StrokePhase 1NCT01139034
A Pilot Study of Shoulder Subluxation Treatment by Using the Self-Designed Surface Functional Electrical Stimulator
A Phase 1 study testing Self-designed surface functional electrical stimulator in people with Stroke, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
The purpose of this study is to investigate the effects of the self-designed surface functional electrical stimulator on shoulder joint subluxation for stroke patients Read more about this study
- Who is it for?
- Ages 25 to 65 years
- Conditions the study is for
- Stroke
- What is being tested?
- Self-designed surface functional electrical stimulator
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteTaiwan
- Study dates
- Mar 2010to Mar 2011
- 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 25 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- stroke (1-3 months)
- Brunnstrom Stage I-III
- single, unilateral
Who cannot join
- aphasic
- shoulder impairment
- severe osteoporosis
- cardiac arrhythmias or having a pacemaker implanted
- abnormal cutaneous sensation at the target areas
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Department of Physical Medicine and Rehabilitation, NTUH
Taipei
Jin-Shin Lai, 886-2-23123456 ext. 66583, jslai@ntu.edu.tw
Jin-Shin Lai, MD
About this study
Official title: Rehabilitation Robot for Upper Limbs, Component Project 2: Hybrid of FES and Rehabilitation Robot for Treatment of Shoulder Subluxation
The purpose of this study is to investigate the effects of the self-designed surface functional electrical stimulator on shoulder joint subluxation for stroke patients
Read the detailed description
Functional electrical stimulation (FES) is a common and effective therapeutic approach for clinical treatments of shoulder subluxation. By applying low-frequency electrical stimulation to the target muscle groups, improvements may be observed in terms of muscle strength, subluxation, and passive humeral lateral rotation of the shoulder joint. In order to overcome issues regarding the integration of an FES and a rehabilitation robot, group members have designed a customized FES system approved by medical safety regulations. Despite sharing identical specifications with commercial models, the approved 2-channel FES system provides better integrity and control when working with the upper extremity rehabilitation robot. In this study, three patients with unilateral shoulder subluxation will be recruited. Limited shoulder x-ray photos shall be taken before, during, and after the FES shoulder subluxation treatment for studying the effects.
- Conditions
- Stroke
- Being tested
- Self-designed surface functional electrical stimulator
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-designed surface functional electrical stimulatorDevice
Also called Self-designed surface functional electrical stimulation
Use the self-designed surface functional electrical stimulator to improve the shoulder joint subluxation.
| Study group | Role | What they receive |
|---|---|---|
| shoulder FES treatment | Experimental | Not described Receives: Device: Self-designed surface functional electrical stimulator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Upward migration index
Measured: 1 year
Secondary outcomes (1)
Acromiohumeral distance
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 posted8 Jun 2010 (estimated)
- Study startMar 2010
- Primary completionDec 2010 (estimated)
- Study completionMar 2011 (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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Jin-Shin Lai, MD, Principal investigator, Department of Physical Medicine and Rehabilitation, NTUH, Taipei, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01139034
- Sponsor's protocol ID
- 201002029D
- Status last verified
- Jun 2010
- First submitted
- 7 Jun 2010
- Last updated
- 22 Jun 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rehabilitation Robot for Upper Limbs, Component Project 2: Hybrid of FES and Rehabilitation Robot for Treatment of Shoulder Subluxation
- ClinicalTrials.gov ID
- NCT01139034
- Acronym / sponsor ID
- 201002029D
- Conditions
- Stroke
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 3 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Mar 2010
- Primary completion
- Dec 2010 (estimated)
- Study completion
- Mar 2011 (estimated)
- First posted
- 8 Jun 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 of this study is to investigate the effects of the self-designed surface functional electrical stimulator on shoulder joint subluxation for stroke patients
Detailed description
Functional electrical stimulation (FES) is a common and effective therapeutic approach for clinical treatments of shoulder subluxation. By applying low-frequency electrical stimulation to the target muscle groups, improvements may be observed in terms of muscle strength, subluxation, and passive humeral lateral rotation of the shoulder joint. In order to overcome issues regarding the integration of an FES and a rehabilitation robot, group members have designed a customized FES system approved by medical safety regulations. Despite sharing identical specifications with commercial models, the approved 2-channel FES system provides better integrity and control when working with the upper extremity rehabilitation robot. In this study, three patients with unilateral shoulder subluxation will be recruited. Limited shoulder x-ray photos shall be taken before, during, and after the FES shoulder subluxation treatment for studying the effects.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| shoulder FES treatment | Experimental | Device: Self-designed surface functional electrical stimulator |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- stroke (1-3 months)
- Brunnstrom Stage I-III
- single, unilateral
Key exclusion criteria (5 listed)
- aphasic
- shoulder impairment
- severe osteoporosis
- cardiac arrhythmias or having a pacemaker implanted
- abnormal cutaneous sensation at the target areas
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 |
|---|---|---|
| Self-designed surface functional electrical stimulatorAlso: Self-designed surface functional electrical stimulationUse the self-designed surface functional electrical stimulator to improve the shoulder joint subluxation. | Device | shoulder FES treatment |
Primary outcome
Upward migration index
Time frame: 1 year
1 secondary outcome
Acromiohumeral distance
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 22 Jun 2010.
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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.
Jin-Shin Lai, MD principal investigator
Department of 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 Self-designed surface functional electrical stimulator 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 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: status not confirmed, as of the sponsor's last update on 22 Jun 2010. 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 Jin-Shin Lai (+886-2-23123456 ext. 66583, jslai@ntu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Upward migration index (time frame: 1 year). 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 22 Jun 2010.