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Active Smart Wearable Orthosis for Enhanched Rehabilitation THErapy (ARTHE)

Primary Purpose

Stroke

Status
Unknown status
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Test upper limb robot assisted therapy device
Training with new upper limb robot assisted therapy device
Sponsored by
Thomas More Kempen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Stroke focused on measuring Upper extremity, Rehabilitation, Robot assisted therapy, Robotics, Devices, Orthosis

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

  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

Sites / Locations

  • RevArtheRecruiting
  • Thomas More - Mobilab
  • REVAlution
  • Revalidatie & MS CentrumRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Healthy persons

Stroke patients

Arm Description

Test upper limb robot assisted therapy device. During 1 session of 1/2 hour.

Training with new upper limb robot assisted therapy device. During 2 to 5 sessions of 1/2 hour.

Outcomes

Primary Outcome Measures

Investigate user experience by a self-composed questionnaire.
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.
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).
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.

Full Information

First Posted
March 6, 2017
Last Updated
August 20, 2018
Sponsor
Thomas More Kempen
Collaborators
Ortho-Medico
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1. Study Identification

Unique Protocol Identification Number
NCT03153254
Brief Title
Active Smart Wearable Orthosis for Enhanched Rehabilitation THErapy
Acronym
ARTHE
Official Title
Usability Study of an Active Smart Wearable Orthosis for Enhanched Rehabilitation Therapy in Stroke Patients
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Unknown status
Study Start Date
September 15, 2017 (Actual)
Primary Completion Date
September 30, 2018 (Anticipated)
Study Completion Date
September 30, 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Thomas More Kempen
Collaborators
Ortho-Medico

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
Upper extremity, Rehabilitation, Robot assisted therapy, Robotics, Devices, Orthosis

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Model Description
Phase 1: Healthy persons Phase 2: Stroke patients
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Healthy persons
Arm Type
Experimental
Arm Description
Test upper limb robot assisted therapy device. During 1 session of 1/2 hour.
Arm Title
Stroke patients
Arm Type
Experimental
Arm Description
Training with new upper limb robot assisted therapy device. During 2 to 5 sessions of 1/2 hour.
Intervention Type
Device
Intervention Name(s)
Test upper limb robot assisted therapy device
Other Intervention Name(s)
active orthosis, exoskeleton
Intervention Description
During 1 session of 1/2 hour.
Intervention Type
Device
Intervention Name(s)
Training with new upper limb robot assisted therapy device
Other Intervention Name(s)
active orthosis, exoskeleton
Intervention Description
During 2 to 5 sessions of 1/2 hour.
Primary Outcome Measure Information:
Title
Investigate user experience by a self-composed questionnaire.
Description
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).
Time Frame
Up to 30 minutes at the last session
Secondary Outcome Measure Information:
Title
Measure the rate of perceived exertion by the Borg scale.
Description
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).
Time Frame
Up to 5 minutes at the last session
Title
Investigate whether wearing the device improves functionality by the Action Research Arm Test (ARAT).
Description
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.
Time Frame
Up to 5 weeks (at week 1, week 2 and week 5)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lieven De Maesschalck
Phone
014/56 23 10
Ext
32
Email
lieven.demaesschalck@thomasmore.be
First Name & Middle Initial & Last Name or Official Title & Degree
Romy Sels
Phone
014/56 23 10
Ext
32
Email
romy.sels@thomasmore.be
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lieven De Maesschalck
Organizational Affiliation
Thomas More Kempen
Official's Role
Principal Investigator
Facility Information:
Facility Name
RevArthe
City
Edegem
State/Province
Antwerp
ZIP/Postal Code
2650
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christhophe Lafosse, Prof.
Facility Name
Thomas More - Mobilab
City
Geel
State/Province
Antwerp
ZIP/Postal Code
2440
Country
Belgium
Individual Site Status
Completed
Facility Name
REVAlution
City
Herentals
State/Province
Antwerp
ZIP/Postal Code
2200
Country
Belgium
Individual Site Status
Active, not recruiting
Facility Name
Revalidatie & MS Centrum
City
Overpelt
State/Province
Antwerp
ZIP/Postal Code
3900
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Martine Verhoeven

12. IPD Sharing Statement

Plan to Share IPD
No

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Active Smart Wearable Orthosis for Enhanched Rehabilitation THErapy

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