NCT03459872

Brief Summary

Can acupuncture be quantified. This study sets out to observe if there are measurable effects of fine motor control that are attributable to acupuncture. The study utilizes an FDA approved medical device for measurements of fine motor control called the RU-Fit.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2016

Shorter than P25 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 28, 2016

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 21, 2017

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 19, 2017

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

February 26, 2018

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 9, 2018

Completed
Last Updated

March 9, 2018

Status Verified

March 1, 2018

Enrollment Period

4 months

First QC Date

February 26, 2018

Last Update Submit

March 3, 2018

Conditions

Keywords

acupuncturequantitative dataoutcomes based rehabilitationfine motor control

Outcome Measures

Primary Outcomes (1)

  • Assessing Changes in Fine Motor Control from Acupuncture

    Fine Motor Control measurements (probability percentage of normal capability) from RU-Fit, FDA approved medical device

    Before and after acupuncture treatment or space of 40 minutes for control group between testing

Study Arms (2)

Acupuncture Intervention group

RU-Fit gathers measurements of fine motor control were gathered from this group before and after acupuncture treatments.

Procedure: AcupunctureDevice: RU-Fit

Control/ Non-Intervention

This group received no intervention but still had measurements of fine motor control gathered from RU-Fit medical device.

Device: RU-Fit

Interventions

AcupuncturePROCEDURE

Alternative medicine therapeutic intervention

Acupuncture Intervention group
RU-FitDEVICE

FDA approved medical device for the measurement of fine motor control

Acupuncture Intervention groupControl/ Non-Intervention

Eligibility Criteria

Age13 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Study participants were selected from the acupuncture patient population freely visiting the clinic. Patients were asked if they would be interested in a research study. They were informed about the objectives of the study, what their role would be and that this was a free non-invasive test that they would undergo before and after their regular acupuncture treatment. Before inclusion into the program, patients are provided with informed consent forms and after agreeing and signing the form, individuals then become participants.

You may qualify if:

  • Male or female 13 years old or older

You may not qualify if:

  • Younger than 13 years old

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Pain

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeutics

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Target Duration
6 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 26, 2018

First Posted

March 9, 2018

Study Start

September 28, 2016

Primary Completion

January 21, 2017

Study Completion

February 19, 2017

Last Updated

March 9, 2018

Record last verified: 2018-03

Data Sharing

IPD Sharing
Will not share

Information will be shared regarding measurements that were obtained from medical device testing such as fine motor control