes values between 0 and 1, 0 reflects poor motor performance and 1 perfect performance. An iMPS of 0 was recorded if the car was not moving, the car was going in the opposite direction, or if the car was further than 5 meters away from the ideal path.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2024.
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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.
Juergen Konczak, PhD principal investigator
University of Minnesota
Questions about this trial
What is this clinical trial studying?
A study testing Dyad learning in people with Chronic Stroke, run by University of Minnesota.
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 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 30 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
Motor performance score (time frame: Day 2). 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?
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 30 Jan 2024.