Back to results

Electro-acupuncture for Gait and Balance in Parkinson's Disease

Primary Purpose

Parkinson's Disease

Status

Completed

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Electroacupuncture

Body-worn sensor technology

About this trial

This is an interventional treatment trial for Parkinson's Disease focused on measuring Electroacupuncture, Body Worn Sensor, Gait, Balance

Eligibility Criteria

55 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Real EA

Sham EA

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

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.

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.

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)

Change of SF-12 health survey

SF-12 health survey (MCS, PCS)

Change of Short Falls Efficacy Scale-International

(Short FES-I, 7-28)

Change of the visual analog scale

the visual analog scale (VAS, 0-10) for pain,

Potential adverse events related to acupuncture

measured by Adverse Events Report Related to Acupuncture

Full Information

NCT ID

NCT02556164

First Posted

September 8, 2015

Last Updated

November 8, 2017

Sponsor

University of Arizona

1. Study Identification

Unique Protocol Identification Number

NCT02556164

Brief Title

Electro-acupuncture for Gait and Balance in Parkinson's Disease

Official Title

Objective Assessment of Electro-acupuncture Efficacy for Gait and Balance in Patients With Parkinson's Disease

Study Type

Interventional

2. Study Status

Record Verification Date

November 2017

Overall Recruitment Status

Completed

Study Start Date

May 2013 (undefined)

Primary Completion Date

June 30, 2016 (Actual)

Study Completion Date

June 30, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Arizona

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Parkinson's Disease

Keywords

Electroacupuncture, Body Worn Sensor, Gait, Balance

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

15 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Real EA

Arm Type

Experimental

Arm Description

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.

Arm Title

Sham EA

Arm Type

Sham Comparator

Arm Description

Intervention Type

Procedure

Intervention Name(s)

Electroacupuncture

Intervention Description

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.

Intervention Type

Other

Intervention Name(s)

Body-worn sensor technology

Intervention Description

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)

Primary Outcome Measure Information:

Title

Change of gait speed by objective measurement

Description

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.

Time Frame

3 weeks

Secondary Outcome Measure Information:

Title

Change of postural balance (COG) by objective measurement

Description

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.

Time Frame

3 weeks

Title

Change of stride length by objective measurement

Description

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.

Time Frame

3 weeks

Title

Change of postural balance (Ankle/hip sway) by objective measurement

Description

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.

Time Frame

3 weeks

Title

Change of Unified Parkinson's Disease Rating Scale

Description

Time Frame

3 weeks

Title

Change of SF-12 health survey

Description

SF-12 health survey (MCS, PCS)

Time Frame

3 weeks

Title

Change of Short Falls Efficacy Scale-International

Description

(Short FES-I, 7-28)

Time Frame

3 weeks

Title

Change of the visual analog scale

Description

the visual analog scale (VAS, 0-10) for pain,

Time Frame

3 weeks

Title

Potential adverse events related to acupuncture

Description

measured by Adverse Events Report Related to Acupuncture

Time Frame

Baseline, 1 week, 2 week and 3 weeks.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Bijan Najafi, PhD

Organizational Affiliation

University of Arizona

Official's Role

Principal Investigator

12. IPD Sharing Statement

Citations:

PubMed Identifier

27227460

Citation

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.

Results Reference

derived

Learn more about this trial

Electro-acupuncture for Gait and Balance in Parkinson's Disease

We'll reach out to this number within 24 hrs