Ignite Creation Date:
2024-05-06 @ 8:04 PM
Last Modification Date:
2024-10-26 @ 3:20 PM
Study NCT ID:
NCT06249737
Status:
RECRUITING
Last Update Posted:
2024-02-08
First Post:
2024-01-31
Brief Title:
Interference During Motor Learning of Different Degrees of Freedom in the Paretic Upper Extremity of People With Stroke
Sponsor:
University of Valencia
Organization:
University of Valencia
Study Overview
Official Title:
Interference During Motor Learning of Different Degrees of Freedom in the Paretic Upper Extremity of People With Stroke
Status:
RECRUITING
Status Verified Date:
2024-01
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:
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
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
1 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
2 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 005
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
1 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
2 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 005
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