StrokeNCT02066116
Kinect-based Upper Limb Rehabilitation System in Stroke Patients
A study testing Kinect-based rehabilitation plus occupational therapy in people with Stroke and Hemiplegia, run by Seoul National University Bundang Hospital at 1 site in South Korea.
Trial summary
The investigators have developed the kinect-based upper extremity rehabilitation program and designed this protocol to prove the efficacy of this program. In brief, subacute stroke patients allocated to intervention group will receive the kinect based-rehabilitation program plus conventional occupational therapy and… Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Stroke, Hemiplegia, Virtual Rehabilitation
- What is being tested?
- Kinect-based rehabilitation plus occupational therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 23 participants
- Where
- 1 siteSouth Korea
- Study dates
- Nov 2014to Nov 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age from 20 to 80 years
- Stroke within prior 3 months
- Unilateral upper extremity weakness
Who cannot join
- Uncontrolled medical conditions
- Who cannot obey the simple command
- Who has the hemispatial neglect, visual impairment, apraxia
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National University Hospital
Seongnam-si, Gyeonggi-do, 463-707
About this study
Official title: Effect of Kinect-based Upper Limb Rehabilitation System in Patients With Stroke: A Pilot Trial
The investigators have developed the kinect-based upper extremity rehabilitation program and designed this protocol to prove the efficacy of this program.
In brief, subacute stroke patients allocated to intervention group will receive the kinect based-rehabilitation program plus conventional occupational therapy and patients allocated to control group will receive the sham virtual rehabilitation plus conventional occupational therapy, for 10 days.
20 patients with subacute stroke will be allocated into each group and after completing the 10 days intervention, they will be assessed by using objective assessment tools for upper extremity function.
- Conditions
- Stroke, Hemiplegia, Virtual Rehabilitation
- Being tested
- Kinect-based rehabilitation plus occupational therapy, sham virtual rehabilitation education plus occupational therapy
- Medical subject headings
- Stroke, Hemiplegia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kinect-based rehabilitation plus occupational therapyProcedure or surgery
The developed kinect-based rehabilitation system will be used for 30min/session. Conventional 30min occupational therapy also will be applied for the patient enrolled.
sham virtual rehabilitation education plus occupational therapyOther
For the sham virtual rehabilitation, computer-based cognitive rehabilitation program will be used. Patients will be encouraged to use their affected arm to push the button but the motion will be minimal and not related to the concept of upper extremity rehabilitation.
| Study group | Role | What they receive |
|---|---|---|
| Kinect-based Rehabilitation | Experimental | Not described Receives: Procedure: Kinect-based rehabilitation plus occupational therapy |
| Self-exercises education | Active comparator | Not described Receives: Other: sham virtual rehabilitation education plus occupational therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Fugl-Meyer Assessment Scale for upper extremity at 2 weeks
Measured: Baseline, 2 weeks after the baseline
Secondary outcomes (4)
Brunnstrom stage
This is composed of 6 stages. Higher score means better function. The description for each stage as follows.
- Flaccidity: no voluntary movement.
- Synergies or minimal voluntary movement.
- Synergies performed voluntary (spasticity gratest).
- Some deviation from synergy.
- Independent or isolated movement.
- Individual joint movement nearly normal with minimal spasticity.
Measured: Baseline, 2 weeks after the baseline, 6 weeks after the baseline, 14 weeks after the baseline
Modified Barthel Index
Measured: Baseline, 2 weeks after the baseline, 6 weeks after the baseline, 14 weeks after the baseline
Box and Block Test
Individuals are seated at a table, facing a rectangular box that is divided into two square compartments of equal dimension by means of a partition.
One hundred and fifty, 2.5 cm, colored, wooden cubes or blocks are placed in one compartment or the other.
The individual is instructed to move as many blocks as possible, one at a time, from one compartment to the other for a period of 60 seconds.
The BBT is scored by counting the number of blocks carried over the partition from one compartment to the other during the one-minute trial period.
Measured: Baseline, 2 weeks after the baseline, 6 weeks after the baseline, 14 weeks after the baseline
Number of movement counts during rehabilitation using accelerometer data
Measured: Baseline, 2 weeks after the baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2014 (estimated)
- Study startNov 2014
- Primary completionNov 2017
- Study completionNov 2017
Why it stopped: enrollment is difficult and pilot nature of this study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Bundang Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Microsoft Research, Ministry of Science and ICT, Republic of Korea
- Responsible party
- Principal investigator, Nam-Jong Paik, Seoul National University Bundang Hospital
- Investigators
- Nam-Jong Paik, MD, PhD, Principal investigator, Department of Rehabilitation Medicine, Seoul National University College of Medicine, Seoul National University Bundang Hospital, Seongnam, Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02066116
- Sponsor's protocol ID
- B1401-234-001
- Status last verified
- Nov 2017
- First submitted
- 13 Feb 2014
- Last updated
- 6 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Kinect-based Upper Limb Rehabilitation System in Patients With Stroke: A Pilot Trial
- ClinicalTrials.gov ID
- NCT02066116
- Acronym / sponsor ID
- B1401-234-001
- Conditions
- Stroke, Hemiplegia, Virtual Rehabilitation
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: enrollment is difficult and pilot nature of this study
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Seoul National University Bundang HospitalUniversity, hospital or other
- Collaborators
- Microsoft Research, Ministry of Science and ICT, Republic of Korea
- Study start
- Nov 2014
- Primary completion
- Nov 2017 (actual)
- Study completion
- Nov 2017 (actual)
- First posted
- 19 Feb 2014 (estimated)
- 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 investigators have developed the kinect-based upper extremity rehabilitation program and designed this protocol to prove the efficacy of this program.
In brief, subacute stroke patients allocated to intervention group will receive the kinect based-rehabilitation program plus conventional occupational therapy and patients allocated to control group will receive the sham virtual rehabilitation plus conventional occupational therapy, for 10 days.
20 patients with subacute stroke will be allocated into each group and after completing the 10 days intervention, they will be assessed by using objective assessment tools for upper extremity function.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Kinect-based Rehabilitation | Experimental | Procedure: Kinect-based rehabilitation plus occupational therapy |
| Self-exercises education | Active comparator | Other: sham virtual rehabilitation education plus occupational therapy |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age from 20 to 80 years
- Stroke within prior 3 months
- Unilateral upper extremity weakness
Key exclusion criteria (3 listed)
- Uncontrolled medical conditions
- Who cannot obey the simple command
- Who has the hemispatial neglect, visual impairment, apraxia
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 |
|---|---|---|
| Kinect-based rehabilitation plus occupational therapyThe developed kinect-based rehabilitation system will be used for 30min/session. Conventional 30min occupational therapy also will be applied for the patient enrolled. | Procedure or surgery | Kinect-based Rehabilitation |
| sham virtual rehabilitation education plus occupational therapyFor the sham virtual rehabilitation, computer-based cognitive rehabilitation program will be used. Patients will be encouraged to use their affected arm to push the button but the motion will be minimal and not related to the concept of upper extremity rehabilitation. | Other | Self-exercises education |
Primary outcome
Change from Baseline in Fugl-Meyer Assessment Scale for upper extremity at 2 weeks
Time frame: Baseline, 2 weeks after the baseline
4 secondary outcomes
Brunnstrom stage
Time frame: Baseline, 2 weeks after the baseline, 6 weeks after the baseline, 14 weeks after the baseline
Modified Barthel Index
Time frame: Baseline, 2 weeks after the baseline, 6 weeks after the baseline, 14 weeks after the baseline
Box and Block Test
Time frame: Baseline, 2 weeks after the baseline, 6 weeks after the baseline, 14 weeks after the baseline
Number of movement counts during rehabilitation using accelerometer data
Time frame: Baseline, 2 weeks after the baseline
Results and safety
The study was stopped early (reason given: enrollment is difficult and pilot nature of this study). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2017.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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.
Nam-Jong Paik, MD, PhD principal investigator
Department of Rehabilitation Medicine, Seoul National University College of Medicine, Seoul National University Bundang Hospital, Seongnam, Korea
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Kinect-based rehabilitation plus occupational therapy in people with Stroke and Hemiplegia, run by Seoul National University Bundang Hospital at 1 site in South Korea.
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 3 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: stopped early, as of the sponsor's last update on 6 Nov 2017. 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 South Korea. 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 was stopped early (reason given: enrollment is difficult and pilot nature of 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?
Change from Baseline in Fugl-Meyer Assessment Scale for upper extremity at 2 weeks (time frame: Baseline, 2 weeks after the baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Nov 2017.