Parkinson's DiseaseNCT02556164
Electro-acupuncture for Gait and Balance in Parkinson's Disease
A study testing Electroacupuncture and Body-worn sensor technology in people with Parkinson's Disease, run by University of Arizona.
Trial summary
Gait and balance disorders, key contributors to fall and poor quality of life, represent a major therapeutic challenge in Parkinson's disease (PD). Despite the widespread use of acupuncture in recent years in PD, its efficacy remains unclear, largely due to methodological flaws and lack of high quality studies using… Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Parkinson's Disease
- What is being tested?
- Electroacupuncture and Body-worn sensor technology
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- No sites listed yet
- Study dates
- May 2013to 30 Jun 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 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Community-dwelling men or women ages 55 years or older with diagnosis of PD;
- patients who have the ability to walk 20meters without walking assistance; and
- patients who are stable without anti-PD medication(s) change for at least 1 month. The PD diagnosis was made by movement disorder specialists based on the UK Brain Bank criteria and supported by DaTscan (Ioflupane I 123 injection) when possible.
Who cannot join
- patients who have received previous acupuncture;
- patients who have had DBS;
- patients with any clinically significant medical condition, psychiatric condition, drug or alcohol abuse, or laboratory abnormality that would, in the judgment of the investigators, interfere with the ability to participate in the study; and
- patients with non-PD related gait disorders.
About this study
Official title: Objective Assessment of Electro-acupuncture Efficacy for Gait and Balance in Patients With Parkinson's Disease
Gait and balance disorders, key contributors to fall and poor quality of life, represent a major therapeutic challenge in Parkinson's disease (PD). Despite the widespread use of acupuncture in recent years in PD, its efficacy remains unclear, largely due to methodological flaws and lack of high quality studies using objective outcome measures. In a patient and assessor-blind pilot study, investigators objectively assess the efficacy of electroacupuncture (EA) for gait and balance disorders using body-worn sensor technology in patients with PD.
Read the detailed description
In this study, investigators employee objective innovative body-worn sensor technologies to assess potential mobility-associated outcomes of PD. Investigators compare acute changes in gait and balance that occurred after repeated administration of two interventions: A specific real EA and a sham EA. The design of the experiments uses a control that accounts for both placebo and possible some active components of a generalized needle-insertion-based procedure. By using a sham control, the investigators were able to more fully test whether the specific EA intervention could lead to changes in objective gait and balance parameters, or subjective self-reported improvements that are beyond placebo induced effects and the natural course of the disease.
- Conditions
- Parkinson's Disease
- Being tested
- Electroacupuncture, Body-worn sensor technology
- Keywords
- Electroacupuncture, Body Worn Sensor, Gait, Balance
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ElectroacupunctureProcedure or surgery
Acupuncture is an alternative medicine methodology that treats patient by various techniques including inserting small, thin needles at specific points of body. Electroacupuncture (EA), like the name implies, combines classical acupuncture and low electric current running through the needles, which are often used to enhance a treatment.
Body-worn sensor technologyOther
Three-dimensional acceleration and angular velocity of shanks, thighs and the trunk were measured using wearable sensors each included a triaxial accelerometer and a triaxial gyroscope (LEGSys™ and BalanSens™ - BioSensics, Boston, MA)
| Study group | Role | What they receive |
|---|---|---|
| Real EA | Experimental | Real EA as intervention is performed at the selected standard acupuncture points and "De-qi" is achieved with needle manipulation before electric stimulation is delivered. Receives: Procedure: Electroacupuncture; Other: Body-worn sensor technology |
| Sham EA | Sham comparator | Sham EA as intervention is performed for the control group at non-acupuncture points without needle manipulation. The electric stimulation in sham acupuncture was performed in a similar fashion to the real EA. Receives: Procedure: Electroacupuncture; Other: Body-worn sensor technology |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of gait speed by objective measurement
Participant performs two tests of normal gait (> 25 steps) under single task and dual task conditions. Gait speed (m/s) is assessed using body-worn sensor technology.
Measured: 3 weeks
Secondary outcomes (8)
Change of postural balance (COG) by objective measurement
Each participant performs 30-second trials of balance assessment with eyes open or closed. Center of gravity (COG, cm) is assessed using body-worn sensor technology.
Measured: 3 weeks
Change of stride length by objective measurement
Participant performs two tests of normal gait (> 25 steps) under single task and dual task conditions. Stride length (m) is assessed using body-worn sensor technology.
Measured: 3 weeks
Change of postural balance (Ankle/hip sway) by objective measurement
Each participant performs 30-second trials of balance assessment with eyes open or closed. Ankle sway (deg2), Hip sway (deg2), Ankle/hip sway is assessed using body-worn sensor technology.
Measured: 3 weeks
Change of Unified Parkinson's Disease Rating Scale
Unified Parkinson's disease rating scale (UPDRS) is utilized. Parts I: to assess mentation, behavior and mood (0-16); Part II: to assess activities of daily living ( 0-52); Part III to motor assessment (0-104)
Measured: 3 weeks
Change of SF-12 health survey
SF-12 health survey (MCS, PCS)
Measured: 3 weeks
Change of Short Falls Efficacy Scale-International
(Short FES-I, 7-28)
Measured: 3 weeks
Change of the visual analog scale
the visual analog scale (VAS, 0-10) for pain,
Measured: 3 weeks
Potential adverse events related to acupuncture
measured by Adverse Events Report Related to Acupuncture
Measured: Baseline, 1 week, 2 week and 3 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2015 (estimated)
- Study startMay 2013
- Primary completion30 Jun 2016
- Study completion30 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
- More trials run by University of ArizonaThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arizona
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hong Lei, University of Arizona
- Investigators
- Bijan Najafi, PhD, Principal investigator, University of Arizona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02556164
- Sponsor's protocol ID
- UArizona
- Status last verified
- Nov 2017
- First submitted
- 8 Sep 2015
- Last updated
- 9 Nov 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Lei H, Toosizadeh N, Schwenk M, Sherman S, Karp S, Sternberg E, Najafi B. A Pilot Clinical Trial to Objectively Assess the Efficacy of Electroacupuncture on Gait in Patients with Parkinson's Disease Using Body Worn Sensors. PLoS One. 2016 May 26;11(5):e0155613. doi: 10.1371/journal.pone.0155613. eCollection 2016.
PubMed 27227460
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Objective Assessment of Electro-acupuncture Efficacy for Gait and Balance in Patients With Parkinson's Disease
- ClinicalTrials.gov ID
- NCT02556164
- Acronym / sponsor ID
- UArizona
- Conditions
- Parkinson's Disease
- Keywords
- Electroacupuncture, Body Worn Sensor, Gait, Balance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University of ArizonaUniversity, hospital or other
- Study start
- May 2013
- Primary completion
- 30 Jun 2016 (actual)
- Study completion
- 30 Jun 2017 (actual)
- First posted
- 22 Sep 2015 (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.
Gait and balance disorders, key contributors to fall and poor quality of life, represent a major therapeutic challenge in Parkinson's disease (PD). Despite the widespread use of acupuncture in recent years in PD, its efficacy remains unclear, largely due to methodological flaws and lack of high quality studies using objective outcome measures. In a patient and assessor-blind pilot study, investigators objectively assess the efficacy of electroacupuncture (EA) for gait and balance disorders using body-worn sensor technology in patients with PD.
Detailed description
In this study, investigators employee objective innovative body-worn sensor technologies to assess potential mobility-associated outcomes of PD. Investigators compare acute changes in gait and balance that occurred after repeated administration of two interventions: A specific real EA and a sham EA. The design of the experiments uses a control that accounts for both placebo and possible some active components of a generalized needle-insertion-based procedure. By using a sham control, the investigators were able to more fully test whether the specific EA intervention could lead to changes in objective gait and balance parameters, or subjective self-reported improvements that are beyond placebo induced effects and the natural course of the disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Real EA | Experimental | Procedure: Electroacupuncture, Other: Body-worn sensor technologyReal EA as intervention is performed at the selected standard acupuncture points and "De-qi" is achieved with needle manipulation before electric stimulation is delivered. |
| Sham EA | Sham comparator | Procedure: Electroacupuncture, Other: Body-worn sensor technologySham EA as intervention is performed for the control group at non-acupuncture points without needle manipulation. The electric stimulation in sham acupuncture was performed in a similar fashion to the real EA. |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Community-dwelling men or women ages 55 years or older with diagnosis of PD;
- patients who have the ability to walk 20meters without walking assistance; and
- patients who are stable without anti-PD medication(s) change for at least 1 month. The PD diagnosis was made by movement disorder specialists based on the UK Brain Bank criteria and supported by DaTscan (Ioflupane I 123 injection) when possible.
Key exclusion criteria (4 listed)
- patients who have received previous acupuncture;
- patients who have had DBS;
- patients with any clinically significant medical condition, psychiatric condition, drug or alcohol abuse, or laboratory abnormality that would, in the judgment of the investigators, interfere with the ability to participate in the study; and
- patients with non-PD related gait disorders.
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 |
|---|---|---|
| ElectroacupunctureAcupuncture is an alternative medicine methodology that treats patient by various techniques including inserting small, thin needles at specific points of body. Electroacupuncture (EA), like the name implies, combines classical acupuncture and low electric current running through the needles, which are often used to enhance a treatment. | Procedure or surgery | Real EA, Sham EA |
| Body-worn sensor technologyThree-dimensional acceleration and angular velocity of shanks, thighs and the trunk were measured using wearable sensors each included a triaxial accelerometer and a triaxial gyroscope (LEGSys™ and BalanSens™ - BioSensics, Boston, MA) | Other | Real EA, Sham EA |
Primary outcome
Change of gait speed by objective measurement
Time frame: 3 weeks
Participant performs two tests of normal gait (> 25 steps) under single task and dual task conditions. Gait speed (m/s) is assessed using body-worn sensor technology.
8 secondary outcomes
Change of postural balance (COG) by objective measurement
Time frame: 3 weeks
Change of stride length by objective measurement
Time frame: 3 weeks
Change of postural balance (Ankle/hip sway) by objective measurement
Time frame: 3 weeks
Change of Unified Parkinson's Disease Rating Scale
Time frame: 3 weeks
Change of SF-12 health survey
Time frame: 3 weeks
Change of Short Falls Efficacy Scale-International
Time frame: 3 weeks
Change of the visual analog scale
Time frame: 3 weeks
Potential adverse events related to acupuncture
Time frame: Baseline, 1 week, 2 week and 3 weeks.
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 9 Nov 2017.
- Derived from this study: PubMed 27227460Lei H, Toosizadeh N, Schwenk M, Sherman S, Karp S, Sternberg E, Najafi B. A Pilot Clinical Trial to Objectively Assess the Efficacy of Electroacupuncture on Gait in Patients with Parkinson's Disease Using Body Worn Sensors. PLoS One. 2016 May 26;11(5):e0155613. doi: 10.1371/journal.pone.0155613. eCollection 2016.
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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.
Bijan Najafi, PhD principal investigator
University of Arizona
Questions about this trial
What is this clinical trial studying?
A study testing Electroacupuncture and Body-worn sensor technology in people with Parkinson's Disease, run by University of Arizona.
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 4 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 9 Nov 2017. 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. Some participants in this study may receive a placebo. 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 of gait speed by objective measurement (time frame: 3 weeks). 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 NCT02556164, which also lists 1 linked publication.
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 9 Nov 2017.