StrokeNCT03502122

Design and Verification of Individualized Smart Assistive Devices for Stroke Rehabilitation

A study testing VR rehabilitation for motor function in people with Stroke, run by National Central University, Taiwan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

This study aims to design and verify a multi-mode smart assistive device system for Stroke Rehabilitation by using EEG, fMRI, IMU and questioners Read more about this study

Who is it for?: Ages 20 to 85 years
Conditions the study is for: Stroke
What is being tested?: VR rehabilitation for motor function
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 48 participants
Where: No sites listed yet
Study dates: 24 Apr 2012to 28 May 2014
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 85 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

the first time hemiparetic stroke;
diagnosis confirmed by a physician on the basis of the findings of neurological examinations and brain imaging (magnetic resonance imaging or computed tomography scan);
aged between 20 and 85 years;
Brunnstrom's stage II to V over the proximal and distal part of the upper extremity on the affected side;
no cognitive dysfunction, measured by the Mini-Mental State Exam (≧24; suggested by 36 with respect to age and educational level)
willing/able to participate and having signed an informed consent form.

Who cannot join

unstable vital sign
irreversible contracture over any of the joints of the affected upper extremity
history of surgery, fracture, arthritis, pain, or any other complications that might influence the recovery of upper extremity function like aphasia, apraxia and neglect;
having spasticity, as measured using the Modified Ashworth scale (score > 2);
poststroke seizure;
heart attack within 3 months poststroke; cortical lesions in any of the five core motor areas of interest, including the bilateral M1, the bilateral PM, and the SMA.

About this study

This study aims to design and verify a multi-mode smart assistive device system for Stroke Rehabilitation by using EEG, fMRI, IMU and questioners

Conditions: Stroke
Being tested: VR rehabilitation for motor function
Keywords: stroke, rehabilitation
Medical subject headings: Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

VR rehabilitation for motor functionOther
Also called VR rehabilitation therapy
rehabilitation for motor function

Study groups in NCT03502122
Study group	Role	What they receive
VR rehabilitation	Experimental	Virtual Reality based rehabilitation therapy for motor function, 1 hour a time at an intensity of three times per week over 8 weeks (total, 24 sessions). Receives: Other: VR rehabilitation for motor function
control- conventional rehabilitation	Active comparator	conventional rehabilitation therapy for motor function, 1 hour a time at an intensity of three times per week over 8 weeks (total, 24 sessions). Receives: Other: VR rehabilitation for motor function

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in FUGL- MEYER ASSESSMENT OF PHYSICAL PERFORMANCE (FMA)
FUGL- MEYER ASSESSMENT OF PHYSICAL PERFORMANCE (FMA)
Measured: pre, post (after 24 hrs of intervention) and follow-up (one month after finishing intervention )

Secondary outcomes (3)

change in upper extremity performance evaluation test for the elderly (TEMPA)
upper extremity performance evaluation test for the elderly (TEMPA)
Measured: pre, post (after 24 hrs of intervention) and follow-up (one month after finishing intervention )
change in Brunnstrom stage
Brunnstrom stage
Measured: pre, post (after 24 hrs of intervention) and follow-up (one month after finishing intervention )
change in Wolf motor function
Wolf motor function
Measured: pre, post (after 24 hrs of intervention) and follow-up (one month after finishing intervention )

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

24 Apr 201228 May 2014

First posted18 Apr 2018
Study start24 Apr 2012
Primary completion28 May 2014
Study completion28 May 2014

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: Single blind
Who is masked: Outcomes assessor
Enrolment: 48 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03502122
Sponsor's protocol ID: 201012009IA
Status last verified: Jul 2018
First submitted: 31 Mar 2018
Last updated: 5 Jul 2018
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided: undecided .

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
Recruiting
Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
Stroke, Upper Extremity Paresis
Recruiting
Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion

All Stroke trials

Study at a glance

From the registry record, last updated by the sponsor on 5 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Design and Verification of Individualized Smart Assistive Devices for Stroke Rehabilitation
ClinicalTrials.gov ID: NCT03502122
Acronym / sponsor ID: 201012009IA
Conditions: Stroke
Keywords: stroke, rehabilitation
Study type: Interventional
Recruitment status: Completed
Enrolment: 48 participants (actual)
Lead sponsor: National Central University, TaiwanUniversity, hospital or other
Study start: 24 Apr 2012 (actual)
Primary completion: 28 May 2014 (actual)
Study completion: 28 May 2014 (actual)
First posted: 18 Apr 2018 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This study aims to design and verify a multi-mode smart assistive device system for Stroke Rehabilitation by using EEG, fMRI, IMU and questioners

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
VR rehabilitation	Experimental	Other: VR rehabilitation for motor functionVirtual Reality based rehabilitation therapy for motor function, 1 hour a time at an intensity of three times per week over 8 weeks (total, 24 sessions).
control- conventional rehabilitation	Active comparator	Other: VR rehabilitation for motor functionconventional rehabilitation therapy for motor function, 1 hour a time at an intensity of three times per week over 8 weeks (total, 24 sessions).

Who may qualify

Ages: 20 to 85 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

the first time hemiparetic stroke;
diagnosis confirmed by a physician on the basis of the findings of neurological examinations and brain imaging (magnetic resonance imaging or computed tomography scan);
aged between 20 and 85 years;
Brunnstrom's stage II to V over the proximal and distal part of the upper extremity on the affected side;
no cognitive dysfunction, measured by the Mini-Mental State Exam (≧24; suggested by 36 with respect to age and educational level)

Key exclusion criteria (6 listed)

unstable vital sign
irreversible contracture over any of the joints of the affected upper extremity
history of surgery, fracture, arthritis, pain, or any other complications that might influence the recovery of upper extremity function like aphasia, apraxia and neglect;
having spasticity, as measured using the Modified Ashworth scale (score > 2);
poststroke seizure;

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
VR rehabilitation for motor functionAlso: VR rehabilitation therapyrehabilitation for motor function	Other	VR rehabilitation, control- conventional rehabilitation

Primary outcome

Change in FUGL- MEYER ASSESSMENT OF PHYSICAL PERFORMANCE (FMA)
Time frame: pre, post (after 24 hrs of intervention) and follow-up (one month after finishing intervention )
FUGL- MEYER ASSESSMENT OF PHYSICAL PERFORMANCE (FMA)

3 secondary outcomes

change in upper extremity performance evaluation test for the elderly (TEMPA)
Time frame: pre, post (after 24 hrs of intervention) and follow-up (one month after finishing intervention )
change in Brunnstrom stage
Time frame: pre, post (after 24 hrs of intervention) and follow-up (one month after finishing intervention )
change in Wolf motor function
Time frame: pre, post (after 24 hrs of intervention) and follow-up (one month after finishing intervention )

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 5 Jul 2018.
Individual participant dataSharing planned: Undecided. undecided .

Related trials for Stroke

Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
Recruiting
Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
Stroke, Upper Extremity Paresis
Recruiting
Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion

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.

The record lists no contact. Use the official record to reach the sponsor.

Questions about this trial

What is this clinical trial studying?

A study testing VR rehabilitation for motor function in people with Stroke, run by National Central University, 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 6 inclusion and 6 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 5 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?

Change in FUGL- MEYER ASSESSMENT OF PHYSICAL PERFORMANCE (FMA) (time frame: pre, post (after 24 hrs of intervention) and follow-up (one month after finishing intervention )). 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 NCT03502122.

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 5 Jul 2018.