StrokeNCT06249737
Interference During Motor Learning of Different Degrees of Freedom in the Paretic Upper Extremity of People With Stroke
A study testing Training in people with Stroke, run by University of Valencia at 2 sites in Spain.
Trial summary
Post-stroke rehabilitation of the upper extremity is a challenge in neurorehabilitation. Selective training of different degrees of freedom (training of specific monoarticular movements and in one plane of movement of the upper extremity) to achieve true recovery could be a good approach. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Stroke
- What is being tested?
- Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 99 participants
- Where
- 2 sitesSpain
- Study dates
- 22 Jan 2024to 31 Jul 2025
- 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 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Stroke diagnosis
- Muscular strength according to the MRC scale of 2 or more in the shoulder flexor, shoulder abductor and wrist extensor muscles.
Who cannot join
- Presence of another neurological or musculoskeletal disease that affects the mobility of the paretic upper extremity
- Inability to follow instructions
- Spasticity graded as 3 or more on the Modified Ashworth scale of flexor muscles of the upper extremity
- Signs of cerebellar damage such as the presence of ataxia or dysmetria in the upper extremity
Trial locations and contacts
2 sites in 1 country.
María Luz Sánchez-Sánchez, Ph.D contact
Spain2 sites, 2 recruiting
- Recruiting
Universitat de Valencia
Valencia, Valencia, 46010
Maria Luz Sánchez-Sánchez, Ph.D
Trinidad Bruna-Melo, MSc
- Recruiting
Unitat de dany Cerebral Adquirit
Valencia, 46014
Sara Torromé, PT, 627706905, saratorromebelda@gmail.com
Sara Torromé Belda, PT
About this study
Post-stroke rehabilitation of the upper extremity is a challenge in neurorehabilitation. Selective training of different degrees of freedom (training of specific monoarticular movements and in one plane of movement of the upper extremity) to achieve true recovery could be a good approach. However, it is not known how the training should be structured to avoid interference between the different movements trained, hindering the motor learning process during neurorehabilitation. This research aims to determine the effect on performance and kinematic control of a selective movement control task during one- or three-days training of 2 different degrees of freedom, close or distant in cortical representation, of the upper extremity in people with early subacute and chronic phase of stroke.
The hypothesis is that in the upper extremity of subacute or chronic phase stroke survivors, learning 1 target DoF is interfered by training another DoF of the same joint. In contrast, learning 1 DoF from a different, distant joint does not interfere with learning the target DoF in a training session. Likewise, this interference is diminished in multiple training sessions. On the other hand, in early post-stroke phase, within the first 5 weeks, the gain in kinematic control of each controlled DoF is greater than in later post-stroke phases (between 9 to 12 weeks of evolution or chronic phase).
An experimental design of 4 days of training, of approximately 60 minutes per day, will be carried out in people who are within the first 3 months after a stroke or in a chronic stage. There will be 3 intervention groups that will train the shoulder flexion movement of the paretic upper extremity and another movement, which can be of the same affected upper extremity or another of the contralateral lower extremity.
Read the detailed description
Post-stroke rehabilitation of the upper extremity is a challenge in neurorehabilitation. Selective training of different degrees of freedom (training of specific monoarticular movements and in one plane of movement of the upper extremity) to achieve true recovery could be a good approach. However, it is not known how the training should be structured to avoid interference between the different movements trained, hindering the motor learning process during neurorehabilitation.
The objective is to determine the effect on performance and kinematic control of a selective movement control task during training of 2 different degrees of freedom, close or distant in cortical representation, of the upper extremity in persons with early (within the 5 first weeks and between 9 to 12 weeks) and chronic subacute stroke.
The hypothesis is that in the upper extremity of subacute or chronic phase stroke survivors, learning 1 target DoF is interfered by training another DoF of the same joint. In contrast, learning 1 DoF from a different, distant joint does not interfere with learning the target DoF in a training session. Likewise, this interference is diminished when multiple training sessions are performed. On the other hand, in early post-stroke stages, within the first 5 weeks, the gain in kinematic control of each controlled DoF is greater than in later post-stroke stages (between 9 to 12 weeks of evolution or chronic stages).
An experimental design of 4 days of training, of approximately 60 minutes per day, which are distributed in 3 days of training (days 1, 2, and 3) and 2 days of evaluation (days 2 and 4) will be carried out in people who are within the first 3 months after a stroke or in a chronic stage. Each group of different evolution times will have 3 intervention groups where they will train the movement of different DoF of the affected upper extremity or with another effector to maintain the practice dose among all groups. A randomization will be performed to distribute the participants in the different intervention groups.
The DoF of interest (DoF target) is shoulder flexo-extension. The first group, the control group: will train the DoF target and DoF dorsi-ankle flexion of the contralateral lower extremity. The second group, the proximal interference group, will train the DoF target and the shoulder abduction-adduction DoF. The third group, the distal interference group, will train the DoF target and the wrist flexo-extension DoF.
The training will be performed by a videogame, which is controlled by the acceleration signal of an inertial sensor. The person by selective movement of each DoF must follow the trajectory of a sinusoid.
To achieve the objective of this study, performance and kinematic variables of the movement obtained during the training (days 1, 2, and 3 of the protocol) and in the retention tests (days 2 and 4 of the protocol) will be analyzed.
The recruitment will be carried out in the Acquired Brain Injury Unit of the Hospital General from Valencia and in the Physiotherapy Faculty at the Universitat de Valencia.
In order to answer the study hypothesis, two variables will be examined:
- Changes in performance associated with the error in the trajectory: based on the expected trajectory and the realized trajectory, the difference between the expected trajectory and the one realized will be calculated to be able to compare the changes between the beginning of training, the end of training and the retention tests of each trained DoF.
- Kinematics: based on the acceleration data that are delivered by the inertial sensor, an analysis of the smoothness of the movement will be carried out, understanding it as a quality related to the continuity or intermittency of the movement to determine the specific changes associated with the kinematic control of each trained DoF.
For both the performance and kinematic control data, an analysis of the variance of repeated measures of 2 factors (time and intervention) is expected to be performed, if the data have a normal distribution. The sphericity and homogeneity of the data will be analyzed, and the effect size will be reported. Then, a post hoc analysis will be performed using the Bonferroni test. The level of statistical significance will have a p-value of 0.05.
- Conditions
- Stroke
- Being tested
- Training
- Keywords
- stroke recovery, motor learning, upper extremity recovery, learning interference
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TrainingBehavioural
Each participan will train the kinematic control of each degree of freedom, according to each arm, playing a videogame using an inertial sensor.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Experimental | This group will train the DoF target (shoulder flexo-extension) and DoF dorsi-ankle flexion of the contralateral lower extremity. Receives: Behavioral: Training |
| Proximal Interference Group | Experimental | This group will train the DoF target and shoulder abduction-adduction DoF. Receives: Behavioral: Training |
| Distal Interference Group | Experimental | This group will train the DoF Tf and the wrist flexion-extension DoF. Receives: Behavioral: Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
1 day performance changes
Based on the expected trajectory and the actual trajectory of the videogame, the difference between these trajectories will be calculated to compare the changes of each trained DoF between the performance made at the beginning of one day of training, at the end of that same day and between the second day (retention test).
Measured: day 2
3 days performance changes
Based on the expected trajectory and the actual trajectory of the videogame, the difference between these trajectories will be calculated to compare the changes of each trained DoF t the beginning of the first day of training andafter completing the four days of training.
Measured: day 4
Secondary outcomes (2)
1 day smoothness changes
based on the accelemetry data, the change between day one and two in the smoothness of the movement of each DoF will be analized
Measured: day 2
3 days smoothness changes
based on the accelemetry data, the change between day one and four in the smoothness of the movement of each DoF will be analized
Measured: day 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2024
- Study start22 Jan 2024
- Primary completion31 Jul 2025 (estimated)
- Study completion31 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by University of ValenciaThe sponsor's other registered studies.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- There will be 3 intervention groups where they will train the movement of different DoF of the affected upper extremity (the DoF target and other DoF of the shoulder or wrist) or the DoF target and other DoF of the contralateral lower extremity (to maintain the practice dose among all groups)
- Masking
- None (open label)
- Enrolment
- 99 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Valencia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, M Luz Sanchez, University of Valencia
- Investigators
- Trinidad Bruna-Melo, MSc, Principal investigator, Universitat de Valencia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06249737
- Sponsor's protocol ID
- interference_stroke
- Status last verified
- Jan 2024
- First submitted
- 31 Jan 2024
- Last updated
- 8 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: for now, there is no plan to make IPD available to other researchers
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interference During Motor Learning of Different Degrees of Freedom in the Paretic Upper Extremity of People With Stroke
- ClinicalTrials.gov ID
- NCT06249737
- Acronym / sponsor ID
- interference_stroke
- Conditions
- Stroke
- Keywords
- stroke recovery, motor learning, upper extremity recovery, learning interference
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 99 participants (estimated)
- Lead sponsor
- University of ValenciaUniversity, hospital or other
- Study start
- 22 Jan 2024 (actual)
- Primary completion
- 31 Jul 2025 (estimated)
- Study completion
- 31 Jul 2025 (estimated)
- First posted
- 8 Feb 2024 (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.
Post-stroke rehabilitation of the upper extremity is a challenge in neurorehabilitation. Selective training of different degrees of freedom (training of specific monoarticular movements and in one plane of movement of the upper extremity) to achieve true recovery could be a good approach. However, it is not known how the training should be structured to avoid interference between the different movements trained, hindering the motor learning process during neurorehabilitation. This research aims to determine the effect on performance and kinematic control of a selective movement control task during one- or three-days training of 2 different degrees of freedom, close or distant in cortical representation, of the upper extremity in people with early subacute and chronic phase of stroke.
The hypothesis is that in the upper extremity of subacute or chronic phase stroke survivors, learning 1 target DoF is interfered by training another DoF of the same joint. In contrast, learning 1 DoF from a different, distant joint does not interfere with learning the target DoF in a training session. Likewise, this interference is diminished in multiple training sessions. On the other hand, in early post-stroke phase, within the first 5 weeks, the gain in kinematic control of each controlled DoF is greater than in later post-stroke phases (between 9 to 12 weeks of evolution or chronic phase).
An experimental design of 4 days of training, of approximately 60 minutes per day, will be carried out in people who are within the first 3 months after a stroke or in a chronic stage. There will be 3 intervention groups that will train the shoulder flexion movement of the paretic upper extremity and another movement, which can be of the same affected upper extremity or another of the contralateral lower extremity.
Detailed description
Post-stroke rehabilitation of the upper extremity is a challenge in neurorehabilitation. Selective training of different degrees of freedom (training of specific monoarticular movements and in one plane of movement of the upper extremity) to achieve true recovery could be a good approach. However, it is not known how the training should be structured to avoid interference between the different movements trained, hindering the motor learning process during neurorehabilitation.
The objective is to determine the effect on performance and kinematic control of a selective movement control task during training of 2 different degrees of freedom, close or distant in cortical representation, of the upper extremity in persons with early (within the 5 first weeks and between 9 to 12 weeks) and chronic subacute stroke.
The hypothesis is that in the upper extremity of subacute or chronic phase stroke survivors, learning 1 target DoF is interfered by training another DoF of the same joint. In contrast, learning 1 DoF from a different, distant joint does not interfere with learning the target DoF in a training session. Likewise, this interference is diminished when multiple training sessions are performed. On the other hand, in early post-stroke stages, within the first 5 weeks, the gain in kinematic control of each controlled DoF is greater than in later post-stroke stages (between 9 to 12 weeks of evolution or chronic stages).
An experimental design of 4 days of training, of approximately 60 minutes per day, which are distributed in 3 days of training (days 1, 2, and 3) and 2 days of evaluation (days 2 and 4) will be carried out in people who are within the first 3 months after a stroke or in a chronic stage. Each group of different evolution times will have 3 intervention groups where they will train the movement of different DoF of the affected upper extremity or with another effector to maintain the practice dose among all groups. A randomization will be performed to distribute the participants in the different intervention groups.
The DoF of interest (DoF target) is shoulder flexo-extension. The first group, the control group: will train the DoF target and DoF dorsi-ankle flexion of the contralateral lower extremity. The second group, the proximal interference group, will train the DoF target and the shoulder abduction-adduction DoF. The third group, the distal interference group, will train the DoF target and the wrist flexo-extension DoF.
The training will be performed by a videogame, which is controlled by the acceleration signal of an inertial sensor. The person by selective movement of each DoF must follow the trajectory of a sinusoid.
To achieve the objective of this study, performance and kinematic variables of the movement obtained during the training (days 1, 2, and 3 of the protocol) and in the retention tests (days 2 and 4 of the protocol) will be analyzed.
The recruitment will be carried out in the Acquired Brain Injury Unit of the Hospital General from Valencia and in the Physiotherapy Faculty at the Universitat de Valencia.
In order to answer the study hypothesis, two variables will be examined:
- Changes in performance associated with the error in the trajectory: based on the expected trajectory and the realized trajectory, the difference between the expected trajectory and the one realized will be calculated to be able to compare the changes between the beginning of training, the end of training and the retention tests of each trained DoF.
- Kinematics: based on the acceleration data that are delivered by the inertial sensor, an analysis of the smoothness of the movement will be carried out, understanding it as a quality related to the continuity or intermittency of the movement to determine the specific changes associated with the kinematic control of each trained DoF.
For both the performance and kinematic control data, an analysis of the variance of repeated measures of 2 factors (time and intervention) is expected to be performed, if the data have a normal distribution. The sphericity and homogeneity of the data will be analyzed, and the effect size will be reported. Then, a post hoc analysis will be performed using the Bonferroni test. The level of statistical significance will have a p-value of 0.05.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- There will be 3 intervention groups where they will train the movement of different DoF of the affected upper extremity (the DoF target and other DoF of the shoulder or wrist) or the DoF target and other DoF of the contralateral lower extremity (to maintain the practice dose among all groups)
| Arm | Type | Receives |
|---|---|---|
| Control Group | Experimental | Behavioral: TrainingThis group will train the DoF target (shoulder flexo-extension) and DoF dorsi-ankle flexion of the contralateral lower extremity. |
| Proximal Interference Group | Experimental | Behavioral: TrainingThis group will train the DoF target and shoulder abduction-adduction DoF. |
| Distal Interference Group | Experimental | Behavioral: TrainingThis group will train the DoF Tf and the wrist flexion-extension DoF. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Stroke diagnosis
- Muscular strength according to the MRC scale of 2 or more in the shoulder flexor, shoulder abductor and wrist extensor muscles.
Key exclusion criteria (4 listed)
- Presence of another neurological or musculoskeletal disease that affects the mobility of the paretic upper extremity
- Inability to follow instructions
- Spasticity graded as 3 or more on the Modified Ashworth scale of flexor muscles of the upper extremity
- Signs of cerebellar damage such as the presence of ataxia or dysmetria in the upper extremity
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 |
|---|---|---|
| TrainingEach participan will train the kinematic control of each degree of freedom, according to each arm, playing a videogame using an inertial sensor. | Behavioural | Control Group, Distal Interference Group, Proximal Interference Group |
Primary outcome
1 day performance changes
Time frame: day 2
Based on the expected trajectory and the actual trajectory of the videogame, the difference between these trajectories will be calculated to compare the changes of each trained DoF between the performance made at the beginning of one day of training, at the end of that same day and between the second day (retention test).
3 days performance changes
Time frame: day 4
Based on the expected trajectory and the actual trajectory of the videogame, the difference between these trajectories will be calculated to compare the changes of each trained DoF t the beginning of the first day of training andafter completing the four days of training.
2 secondary outcomes
1 day smoothness changes
Time frame: day 2
3 days smoothness changes
Time frame: day 4
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2024.
- Individual participant dataSharing planned: No. for now, there is no plan to make IPD available to other researchers
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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.
María Luz Sánchez-Sánchez, Ph.D contact
Trinidad Bruna-Melo, MSc principal investigator
Universitat de Valencia
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Training in people with Stroke, run by University of Valencia at 2 sites in Spain.
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 2 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 8 Feb 2024. 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 Spain. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Trinidad Bruna-Melo, MSc (+34657278264, tribrume@uv.alumni.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1 day performance changes (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 8 Feb 2024; AzTrials last refreshed its copy on 7 Nov 2026.