Active Smart Wearable Orthosis for Enhanched Rehabilitation THErapy (ARTHE)

August 20, 2018 updated by: Lieven De Maesschalck, Thomas More Kempen

Usability Study of an Active Smart Wearable Orthosis for Enhanched Rehabilitation Therapy in Stroke Patients

The purpose of this study is to investigate the usability of a new upper limb robot assisted therapy device in stroke patients.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The number of physically weak individuals is increasing, resulting in a higher burden on health care and health care workers. The use of robot assisted therapy (RAT) might partly solve this problem. Rehabilitation progress highly depends on training intensity and training duration, favouring the use of RAT.

In this pilot study, the usability of a new upper arm RAT device for upper arm rehabilitation in stroke patients is investigated. Myo-electrical signals will serve as input for the device, assisting the user in flexion and extension of the elbow, which is combined with a stabilizing shoulder brace and a bionic glove.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Belgium
    • Antwerp
      • Edegem, Antwerp, Belgium, 2650
        • Recruiting
        • RevArthe
        • Contact:
          • Christhophe Lafosse, Prof.
      • Geel, Antwerp, Belgium, 2440
        • Completed
        • Thomas More - Mobilab
      • Herentals, Antwerp, Belgium, 2200
        • Active, not recruiting
        • REVAlution
      • Overpelt, Antwerp, Belgium, 3900
        • Recruiting
        • Revalidatie & MS Centrum
        • Contact:
          • Martine Verhoeven

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 85 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

  1. Healthy subjects:

    Inclusion criteria:

    • Persons between 18 and 85 years old that can perform all sorts of daily activities with their upper limbs
    • Ability to sit on a chair with adequate trunk stability
    • Ability to follow verbal instructions
    • Ability to communicate verbally with the researchers

    Exclusion criteria:

    • Ever had a fracture in the upper limbs
    • Ever had a surgery in the upper limbs
    • Pain in the upper limbs obstructing the execution of daily activities with the upper limbs
    • Physical trauma in the two months preceding the research
    • Mental problems that make the execution of daily activities unreliable
    • (Chronic) subluxation of the shoulder joint
    • Secundary soft tissue problems which may complicate the research or make it impossible (e.g. shoulder impingement, musculoskeletal problems, sensory deficits)
    • Pregnancy
    • Pacemaker
    • Known allergies for one of the components of the ARTHE rehabilitation tool
  2. Stroke patients:

Inclusion criteria:

  • Stroke patients, more than three months after onset
  • Aged between 18 and 85 years
  • None to moderate spasticity in the hemiplegic arm (Modified Ashworth Scale: 0-2)
  • Detectable voluntary muscle activity at elbow flexion and elbow extension of the hemiplegic arm (Medical research council score: 1-5)
  • Ability to sit on a chair with adequate trunk stability
  • Ability to follow verbal instructions
  • Ability to communicate verbally with the researchers

Exclusion criteria:

  • Stroke patients, less than three months after onset
  • Massive spastic patterns
  • Severe medical conditions that interfere with the proper execution of the research, patients who are medically unstable
  • Cognitive disorders which may complicate the research or make it impossible
  • Speaking disorders (aphasia, dysarthria) which may complicate the proper execution of the research and the communication of important verbal information
  • Visual disorders which may complicate the research or make it impossible
  • (Chronic) subluxation of the shoulder joint
  • Shoulder-hand-syndrom
  • Pusher syndrom
  • Secundary soft tissue problems which may complicate the research or make it impossible (e.g. shoulder impingement, musculoskeletal problems, sensory deficits)
  • Pregnancy
  • Pacemaker
  • Known allergies for one of the components of the ARTHE rehabilitation tool

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SEQUENTIAL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Healthy persons
Test upper limb robot assisted therapy device. During 1 session of 1/2 hour.
Device: Test upper limb robot assisted therapy device
During 1 session of 1/2 hour.
Other Names:
  • exoskeleton
  • active orthosis
EXPERIMENTAL: Stroke patients
Training with new upper limb robot assisted therapy device. During 2 to 5 sessions of 1/2 hour.
Device: Training with new upper limb robot assisted therapy device
During 2 to 5 sessions of 1/2 hour.
Other Names:
  • exoskeleton
  • active orthosis

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Investigate user experience by a self-composed questionnaire.
Time Frame: Up to 30 minutes at the last session
Investigate user experience by a self-composed questionnaire with theorems where upon users have to score. Possible scores range from 1 (totally disagree) to 4 (totally agree).
Up to 30 minutes at the last session

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Measure the rate of perceived exertion by the Borg scale.
Time Frame: Up to 5 minutes at the last session
Measure the rate of perceived exertion by the Borg scale. The Borg scale is a way of measuring physical activity intensity level. Possible scores range from 0 (no fatigue at all) to 10 (worst imaginable fatigue).
Up to 5 minutes at the last session
Investigate whether wearing the device improves functionality by the Action Research Arm Test (ARAT).
Time Frame: Up to 5 weeks (at week 1, week 2 and week 5)
The Action Research Arm Test (ARAT) is an evaluative measure to assess specific changes in limb function among individuals who sustained cortical damage resulting in hemiplegia.
Up to 5 weeks (at week 1, week 2 and week 5)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Thomas More Kempen

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Ortho-Medico

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Lieven De Maesschalck, Thomas More Kempen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 15, 2017

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 30, 2018

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 30, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 6, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 12, 2017

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 15, 2017

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 21, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 20, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • S60144

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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