StrokePhase 1NCT01117194
Effect on Shoulder Training Using Rehabilitation Robot for Stroke Patients
A Phase 1 study testing Rehabilitation Robot for Upper Limb Dysfunction (NTUH Model One) in people with Stroke, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
The purpose is to study the effect of rehabilitation robot on shoulder training for stroke patients. Read more about this study
- Who is it for?
- Ages 50 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Stroke
- What is being tested?
- Rehabilitation Robot for Upper Limb Dysfunction (NTUH Model One)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteTaiwan
- Study dates
- Jan 2010to Feb 2013
- Phase
- Phase 1
- 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 50 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- stroke (1-3 months)
- Brunnstrom Stage II-III
- single, unilateral
Who cannot join
- aphasic
- shoulder impairment
- severe osteoporosis
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Dpt. Physical Medicine and Rehabilitation, NTUH
Taipei, 100
Wen-Shiang Chen, +886-2-2123456 ext. 67087, wenshiang@gmail.com
Wen-Shiang Chen, MD PhD
About this study
Official title: Rehabilitation Robot for Upper Limbs, Component Project 5: Effect on Shoulder Training Using Rehabilitation Robot for Stroke Patients
The purpose is to study the effect of rehabilitation robot on shoulder training for stroke patients.
- Conditions
- Stroke
- Being tested
- Rehabilitation Robot for Upper Limb Dysfunction (NTUH Model One)
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rehabilitation Robot for Upper Limb Dysfunction (NTUH Model One)Device
Also called self-developed robotic arm
Use an intelligent robot to assist upper limb rehabilitation.
| Study group | Role | What they receive |
|---|---|---|
| shoulder training, rehabilitation robot | Experimental | Not described Receives: Device: Rehabilitation Robot for Upper Limb Dysfunction (NTUH Model One) |
| control group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Barthel index,
Measured: 1 year
Modified Asworth Scale
Measured: 1 year
STREAM and PASS scales
Measured: 1 year
Secondary outcomes (1)
shoulder range of motion, VAS
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2010 (estimated)
- Study startJan 2010
- Primary completionFeb 2013 (estimated)
- Study completionFeb 2013 (estimated)
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.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- 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 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wen-Shiang Chen, MD, PhD, Principal investigator, Dpt. Physical Medicine and Rehabilitation, NTUH Taipei, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01117194
- Sponsor's protocol ID
- 200804031D
- Status last verified
- Nov 2012
- First submitted
- 18 Jan 2010
- Last updated
- 21 Dec 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rehabilitation Robot for Upper Limbs, Component Project 5: Effect on Shoulder Training Using Rehabilitation Robot for Stroke Patients
- ClinicalTrials.gov ID
- NCT01117194
- Acronym / sponsor ID
- 200804031D
- Conditions
- Stroke
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Feb 2013 (estimated)
- Study completion
- Feb 2013 (estimated)
- First posted
- 5 May 2010 (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 purpose is to study the effect of rehabilitation robot on shoulder training for stroke patients.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| shoulder training, rehabilitation robot | Experimental | Device: Rehabilitation Robot for Upper Limb Dysfunction (NTUH Model One) |
| control group | No intervention | – |
Who may qualify
- Ages
- 50 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- stroke (1-3 months)
- Brunnstrom Stage II-III
- single, unilateral
Key exclusion criteria (3 listed)
- aphasic
- shoulder impairment
- severe osteoporosis
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 |
|---|---|---|
| Rehabilitation Robot for Upper Limb Dysfunction (NTUH Model One)Also: self-developed robotic armUse an intelligent robot to assist upper limb rehabilitation. | Device | shoulder training, rehabilitation robot |
Primary outcome
Barthel index,
Time frame: 1 year
Modified Asworth Scale
Time frame: 1 year
STREAM and PASS scales
Time frame: 1 year
1 secondary outcome
shoulder range of motion, VAS
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2012.
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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.
Wen-Shiang Chen, MD, PhD principal investigator
Dpt. Physical Medicine and Rehabilitation, NTUH Taipei, Taiwan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Rehabilitation Robot for Upper Limb Dysfunction (NTUH Model One) in people with Stroke, run by National Taiwan University 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 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: status not confirmed, as of the sponsor's last update on 21 Dec 2012. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wen-Shiang Chen (+886-2-2123456 ext. 67087, wenshiang@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Barthel index, (time frame: 1 year). The study lists 3 primary outcomes in all. 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 21 Dec 2012.