StrokeNCT04154371
EMG-controlled Virtual Reality to Improve Upper Extremity Function in Chronic Stroke Patients
A study of Stroke and Upper Extremity Dysfunction, run by Chalmers University of Technology at 1 site in Sweden.
Trial summary
This is a single subject design study to investigate the effectiveness of electromyography-controlled virtual reality and serious gaming treatment on upper extremity functionality in patients in the chronic recovery stage after stroke. The treatment consists of 18 sessions, 3 times per week, 2 hours each session. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Stroke, Upper Extremity Dysfunction
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteSweden
- Study dates
- 11 Nov 2019to 20 Dec 2022
- 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
- Able to sign an informed consent document
- Detectable muscle signals in the affected upper limb.
- Age between 18 and 80 years of age
- Montreal Cognitive Assessment test score of at least 22
- At least 6 months after stroke
- Experiencing upper-limb weakness, paralysis, or other loss of functionality
Show all 9Show fewer
- Having a score below 50 on the Fugl-Meyer Assessment - Upper Extremity score
- Modified Ashworth score (0-5) of less than 3 pts
- Able to communicate and follow instructions needed for assessment and intervention adherence
Who cannot join
- Patients who are blind
- Presence of a condition or abnormality that in the opinion of the investigator would compromise the safety of the patient or the quality of the data
- Patients who have open wounds or other acute complications on their arms
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Electromyography-controlled Virtual Reality and Serious Gaming to Improve Upper Extremity Function in Chronic Stroke Patients
This is a single subject design study to investigate the effectiveness of electromyography-controlled virtual reality and serious gaming treatment on upper extremity functionality in patients in the chronic recovery stage after stroke.
The treatment consists of 18 sessions, 3 times per week, 2 hours each session.
The investigator's hypothesis is that this treatment will improve upper limb functionality in our study population, this outcome will be measured with Fugl-Meyer Upper-Extremity (FMA-UE) and Action Research Arm Test (ARAT) tests and Kinematic analysis. In addition, we expect to see an increase in the strength of the affected limb and an increase in the embodiment of the upper limb trained.
Read the detailed description
Background
The World Health Organization (WHO) defines stroke as rapidly developing clinical signs of focal or global disturbance of cerebral function, with symptoms lasting more than 24 hours or leading to death and with no apparent non-vascular cause. The incidence of stroke in Sweden is 300 cases per 100.000 inhabitants in a year of whom 200 suffer the first incidence of stroke leading to 18.000 new stroke victims. Of these, about 20% will die within the first month and about 1/3 of the survivors will remain significantly disabled after 6-12 months.
The upper extremity function is impaired after stroke in approximately 70-80% of patients in the acute phase and in 40% in chronic phase. This impairment limits the voluntary, well-coordinated, and effective movements as well as a person's level of activity and participation in their social and physical environment. This longstanding disability also affects the quality of life. Improved upper extremity function is one of the suggested areas for research by survivors of stroke.
Objectives
Primary Objective:
Investigate the effectiveness of electromyography-controlled augmented reality, and serious gaming on upper extremity functionality in patients in the chronic recovery stage after stroke, measure with FMA-UE and ARAT tests
Secondary Objectives:
- Investigate changes in the movement quality when performing a daily task using kinematic analysis and perceived difficulties in daily activities.
- Measure how strength changes on the affected limb after the treatment. Measure by a dynamometer.
- Measure with embodiment questioner if the treatment makes some changes on the embodiment of the affected limb.
- Measure with thermography the skin temperature differences between the affected and non-affected limb pre- and post-treatment.
Tertiary Objectives:
The tertiary objectives of this study are to investigate the effect of training on electromyography-based pattern recognition accuracy and Targeted Achievement Control scores, changes in kinematics, and changes in ABILHAND, Barthel index, muscle tone, and sensation scores in the affected limb over the recovery period.
Study Design
Inclusion and exclusion criteria for prospective patients will be addressed at the first measurement session. Baseline measurements will start at week 1 and, if necessary, inclusion and exclusion criteria will be reassessed.
Patients will undergo a single subject design (A-B-A-FU). Intervention stages are as follows:
A (Baseline). 2-3 weeks of no intervention with measurements taken once or twice per week, with a minimum of 3 assessments.
B (Intervention). 6 weeks of intervention three times per week with measurements taken once per week (18 sessions).
A (Reversal). 2-3 weeks of no intervention with measurements taken once or twice per week, with a minimum of 3 assessments.
FU (Follow-up). Follow-up measurements taken after 3 months without treatment.
Treatment Administration
Surface electrodes and a tracking marker are placed on the subject's affected upper extremity. Electrodes are placed on active muscle sites along the affected extremity determined by palpation. If no active sites can be determined, electrodes are placed along with major muscle groups regardless of activation. Electrodes are fixed to an electromyography recording device, and signal acquisition and processing software (BioPatRec) is used to record electromyography (EMG) signals and display feedback. EMG signals are observed, and the most active electrode locations are documented and used for further experiments.
The subject should attempt to perform different hand and arm movements with the extremity indicated by a nearby computer screen while the computer records EMG signals from the arm (referred to as offline training). Agonist-antagonist movement pairs should always be used in combination when selecting movements. Treatment sessions should start with one movement pair at a time and progress to multiple and simultaneous movements as treatment progresses and the patients perform better with the system.
The computer system recognizes the different movements while the computer system records closely related EMG signals and will perform the subject's intended movements with a computer-simulated upper extremity.
The subject will then use previously recorded movements to control a computer-simulated limb and attempt to match limb positions indicated on the computer screen. The system will measure how fast and how efficiently the subject reaches the target position with the simulated extremity Targeted Achievement Control (TAC Test). TAC tests will initially involve control over one degree of freedom at a time, e.g. rotation of the wrist or open/close hand movements. As the patient gains better control of their affected extremity and learn to use the system, the difficulty of the TAC Tests will be increased by adding additional and simultaneous movements.
Duration of the Treatment:
Each intervention session should take approximately two hours. The intervention stage of the trial will last six weeks with three sessions per week, total of 18 sessions.
- Conditions
- Stroke, Upper Extremity Dysfunction
- Being tested
- Electromyography-controlled virtual and augmented reality using serious gaming
- Keywords
- Electromyography, Virtual Reality
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electromyography-controlled virtual and augmented reality using serious gamingDevice
Surface electrodes and a tracking marker are placed on the subject's affected upper extremity. Electrodes are placed on active muscle sites along the affected extremity determined by palpation. Electrodes are connected to an electromyography recording device, and signal acquisition and processing software are used to record EMG signals and display feedback. Myoelectric signals are used to control a virtual limb on the screen. The intervention consists of different steps: virtual reality, augmented reality, and serious gaming, which the participant must control with their muscle activity, record by EMG, in their affected limb.
| Study group | Role | What they receive |
|---|---|---|
| Single-arm or non-randomized trial | Experimental | Six post-stroke patients, in the chronic recovery stage, will receive a treatment in which motor execution is promoted by virtual and augmented reality using serious gaming controlled by myoelectric pattern recognition. The aim of this treatment is to improve upper limb functionality. Receives: Device: Electromyography-controlled virtual and augmented reality using serious gaming |
What is being measured
The primary outcome is the main question the study is designed to answer.
Upper Extremity Scale of Fugl-Meyer Assessment
The upper extremity portion of the Fugl-Meyer is a 33-item observational measure of upper limb function (Fugl-Meyer, et al., 1975). Each item is measured on an ordinal scale of 0-2 with 2 indicating normal functionality. The total score ranges from 0-66.
Measured: 3 times over 3 weeks immediately prior to intervention, once per week at the beginning of the session during intervention (6 weeks), 3 times over 3 weeks immediately after the end intervention, and once more 3 months after the end of intervention
Action Research Arm Test
The Action Research Arm Test is a 19-item observational measure of upper limb function (Lyle, 1981). Each item is measured on an ordinal scale of 0-3, with 3 indicating normal functionality. The total score ranges from 0-57.
Measured: 3 times over 3 weeks immediately prior to intervention, once per week at the beginning of the session during intervention (6 weeks), 3 times over 3 weeks immediately after the end intervention, and once more 3 months after the end of intervention
Secondary outcomes (4)
Kinematic Analysis
Kinematic analysis is a 4-item measure of upper-limb movement quality during a daily life activity (Murphy, et al., 2011). Items measured are movement time (seconds), movement smoothness (number of movement units), peak angular velocity of the elbow (mm per second), and maximum compensatory trunk displacement (cm).
Measured: Once in the 3 weeks immediately prior to intervention, once every other week during intervention at the beginning of the session, once in the 3 weeks immediately after the end of intervention, and once more 3 months after the end of intervention
Embodiment Questionnaire
Perceived embodiment of the affected limb will be measured by a 6-item questionnaire. Each item is rated on a scale of 0 (completely disagree) to 7 (completely agree) regarding perception of agency and ownership of both the affected limb and the virtual limb used during the intervention. The total score ranges from 0-42.
Measured: Once in the 3 weeks immediately prior to intervention, once per week during the intervention at the end of the session, once in the 3 weeks immediately after the end of intervention, and once more 3 months after the end of intervention
Thermography
The temperature difference (in degrees celsius) between the affected and non-affected limbs will be measured via thermographic camera. Healthy humans have a negligible difference between limbs, whereas an altered sense of embodiment may cause an increase in temperature difference (Moseley, et al., 2008).
Measured: Once in the 3 weeks immediately prior to intervention, once in the 3 weeks immediately after the end of intervention, and once more 3 months after the end of intervention
Grip Strength
Grip strength (kg) will be measured with a handheld dynamometer.
Measured: 3 times over 3 weeks immediately prior to intervention, once per week at the beginning of the session during intervention (6 weeks), 3 times over 3 weeks immediately after the end intervention, and once more 3 months after the end of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2019
- Study start11 Nov 2019
- Primary completion20 Jan 2022
- Study completion20 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for 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
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chalmers University of Technology
- Sponsor type
- University, hospital or other
- Collaborators
- Sahlgrenska University Hospital, Göteborg University
- Responsible party
- Principal investigator, Max Ortiz Catalan, Chalmers University of Technology
- Investigators
- Max Ortiz Catalan, PHD, Principal investigator, Chalmers University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04154371
- Sponsor's protocol ID
- BNL2019-1
- Status last verified
- Mar 2022
- First submitted
- 31 Oct 2019
- Last updated
- 9 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Socialstyrelsen, "Statistical Database: In-Patient Care Diagnosis." [Online]. Available: http://www.socialstyrelsen.se/statistics/statisticaldatabase/. [Accessed: 14-Jan-2018].
Raffin E, Hummel FC. Restoring Motor Functions After Stroke: Multiple Approaches and Opportunities. Neuroscientist. 2018 Aug;24(4):400-416. doi: 10.1177/1073858417737486. Epub 2017 Nov 7.
PubMed 29283026Miller ET, Easton KL. Perceived losses following stroke. Rehabil Nurs. 2000 Sep-Oct;25(5):192-5. doi: 10.1002/j.2048-7940.2000.tb01904.x. No abstract available.
PubMed 11998085Woodman P, Riazi A, Pereira C, Jones F. Social participation post stroke: a meta-ethnographic review of the experiences and views of community-dwelling stroke survivors. Disabil Rehabil. 2014;36(24):2031-43. doi: 10.3109/09638288.2014.887796. Epub 2014 Mar 6.
PubMed 24597937Lang CE, Bland MD, Bailey RR, Schaefer SY, Birkenmeier RL. Assessment of upper extremity impairment, function, and activity after stroke: foundations for clinical decision making. J Hand Ther. 2013 Apr-Jun;26(2):104-14;quiz 115. doi: 10.1016/j.jht.2012.06.005. Epub 2012 Sep 10.
PubMed 22975740M. Klocek, "Quality of life after stroke," in Health-Related Quality of Life in Cardiovascular Patients, 2013.
Lyle RC. A performance test for assessment of upper limb function in physical rehabilitation treatment and research. Int J Rehabil Res. 1981;4(4):483-92. doi: 10.1097/00004356-198112000-00001. No abstract available.
PubMed 7333761Perez-Marcos D. Virtual reality experiences, embodiment, videogames and their dimensions in neurorehabilitation. J Neuroeng Rehabil. 2018 Nov 26;15(1):113. doi: 10.1186/s12984-018-0461-0.
PubMed 30477527Ortiz-Catalan M, Guethmundsdottir RA, Kristoffersen MB, Zepeda-Echavarria A, Caine-Winterberger K, Kulbacka-Ortiz K, Widehammar C, Eriksson K, Stockselius A, Ragno C, Pihlar Z, Burger H, Hermansson L. Phantom motor execution facilitated by machine learning and augmented reality as treatment for phantom limb pain: a single group, clinical trial in patients with chronic intractable phantom limb pain. Lancet. 2016 Dec 10;388(10062):2885-2894. doi: 10.1016/S0140-6736(16)31598-7. Epub 2016 Dec 2.
PubMed 27916234Woytowicz EJ, Rietschel JC, Goodman RN, Conroy SS, Sorkin JD, Whitall J, McCombe Waller S. Determining Levels of Upper Extremity Movement Impairment by Applying a Cluster Analysis to the Fugl-Meyer Assessment of the Upper Extremity in Chronic Stroke. Arch Phys Med Rehabil. 2017 Mar;98(3):456-462. doi: 10.1016/j.apmr.2016.06.023. Epub 2016 Aug 9.
PubMed 27519928Simon AM, Hargrove LJ, Lock BA, Kuiken TA. Target Achievement Control Test: evaluating real-time myoelectric pattern-recognition control of multifunctional upper-limb prostheses. J Rehabil Res Dev. 2011;48(6):619-27. doi: 10.1682/jrrd.2010.08.0149.
PubMed 21938650MAHONEY FI, BARTHEL DW. FUNCTIONAL EVALUATION: THE BARTHEL INDEX. Md State Med J. 1965 Feb;14:61-5. No abstract available.
PubMed 14258950Fugl-Meyer AR, Jaasko L, Leyman I, Olsson S, Steglind S. The post-stroke hemiplegic patient. 1. a method for evaluation of physical performance. Scand J Rehabil Med. 1975;7(1):13-31.
PubMed 1135616Moseley GL, Olthof N, Venema A, Don S, Wijers M, Gallace A, Spence C. Psychologically induced cooling of a specific body part caused by the illusory ownership of an artificial counterpart. Proc Natl Acad Sci U S A. 2008 Sep 2;105(35):13169-73. doi: 10.1073/pnas.0803768105. Epub 2008 Aug 25.
PubMed 18725630Alt Murphy M, Willen C, Sunnerhagen KS. Kinematic variables quantifying upper-extremity performance after stroke during reaching and drinking from a glass. Neurorehabil Neural Repair. 2011 Jan;25(1):71-80. doi: 10.1177/1545968310370748. Epub 2010 Sep 9.
PubMed 20829411
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electromyography-controlled Virtual Reality and Serious Gaming to Improve Upper Extremity Function in Chronic Stroke Patients
- ClinicalTrials.gov ID
- NCT04154371
- Acronym / sponsor ID
- BNL2019-1
- Conditions
- Stroke, Upper Extremity Dysfunction
- Keywords
- Electromyography, Virtual Reality
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Chalmers University of TechnologyUniversity, hospital or other
- Collaborators
- Sahlgrenska University Hospital, Göteborg University
- Study start
- 11 Nov 2019 (actual)
- Primary completion
- 20 Jan 2022 (actual)
- Study completion
- 20 Dec 2022 (estimated)
- First posted
- 6 Nov 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 is a single subject design study to investigate the effectiveness of electromyography-controlled virtual reality and serious gaming treatment on upper extremity functionality in patients in the chronic recovery stage after stroke.
The treatment consists of 18 sessions, 3 times per week, 2 hours each session.
The investigator's hypothesis is that this treatment will improve upper limb functionality in our study population, this outcome will be measured with Fugl-Meyer Upper-Extremity (FMA-UE) and Action Research Arm Test (ARAT) tests and Kinematic analysis. In addition, we expect to see an increase in the strength of the affected limb and an increase in the embodiment of the upper limb trained.
Detailed description
Background
The World Health Organization (WHO) defines stroke as rapidly developing clinical signs of focal or global disturbance of cerebral function, with symptoms lasting more than 24 hours or leading to death and with no apparent non-vascular cause. The incidence of stroke in Sweden is 300 cases per 100.000 inhabitants in a year of whom 200 suffer the first incidence of stroke leading to 18.000 new stroke victims. Of these, about 20% will die within the first month and about 1/3 of the survivors will remain significantly disabled after 6-12 months.
The upper extremity function is impaired after stroke in approximately 70-80% of patients in the acute phase and in 40% in chronic phase. This impairment limits the voluntary, well-coordinated, and effective movements as well as a person's level of activity and participation in their social and physical environment. This longstanding disability also affects the quality of life. Improved upper extremity function is one of the suggested areas for research by survivors of stroke.
Objectives
Primary Objective:
Investigate the effectiveness of electromyography-controlled augmented reality, and serious gaming on upper extremity functionality in patients in the chronic recovery stage after stroke, measure with FMA-UE and ARAT tests
Secondary Objectives:
- Investigate changes in the movement quality when performing a daily task using kinematic analysis and perceived difficulties in daily activities.
- Measure how strength changes on the affected limb after the treatment. Measure by a dynamometer.
- Measure with embodiment questioner if the treatment makes some changes on the embodiment of the affected limb.
- Measure with thermography the skin temperature differences between the affected and non-affected limb pre- and post-treatment.
Tertiary Objectives:
The tertiary objectives of this study are to investigate the effect of training on electromyography-based pattern recognition accuracy and Targeted Achievement Control scores, changes in kinematics, and changes in ABILHAND, Barthel index, muscle tone, and sensation scores in the affected limb over the recovery period.
Study Design
Inclusion and exclusion criteria for prospective patients will be addressed at the first measurement session. Baseline measurements will start at week 1 and, if necessary, inclusion and exclusion criteria will be reassessed.
Patients will undergo a single subject design (A-B-A-FU). Intervention stages are as follows:
A (Baseline). 2-3 weeks of no intervention with measurements taken once or twice per week, with a minimum of 3 assessments.
B (Intervention). 6 weeks of intervention three times per week with measurements taken once per week (18 sessions).
A (Reversal). 2-3 weeks of no intervention with measurements taken once or twice per week, with a minimum of 3 assessments.
FU (Follow-up). Follow-up measurements taken after 3 months without treatment.
Treatment Administration
Surface electrodes and a tracking marker are placed on the subject's affected upper extremity. Electrodes are placed on active muscle sites along the affected extremity determined by palpation. If no active sites can be determined, electrodes are placed along with major muscle groups regardless of activation. Electrodes are fixed to an electromyography recording device, and signal acquisition and processing software (BioPatRec) is used to record electromyography (EMG) signals and display feedback. EMG signals are observed, and the most active electrode locations are documented and used for further experiments.
The subject should attempt to perform different hand and arm movements with the extremity indicated by a nearby computer screen while the computer records EMG signals from the arm (referred to as offline training). Agonist-antagonist movement pairs should always be used in combination when selecting movements. Treatment sessions should start with one movement pair at a time and progress to multiple and simultaneous movements as treatment progresses and the patients perform better with the system.
The computer system recognizes the different movements while the computer system records closely related EMG signals and will perform the subject's intended movements with a computer-simulated upper extremity.
The subject will then use previously recorded movements to control a computer-simulated limb and attempt to match limb positions indicated on the computer screen. The system will measure how fast and how efficiently the subject reaches the target position with the simulated extremity Targeted Achievement Control (TAC Test). TAC tests will initially involve control over one degree of freedom at a time, e.g. rotation of the wrist or open/close hand movements. As the patient gains better control of their affected extremity and learn to use the system, the difficulty of the TAC Tests will be increased by adding additional and simultaneous movements.
Duration of the Treatment:
Each intervention session should take approximately two hours. The intervention stage of the trial will last six weeks with three sessions per week, total of 18 sessions.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single-arm or non-randomized trial | Experimental | Device: Electromyography-controlled virtual and augmented reality using serious gamingSix post-stroke patients, in the chronic recovery stage, will receive a treatment in which motor execution is promoted by virtual and augmented reality using serious gaming controlled by myoelectric pattern recognition. The aim of this treatment is to improve upper limb functionality. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Able to sign an informed consent document
- Detectable muscle signals in the affected upper limb.
- Age between 18 and 80 years of age
- Montreal Cognitive Assessment test score of at least 22
- At least 6 months after stroke
Key exclusion criteria (3 listed)
- Patients who are blind
- Presence of a condition or abnormality that in the opinion of the investigator would compromise the safety of the patient or the quality of the data
- Patients who have open wounds or other acute complications on their arms
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 |
|---|---|---|
| Electromyography-controlled virtual and augmented reality using serious gamingSurface electrodes and a tracking marker are placed on the subject's affected upper extremity. Electrodes are placed on active muscle sites along the affected extremity determined by palpation. Electrodes are connected to an electromyography recording device, and signal acquisition and processing software are used to record EMG signals and display feedback. Myoelectric signals are used to control a virtual limb on the screen. The intervention consists of different steps: virtual reality, augmented reality, and serious gaming, which the participant must control with their muscle activity, record by EMG, in their affected limb. | Device | Single-arm or non-randomized trial |
Primary outcome
Upper Extremity Scale of Fugl-Meyer Assessment
Time frame: 3 times over 3 weeks immediately prior to intervention, once per week at the beginning of the session during intervention (6 weeks), 3 times over 3 weeks immediately after the end intervention, and once more 3 months after the end of intervention
The upper extremity portion of the Fugl-Meyer is a 33-item observational measure of upper limb function (Fugl-Meyer, et al., 1975). Each item is measured on an ordinal scale of 0-2 with 2 indicating normal functionality. The total score ranges from 0-66.
Action Research Arm Test
Time frame: 3 times over 3 weeks immediately prior to intervention, once per week at the beginning of the session during intervention (6 weeks), 3 times over 3 weeks immediately after the end intervention, and once more 3 months after the end of intervention
The Action Research Arm Test is a 19-item observational measure of upper limb function (Lyle, 1981). Each item is measured on an ordinal scale of 0-3, with 3 indicating normal functionality. The total score ranges from 0-57.
4 secondary outcomes
Kinematic Analysis
Time frame: Once in the 3 weeks immediately prior to intervention, once every other week during intervention at the beginning of the session, once in the 3 weeks immediately after the end of intervention, and once more 3 months after the end of intervention
Embodiment Questionnaire
Time frame: Once in the 3 weeks immediately prior to intervention, once per week during the intervention at the end of the session, once in the 3 weeks immediately after the end of intervention, and once more 3 months after the end of intervention
Thermography
Time frame: Once in the 3 weeks immediately prior to intervention, once in the 3 weeks immediately after the end of intervention, and once more 3 months after the end of intervention
Grip Strength
Time frame: 3 times over 3 weeks immediately prior to intervention, once per week at the beginning of the session during intervention (6 weeks), 3 times over 3 weeks immediately after the end intervention, and once more 3 months after the end of intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2022.
- BackgroundSocialstyrelsen, "Statistical Database: In-Patient Care Diagnosis." [Online]. Available: http://www.socialstyrelsen.se/statistics/statisticaldatabase/. [Accessed: 14-Jan-2018].
- Background: PubMed 29283026Raffin E, Hummel FC. Restoring Motor Functions After Stroke: Multiple Approaches and Opportunities. Neuroscientist. 2018 Aug;24(4):400-416. doi: 10.1177/1073858417737486. Epub 2017 Nov 7.
- Background: PubMed 11998085Miller ET, Easton KL. Perceived losses following stroke. Rehabil Nurs. 2000 Sep-Oct;25(5):192-5. doi: 10.1002/j.2048-7940.2000.tb01904.x. No abstract available.
- Background: PubMed 24597937Woodman P, Riazi A, Pereira C, Jones F. Social participation post stroke: a meta-ethnographic review of the experiences and views of community-dwelling stroke survivors. Disabil Rehabil. 2014;36(24):2031-43. doi: 10.3109/09638288.2014.887796. Epub 2014 Mar 6.
- Background: PubMed 22975740Lang CE, Bland MD, Bailey RR, Schaefer SY, Birkenmeier RL. Assessment of upper extremity impairment, function, and activity after stroke: foundations for clinical decision making. J Hand Ther. 2013 Apr-Jun;26(2):104-14;quiz 115. doi: 10.1016/j.jht.2012.06.005. Epub 2012 Sep 10.
- BackgroundM. Klocek, "Quality of life after stroke," in Health-Related Quality of Life in Cardiovascular Patients, 2013.
- Background: PubMed 7333761Lyle RC. A performance test for assessment of upper limb function in physical rehabilitation treatment and research. Int J Rehabil Res. 1981;4(4):483-92. doi: 10.1097/00004356-198112000-00001. No abstract available.
- Background: PubMed 30477527Perez-Marcos D. Virtual reality experiences, embodiment, videogames and their dimensions in neurorehabilitation. J Neuroeng Rehabil. 2018 Nov 26;15(1):113. doi: 10.1186/s12984-018-0461-0.
- Background: PubMed 27916234Ortiz-Catalan M, Guethmundsdottir RA, Kristoffersen MB, Zepeda-Echavarria A, Caine-Winterberger K, Kulbacka-Ortiz K, Widehammar C, Eriksson K, Stockselius A, Ragno C, Pihlar Z, Burger H, Hermansson L. Phantom motor execution facilitated by machine learning and augmented reality as treatment for phantom limb pain: a single group, clinical trial in patients with chronic intractable phantom limb pain. Lancet. 2016 Dec 10;388(10062):2885-2894. doi: 10.1016/S0140-6736(16)31598-7. Epub 2016 Dec 2.
- Background: PubMed 27519928Woytowicz EJ, Rietschel JC, Goodman RN, Conroy SS, Sorkin JD, Whitall J, McCombe Waller S. Determining Levels of Upper Extremity Movement Impairment by Applying a Cluster Analysis to the Fugl-Meyer Assessment of the Upper Extremity in Chronic Stroke. Arch Phys Med Rehabil. 2017 Mar;98(3):456-462. doi: 10.1016/j.apmr.2016.06.023. Epub 2016 Aug 9.
- Background: PubMed 21938650Simon AM, Hargrove LJ, Lock BA, Kuiken TA. Target Achievement Control Test: evaluating real-time myoelectric pattern-recognition control of multifunctional upper-limb prostheses. J Rehabil Res Dev. 2011;48(6):619-27. doi: 10.1682/jrrd.2010.08.0149.
- Background: PubMed 14258950MAHONEY FI, BARTHEL DW. FUNCTIONAL EVALUATION: THE BARTHEL INDEX. Md State Med J. 1965 Feb;14:61-5. No abstract available.
- Individual participant dataSharing planned: No
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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.
Max Ortiz Catalan, PHD principal investigator
Chalmers University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Stroke and Upper Extremity Dysfunction, run by Chalmers University of Technology at 1 site in Sweden.
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 9 inclusion and 3 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 9 Mar 2022. 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 Sweden. 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?
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?
Upper Extremity Scale of Fugl-Meyer Assessment (time frame: 3 times over 3 weeks immediately prior to intervention, once per week at the beginning of the session during intervention (6 weeks), 3 times over 3 weeks immediately after the end intervention, and once more 3 months after the end of intervention). 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?
On the ClinicalTrials.gov record for NCT04154371, which also lists 18 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 9 Mar 2022.