StrokeNCT04036422
Effects of a Computerised Exercise System on Functionality of the Arm,Cognition and Quality of Life in Stroke Patients
A study testing Rejoyce (Rehabilitation Joystick for Computerized Exercise), Conventional physical therapy and Occupational therapy in people with Stroke and Neuronal Plasticity, run by Baskent University at 1 site in Turkey (Türkiye).
Trial summary
Stroke occurs as a result of blood vessels of the brain becoming blocked or bleeding which in turn can result in loss of function in the limbs. Rehabilitation of patients following stroke includes repetitive, task based exercises to help regain normal limb function. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Stroke, Neuronal Plasticity, Hemiplegia
- What is being tested?
- Rejoyce (Rehabilitation Joystick for Computerized Exercise), Conventional physical therapy and Occupational therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Aug 2019to 15 Nov 2020
- 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
- Between the ages of 18-80 years
- Admitted to our PRM Department with a diagnosis of hemiplegia secondary to stroke for rehabilitation
- Upper extremity and hand Brunnstrom staging of ≥3.
- MMSE score of ≥23.
Who cannot join
- Presence of disability of the arms and hand which affects upper extremity motor function prior to stroke
- Presence of diplegia
- Presence of neglect
- Presence of visual field defect
- Presence of loss of hearing
- Presence of spasticity in the hemiplegic upper extremity and hand of grade 3 and above according to the Modified Ashworth Scale
Show all 9Show fewer
- Presence of acute musculoskeletal pain which will affect exercise participation
- Inability to sit upright in a chair for 30 minutes.
- Those who are clinically unstable due to comorbidities.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Baskent University Faculty of Medicine, Ankara Hospital
Ankara, 06800
About this study
Official title: The Effects of a Task Based Computerised Exercise System Versus Conventional Physiotherapy on Upper Extremity Functionality, Cognitive Function and Quality of Life in the Rehabilitation of Stroke Patients: a Randomised Control Study
Stroke occurs as a result of blood vessels of the brain becoming blocked or bleeding which in turn can result in loss of function in the limbs. Rehabilitation of patients following stroke includes repetitive, task based exercises to help regain normal limb function. Developments in stroke rehabilitation have resulted in more and more therapeutic options being available for inclusion in the treatment plan of stroke patients. The benefits of computerised task based arm and hand rehabilitation exercises in stroke rehabilitation are well known. Computer based rehabilitation supports the stroke patient in performing high intensity, multiple repetition exercises and in doing so encourages the regeneration of brain cells. In addition, it is believed that the stimulating environment provided by computerised exercise programs encourages the ability to problem solve and perform tasks. However, the effects of such computer based treatments on cognition have rarely been studied.
In Turkey to date there are no community based, task specific computerised exercise programmes available to stroke sufferers. Such systems may provide inpatient and community based stroke sufferers with a practical and economical therapeutic option as a part of stroke rehabilitation. Moreover, this may provide the patient with a mode of ongoing, long term therapeutic exercise and maintenance of skills acquired in the hospital rehabilitation period shortly after stroke.
The aim of this study was to investigate the benefits of computer based, task specific exercises when compared to conventional rehabilitation alone on arm and hand function, quality of life and cognition in stroke patients.
Read the detailed description
In developed countries only 5-10% of chronic stroke patients receive an active rehabilitation program. In Turkey, there is no community based rehabilitation program available to stroke patients in the subacute - chronic phase of the disease, even though it is known that functional gain can continue in this part of the disease when supported by an adequate rehabilitation program. Equally, functional gain can be lost over time if appropriate physical therapy is discontinued.
Recent Advances in technology have allowed for the development of new approaches in stroke rehabilitation. Computer based treatment options include virtual reality (VR), robotic training and computer based task specific games. Computer based rehabilitation can encourage patients in performing high intensity, repetitive exercises which in turn aids neuroplasticity; the benefits of such treatments in upper extremity rehabilitation following stroke have been established. It is also believed that the stimulating environment provided by computed based exercises can enhance the development of problem solving and functionality in stroke patients. However, the effects of such technology on cognitive function in stroke patients has not been established in the literature. The disadvantages of VR and robotic training is that the necessary hard and software is often expensive and use of the machinery requires special training. Therefore, these options are often unavailable in rehabilitation centres. Contrary to this, computerized task specific gaming systems can be more economical and practical for both therapist and patient and can be used in the home environment without the necessity of direct supervision of a physiatrist.
A review by Johansson et al. on home computer based task specific gaming exercises in stroke patients concluded that patients enjoyed the treatment but determining the benefits of treatment require further randomized control studies of better quality to be conducted. A pilot study based on a six week computer based task specific gaming exercise program in chronic stroke patients resulted in an improvement in learnt tasks and clinical evaluation.
Rejoyce (Rehabilitation Joystick for Computerized Exercise), is a computer game based task specific exercise system developed by Rehabtronics Inc. for use as part of the treatment of stroke and spinal cord injury patients. Rejoyce aims to improve upper extremity and hand function by encouraging neuroplasticity through repeated task specific games.
The aim of this study was to study the effects of computer game based task specific exercise system on upper extremity and hand function as well as cognitive function and quality of life compared to conventional rehabilitation in stroke patients.
Patients who have developed a stroke in the past year and who have been admitted to our Physical and Rehabilitation Medicine (PRM) Department in Turkey for stroke rehabilitation will be included in the study. The total number of patients to be included in the study to obtain a study power of 80% and 5% type I error is thirty.
- Conditions
- Stroke, Neuronal Plasticity, Hemiplegia
- Being tested
- Rejoyce (Rehabilitation Joystick for Computerized Exercise), Conventional physical therapy, Occupational therapy
- Keywords
- stroke, neuronal plasticity, cognition, hemiplegia, Remote rehabilitation
- Medical subject headings
- Stroke, Hemiplegia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rejoyce (Rehabilitation Joystick for Computerized Exercise)Device
Rejoyce (Rehabilitation Joystick for Computerized Exercise), is a computer game based task specific exercise system developed by Rehabtronics Inc. for use as part of the treatment of stroke and spinal cord injury patients. Rejoyce aims to improve upper extremity and hand function by encouraging neuroplasticity through repeated task specific games.
Conventional physical therapyOther
A physical therapy session customised to the patient's needs overseen by a physical medicine and rehabilitation specialist and conducted by a physiotherapist which includes range of motion, neurophysiological and strengthening exercises, balance and coordination training and walking exercises.
Occupational therapyOther
Task based exercises overseen by a physical medicine and rehabilitation specialist and conducted by an occupational therapist aimed at improving upper arm dexterity, coordination and strength.
| Study group | Role | What they receive |
|---|---|---|
| Computer based exercise group | Experimental | The fifteen patients included in this arm of the study will receive a one hourly 'one-on-one' session of conventional physical therapy five days a week to a total of twenty hours over a four week period. In addition to this, these patients will receive half an hour of conventional occupational therapy and half an hour of Rejoyce computerized exercise seven days a week to a total of twenty eight hours over a four weeks period. Receives: Device: Rejoyce (Rehabilitation Joystick for Computerized Exercise); Other: Conventional physical therapy; Other: Occupational therapy |
| Conventional treatment group | Active comparator | The fifteen patients included in this arm of the study will receive a one hourly 'one-on-one' session of conventional physical therapy five days a week, to a total of twenty hours over a four week period. In addition to this, patients in this group will receive one hourly sessions of conventional occupational therapy seven days a week to a total of twenty eight hours over a four week period. Receives: Device: Rejoyce (Rehabilitation Joystick for Computerized Exercise); Other: Conventional physical therapy; Other: Occupational therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in upper extremity impairment
The Fugl-Meyer Upper Extremity (FMUE) Scale is a widely used and highly recommended stroke-specific, performance-based measure of impairment. It is designed to assess reflex activity, movement control and muscle strength in the upper extremity of people with post-stroke hemiplegia. It has been extensively used as an outcome measure in rehabilitation trials and to record poststroke recovery, particularly in the USA.
The FMUE Scale comprises 33 items, each scored on a scale of 0 to 2, where 0 = cannot perform, 1 = performs partially and 2 = performs fully. It is free, requires only household items for testing, and takes up to 30 minutes to administer.The total score ranges from 0-66 where 66. The higher the score the less the level of impairment.
Measured: Before treatment sessions begin and after twenty hours of conventional physical therapy and 28 hours of occupational therapy have been completed (i.e. four weeks after the initial onset of treatment).
Secondary outcomes (4)
Change in motor activity
The Brunnstrom Stages of Stroke Recovery is a test that evaluates the motor development of stroke patients. In 1966, Signe Brunnstrom identified the stages of motor development observed in a large number of hemiplegic patients. In this staging, the hemiplegic upper extremity, lower extremity and hand are evaluated separately and the motor development of these three areas are staged from 1-6. The lowest stage according to this staging system is stage 1 (flask, no movement); the highest stage is stage 6 (normal motor function). Higher Brunnstrom stages indicate better motor development.
Measured: Before treatment sessions begin and after twenty hours of conventional physical therapy and 28 hours of occupational therapy have been completed (i.e. four weeks after the initial onset of treatment).
Mini mental state examination (MMSE)
The MMS is a test used to evaluate cognitive function which consists of eleven questions. The maximum score which can be obtained is thirty. The cut off score for normal cognitive function is 23. The MMS is divided into two sections, the first of which requires vocal responses only and covers orientation, memory, and attention; the maximum score is 21. The second part tests ability to name, follow verbal and written commands, write a sentence spontaneously, and copy a complex polygon similar to a Bender-Gestalt Figure; the maximum score is nine. The validity and reliability of the Turkish version of the MMS has been studied and proven
Measured: Before treatment sessions begin and after twenty hours of conventional physical therapy and 28 hours of occupational therapy have been completed (i.e. four weeks after the initial onset of treatment).
Montreal Cognitive Assessment (MoCA) test
The MoCA is used to assess and detect mild cognitive impairment and has been shown to be a reliable tool in the assessment of cognitive function following acute onset of stroke. The MoCA is a thirty point test with a cut off for 'normal' cognition of 21. The MoCA consists of a series of questions aimed at evaluating short-term memory recall, visuospatial abilities, executive functions, attention, concentration, and working memory and language.
Measured: Before treatment sessions begin and after twenty hours of conventional physical therapy and 28 hours of occupational therapy have been completed (i.e. four weeks after the initial onset of treatment).
Stroke Specific Quality of Life (SS-QOL) Scale
The SS-QOL is a questionnaire used to evaluate a stroke patient's independence in activities of daily living, social role within the family and community and quality of life (QOL). The SS-QOL consists of 49 questions which are each given a score between 1 and 5 giving a total score between 49 and 245. The higher the total score the better the patient's QOL. The validity and reliability of the Turkish version of the SS-QOL has been studied.
Measured: Before treatment sessions begin and after twenty hours of conventional physical therapy and 28 hours of occupational therapy have been completed (i.e. four weeks after the initial onset of treatment).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2019
- Study start1 Aug 2019
- Primary completion15 Nov 2020
- Study completion15 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (20)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
- Randomised
- Intervention model
- Parallel groups
- Model description
- The patients will be randomized into one of two groups (fifteen patients in each group) using the Random Allocation Software. All patients will receive a one hourly 'one-on-one' session of physiotherapy five days a week to a total of twenty hours (four weeks) which includes strengthening, balance and walking exercises. In addition to this, one group will receive half and hour of conventional occupational therapy which includes task based exercises aimed at improving upper arm dexterity, coordination and strength seven days a week to a total of twenty eight hours (four weeks), whereas patients in the other group will receive half an hour of Rejoyce computerized exercise to a total of twenty eight hours (four weeks).
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baskent University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Selin Ozen, Baskent University
- Investigators
- Selin Ozen, MBBS,BSc, Principal investigator, Baskent University Faculty of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04036422
- Sponsor's protocol ID
- KA19/192
- Status last verified
- May 2021
- First submitted
- 25 Jul 2019
- Last updated
- 4 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kowalczewski J, Prochazka A. Technology improves upper extremity rehabilitation. In: Green AM, Chapman CE, Kalaska JF, Lepore F (eds.) Enhancing Performance for Action and Perception. Elsevier, Amsterdam, 2011b, pp.147-159
Veerbeek JM, van Wegen E, van Peppen R, van der Wees PJ, Hendriks E, Rietberg M, Kwakkel G. What is the evidence for physical therapy poststroke? A systematic review and meta-analysis. PLoS One. 2014 Feb 4;9(2):e87987. doi: 10.1371/journal.pone.0087987. eCollection 2014.
PubMed 24505342Adkins DL, Boychuk J, Remple MS, Kleim JA. Motor training induces experience-specific patterns of plasticity across motor cortex and spinal cord. J Appl Physiol (1985). 2006 Dec;101(6):1776-82. doi: 10.1152/japplphysiol.00515.2006. Epub 2006 Sep 7.
PubMed 16959909Risedal A, Mattsson B, Dahlqvist P, Nordborg C, Olsson T, Johansson BB. Environmental influences on functional outcome after a cortical infarct in the rat. Brain Res Bull. 2002 Jul;58(3):315-21. doi: 10.1016/s0361-9230(02)00796-7.
PubMed 12128159Taub E, Uswatte G, Elbert T. New treatments in neurorehabilitation founded on basic research. Nat Rev Neurosci. 2002 Mar;3(3):228-36. doi: 10.1038/nrn754.
PubMed 11994754Paolucci S, Grasso MG, Antonucci G, Bragoni M, Troisi E, Morelli D, Coiro P, De Angelis D, Rizzi F. Mobility status after inpatient stroke rehabilitation: 1-year follow-up and prognostic factors. Arch Phys Med Rehabil. 2001 Jan;82(1):2-8. doi: 10.1053/apmr.2001.18585.
PubMed 11239278Johansson T, Wild C. Telerehabilitation in stroke care--a systematic review. J Telemed Telecare. 2011;17(1):1-6. doi: 10.1258/jtt.2010.100105. Epub 2010 Nov 19.
PubMed 21097560Langan J, Delave K, Phillips L, Pangilinan P, Brown SH. Home-based telerehabilitation shows improved upper limb function in adults with chronic stroke: a pilot study. J Rehabil Med. 2013 Feb;45(2):217-20. doi: 10.2340/16501977-1115.
PubMed 23319181Kowalczewski J, Chong SL, Galea M, Prochazka A. In-home tele-rehabilitation improves tetraplegic hand function. Neurorehabil Neural Repair. 2011 Jun;25(5):412-22. doi: 10.1177/1545968310394869. Epub 2011 Mar 3.
PubMed 21372246Kowalczewski J, Gritsenko V, Ashworth N, Ellaway P, Prochazka A. Upper-extremity functional electric stimulation-assisted exercises on a workstation in the subacute phase of stroke recovery. Arch Phys Med Rehabil. 2007 Jul;88(7):833-9. doi: 10.1016/j.apmr.2007.03.036.
PubMed 17601461Folstein MF, Folstein SE, McHugh PR. "Mini-mental state". A practical method for grading the cognitive state of patients for the clinician. J Psychiatr Res. 1975 Nov;12(3):189-98. doi: 10.1016/0022-3956(75)90026-6. No abstract available.
PubMed 1202204Gungen C, Ertan T, Eker E, Yasar R, Engin F. [Reliability and validity of the standardized Mini Mental State Examination in the diagnosis of mild dementia in Turkish population]. Turk Psikiyatri Derg. 2002 Winter;13(4):273-81. Turkish.
PubMed 12794644Sullivan KJ, Tilson JK, Cen SY, Rose DK, Hershberg J, Correa A, Gallichio J, McLeod M, Moore C, Wu SS, Duncan PW. Fugl-Meyer assessment of sensorimotor function after stroke: standardized training procedure for clinical practice and clinical trials. Stroke. 2011 Feb;42(2):427-32. doi: 10.1161/STROKEAHA.110.592766. Epub 2010 Dec 16.
PubMed 21164120Kowalczewski J, Ravid E, Prochazka A. Fully-automated test of upper-extremity function. Annu Int Conf IEEE Eng Med Biol Soc. 2011;2011:7332-5. doi: 10.1109/IEMBS.2011.6091710.
PubMed 22256032Prochazka A, Kowalczewski J. A fully automated, quantitative test of upper limb function. J Mot Behav. 2015;47(1):19-28. doi: 10.1080/00222895.2014.953442.
PubMed 25575220
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of a Task Based Computerised Exercise System Versus Conventional Physiotherapy on Upper Extremity Functionality, Cognitive Function and Quality of Life in the Rehabilitation of Stroke Patients: a Randomised Control Study
- ClinicalTrials.gov ID
- NCT04036422
- Acronym / sponsor ID
- KA19/192
- Conditions
- Stroke, Neuronal Plasticity, Hemiplegia
- Keywords
- stroke, neuronal plasticity, cognition, hemiplegia, Remote rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Baskent UniversityUniversity, hospital or other
- Study start
- 1 Aug 2019 (actual)
- Primary completion
- 15 Nov 2020 (actual)
- Study completion
- 15 Nov 2020 (actual)
- First posted
- 29 Jul 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.
Stroke occurs as a result of blood vessels of the brain becoming blocked or bleeding which in turn can result in loss of function in the limbs. Rehabilitation of patients following stroke includes repetitive, task based exercises to help regain normal limb function. Developments in stroke rehabilitation have resulted in more and more therapeutic options being available for inclusion in the treatment plan of stroke patients. The benefits of computerised task based arm and hand rehabilitation exercises in stroke rehabilitation are well known. Computer based rehabilitation supports the stroke patient in performing high intensity, multiple repetition exercises and in doing so encourages the regeneration of brain cells. In addition, it is believed that the stimulating environment provided by computerised exercise programs encourages the ability to problem solve and perform tasks. However, the effects of such computer based treatments on cognition have rarely been studied.
In Turkey to date there are no community based, task specific computerised exercise programmes available to stroke sufferers. Such systems may provide inpatient and community based stroke sufferers with a practical and economical therapeutic option as a part of stroke rehabilitation. Moreover, this may provide the patient with a mode of ongoing, long term therapeutic exercise and maintenance of skills acquired in the hospital rehabilitation period shortly after stroke.
The aim of this study was to investigate the benefits of computer based, task specific exercises when compared to conventional rehabilitation alone on arm and hand function, quality of life and cognition in stroke patients.
Detailed description
In developed countries only 5-10% of chronic stroke patients receive an active rehabilitation program. In Turkey, there is no community based rehabilitation program available to stroke patients in the subacute - chronic phase of the disease, even though it is known that functional gain can continue in this part of the disease when supported by an adequate rehabilitation program. Equally, functional gain can be lost over time if appropriate physical therapy is discontinued.
Recent Advances in technology have allowed for the development of new approaches in stroke rehabilitation. Computer based treatment options include virtual reality (VR), robotic training and computer based task specific games. Computer based rehabilitation can encourage patients in performing high intensity, repetitive exercises which in turn aids neuroplasticity; the benefits of such treatments in upper extremity rehabilitation following stroke have been established. It is also believed that the stimulating environment provided by computed based exercises can enhance the development of problem solving and functionality in stroke patients. However, the effects of such technology on cognitive function in stroke patients has not been established in the literature. The disadvantages of VR and robotic training is that the necessary hard and software is often expensive and use of the machinery requires special training. Therefore, these options are often unavailable in rehabilitation centres. Contrary to this, computerized task specific gaming systems can be more economical and practical for both therapist and patient and can be used in the home environment without the necessity of direct supervision of a physiatrist.
A review by Johansson et al. on home computer based task specific gaming exercises in stroke patients concluded that patients enjoyed the treatment but determining the benefits of treatment require further randomized control studies of better quality to be conducted. A pilot study based on a six week computer based task specific gaming exercise program in chronic stroke patients resulted in an improvement in learnt tasks and clinical evaluation.
Rejoyce (Rehabilitation Joystick for Computerized Exercise), is a computer game based task specific exercise system developed by Rehabtronics Inc. for use as part of the treatment of stroke and spinal cord injury patients. Rejoyce aims to improve upper extremity and hand function by encouraging neuroplasticity through repeated task specific games.
The aim of this study was to study the effects of computer game based task specific exercise system on upper extremity and hand function as well as cognitive function and quality of life compared to conventional rehabilitation in stroke patients.
Patients who have developed a stroke in the past year and who have been admitted to our Physical and Rehabilitation Medicine (PRM) Department in Turkey for stroke rehabilitation will be included in the study. The total number of patients to be included in the study to obtain a study power of 80% and 5% type I error is thirty.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- The patients will be randomized into one of two groups (fifteen patients in each group) using the Random Allocation Software. All patients will receive a one hourly 'one-on-one' session of physiotherapy five days a week to a total of twenty hours (four weeks) which includes strengthening, balance and walking exercises. In addition to this, one group will receive half and hour of conventional occupational therapy which includes task based exercises aimed at improving upper arm dexterity, coordination and strength seven days a week to a total of twenty eight hours (four weeks), whereas patients in the other group will receive half an hour of Rejoyce computerized exercise to a total of twenty eight hours (four weeks).
| Arm | Type | Receives |
|---|---|---|
| Computer based exercise group | Experimental | Device: Rejoyce (Rehabilitation Joystick for Computerized Exercise), Other: Conventional physical therapy, Other: Occupational therapyThe fifteen patients included in this arm of the study will receive a one hourly 'one-on-one' session of conventional physical therapy five days a week to a total of twenty hours over a four week period. In addition to this, these patients will receive half an hour of conventional occupational therapy and half an hour of Rejoyce computerized exercise seven days a week to a total of twenty eight hours over a four weeks period. |
| Conventional treatment group | Active comparator | Device: Rejoyce (Rehabilitation Joystick for Computerized Exercise), Other: Conventional physical therapy, Other: Occupational therapyThe fifteen patients included in this arm of the study will receive a one hourly 'one-on-one' session of conventional physical therapy five days a week, to a total of twenty hours over a four week period. In addition to this, patients in this group will receive one hourly sessions of conventional occupational therapy seven days a week to a total of twenty eight hours over a four week period. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Between the ages of 18-80 years
- Admitted to our PRM Department with a diagnosis of hemiplegia secondary to stroke for rehabilitation
- Upper extremity and hand Brunnstrom staging of ≥3.
- MMSE score of ≥23.
Key exclusion criteria (9 listed)
- Presence of disability of the arms and hand which affects upper extremity motor function prior to stroke
- Presence of diplegia
- Presence of neglect
- Presence of visual field defect
- Presence of loss of hearing
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 |
|---|---|---|
| Rejoyce (Rehabilitation Joystick for Computerized Exercise)Rejoyce (Rehabilitation Joystick for Computerized Exercise), is a computer game based task specific exercise system developed by Rehabtronics Inc. for use as part of the treatment of stroke and spinal cord injury patients. Rejoyce aims to improve upper extremity and hand function by encouraging neuroplasticity through repeated task specific games. | Device | Computer based exercise group, Conventional treatment group |
| Conventional physical therapyA physical therapy session customised to the patient's needs overseen by a physical medicine and rehabilitation specialist and conducted by a physiotherapist which includes range of motion, neurophysiological and strengthening exercises, balance and coordination training and walking exercises. | Other | Computer based exercise group, Conventional treatment group |
| Occupational therapyTask based exercises overseen by a physical medicine and rehabilitation specialist and conducted by an occupational therapist aimed at improving upper arm dexterity, coordination and strength. | Other | Computer based exercise group, Conventional treatment group |
Primary outcome
Change in upper extremity impairment
Time frame: Before treatment sessions begin and after twenty hours of conventional physical therapy and 28 hours of occupational therapy have been completed (i.e. four weeks after the initial onset of treatment).
The Fugl-Meyer Upper Extremity (FMUE) Scale is a widely used and highly recommended stroke-specific, performance-based measure of impairment. It is designed to assess reflex activity, movement control and muscle strength in the upper extremity of people with post-stroke hemiplegia. It has been extensively used as an outcome measure in rehabilitation trials and to record poststroke recovery, particularly in the USA. The FMUE Scale comprises 33 items, each scored on a scale of 0 to 2, where 0 = cannot perform, 1 = performs partially and 2 = performs fully. It is free, requires only household items for testing, and takes up to 30 minutes to administer.The total score ranges from 0-66 where 66. The higher the score the less the level of impairment.
4 secondary outcomes
Change in motor activity
Time frame: Before treatment sessions begin and after twenty hours of conventional physical therapy and 28 hours of occupational therapy have been completed (i.e. four weeks after the initial onset of treatment).
Mini mental state examination (MMSE)
Time frame: Before treatment sessions begin and after twenty hours of conventional physical therapy and 28 hours of occupational therapy have been completed (i.e. four weeks after the initial onset of treatment).
Montreal Cognitive Assessment (MoCA) test
Time frame: Before treatment sessions begin and after twenty hours of conventional physical therapy and 28 hours of occupational therapy have been completed (i.e. four weeks after the initial onset of treatment).
Stroke Specific Quality of Life (SS-QOL) Scale
Time frame: Before treatment sessions begin and after twenty hours of conventional physical therapy and 28 hours of occupational therapy have been completed (i.e. four weeks after the initial onset of treatment).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2021.
- BackgroundKowalczewski J, Prochazka A. Technology improves upper extremity rehabilitation. In: Green AM, Chapman CE, Kalaska JF, Lepore F (eds.) Enhancing Performance for Action and Perception. Elsevier, Amsterdam, 2011b, pp.147-159
- Background: PubMed 24505342Veerbeek JM, van Wegen E, van Peppen R, van der Wees PJ, Hendriks E, Rietberg M, Kwakkel G. What is the evidence for physical therapy poststroke? A systematic review and meta-analysis. PLoS One. 2014 Feb 4;9(2):e87987. doi: 10.1371/journal.pone.0087987. eCollection 2014.
- Background: PubMed 16959909Adkins DL, Boychuk J, Remple MS, Kleim JA. Motor training induces experience-specific patterns of plasticity across motor cortex and spinal cord. J Appl Physiol (1985). 2006 Dec;101(6):1776-82. doi: 10.1152/japplphysiol.00515.2006. Epub 2006 Sep 7.
- Background: PubMed 12128159Risedal A, Mattsson B, Dahlqvist P, Nordborg C, Olsson T, Johansson BB. Environmental influences on functional outcome after a cortical infarct in the rat. Brain Res Bull. 2002 Jul;58(3):315-21. doi: 10.1016/s0361-9230(02)00796-7.
- Background: PubMed 11994754Taub E, Uswatte G, Elbert T. New treatments in neurorehabilitation founded on basic research. Nat Rev Neurosci. 2002 Mar;3(3):228-36. doi: 10.1038/nrn754.
- Background: PubMed 11239278Paolucci S, Grasso MG, Antonucci G, Bragoni M, Troisi E, Morelli D, Coiro P, De Angelis D, Rizzi F. Mobility status after inpatient stroke rehabilitation: 1-year follow-up and prognostic factors. Arch Phys Med Rehabil. 2001 Jan;82(1):2-8. doi: 10.1053/apmr.2001.18585.
- Background: PubMed 21097560Johansson T, Wild C. Telerehabilitation in stroke care--a systematic review. J Telemed Telecare. 2011;17(1):1-6. doi: 10.1258/jtt.2010.100105. Epub 2010 Nov 19.
- Background: PubMed 23319181Langan J, Delave K, Phillips L, Pangilinan P, Brown SH. Home-based telerehabilitation shows improved upper limb function in adults with chronic stroke: a pilot study. J Rehabil Med. 2013 Feb;45(2):217-20. doi: 10.2340/16501977-1115.
- Background: PubMed 21372246Kowalczewski J, Chong SL, Galea M, Prochazka A. In-home tele-rehabilitation improves tetraplegic hand function. Neurorehabil Neural Repair. 2011 Jun;25(5):412-22. doi: 10.1177/1545968310394869. Epub 2011 Mar 3.
- Background: PubMed 17601461Kowalczewski J, Gritsenko V, Ashworth N, Ellaway P, Prochazka A. Upper-extremity functional electric stimulation-assisted exercises on a workstation in the subacute phase of stroke recovery. Arch Phys Med Rehabil. 2007 Jul;88(7):833-9. doi: 10.1016/j.apmr.2007.03.036.
- Background: PubMed 1202204Folstein MF, Folstein SE, McHugh PR. "Mini-mental state". A practical method for grading the cognitive state of patients for the clinician. J Psychiatr Res. 1975 Nov;12(3):189-98. doi: 10.1016/0022-3956(75)90026-6. No abstract available.
- Background: PubMed 12794644Gungen C, Ertan T, Eker E, Yasar R, Engin F. [Reliability and validity of the standardized Mini Mental State Examination in the diagnosis of mild dementia in Turkish population]. Turk Psikiyatri Derg. 2002 Winter;13(4):273-81. Turkish.
- 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.
Selin Ozen, MBBS,BSc principal investigator
Baskent University Faculty of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rejoyce (Rehabilitation Joystick for Computerized Exercise), Conventional physical therapy and Occupational therapy in people with Stroke and Neuronal Plasticity, run by Baskent University at 1 site in Turkey (Türkiye).
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 4 inclusion and 9 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: finished, as of the sponsor's last update on 4 May 2021. 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 Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in upper extremity impairment (time frame: Before treatment sessions begin and after twenty hours of conventional physical therapy and 28 hours of occupational therapy have been completed (i.e. four weeks after the initial onset of treatment).). 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 NCT04036422, which also lists 20 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 4 May 2021.