Studies
| Study First Submitted Date | 2019-08-02 |
| Study First Posted Date | 2019-08-07 |
| Last Update Posted Date | 2019-08-07 |
| Start Month Year | March 11, 2014 |
| Primary Completion Month Year | September 9, 2016 |
| Verification Month Year | August 2019 |
| Verification Date | 2019-08-31 |
| Last Update Posted Date | 2019-08-07 |
Detailed Descriptions
| Sequence: | 20687486 |
| Description | This project will explore a potentially powerful trainings that may be administered before upper extremity transplantation to induced plasticity of sensorimotor cortex in humans with congenital absence of upper limbs.
Our aim is to compare neurophysiological outcome of bilateral upper limb congenital transverse deficiency humans who are engaged in different types of training (mental-MT, computer-aided training-CAT and subjects receiving both type of trainings-CAMT). We hypothesize that all forms of training provide plastic changes in sensorimotor cortex. Specifically, we hypothesize that for CAMT group we will observe more prompt CNS-reorganization as compared to MT and CAT groups. Our second aim is to examine mechanisms of neural and muscular system plasticity underlying neurophysiological function reorganization following the specific training and also to develop a computer system for training subjects through visual biofeedback. The control procedure of virtual upper extremity should be realized through recognition of intention of hand motion based on biosignals analysis. Our protocol contains twelve weeks of trainings with three training sessions during a week (on Monday, Wednesday and Friday) and four measurement sessions (before the training period – PRE, after 4 weeks of trainings – POST4, after 8 weeks of trainings – POST8 and after 12 weeks of training – POST12). Based on different methods we will use, we would like to ewaluate: structural changes in CNS, functional changes in CNS, functional changes in peripheral nervous system and functional changes in muscles of upper extremity stump by comparing results to the pre-training (PRE) values (with results from POST4, POST8 and POST12) and across the groups. |
Facilities
| Sequence: | 199683584 |
| Status | Recruiting |
| Name | University School of Physical Education in Wroclaw |
| City | Wroclaw |
| State | Lower Silesia |
| Zip | 51 612 |
| Country | Poland |
Facility Contacts
| Sequence: | 28066029 | Sequence: | 28066030 |
| Facility Id | 199683584 | Facility Id | 199683584 |
| Contact Type | primary | Contact Type | backup |
| Name | Katarzyna Kisiel-Sajewicz, PhD | Name | Joanna Mencel, MSc |
| [email protected] | [email protected] | ||
| Phone | 71 347 3534 | Phone | 71 347 3531 |
| Phone Extension | +48 | Phone Extension | +48 |
Conditions
| Sequence: | 52080206 |
| Name | Amelia of Upper Limb |
| Downcase Name | amelia of upper limb |
Id Information
| Sequence: | 40086249 |
| Id Source | org_study_id |
| Id Value | DEC-2011/03/B/NZ7/00588 |
Countries
| Sequence: | 42485792 |
| Name | Poland |
| Removed | False |
Design Groups
| Sequence: | 55493824 | Sequence: | 55493825 | Sequence: | 55493826 | Sequence: | 55493827 |
| Group Type | Experimental | Group Type | Experimental | Group Type | Experimental | Group Type | Active Comparator |
| Title | Patients-MT | Title | Patients-CAT | Title | Patients-CAMT | Title | Healthy-controls |
| Description | 3 Patients with bilateral upper limb congenital transverse deficiency that participated in kinesthetic mental training (MT) of reaching to grasp movements | Description | 3 Patients with bilateral upper limb congenital transverse deficiency that participated in computer-aided training (CAT) of reaching to grasp movements using virtual environment with visual-feedback. | Description | 3 Patients with bilateral upper limb congenital transverse deficiency that participated in kinesthetic mental training of reaching to grasp movements supplemented by virtual environment (patients that received both types of training). | Description | 9 Healthy, age and gender-matched subjects, without any kind of training |
Interventions
| Sequence: | 52393402 | Sequence: | 52393403 | Sequence: | 52393404 | Sequence: | 52393405 |
| Intervention Type | Behavioral | Intervention Type | Behavioral | Intervention Type | Behavioral | Intervention Type | Other |
| Name | Mental trainings | Name | Computer-aided trainings | Name | Computer-aided and mental trainings | Name | No trainings |
| Description | Patients will receive 36 trainings (12 weeks with 3 trainings a week) of mental, kinesthetic reaching-to-grasp movement. During each training session they will perform 3 practice trials by following the instructions, after practicing 3 trials, the instructions will be discontinued, and subjects will perform 30 mental movements by following auditory cues. | Description | Patients will receive 36 trainings (12 weeks with 3 trainings a week) of visual feedback of reaching-to-grasp movement. During each training session they will be sitting on a chair, in front of a computer screen observing simple tasks of reaching and precision fine grasping of a small object with 4 fingers of virtual upper extremity using the visualization software that will be coded specifically for the purpose of this experiment. | Description | Patients will receive 36 trainings (12 weeks with 3 trainings a week) of mental, kinesthetic reaching-to-grasp movement that will be supplemented by visual feedback of this task by the visualization software that will be coded specifically for the purpose of this experiment (they will receive trainings that link the features of the two mentioned above types of training (MT and CAT). | Description | Healthy controls without any kind of training |
Keywords
| Sequence: | 79718709 | Sequence: | 79718710 | Sequence: | 79718711 | Sequence: | 79718712 | Sequence: | 79718713 |
| Name | bilateral upper limb congenital transverse deficiency | Name | neuroplasticity | Name | sensorimotor cortex | Name | mental training | Name | virtual environment |
| Downcase Name | bilateral upper limb congenital transverse deficiency | Downcase Name | neuroplasticity | Downcase Name | sensorimotor cortex | Downcase Name | mental training | Downcase Name | virtual environment |
Design Outcomes
| Sequence: | 177069169 | Sequence: | 177069170 | Sequence: | 177069171 | Sequence: | 177069172 | Sequence: | 177069173 | Sequence: | 177069174 | Sequence: | 177069175 | Sequence: | 177069176 | Sequence: | 177069177 | Sequence: | 177069178 | Sequence: | 177069179 | Sequence: | 177069180 | Sequence: | 177069181 | Sequence: | 177069182 | Sequence: | 177069183 | Sequence: | 177069184 | Sequence: | 177069185 | Sequence: | 177069186 | Sequence: | 177069187 | Sequence: | 177069188 | Sequence: | 177069189 | Sequence: | 177069190 | Sequence: | 177069191 | Sequence: | 177069192 | Sequence: | 177069193 | Sequence: | 177069194 | Sequence: | 177069195 | Sequence: | 177069196 | Sequence: | 177069197 | Sequence: | 177069198 | Sequence: | 177069199 | Sequence: | 177069200 |
| Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary |
| Measure | Magnetic Resonance Imaging (MRI) | Measure | Magnetic Resonance Imaging (MRI) | Measure | Magnetic Resonance Imaging (MRI) | Measure | Magnetic Resonance Imaging (MRI) | Measure | Functional Magnetic Resonance Imaging (fMRI) | Measure | Functional Magnetic Resonance Imaging (fMRI) | Measure | Functional Magnetic Resonance Imaging (fMRI) | Measure | Functional Magnetic Resonance Imaging (fMRI) | Measure | Transcranial magnetic stimulation (TMS) | Measure | Transcranial magnetic stimulation (TMS) | Measure | Transcranial magnetic stimulation (TMS) | Measure | Transcranial magnetic stimulation (TMS) | Measure | Electroencephalography (EEG) | Measure | Electroencephalography (EEG) | Measure | Electroencephalography (EEG) | Measure | Electroencephalography (EEG) | Measure | Near-infrared spectroscopy (NIRS) | Measure | Near-infrared spectroscopy (NIRS) | Measure | Near-infrared spectroscopy (NIRS) | Measure | Near-infrared spectroscopy (NIRS) | Measure | Electromyography (EMG) | Measure | Electromyography (EMG) | Measure | Electromyography (EMG) | Measure | Electromyography (EMG) | Measure | Mechanomyography (MMG) | Measure | Mechanomyography (MMG) | Measure | Mechanomyography (MMG) | Measure | Mechanomyography (MMG) | Measure | Temperature measurements (Temp) | Measure | Temperature measurements (Temp) | Measure | Temperature measurements (Temp) | Measure | Temperature measurements (Temp) |
| Time Frame | Before trainings period (PRE) | Time Frame | After 4 weeks of trainings period (POST4) | Time Frame | After 8 weeks of trainings period (POST8) | Time Frame | After 12 weeks of trainings period (POST12) | Time Frame | Before trainings period (PRE) | Time Frame | After 4 weeks of trainings period (POST4) | Time Frame | After 8 weeks of trainings period (POST8) | Time Frame | After 12 weeks of trainings period (POST12) | Time Frame | Before trainings period (PRE) | Time Frame | After 4 weeks of trainings period (POST4) | Time Frame | After 8 weeks of trainings period (POST8) | Time Frame | After 12 weeks of trainings period (POST12) | Time Frame | Before trainings period (PRE) | Time Frame | After 4 weeks of trainings period (POST4) | Time Frame | After 8 weeks of trainings period (POST8) | Time Frame | After 12 weeks of trainings period (POST12) | Time Frame | Before trainings period (PRE) | Time Frame | After 4 weeks of trainings period (POST4) | Time Frame | After 8 weeks of trainings period (POST8) | Time Frame | After 12 weeks of trainings period (POST12) | Time Frame | Before trainings period (PRE) | Time Frame | After 4 weeks of trainings period (POST4) | Time Frame | After 8 weeks of trainings period (POST8) | Time Frame | After 12 weeks of trainings period (POST12) | Time Frame | Before trainings period (PRE) | Time Frame | After 4 weeks of trainings period (POST4) | Time Frame | After 8 weeks of trainings period (POST8) | Time Frame | After 12 weeks of trainings period (POST12) | Time Frame | Before trainings period (PRE) | Time Frame | After 4 weeks of trainings period (POST4) | Time Frame | After 8 weeks of trainings period (POST8) | Time Frame | After 12 weeks of trainings period (POST12) |
| Description | To evaluate structural changes in central nervous system (CNS) the MRI method will be used | Description | To evaluate structural changes in central nervous system (CNS) the MRI method will be used | Description | To evaluate structural changes in central nervous system (CNS) the MRI method will be used | Description | To evaluate structural changes in central nervous system (CNS) the MRI method will be used | Description | To evaluate functional changes in CNS, the fMRI will be used | Description | To evaluate functional changes in CNS, the fMRI will be used | Description | To evaluate functional changes in CNS, the fMRI will be used | Description | To evaluate functional changes in CNS, the fMRI will be used | Description | To evaluate excitability of the sensory-motor cortex of the brain. | Description | To evaluate excitability of the sensory-motor cortex of the brain. | Description | To evaluate excitability of the sensory-motor cortex of the brain. | Description | To evaluate excitability of the sensory-motor cortex of the brain. | Description | To evaluate functional changes in CNS, the 128-channels EEG will be used. | Description | To evaluate functional changes in CNS, the 128-channels EEG will be used. | Description | To evaluate functional changes in CNS, the 128-channels EEG will be used. | Description | To evaluate functional changes in CNS, the 128-channels EEG will be used. | Description | To evaluate functional changes in peripheral nervous system. | Description | To evaluate functional changes in peripheral nervous system. | Description | To evaluate functional changes in peripheral nervous system. | Description | To evaluate functional changes in peripheral nervous system. | Description | To evaluate functional changes in muscles of upper extremity stump | Description | To evaluate functional changes in muscles of upper extremity stump | Description | To evaluate functional changes in muscles of upper extremity stump | Description | To evaluate functional changes in muscles of upper extremity stump | Description | To evaluate functional changes in muscles of upper extremity stump | Description | To evaluate functional changes in muscles of upper extremity stump | Description | To evaluate functional changes in muscles of upper extremity stump | Description | To evaluate functional changes in muscles of upper extremity stump | Description | To evaluate functional changes in muscles of upper extremity stump | Description | To evaluate functional changes in muscles of upper extremity stump | Description | To evaluate functional changes in muscles of upper extremity stump | Description | To evaluate functional changes in muscles of upper extremity stump |
Sponsors
| Sequence: | 48235053 | Sequence: | 48235054 | Sequence: | 48235055 | Sequence: | 48235056 | Sequence: | 48235057 |
| Agency Class | OTHER | Agency Class | OTHER | Agency Class | OTHER | Agency Class | UNKNOWN | Agency Class | UNKNOWN |
| Lead Or Collaborator | lead | Lead Or Collaborator | collaborator | Lead Or Collaborator | collaborator | Lead Or Collaborator | collaborator | Lead Or Collaborator | collaborator |
| Name | Wroclaw University of Health and Sport Sciences | Name | Wrocław University of Science and Technology | Name | Kessler Foundation | Name | Nencki Institute of Experimental Biology, Warsaw, Poland | Name | Hospital of St. Hedwig in Trzebnica |
Overall Officials
| Sequence: | 29232282 |
| Role | Principal Investigator |
| Name | Katarzyna Kisiel-Sajewicz, PhD |
| Affiliation | Wroclaw University of Health and Sport Sciences |
Central Contacts
| Sequence: | 11989793 | Sequence: | 11989794 |
| Contact Type | primary | Contact Type | backup |
| Name | Andrzej Rokita, PhD | Name | Joanna Mencel, MSc |
| Phone | 713473101 | Phone | 71 3473531 |
| [email protected] | [email protected] | ||
| Phone Extension | +48 | Phone Extension | +48 |
| Role | Contact | Role | Contact |
Design Group Interventions
| Sequence: | 68028434 | Sequence: | 68028435 | Sequence: | 68028436 | Sequence: | 68028437 |
| Design Group Id | 55493824 | Design Group Id | 55493825 | Design Group Id | 55493826 | Design Group Id | 55493827 |
| Intervention Id | 52393402 | Intervention Id | 52393403 | Intervention Id | 52393404 | Intervention Id | 52393405 |
Eligibilities
| Sequence: | 30712527 |
| Gender | All |
| Minimum Age | 18 Years |
| Maximum Age | 25 Years |
| Healthy Volunteers | Accepts Healthy Volunteers |
| Criteria | Inclusion Criteria for patients:
Age between 18 and 25 years Exclusion Criteria for patients: Presence of neurological impairment (history of central or peripheral nervous system dysfunction) Inclusion Criteria for control subjects: Age between 18 and 25 years Exclusion Criteria for control subjects: Presence of neurological impairment (history of central or peripheral nervous system dysfunction) |
| Adult | True |
| Child | False |
| Older Adult | False |
Calculated Values
| Sequence: | 253941331 |
| Number Of Facilities | 1 |
| Registered In Calendar Year | 2019 |
| Actual Duration | 30 |
| Were Results Reported | False |
| Has Us Facility | False |
| Has Single Facility | True |
| Minimum Age Num | 18 |
| Maximum Age Num | 25 |
| Minimum Age Unit | Years |
| Maximum Age Unit | Years |
| Number Of Primary Outcomes To Measure | 32 |
Designs
| Sequence: | 30459104 |
| Allocation | Randomized |
| Intervention Model | Parallel Assignment |
| Observational Model | |
| Primary Purpose | Basic Science |
| Time Perspective | |
| Masking | Single |
| Outcomes Assessor Masked | True |
Responsible Parties
| Sequence: | 28825573 |
| Responsible Party Type | Principal Investigator |
| Name | Jaroslaw Marusiak |
| Title | Co-Investigator |
| Affiliation | Wroclaw University of Health and Sport Sciences |
Study References
| Sequence: | 51976114 | Sequence: | 51976115 | Sequence: | 51976116 |
| Pmid | 28641235 | Pmid | 36329083 | Pmid | 33828507 |
| Reference Type | background | Reference Type | derived | Reference Type | derived |
| Citation | Kurzynski M, Jaskolska A, Marusiak J, Wolczowski A, Bierut P, Szumowski L, Witkowski J, Kisiel-Sajewicz K. Computer-aided training sensorimotor cortex functions in humans before the upper limb transplantation using virtual reality and sensory feedback. Comput Biol Med. 2017 Aug 1;87:311-321. doi: 10.1016/j.compbiomed.2017.06.010. Epub 2017 Jun 15. | Citation | Mencel J, Marusiak J, Jaskolska A, Kaminski L, Kurzynski M, Wolczowski A, Jaskolski A, Kisiel-Sajewicz K. Motor imagery training of goal-directed reaching in relation to imagery of reaching and grasping in healthy people. Sci Rep. 2022 Nov 3;12(1):18610. doi: 10.1038/s41598-022-21890-1. | Citation | Mencel J, Jaskolska A, Marusiak J, Kaminski L, Kurzynski M, Wolczowski A, Jaskolski A, Kisiel-Sajewicz K. Motor Imagery Training of Reaching-to-Grasp Movement Supplemented by a Virtual Environment in an Individual With Congenital Bilateral Transverse Upper-Limb Deficiency. Front Psychol. 2021 Mar 22;12:638780. doi: 10.3389/fpsyg.2021.638780. eCollection 2021. |