StrokeNCT03229733
Design and Evaluation the Effects of Kinect-based Computer Games for U/E Training in Chronic Stroke Patients
A study testing Kinect and Traditional occupational therapy in people with Stroke, run by Chang Gung Memorial Hospital.
Trial summary
The aims of this study are to (i) develop exergames by using Kinect system for training UE function in patient with stroke; and (ii) to test the game's feasibility and effects in a group of patient with chronic stroke. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- Kinect and Traditional occupational therapy
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- No sites listed yet
- Study dates
- Nov 2015to Dec 2017
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- First ever ischemic or hemorrhagic stroke or former stroke without any significant residual motor impairment
- 3 months post stroke
- Impaired arm motor function at Brunnstrom stage 3-5
- Age 18 years or older
Who cannot join
- severe cognitive impairment defined as < 20 on Mini Mental State Examination
- visual disorders or neglect limiting the ability to comply with treatment regimen
- orthopedic problem or other neurological diagnosis that makes the UE dysfunction.
About this study
Official title: Design and Evaluation the Feasibility, Effects of Kinect-based Computer Games for Rehabilitation Training of Upper Extremity Function in Patients With Chronic Stroke
The aims of this study are to (i) develop exergames by using Kinect system for training UE function in patient with stroke; and (ii) to test the game's feasibility and effects in a group of patient with chronic stroke.
Read the detailed description
Exercise based computer games can facilitate high volume complex task practice, enhance feedback of movement and increase motivation of participants. Those effects are difficult to achieve with standard rehabilitation therapy. The Kinect system is a camera-based controller which a player can use to directly control a game through body movement without the need for handheld controllers. Using Kinect to capture movement is a feasible way to help patients who have difficulties to hold controllers to play exergames. Scratch 2.0 is a programming language for kids from the MIT Media Laboratory. It is easy to use for game designing. Kinect2Scratch allows data from the Microsoft Kinect controller to be sent to Scratch, This means that game programs can be designed with motion control. The aims of this study were to i) develop exergames by using Scratch and Kinect system for training upper extremity function in patient with stroke; and ii) to test the game's feasibility and effects in a group of patient with chronic stroke.
This program will be done within two years. During the first year, investigators will design several exergames which are suitable for training upper extremity function in patient with stroke. Investigators will have several experts meetings, involved by physiatrists, occupational therapists and engineers to design the game. When a prototype game is created, investigators will invite two to four patients with stroke to pilot test the game. The game design will be completed till patients and therapists satisfy the design.
During the 2nd year, investigators will test the feasibility and effects of the exergames by doing a pilot randomized control trial. Investigators will recruit 60 patients with chronic stroke who are admitted to a rehabilitation ward for outpatient rehabilitation, and will randomize participants to experiment or control group. All participants will receive PT and OT training as routine. The additional intervention either exergames or conventional OT will be delivered for 8 weeks with 3 training sessions/week of up to 30 minutes.
- Conditions
- Stroke
- Being tested
- Kinect, Traditional occupational therapy
- Keywords
- Stroke, Kinect, Rehabilitation, Upper limbs
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KinectDevice
Receive Kinect games training for 30 minutes. There are 3 sections for 1 week; the intervention period will be 8 weeks
Traditional occupational therapyBehavioural
Patients will receive individually tailored conventional training consisting of the similar movement and dose by using the traditional equipment, such as climbing bar.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Patients randomized to the experimental group participate in exergames training with Kinect. The supervised OT chooses different games according to the patient's needs and abilities. During therapy patients are at sitting position. The game program will be adjusted when patients got improvement. After 30 minutes of exergames training, participants will receive a 30-minutes of traditional occupational therapy. Receives: Device: Kinect; Behavioral: Traditional occupational therapy |
| Control group | Active comparator | Patients in the control group will receive individually tailored traditional occupational therapy consisting of the similar movement and dose as the experimental group doing by using the traditional equipment, such as climbing bar. Receives: Behavioral: Traditional occupational therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Motor function assessed on Fugl-Meyer Assessment (FMA)
The outcome will be measured at 3 time points: 0 week, 8 weeks, and 5 months after recruitment.
Measured: Change from baseline at 5 months
Secondary outcomes (7)
The amount of movement assessed on Actigraph Assessment
The outcome will be measured at 2 time points: 0 week, and 8 weeks after recruitment.
Measured: Change from baseline at 2 months
The upper extremity motor ability assessed on Wolf Motor Function Test (WMFT)
The outcome will be measured at 3 time points: 0 week, 8 weeks, and 5 months after recruitment.
Measured: Change from baseline at 5 months
The quality of movement and amount of use assessed on Motor Activity Log (MAL)
The outcome will be measured at 3 time points: 0 week, 8 weeks, and 5 months after recruitment.
Measured: Change from baseline at 5 months
The instrumental activities of daily living assessed on Nottingham Extended Activities of Daily Living Scale (NEADL)
The outcome will be measured at 3 time points: 0 week, 8 weeks, and 5 months after recruitment.
Measured: Change from baseline at 5 months
The relevant for upper-extremity function self-report questionnaire on Stroke Impact Scale (SIS)
The outcome will be measured at 3 time points: 0 week, 8 weeks, and 5 months after recruitment.
Measured: Change from baseline at 5 months
Standing balance assessed on The Functional reach test (FR)
The outcome will be measured at 3 time points: 0 week, 8 weeks, and 5 months after recruitment.
Measured: Change from baseline at 5 months
Muscle power assessed on Medical Research Council Scale (MRC)
The outcome will be measured at 3 time points: 0 week, 8 weeks, and 5 months after recruitment.
Measured: Change from baseline at 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2017
- Study startNov 2015
- Primary completionDec 2017
- Study completionDec 2017
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 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jen-Wen Hung, Principal investigator, Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03229733
- Sponsor's protocol ID
- CMRPG8E0931
- Status last verified
- Feb 2017
- First submitted
- 23 Jul 2017
- Last updated
- 18 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Noorkoiv M, Rodgers H, Price CI. Accelerometer measurement of upper extremity movement after stroke: a systematic review of clinical studies. J Neuroeng Rehabil. 2014 Oct 9;11:144. doi: 10.1186/1743-0003-11-144.
PubMed 25297823Adams RJ, Lichter MD, Krepkovich ET, Ellington A, White M, Diamond PT. Assessing upper extremity motor function in practice of virtual activities of daily living. IEEE Trans Neural Syst Rehabil Eng. 2015 Mar;23(2):287-96. doi: 10.1109/TNSRE.2014.2360149. Epub 2014 Sep 24.
PubMed 25265612Wolf SL, Catlin PA, Ellis M, Archer AL, Morgan B, Piacentino A. Assessing Wolf motor function test as outcome measure for research in patients after stroke. Stroke. 2001 Jul;32(7):1635-9. doi: 10.1161/01.str.32.7.1635.
PubMed 11441212
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Design and Evaluation the Feasibility, Effects of Kinect-based Computer Games for Rehabilitation Training of Upper Extremity Function in Patients With Chronic Stroke
- ClinicalTrials.gov ID
- NCT03229733
- Acronym / sponsor ID
- CMRPG8E0931
- Conditions
- Stroke
- Keywords
- Stroke, Kinect, Rehabilitation, Upper limbs
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- Nov 2015
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 25 Jul 2017 (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.
The aims of this study are to (i) develop exergames by using Kinect system for training UE function in patient with stroke; and (ii) to test the game's feasibility and effects in a group of patient with chronic stroke.
Detailed description
Exercise based computer games can facilitate high volume complex task practice, enhance feedback of movement and increase motivation of participants. Those effects are difficult to achieve with standard rehabilitation therapy. The Kinect system is a camera-based controller which a player can use to directly control a game through body movement without the need for handheld controllers. Using Kinect to capture movement is a feasible way to help patients who have difficulties to hold controllers to play exergames. Scratch 2.0 is a programming language for kids from the MIT Media Laboratory. It is easy to use for game designing. Kinect2Scratch allows data from the Microsoft Kinect controller to be sent to Scratch, This means that game programs can be designed with motion control. The aims of this study were to i) develop exergames by using Scratch and Kinect system for training upper extremity function in patient with stroke; and ii) to test the game's feasibility and effects in a group of patient with chronic stroke.
This program will be done within two years. During the first year, investigators will design several exergames which are suitable for training upper extremity function in patient with stroke. Investigators will have several experts meetings, involved by physiatrists, occupational therapists and engineers to design the game. When a prototype game is created, investigators will invite two to four patients with stroke to pilot test the game. The game design will be completed till patients and therapists satisfy the design.
During the 2nd year, investigators will test the feasibility and effects of the exergames by doing a pilot randomized control trial. Investigators will recruit 60 patients with chronic stroke who are admitted to a rehabilitation ward for outpatient rehabilitation, and will randomize participants to experiment or control group. All participants will receive PT and OT training as routine. The additional intervention either exergames or conventional OT will be delivered for 8 weeks with 3 training sessions/week of up to 30 minutes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Device: Kinect, Behavioral: Traditional occupational therapyPatients randomized to the experimental group participate in exergames training with Kinect. The supervised OT chooses different games according to the patient's needs and abilities. During therapy patients are at sitting position. The game program will be adjusted when patients got improvement. After 30 minutes of exergames training, participants will receive a 30-minutes of traditional occupational therapy. |
| Control group | Active comparator | Behavioral: Traditional occupational therapyPatients in the control group will receive individually tailored traditional occupational therapy consisting of the similar movement and dose as the experimental group doing by using the traditional equipment, such as climbing bar. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- First ever ischemic or hemorrhagic stroke or former stroke without any significant residual motor impairment
- 3 months post stroke
- Impaired arm motor function at Brunnstrom stage 3-5
- Age 18 years or older
Key exclusion criteria (3 listed)
- severe cognitive impairment defined as < 20 on Mini Mental State Examination
- visual disorders or neglect limiting the ability to comply with treatment regimen
- orthopedic problem or other neurological diagnosis that makes the UE 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 |
|---|---|---|
| KinectReceive Kinect games training for 30 minutes. There are 3 sections for 1 week; the intervention period will be 8 weeks | Device | Experimental group |
| Traditional occupational therapyPatients will receive individually tailored conventional training consisting of the similar movement and dose by using the traditional equipment, such as climbing bar. | Behavioural | Control group, Experimental group |
Primary outcome
Motor function assessed on Fugl-Meyer Assessment (FMA)
Time frame: Change from baseline at 5 months
The outcome will be measured at 3 time points: 0 week, 8 weeks, and 5 months after recruitment.
7 secondary outcomes
The amount of movement assessed on Actigraph Assessment
Time frame: Change from baseline at 2 months
The upper extremity motor ability assessed on Wolf Motor Function Test (WMFT)
Time frame: Change from baseline at 5 months
The quality of movement and amount of use assessed on Motor Activity Log (MAL)
Time frame: Change from baseline at 5 months
The instrumental activities of daily living assessed on Nottingham Extended Activities of Daily Living Scale (NEADL)
Time frame: Change from baseline at 5 months
The relevant for upper-extremity function self-report questionnaire on Stroke Impact Scale (SIS)
Time frame: Change from baseline at 5 months
Standing balance assessed on The Functional reach test (FR)
Time frame: Change from baseline at 5 months
Muscle power assessed on Medical Research Council Scale (MRC)
Time frame: Change from baseline at 5 months
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 18 Jul 2018.
- Results publication: PubMed 25297823Noorkoiv M, Rodgers H, Price CI. Accelerometer measurement of upper extremity movement after stroke: a systematic review of clinical studies. J Neuroeng Rehabil. 2014 Oct 9;11:144. doi: 10.1186/1743-0003-11-144.
- Results publication: PubMed 25265612Adams RJ, Lichter MD, Krepkovich ET, Ellington A, White M, Diamond PT. Assessing upper extremity motor function in practice of virtual activities of daily living. IEEE Trans Neural Syst Rehabil Eng. 2015 Mar;23(2):287-96. doi: 10.1109/TNSRE.2014.2360149. Epub 2014 Sep 24.
- Results publication: PubMed 11441212Wolf SL, Catlin PA, Ellis M, Archer AL, Morgan B, Piacentino A. Assessing Wolf motor function test as outcome measure for research in patients after stroke. Stroke. 2001 Jul;32(7):1635-9. doi: 10.1161/01.str.32.7.1635.
- Individual participant dataSharing planned: No
Related trials for Stroke
Not yet recruiting
Closed-Loop SCS-BCI for Post-Stroke Hemiplegia
Stroke, Motor Dysfunction
Active, not recruiting
Transferring Speed of Processing Gains to Everyday Cognitive Tasks After Stroke
Stroke, Cognitive Dysfunction
Not yet recruitingObservational study
A Speaking-Valve-Based Decannulation Protocol for Tracheostomized Stroke Patients
Stroke Patients, Tracheostomy
RecruitingPhase 4
Blood Pressure Reduction to Limit the Evolution of Vascular Brain Lesions in Elderly Individuals
Cerebrovascular Disorders
Not yet recruiting
Effect of Early Tendon Vibrations on Upper Limb Motor Recovery After a Stroke
Acute Stroke, Upper Limb Motor Deficit
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.
Jen-Wen Hung principal investigator
Chang Gung Memorial Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Kinect and Traditional occupational therapy in people with Stroke, run by Chang Gung Memorial Hospital.
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 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: finished, as of the sponsor's last update on 18 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Motor function assessed on Fugl-Meyer Assessment (FMA) (time frame: Change from baseline at 5 months). 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 NCT03229733, 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 18 Jul 2018.