NCT02780817

Brief Summary

Inducing a systematic perturbation forces on the hand during arm reaching movement may improve adaptation. Error-augmentation (EA) training is relatively new concept in motor learning intended to promote the adaptation process. In this study participants will practice one session of training on 3D robotic device. Healthy volunteers will be randomly divided into two groups: study and control. The study group will carry out the training session with EA forces. The control group will carry out the same procedure with null force field. Outcome measure are the average size of trajectory error from the straight line and level of exertion (borg scale).

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P50-P75 for not_applicable healthy-volunteers

Timeline
Completed

Started Dec 2015

Typical duration for not_applicable healthy-volunteers

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2015

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 28, 2016

Completed
3 months until next milestone

First Posted

Study publicly available on registry

May 24, 2016

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2017

Completed
Last Updated

May 24, 2016

Status Verified

May 1, 2016

Enrollment Period

1.4 years

First QC Date

February 28, 2016

Last Update Submit

May 18, 2016

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change in average movement error from baseline

    Average size of trajectory error form the straight line while making arm reaching movement

    At baseline, before the beginning of the training session, and at followup measurement immediately at the the end of the training session, which is about 45 minutes after the first evaluation.

Secondary Outcomes (1)

  • Change in Borg scale score from baseline

    At baseline, before the beginning of the training session, and at followup measurement immediately at the end of the training session, which is about 45 minutes after the first evaluation.

Study Arms (2)

Error enhancement

EXPERIMENTAL

Arm reaching rehabilitation training with error-augmentation perturbation forces. One session of about 25 minutes of practicing arm reaching movements on 3D robotic device.

Other: Error enhancement

Control group

OTHER

Arm reaching rehabilitation training without error-augmentation perturbation forces. One session of about 25 minutes of practicing arm reaching movements on 3D robotic device.

Other: Control group

Interventions

Participants will sit in front of a 3D robotic device and grab the robotic arm handle. The participants will carry out arm reaching tasks appear on a screen on front of them. Each game of tasks will lasts 2 minutes. The participants will carry out one game to be accustomed to device, followed by one game with null force field, followed by 5 games as the main intervention with error enhancement force field, and another last game with null force field.

Error enhancement

Participants will sit in front of a 3D robotic device and grab the robotic arm handle. The participants will carry out arm reaching tasks appear on a screen on front of them. Each game of tasks will lasts 2 minutes. The participants will carry out one game to be accustomed to device and another 7 games with null force field.

Control group

Eligibility Criteria

Age20 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy

You may not qualify if:

  • Neurologic disease, orthopedic syndrome of the dominant upper extremity.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Haifa

Haifa, Israel

RECRUITING

MeSH Terms

Interventions

Control Groups

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • Eli Carmeli, PhD.

    Professor

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sharon Israley, MSc.

CONTACT

Eli Carmeli, PhD.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 28, 2016

First Posted

May 24, 2016

Study Start

December 1, 2015

Primary Completion

May 1, 2017

Study Completion

May 1, 2017

Last Updated

May 24, 2016

Record last verified: 2016-05

Data Sharing

IPD Sharing
Will share

Journal article

Locations