StrokePhase 2NCT00547690
Acupuncture in Stroke Rehabilitation
A Phase 2 study testing Acupuncture and Strengthening and Strengthening Alone in people with Stroke, run by Wen Liu, Ph.D. at 1 site in United States.
Trial summary
The primary purpose of the study is to examine the effect of acupuncture treatment when combined with strength training on the motor functional recovery of stroke survivors Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- Acupuncture and Strengthening and Strengthening Alone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2003to Oct 2008
- Phase
- Phase 2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- After stroke (>6 months)
Who cannot join
- Other neurological diseases
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Kansas Medical Center
Kansas City, Kansas, 66160
About this study
Official title: Electro-acupuncture and Strengthening Exercise for Hemiplegic Elbow and Wrist Joints
The primary purpose of the study is to examine the effect of acupuncture treatment when combined with strength training on the motor functional recovery of stroke survivors
Read the detailed description
In this study, we compare the effect on motor functional improvement between a combined acupuncture and strength training program and the strength training alone. The results may allow us to determine whether the acupuncture may bring in additional benefit to the motor recovery in the upper limb in stroke survivors
- Conditions
- Stroke
- Being tested
- Acupuncture and Strengthening, Strengthening Alone
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acupuncture and StrengtheningOther
Acupuncture and strengthening
Strengthening AloneOther
Strengthening training program
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Acupuncture and strength training Receives: Other: Acupuncture and Strengthening |
| 2 | Other | Strength training Receives: Other: Strengthening Alone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fugl-Meyer Motor Scores
Measured: Before and After 6 Week Treatment
Secondary outcomes (3)
Active wrist ROM
Measured: Before and After 6 Week Treatment
Quantitative Measure of Muscle Spasticity
Measured: Before and After 6 Week Treatment
Ashworth Score
Measured: Before and After 6 Week Treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2007 (estimated)
- Study startApr 2003
- Primary completionOct 2008
- Study completionOct 2008
Why it stopped: Expired IRB approval
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wen Liu, Ph.D.
- Sponsor type
- University, hospital or other
- Collaborators
- American Heart Association
- Responsible party
- Sponsor-investigator, Wen Liu, Ph.D., University of Kansas Medical Center
- Investigators
- Wen Liu, PhD, Principal investigator, University of Kansas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00547690
- Sponsor's protocol ID
- 9179
- Other IDs
- 0555637Z
- Status last verified
- Jun 2012
- First submitted
- 18 Oct 2007
- Last updated
- 6 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electro-acupuncture and Strengthening Exercise for Hemiplegic Elbow and Wrist Joints
- ClinicalTrials.gov ID
- NCT00547690
- Acronym / sponsor ID
- 9179
- Conditions
- Stroke
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Expired IRB approval
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Wen Liu, Ph.D.University, hospital or other
- Collaborators
- American Heart Association
- Study start
- Apr 2003
- Primary completion
- Oct 2008 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 22 Oct 2007 (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 primary purpose of the study is to examine the effect of acupuncture treatment when combined with strength training on the motor functional recovery of stroke survivors
Detailed description
In this study, we compare the effect on motor functional improvement between a combined acupuncture and strength training program and the strength training alone. The results may allow us to determine whether the acupuncture may bring in additional benefit to the motor recovery in the upper limb in stroke survivors
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Other: Acupuncture and StrengtheningAcupuncture and strength training |
| 2 | Other | Other: Strengthening AloneStrength training |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- After stroke (>6 months)
Key exclusion criteria (1 listed)
- Other neurological diseases
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 |
|---|---|---|
| Acupuncture and StrengtheningAcupuncture and strengthening | Other | 1 |
| Strengthening AloneStrengthening training program | Other | 2 |
Primary outcome
Fugl-Meyer Motor Scores
Time frame: Before and After 6 Week Treatment
3 secondary outcomes
Active wrist ROM
Time frame: Before and After 6 Week Treatment
Quantitative Measure of Muscle Spasticity
Time frame: Before and After 6 Week Treatment
Ashworth Score
Time frame: Before and After 6 Week Treatment
Results and safety
The study was stopped early (reason given: Expired IRB approval). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 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 Liu, PhD principal investigator
University of Kansas Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Acupuncture and Strengthening and Strengthening Alone in people with Stroke, run by Wen Liu, Ph.D. at 1 site in United States.
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 1 inclusion and 1 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 Jun 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 United States. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Expired IRB approval). 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?
Fugl-Meyer Motor Scores (time frame: Before and After 6 Week Treatment). 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 Jun 2012.