Healthy VolunteersNCT02780817
Motor Adaptation by Error Augmentation Force Field in Healthy Peoples' Upper Extremity
A study testing Error enhancement in people with Healthy Volunteers, run by University of Haifa at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Error enhancement
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteIsrael
- Study dates
- Dec 2015to May 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 20 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy
Who cannot join
- Neurologic disease, orthopedic syndrome of the dominant upper extremity.
Trial locations and contacts
1 site in 1 country.
Eli Carmeli, PhD. contact
Israel1 site, 1 recruiting
- Recruiting
University of Haifa
Haifa
Eli Carmeli, PhD, 972-04-8288397, ecarmeli@univ.haifa.ac.il
Eli Carmeli, PhD.
About this study
Official title: Motor Adaptation by Error Augmentation Force Field in Healthy Peoples' Upper Extremity, a Randomized Controlled Trial
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).
Read the detailed description
A single process involved in motor learning is adaptation. Hand reaching movement has been extensively used to evaluate the concept of motor adaptation. By inducing a systematic perturbation on the hand, it is possible to examine the implicit motor response on the trajectory of the hand. Error-augmentation (EA) training is relatively new concept in motor learning intended to promote the adaptation process. Applying these perturbating forces on the hand shift the hand trajectory form the straight line to a curve like shape. Making repetitive movement under the same conditions will results in a gradual correction of this faulty movement trajectory toward the straight line, e.g. motor adaptation.
Participants: Healthy volunteers, aged 20-50, males and females. The participants will be randomly assigned into two groups: study or control group.
Procedure: One practice session of 25 minutes on 3D robotic device. The study group will carry out the session with EA forces. The control group will carry out the same training without the EA forces.
Outcome Measures: Size of trajectory error from the straight line, level of exertion.
- Conditions
- Healthy Volunteers
- Being tested
- Error enhancement, Control group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Error enhancementOther
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.
Control groupOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in average movement error from baseline
Average size of trajectory error form the straight line while making arm reaching movement
Measured: 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
A 6-20 scale that intended describe the subjective level of exertion of the participant.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2016 (estimated)
- Study startDec 2015
- Primary completionMay 2017 (estimated)
- Study completionMay 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Haifa
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eli Carmeli, PhD., Principal investigator, Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02780817
- Sponsor's protocol ID
- 036/15
- Status last verified
- May 2016
- First submitted
- 28 Feb 2016
- Last updated
- 24 May 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: Journal article
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Motor Adaptation by Error Augmentation Force Field in Healthy Peoples' Upper Extremity, a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02780817
- Acronym / sponsor ID
- 036/15
- Conditions
- Healthy Volunteers
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of HaifaUniversity, hospital or other
- Study start
- Dec 2015
- Primary completion
- May 2017 (estimated)
- Study completion
- May 2017 (estimated)
- First posted
- 24 May 2016 (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.
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).
Detailed description
A single process involved in motor learning is adaptation. Hand reaching movement has been extensively used to evaluate the concept of motor adaptation. By inducing a systematic perturbation on the hand, it is possible to examine the implicit motor response on the trajectory of the hand. Error-augmentation (EA) training is relatively new concept in motor learning intended to promote the adaptation process. Applying these perturbating forces on the hand shift the hand trajectory form the straight line to a curve like shape. Making repetitive movement under the same conditions will results in a gradual correction of this faulty movement trajectory toward the straight line, e.g. motor adaptation.
Participants: Healthy volunteers, aged 20-50, males and females. The participants will be randomly assigned into two groups: study or control group.
Procedure: One practice session of 25 minutes on 3D robotic device. The study group will carry out the session with EA forces. The control group will carry out the same training without the EA forces.
Outcome Measures: Size of trajectory error from the straight line, level of exertion.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Error enhancement | Experimental | Other: Error enhancementArm reaching rehabilitation training with error-augmentation perturbation forces. One session of about 25 minutes of practicing arm reaching movements on 3D robotic device. |
| Control group | Other | Other: Control groupArm reaching rehabilitation training without error-augmentation perturbation forces. One session of about 25 minutes of practicing arm reaching movements on 3D robotic device. |
Who may qualify
- Ages
- 20 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy
Key exclusion criteria (1 listed)
- Neurologic disease, orthopedic syndrome of the dominant upper extremity.
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 |
|---|---|---|
| Error enhancementParticipants 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. | Other | Error enhancement |
| Control groupParticipants 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. | Other | Control group |
Primary outcome
Change in average movement error from baseline
Time frame: 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.
Average size of trajectory error form the straight line while making arm reaching movement
1 secondary outcome
Change in Borg scale score from baseline
Time frame: 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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2016.
- Individual participant dataSharing planned: Yes. Journal article
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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.
Eli Carmeli, PhD. contact
Eli Carmeli, PhD. principal investigator
Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Error enhancement in people with Healthy Volunteers, run by University of Haifa at 1 site in Israel.
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: status not confirmed, as of the sponsor's last update on 24 May 2016. 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 Israel. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sharon Israley, MSc. (972-523-755-091, sharonis@mh.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in average movement error from baseline (time frame: 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.). 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 24 May 2016.