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Active Smart Wearable Orthosis for Enhanched Rehabilitation THErapy (ARTHE)

This study is not yet open for participant recruitment.
Verified May 2017 by Lieven De Maesschalck, Thomas More Kempen
Sponsor:
ClinicalTrials.gov Identifier:
NCT03153254
First Posted: May 15, 2017
Last Update Posted: May 15, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
Ortho-Medico
Information provided by (Responsible Party):
Lieven De Maesschalck, Thomas More Kempen
  Purpose
The purpose of this study is to investigate the usability of a new upper limb robot assisted therapy device in stroke patients.

Condition Intervention
Stroke Device: Test upper limb robot assisted therapy device Device: Training with new upper limb robot assisted therapy device

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Intervention Model Description:
Phase 1: Healthy persons Phase 2: Stroke patients
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Usability Study of an Active Smart Wearable Orthosis for Enhanched Rehabilitation Therapy in Stroke Patients

Resource links provided by NLM:


Further study details as provided by Lieven De Maesschalck, Thomas More Kempen:

Primary Outcome Measures:
  • 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).


Secondary Outcome Measures:
  • 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).

  • 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.


Estimated Enrollment: 20
Anticipated Study Start Date: September 1, 2017
Estimated Study Completion Date: September 30, 2018
Estimated Primary Completion Date: March 31, 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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:
  • active orthosis
  • exoskeleton
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:
  • active orthosis
  • exoskeleton

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria
  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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03153254


Contacts
Contact: Lieven De Maesschalck 014/56 23 10 ext 32 lieven.demaesschalck@thomasmore.be
Contact: Romy Sels 014/56 23 10 ext 32 romy.sels@thomasmore.be

Sponsors and Collaborators
Thomas More Kempen
Ortho-Medico
Investigators
Principal Investigator: Lieven De Maesschalck Thomas More Kempen
  More Information

Responsible Party: Lieven De Maesschalck, Innovation Manager, Thomas More Kempen
ClinicalTrials.gov Identifier: NCT03153254     History of Changes
Other Study ID Numbers: S60144
First Submitted: March 6, 2017
First Posted: May 15, 2017
Last Update Posted: May 15, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Lieven De Maesschalck, Thomas More Kempen:
Upper extremity
Rehabilitation
Robot assisted therapy
Robotics
Devices
Orthosis

Additional relevant MeSH terms:
Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases