Active Smart Wearable Orthosis for Enhanched Rehabilitation THErapy (ARTHE)

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: Unknown
• Conditions: Stroke
• Intervention / Treatment: Device: Test upper limb robot assisted therapy device; Device: Training with new upper limb robot assisted therapy device

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: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lieven De Maesschalck; Phone Number: 32 014/56 23 10; Email: lieven.demaesschalck@thomasmore.be
• Study Contact Backup: Name: Romy Sels; Phone Number: 32 014/56 23 10; Email: romy.sels@thomasmore.be

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

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
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).	Up to 30 minutes at the last session

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	Up to 5 minutes at the last session
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.	Up to 5 weeks (at week 1, week 2 and week 5)

Collaborators and Investigators

• Sponsor: Thomas More Kempen
• Collaborators: Ortho-Medico
• Investigators: Principal Investigator: Lieven De Maesschalck, Thomas More Kempen

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 15, 2017
• Primary Completion (ANTICIPATED): September 30, 2018
• Study Completion (ANTICIPATED): September 30, 2018

Study Registration Dates

• First Submitted: March 6, 2017
• First Submitted That Met QC Criteria: May 12, 2017
• First Posted (ACTUAL): May 15, 2017

Study Record Updates

• Last Update Posted (ACTUAL): August 21, 2018
• Last Update Submitted That Met QC Criteria: August 20, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Keywords: Rehabilitation; Upper extremity; Robotics; Orthosis; Robot assisted therapy; Devices
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID 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