Amelia of Upper LimbNCT04048083
Computer-aided and Mental Trainings Induced Plasticity of Sensorimotor Cortex in Patients Born Without Upper Limbs
A study testing Mental trainings, Computer-aided trainings and Computer-aided and mental trainings in people with Amelia of Upper Limb, run by Wroclaw University of Health and Sport Sciences at 1 site in Poland.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Amelia of Upper Limb
- What is being tested?
- Mental trainings, Computer-aided trainings and Computer-aided and mental trainings
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 sitePoland
- Study dates
- 11 Mar 2014to Dec 2019
- 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 25 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age between 18 and 25 years
- Health status: bilateral upper limb congenital transverse deficiency individuals. Subjects must be free from neurological impairment. The subjects must have no current or past history of central or peripheral nervous system dysfunction, be taking no current medication known to affect the neuromuscular system, have no greater than moderate consumption of alcohol or caffeine, and be able to remain seated for 1 hour 30 min and lay supine without moving for 30 min (MRI test). All recruited subjects will be interviewed and their health status and medical history will be evaluated by a medical practitioner qualified to practice surgery and transplant surgery.
- Training history: Subjects not participating in any type of training program in the last 5 years
- Right Hemispheric Dominance. We will use Foot Dominance test - Observation of our subjects to see which foot they use to kick a ball, step up onto a stair, and step onto a coin placed on the floor.
- Availability and interest: All candidates for the study must be available for the familiarization, training, and testing sessions and must have transportation to these sessions.
- Age between 18 and 25 years
Show all 10Show fewer
- Health status: subjects must be free from neurological and neuromuscular system impairment. The subjects must have no current or past history of central or peripheral nervous system dysfunction, be taking no current medication known to affect the neuromuscular system, have no greater than moderate consumption of alcohol or caffeine, and be able to remain seated for 1 hour 30 min and lay supine without moving for 30 min (MRI test). ). All recruited subjects will be interviewed and their health status and medical history evaluated by neurologist.
- Training history: subjects not participating in any type of training program in the last 5 years.
- Hemispheric Dominance -right. We will use The Edinburgh inventory (Oldfield, 1971) and Foot Dominance test.
- Availability and interest - All subjects for the study must be available for the familiarization, training, and testing sessions and must have transportation to these sessions.
Who cannot join
- Presence of neurological impairment (history of central or peripheral nervous system dysfunction)
- Taking medication that affects the neuromuscular system
- Left hemispheric dominance
- Participation in training over the last five years
- Presence of neurological impairment (history of central or peripheral nervous system dysfunction)
- Taking medication that affects the neuromuscular system
- Left hemispheric dominance
- Participation in training over the last five years
Trial locations and contacts
1 site in 1 country.
Poland1 site, 1 recruiting
- Recruiting
University School of Physical Education in Wroclaw
Wroclaw, Lower Silesian Voivodeship, 51 612
Katarzyna Kisiel-Sajewicz, PhD, 71 347 3534 ext. +48, katarzyna.kisiel-sajewicz@awf.wroc.pl
Joanna Mencel, MSc, 71 347 3531 ext. +48, joanna.mencel@awf.wroc.pl
About this study
Official title: Effect of Mental and Computer-aided Training of Reaching and Grasping Movements on Motor Control Processes in People With Bilateral Upper Limb Congenital Transverse Deficiency
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. We believe that engaging this population to computer-aided and/or mental trainings would facilitate structural and functional reorganization of the brain to promote motor function recovery.
Read the detailed 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.
- Conditions
- Amelia of Upper Limb
- Being tested
- Mental trainings, Computer-aided trainings, Computer-aided and mental trainings, No trainings
- Keywords
- bilateral upper limb congenital transverse deficiency, neuroplasticity, sensorimotor cortex, mental training, virtual environment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mental trainingsBehavioural
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.
Computer-aided trainingsBehavioural
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.
Computer-aided and mental trainingsBehavioural
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).
No trainingsOther
Healthy controls without any kind of training
| Study group | Role | What they receive |
|---|---|---|
| Patients-MT | Experimental | 3 Patients with bilateral upper limb congenital transverse deficiency that participated in kinesthetic mental training (MT) of reaching to grasp movements Receives: Behavioral: Mental trainings |
| Patients-CAT | Experimental | 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. Receives: Behavioral: Computer-aided trainings |
| Patients-CAMT | Experimental | 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). Receives: Behavioral: Computer-aided and mental trainings |
| Healthy-controls | Active comparator | 9 Healthy, age and gender-matched subjects, without any kind of training Receives: Other: No trainings |
What is being measured
The primary outcome is the main question the study is designed to answer.
Magnetic Resonance Imaging (MRI)
To evaluate structural changes in central nervous system (CNS) the MRI method will be used
Measured: Before trainings period (PRE)
Magnetic Resonance Imaging (MRI)
To evaluate structural changes in central nervous system (CNS) the MRI method will be used
Measured: After 4 weeks of trainings period (POST4)
Magnetic Resonance Imaging (MRI)
To evaluate structural changes in central nervous system (CNS) the MRI method will be used
Measured: After 8 weeks of trainings period (POST8)
Magnetic Resonance Imaging (MRI)
To evaluate structural changes in central nervous system (CNS) the MRI method will be used
Measured: After 12 weeks of trainings period (POST12)
Functional Magnetic Resonance Imaging (fMRI)
To evaluate functional changes in CNS, the fMRI will be used
Measured: Before trainings period (PRE)
Functional Magnetic Resonance Imaging (fMRI)
To evaluate functional changes in CNS, the fMRI will be used
Measured: After 4 weeks of trainings period (POST4)
Functional Magnetic Resonance Imaging (fMRI)
To evaluate functional changes in CNS, the fMRI will be used
Measured: After 8 weeks of trainings period (POST8)
Functional Magnetic Resonance Imaging (fMRI)
To evaluate functional changes in CNS, the fMRI will be used
Measured: After 12 weeks of trainings period (POST12)
Transcranial magnetic stimulation (TMS)
To evaluate excitability of the sensory-motor cortex of the brain.
Measured: Before trainings period (PRE)
Transcranial magnetic stimulation (TMS)
To evaluate excitability of the sensory-motor cortex of the brain.
Measured: After 4 weeks of trainings period (POST4)
Transcranial magnetic stimulation (TMS)
To evaluate excitability of the sensory-motor cortex of the brain.
Measured: After 8 weeks of trainings period (POST8)
Transcranial magnetic stimulation (TMS)
To evaluate excitability of the sensory-motor cortex of the brain.
Measured: After 12 weeks of trainings period (POST12)
Electroencephalography (EEG)
To evaluate functional changes in CNS, the 128-channels EEG will be used.
Measured: Before trainings period (PRE)
Electroencephalography (EEG)
To evaluate functional changes in CNS, the 128-channels EEG will be used.
Measured: After 4 weeks of trainings period (POST4)
Electroencephalography (EEG)
To evaluate functional changes in CNS, the 128-channels EEG will be used.
Measured: After 8 weeks of trainings period (POST8)
Electroencephalography (EEG)
To evaluate functional changes in CNS, the 128-channels EEG will be used.
Measured: After 12 weeks of trainings period (POST12)
Near-infrared spectroscopy (NIRS)
To evaluate functional changes in peripheral nervous system.
Measured: Before trainings period (PRE)
Near-infrared spectroscopy (NIRS)
To evaluate functional changes in peripheral nervous system.
Measured: After 4 weeks of trainings period (POST4)
Near-infrared spectroscopy (NIRS)
To evaluate functional changes in peripheral nervous system.
Measured: After 8 weeks of trainings period (POST8)
Near-infrared spectroscopy (NIRS)
To evaluate functional changes in peripheral nervous system.
Measured: After 12 weeks of trainings period (POST12)
Electromyography (EMG)
To evaluate functional changes in muscles of upper extremity stump
Measured: Before trainings period (PRE)
Electromyography (EMG)
To evaluate functional changes in muscles of upper extremity stump
Measured: After 4 weeks of trainings period (POST4)
Electromyography (EMG)
To evaluate functional changes in muscles of upper extremity stump
Measured: After 8 weeks of trainings period (POST8)
Electromyography (EMG)
To evaluate functional changes in muscles of upper extremity stump
Measured: After 12 weeks of trainings period (POST12)
Mechanomyography (MMG)
To evaluate functional changes in muscles of upper extremity stump
Measured: Before trainings period (PRE)
Mechanomyography (MMG)
To evaluate functional changes in muscles of upper extremity stump
Measured: After 4 weeks of trainings period (POST4)
Mechanomyography (MMG)
To evaluate functional changes in muscles of upper extremity stump
Measured: After 8 weeks of trainings period (POST8)
Mechanomyography (MMG)
To evaluate functional changes in muscles of upper extremity stump
Measured: After 12 weeks of trainings period (POST12)
Temperature measurements (Temp)
To evaluate functional changes in muscles of upper extremity stump
Measured: Before trainings period (PRE)
Temperature measurements (Temp)
To evaluate functional changes in muscles of upper extremity stump
Measured: After 4 weeks of trainings period (POST4)
Temperature measurements (Temp)
To evaluate functional changes in muscles of upper extremity stump
Measured: After 8 weeks of trainings period (POST8)
Temperature measurements (Temp)
To evaluate functional changes in muscles of upper extremity stump
Measured: After 12 weeks of trainings period (POST12)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2019
- Study start11 Mar 2014
- Primary completion9 Sep 2016
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Amelia of Upper LimbStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wroclaw University of Health and Sport Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Wrocław University of Science and Technology, Kessler Foundation, Nencki Institute of Experimental Biology, Warsaw, Poland, Hospital of St. Hedwig in Trzebnica
- Responsible party
- Principal investigator, Jaroslaw Marusiak, Wroclaw University of Health and Sport Sciences
- Investigators
- Katarzyna Kisiel-Sajewicz, PhD, Principal investigator, Wroclaw University of Health and Sport Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04048083
- Sponsor's protocol ID
- DEC-2011/03/B/NZ7/00588
- Status last verified
- Aug 2019
- First submitted
- 2 Aug 2019
- Last updated
- 7 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 28641235Mencel 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.
PubMed 36329083Mencel 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.
PubMed 33828507
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Mental and Computer-aided Training of Reaching and Grasping Movements on Motor Control Processes in People With Bilateral Upper Limb Congenital Transverse Deficiency
- ClinicalTrials.gov ID
- NCT04048083
- Acronym / sponsor ID
- DEC-2011/03/B/NZ7/00588
- Conditions
- Amelia of Upper Limb
- Keywords
- bilateral upper limb congenital transverse deficiency, neuroplasticity, sensorimotor cortex, mental training, virtual environment
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Wroclaw University of Health and Sport SciencesUniversity, hospital or other
- Collaborators
- Wrocław University of Science and Technology, Kessler Foundation, Nencki Institute of Experimental Biology, Warsaw, Poland, Hospital of St. Hedwig in Trzebnica
- Study start
- 11 Mar 2014 (actual)
- Primary completion
- 9 Sep 2016 (actual)
- Study completion
- Dec 2019 (estimated)
- First posted
- 7 Aug 2019 (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.
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. We believe that engaging this population to computer-aided and/or mental trainings would facilitate structural and functional reorganization of the brain to promote motor function recovery.
Detailed 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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Patients-MT | Experimental | Behavioral: Mental trainings3 Patients with bilateral upper limb congenital transverse deficiency that participated in kinesthetic mental training (MT) of reaching to grasp movements |
| Patients-CAT | Experimental | Behavioral: Computer-aided trainings3 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. |
| Patients-CAMT | Experimental | Behavioral: Computer-aided and mental trainings3 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). |
| Healthy-controls | Active comparator | Other: No trainings9 Healthy, age and gender-matched subjects, without any kind of training |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Age between 18 and 25 years
- Health status: bilateral upper limb congenital transverse deficiency individuals. Subjects must be free from neurological impairment. The subjects must have no current or past history of central or peripheral nervous system dysfunction, be taking no current medication known to affect the neuromuscular system, have no greater than moderate consumption of alcohol or caffeine, and be able to remain seated for 1 hour 30 min and lay supine without moving for 30 min (MRI test). All recruited subjects will be interviewed and their health status and medical history will be evaluated by a medical practitioner qualified to practice surgery and transplant surgery.
- Training history: Subjects not participating in any type of training program in the last 5 years
- Right Hemispheric Dominance. We will use Foot Dominance test - Observation of our subjects to see which foot they use to kick a ball, step up onto a stair, and step onto a coin placed on the floor.
- Availability and interest: All candidates for the study must be available for the familiarization, training, and testing sessions and must have transportation to these sessions.
Key exclusion criteria (8 listed)
- Presence of neurological impairment (history of central or peripheral nervous system dysfunction)
- Taking medication that affects the neuromuscular system
- Left hemispheric dominance
- Participation in training over the last five years
- Presence of neurological impairment (history of central or peripheral nervous system dysfunction)
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 |
|---|---|---|
| Mental trainingsPatients 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. | Behavioural | Patients-MT |
| Computer-aided trainingsPatients 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. | Behavioural | Patients-CAT |
| Computer-aided and mental trainingsPatients 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). | Behavioural | Patients-CAMT |
| No trainingsHealthy controls without any kind of training | Other | Healthy-controls |
Primary outcome
Magnetic Resonance Imaging (MRI)
Time frame: Before trainings period (PRE)
To evaluate structural changes in central nervous system (CNS) the MRI method will be used
Magnetic Resonance Imaging (MRI)
Time frame: After 4 weeks of trainings period (POST4)
To evaluate structural changes in central nervous system (CNS) the MRI method will be used
Magnetic Resonance Imaging (MRI)
Time frame: After 8 weeks of trainings period (POST8)
To evaluate structural changes in central nervous system (CNS) the MRI method will be used
Magnetic Resonance Imaging (MRI)
Time frame: After 12 weeks of trainings period (POST12)
To evaluate structural changes in central nervous system (CNS) the MRI method will be used
Functional Magnetic Resonance Imaging (fMRI)
Time frame: Before trainings period (PRE)
To evaluate functional changes in CNS, the fMRI will be used
Functional Magnetic Resonance Imaging (fMRI)
Time frame: After 4 weeks of trainings period (POST4)
To evaluate functional changes in CNS, the fMRI will be used
Functional Magnetic Resonance Imaging (fMRI)
Time frame: After 8 weeks of trainings period (POST8)
To evaluate functional changes in CNS, the fMRI will be used
Functional Magnetic Resonance Imaging (fMRI)
Time frame: After 12 weeks of trainings period (POST12)
To evaluate functional changes in CNS, the fMRI will be used
Transcranial magnetic stimulation (TMS)
Time frame: Before trainings period (PRE)
To evaluate excitability of the sensory-motor cortex of the brain.
Transcranial magnetic stimulation (TMS)
Time frame: After 4 weeks of trainings period (POST4)
To evaluate excitability of the sensory-motor cortex of the brain.
Transcranial magnetic stimulation (TMS)
Time frame: After 8 weeks of trainings period (POST8)
To evaluate excitability of the sensory-motor cortex of the brain.
Transcranial magnetic stimulation (TMS)
Time frame: After 12 weeks of trainings period (POST12)
To evaluate excitability of the sensory-motor cortex of the brain.
Electroencephalography (EEG)
Time frame: Before trainings period (PRE)
To evaluate functional changes in CNS, the 128-channels EEG will be used.
Electroencephalography (EEG)
Time frame: After 4 weeks of trainings period (POST4)
To evaluate functional changes in CNS, the 128-channels EEG will be used.
Electroencephalography (EEG)
Time frame: After 8 weeks of trainings period (POST8)
To evaluate functional changes in CNS, the 128-channels EEG will be used.
Electroencephalography (EEG)
Time frame: After 12 weeks of trainings period (POST12)
To evaluate functional changes in CNS, the 128-channels EEG will be used.
Near-infrared spectroscopy (NIRS)
Time frame: Before trainings period (PRE)
To evaluate functional changes in peripheral nervous system.
Near-infrared spectroscopy (NIRS)
Time frame: After 4 weeks of trainings period (POST4)
To evaluate functional changes in peripheral nervous system.
Near-infrared spectroscopy (NIRS)
Time frame: After 8 weeks of trainings period (POST8)
To evaluate functional changes in peripheral nervous system.
Near-infrared spectroscopy (NIRS)
Time frame: After 12 weeks of trainings period (POST12)
To evaluate functional changes in peripheral nervous system.
Electromyography (EMG)
Time frame: Before trainings period (PRE)
To evaluate functional changes in muscles of upper extremity stump
Electromyography (EMG)
Time frame: After 4 weeks of trainings period (POST4)
To evaluate functional changes in muscles of upper extremity stump
Electromyography (EMG)
Time frame: After 8 weeks of trainings period (POST8)
To evaluate functional changes in muscles of upper extremity stump
Electromyography (EMG)
Time frame: After 12 weeks of trainings period (POST12)
To evaluate functional changes in muscles of upper extremity stump
Mechanomyography (MMG)
Time frame: Before trainings period (PRE)
To evaluate functional changes in muscles of upper extremity stump
Mechanomyography (MMG)
Time frame: After 4 weeks of trainings period (POST4)
To evaluate functional changes in muscles of upper extremity stump
Mechanomyography (MMG)
Time frame: After 8 weeks of trainings period (POST8)
To evaluate functional changes in muscles of upper extremity stump
Mechanomyography (MMG)
Time frame: After 12 weeks of trainings period (POST12)
To evaluate functional changes in muscles of upper extremity stump
Temperature measurements (Temp)
Time frame: Before trainings period (PRE)
To evaluate functional changes in muscles of upper extremity stump
Temperature measurements (Temp)
Time frame: After 4 weeks of trainings period (POST4)
To evaluate functional changes in muscles of upper extremity stump
Temperature measurements (Temp)
Time frame: After 8 weeks of trainings period (POST8)
To evaluate functional changes in muscles of upper extremity stump
Temperature measurements (Temp)
Time frame: After 12 weeks of trainings period (POST12)
To evaluate functional changes in muscles of upper extremity stump
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2019.
- Background: PubMed 28641235Kurzynski 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.
- Derived from this study: PubMed 36329083Mencel 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.
- Derived from this study: PubMed 33828507Mencel 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.
- Individual participant dataSharing planned: Undecided
Related trials for Amelia of Upper Limb
RecruitingObservational study
CNS Changes Following Upper Limb Loss
Amputation, Congenital, Upper Limb; Amelia
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.
Katarzyna Kisiel-Sajewicz, PhD principal investigator
Wroclaw University of Health and Sport Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mental trainings, Computer-aided trainings and Computer-aided and mental trainings in people with Amelia of Upper Limb, run by Wroclaw University of Health and Sport Sciences at 1 site in Poland.
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 10 inclusion and 8 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 7 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. 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 Andrzej Rokita, PhD (713473101 ext. +48, rektor@awf.wroc.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Magnetic Resonance Imaging (MRI) (time frame: Before trainings period (PRE)). The study lists 32 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04048083, which also lists 3 linked publications.
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 7 Aug 2019.