StrokeNCT04296032
Effects of Virtual Reality Game on Upper Extremity Function for Stroke
A study testing virtual reality game traning and standard treatment in people with Stroke, run by Taipei Medical University Shuang Ho Hospital at 1 site in Taiwan.
Trial summary
Virtual reality training had already been used in stroke rehabilitation, and previous studies supported that it could improve upper extremity ability and increase motivation and pleasure than conventional methods. Pablo is a new VR game combined with motion sensor system which can detect subject's activities. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Stroke
- What is being tested?
- virtual reality game traning and standard treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteTaiwan
- Study dates
- 2 May 2020to 25 Jul 2021
- 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 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- First stroke with hemiplegia,
- Chronicity of >6 months
- Could understand instructions
- Brunnstrom stage of UE ≥IV.
Who cannot join
- Patients who were aged <20 years and >75 years
- Patients with visual or auditory impairment who were unable to see or hear the feedback from the device clearly
- Montreal Cognitive Assessment <16
- Modified Ashworth Scale score of >2
- Patients with other medical symptoms that can affect movement were excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Wearable Sensor Based Virtual Reality Game on Upper Extremity Function for Patients With Stroke
Virtual reality training had already been used in stroke rehabilitation, and previous studies supported that it could improve upper extremity ability and increase motivation and pleasure than conventional methods. Pablo is a new VR game combined with motion sensor system which can detect subject's activities. Unlike commercial camera systems such as Kinect or XBOX, the systems require a continuous sightline or enough active range of motion which may increase risk of compensatory movement. Few of studies had investigated the rehabilitation effects on upper extremity with Pablo for patients with stroke.The purpose of this study is to investigate the effects of virtual reality upper extremity training through Pablo system in patients with chronic stroke.
Read the detailed description
PURPOSE: The purpose of this study is to investigate the effects of virtual reality upper extremity training through Pablo system in patients with chronic stroke.
METHODS:Patients with mild to moderate motor deficits were recruited and randomly assigned to "VR plus standard rehabilitation group"(n=19), and "standard rehabilitation group" (n=19). After 12 training sessions (60 minutes a time, 2 times a week), the performance was assessed by a blinded assessor. The outcome measures included Fugl-Meyer Assessment-Upper Limb section(FMAUE), Box and block test(BBT), Dynanometer, active range of motion of shoulder and elbow,and Stroke Impact Scale.Modified Physical Activity Enjoyment Scale and adverse effect were recorded after each sessions.Collected data will be analyzed with sample T test by SPSS version 20.0, and alpha level was set at 0.05.
- Conditions
- Stroke
- Being tested
- virtual reality game traning, standard treatment
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
virtual reality game traningBehavioural
The controllers were attached to upper extremity to control the game. The game could train the shoulder, elbow, and wrist control.
standard treatmentBehavioural
The program included bilateral hand, grasp/release, and pinch activities.
| Study group | Role | What they receive |
|---|---|---|
| virtual reality group | Experimental | Standard treatment 30 minutes plus virtual reality game 30 minutes, twice a week for 9 weeks. Receives: Behavioral: virtual reality game traning; Behavioral: standard treatment |
| standard treatment group | Active comparator | Standard treatment 60 minutes, twice a week for 9 weeks. Receives: Behavioral: standard treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fugl-Meyer Assessment-upper extremity
The Fugl-Meyer Assessment-upper extremity (FMA-UE) measures motor impairment in the upper extremity. The assessment consists of 33 items, including movement, reflex, grasp, and coordination, and a total score of 66.
Measured: Change from Baseline at 9 weeks
Secondary outcomes (6)
Box and block test
The Box and block test (BBT) measures unilateral gross manual dexterity. The BBT score denotes the number of blocks transferred within 60 s.
Measured: Change from Baseline at 9 weeks
Dynanometer
The grip dynamometer was used to measure the maximum isometric strength of the hand and forearm muscles. The mean score of 3 trials was calculated. For this measurement, the elbow was placed at 90° and the forearm was placed in mid-position.
Measured: Change from Baseline at 9 weeks
Active range of motion of shoulder and elbow
The active range of motion of shoulder and elbow were measured through pablo system.
Measured: Change from Baseline at 9 weeks
Stroke Impact Scale
The Stroke Impact Scale (SIS) is a quality of life measure designed specifically for patients with stroke. The instrument is a self-report questionnaire assessing eight domains: strength, hand function, activities of daily living (ADL)/instrumental ADL (IADL), mobility, communication, emotion, memory and thinking, and social participation.
Measured: Change from Baseline at 9 weeks
Modified Physical Activity Enjoyment Scale
It is an scale that assesses enjoyment for physical activity by asking participants to rate "how you feel at the moment about the physical activity you have been doing" using a 7-point bipolar Likert scale, from 1 (I enjoy it) to 7 (I hate it).
Measured: Every training session during 18 sessions, total sessions continued to 9 weeks
Adverse effect times
To record the adverse effect times during the therapy.
Measured: Every training session during 18 sessions, total sessions continued to 9 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2020
- Study start2 May 2020
- Primary completion25 Jun 2021
- Study completion25 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)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
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University Shuang Ho Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hsinchieh Lee, Principal investigator, Taipei Medical University, Taiwan, R.O.C.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04296032
- Sponsor's protocol ID
- TMU-JIRB N201912049
- Status last verified
- Feb 2021
- First submitted
- 2 Mar 2020
- Last updated
- 24 Sep 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hatano S. Experience from a multicentre stroke register: a preliminary report. Bull World Health Organ. 1976;54(5):541-53.
PubMed 1088404Carod-Artal J, Egido JA, Gonzalez JL, Varela de Seijas E. Quality of life among stroke survivors evaluated 1 year after stroke: experience of a stroke unit. Stroke. 2000 Dec;31(12):2995-3000. doi: 10.1161/01.str.31.12.2995.
PubMed 11108762Chiu L, Shyu WC, Liu YH. Comparisons of the cost-effectiveness among hospital chronic care, nursing home placement, home nursing care and family care for severe stroke patients. J Adv Nurs. 2001 Feb;33(3):380-6. doi: 10.1046/j.1365-2648.2001.01703.x.
PubMed 11251725Nordin N, Xie SQ, Wunsche B. Assessment of movement quality in robot- assisted upper limb rehabilitation after stroke: a review. J Neuroeng Rehabil. 2014 Sep 12;11:137. doi: 10.1186/1743-0003-11-137.
PubMed 25217124Jang SH. The recovery of walking in stroke patients: a review. Int J Rehabil Res. 2010 Dec;33(4):285-9. doi: 10.1097/MRR.0b013e32833f0500.
PubMed 20805757Kopp B, Kunkel A, Muhlnickel W, Villringer K, Taub E, Flor H. Plasticity in the motor system related to therapy-induced improvement of movement after stroke. Neuroreport. 1999 Mar 17;10(4):807-10. doi: 10.1097/00001756-199903170-00026.
PubMed 10208552Basteris A, Nijenhuis SM, Stienen AH, Buurke JH, Prange GB, Amirabdollahian F. Training modalities in robot-mediated upper limb rehabilitation in stroke: a framework for classification based on a systematic review. J Neuroeng Rehabil. 2014 Jul 10;11:111. doi: 10.1186/1743-0003-11-111.
PubMed 25012864Correction to: Guidelines for Adult Stroke Rehabilitation and Recovery: A Guideline for Healthcare Professionals From the American Heart Association/American Stroke Association. Stroke. 2017 Dec;48(12):e369. doi: 10.1161/STR.0000000000000156. No abstract available.
PubMed 29180589Susanto EA, Tong RK, Ockenfeld C, Ho NS. Efficacy of robot-assisted fingers training in chronic stroke survivors: a pilot randomized-controlled trial. J Neuroeng Rehabil. 2015 Apr 25;12:42. doi: 10.1186/s12984-015-0033-5.
PubMed 25906983Laver KE, George S, Thomas S, Deutsch JE, Crotty M. Virtual reality for stroke rehabilitation. Cochrane Database Syst Rev. 2015 Feb 12;2015(2):CD008349. doi: 10.1002/14651858.CD008349.pub3.
PubMed 25927099Smith, C., et al., Can non-immersive virtual reality improve physical outcomes of rehabilitation? Physical Therapy Reviews, 2012. 17(1): p. 1-15.
Peters DM, McPherson AK, Fletcher B, McClenaghan BA, Fritz SL. Counting repetitions: an observational study of video game play in people with chronic poststroke hemiparesis. J Neurol Phys Ther. 2013 Sep;37(3):105-11. doi: 10.1097/NPT.0b013e31829ee9bc.
PubMed 23872681Laver, K.E., et al., Virtual reality for stroke rehabilitation. Stroke, 2018. 49(4): p. e160-e161.
Lin LF, Lin YJ, Lin ZH, Chuang LY, Hsu WC, Lin YH. Feasibility and efficacy of wearable devices for upper limb rehabilitation in patients with chronic stroke: a randomized controlled pilot study. Eur J Phys Rehabil Med. 2018 Jun;54(3):388-396. doi: 10.23736/S1973-9087.17.04691-3. Epub 2017 Jun 19.
PubMed 28627862Chen HM, Chen CC, Hsueh IP, Huang SL, Hsieh CL. Test-retest reproducibility and smallest real difference of 5 hand function tests in patients with stroke. Neurorehabil Neural Repair. 2009 Jun;23(5):435-40. doi: 10.1177/1545968308331146. Epub 2009 Mar 4.
PubMed 19261767
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Wearable Sensor Based Virtual Reality Game on Upper Extremity Function for Patients With Stroke
- ClinicalTrials.gov ID
- NCT04296032
- Acronym / sponsor ID
- TMU-JIRB N201912049
- Conditions
- Stroke
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Taipei Medical University Shuang Ho HospitalUniversity, hospital or other
- Study start
- 2 May 2020 (actual)
- Primary completion
- 25 Jun 2021 (actual)
- Study completion
- 25 Jul 2021 (actual)
- First posted
- 5 Mar 2020 (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.
Virtual reality training had already been used in stroke rehabilitation, and previous studies supported that it could improve upper extremity ability and increase motivation and pleasure than conventional methods. Pablo is a new VR game combined with motion sensor system which can detect subject's activities. Unlike commercial camera systems such as Kinect or XBOX, the systems require a continuous sightline or enough active range of motion which may increase risk of compensatory movement. Few of studies had investigated the rehabilitation effects on upper extremity with Pablo for patients with stroke.The purpose of this study is to investigate the effects of virtual reality upper extremity training through Pablo system in patients with chronic stroke.
Detailed description
PURPOSE: The purpose of this study is to investigate the effects of virtual reality upper extremity training through Pablo system in patients with chronic stroke.
METHODS:Patients with mild to moderate motor deficits were recruited and randomly assigned to "VR plus standard rehabilitation group"(n=19), and "standard rehabilitation group" (n=19). After 12 training sessions (60 minutes a time, 2 times a week), the performance was assessed by a blinded assessor. The outcome measures included Fugl-Meyer Assessment-Upper Limb section(FMAUE), Box and block test(BBT), Dynanometer, active range of motion of shoulder and elbow,and Stroke Impact Scale.Modified Physical Activity Enjoyment Scale and adverse effect were recorded after each sessions.Collected data will be analyzed with sample T test by SPSS version 20.0, and alpha level was set at 0.05.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| virtual reality group | Experimental | Behavioral: virtual reality game traning, Behavioral: standard treatmentStandard treatment 30 minutes plus virtual reality game 30 minutes, twice a week for 9 weeks. |
| standard treatment group | Active comparator | Behavioral: standard treatmentStandard treatment 60 minutes, twice a week for 9 weeks. |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- First stroke with hemiplegia,
- Chronicity of >6 months
- Could understand instructions
- Brunnstrom stage of UE ≥IV.
Key exclusion criteria (5 listed)
- Patients who were aged <20 years and >75 years
- Patients with visual or auditory impairment who were unable to see or hear the feedback from the device clearly
- Montreal Cognitive Assessment <16
- Modified Ashworth Scale score of >2
- Patients with other medical symptoms that can affect movement were excluded.
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 |
|---|---|---|
| virtual reality game traningThe controllers were attached to upper extremity to control the game. The game could train the shoulder, elbow, and wrist control. | Behavioural | virtual reality group |
| standard treatmentThe program included bilateral hand, grasp/release, and pinch activities. | Behavioural | standard treatment group, virtual reality group |
Primary outcome
Fugl-Meyer Assessment-upper extremity
Time frame: Change from Baseline at 9 weeks
The Fugl-Meyer Assessment-upper extremity (FMA-UE) measures motor impairment in the upper extremity. The assessment consists of 33 items, including movement, reflex, grasp, and coordination, and a total score of 66.
6 secondary outcomes
Box and block test
Time frame: Change from Baseline at 9 weeks
Dynanometer
Time frame: Change from Baseline at 9 weeks
Active range of motion of shoulder and elbow
Time frame: Change from Baseline at 9 weeks
Stroke Impact Scale
Time frame: Change from Baseline at 9 weeks
Modified Physical Activity Enjoyment Scale
Time frame: Every training session during 18 sessions, total sessions continued to 9 weeks
Adverse effect times
Time frame: Every training session during 18 sessions, total sessions continued to 9 weeks
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 24 Sep 2021.
- Background: PubMed 1088404Hatano S. Experience from a multicentre stroke register: a preliminary report. Bull World Health Organ. 1976;54(5):541-53.
- Background: PubMed 11108762Carod-Artal J, Egido JA, Gonzalez JL, Varela de Seijas E. Quality of life among stroke survivors evaluated 1 year after stroke: experience of a stroke unit. Stroke. 2000 Dec;31(12):2995-3000. doi: 10.1161/01.str.31.12.2995.
- Background: PubMed 11251725Chiu L, Shyu WC, Liu YH. Comparisons of the cost-effectiveness among hospital chronic care, nursing home placement, home nursing care and family care for severe stroke patients. J Adv Nurs. 2001 Feb;33(3):380-6. doi: 10.1046/j.1365-2648.2001.01703.x.
- Background: PubMed 25217124Nordin N, Xie SQ, Wunsche B. Assessment of movement quality in robot- assisted upper limb rehabilitation after stroke: a review. J Neuroeng Rehabil. 2014 Sep 12;11:137. doi: 10.1186/1743-0003-11-137.
- Background: PubMed 20805757Jang SH. The recovery of walking in stroke patients: a review. Int J Rehabil Res. 2010 Dec;33(4):285-9. doi: 10.1097/MRR.0b013e32833f0500.
- Background: PubMed 10208552Kopp B, Kunkel A, Muhlnickel W, Villringer K, Taub E, Flor H. Plasticity in the motor system related to therapy-induced improvement of movement after stroke. Neuroreport. 1999 Mar 17;10(4):807-10. doi: 10.1097/00001756-199903170-00026.
- Background: PubMed 25012864Basteris A, Nijenhuis SM, Stienen AH, Buurke JH, Prange GB, Amirabdollahian F. Training modalities in robot-mediated upper limb rehabilitation in stroke: a framework for classification based on a systematic review. J Neuroeng Rehabil. 2014 Jul 10;11:111. doi: 10.1186/1743-0003-11-111.
- Background: PubMed 29180589Correction to: Guidelines for Adult Stroke Rehabilitation and Recovery: A Guideline for Healthcare Professionals From the American Heart Association/American Stroke Association. Stroke. 2017 Dec;48(12):e369. doi: 10.1161/STR.0000000000000156. No abstract available.
- Background: PubMed 25906983Susanto EA, Tong RK, Ockenfeld C, Ho NS. Efficacy of robot-assisted fingers training in chronic stroke survivors: a pilot randomized-controlled trial. J Neuroeng Rehabil. 2015 Apr 25;12:42. doi: 10.1186/s12984-015-0033-5.
- Background: PubMed 25927099Laver KE, George S, Thomas S, Deutsch JE, Crotty M. Virtual reality for stroke rehabilitation. Cochrane Database Syst Rev. 2015 Feb 12;2015(2):CD008349. doi: 10.1002/14651858.CD008349.pub3.
- BackgroundSmith, C., et al., Can non-immersive virtual reality improve physical outcomes of rehabilitation? Physical Therapy Reviews, 2012. 17(1): p. 1-15.
- Background: PubMed 23872681Peters DM, McPherson AK, Fletcher B, McClenaghan BA, Fritz SL. Counting repetitions: an observational study of video game play in people with chronic poststroke hemiparesis. J Neurol Phys Ther. 2013 Sep;37(3):105-11. doi: 10.1097/NPT.0b013e31829ee9bc.
- 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.
Hsinchieh Lee principal investigator
Taipei Medical University, Taiwan, R.O.C.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing virtual reality game traning and standard treatment in people with Stroke, run by Taipei Medical University Shuang Ho Hospital at 1 site in Taiwan.
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 5 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 24 Sep 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 Taiwan. 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?
Fugl-Meyer Assessment-upper extremity (time frame: Change from Baseline at 9 weeks). 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 NCT04296032, which also lists 16 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 24 Sep 2021.