Clinical trial NCT03153254: Active Smart Wearable Orthosis for Enhanched Rehabilitation THErapy
Official title: Usability Study of an Active Smart Wearable Orthosis for Enhanched Rehabilitation Therapy in Stroke Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stroke
Keywords: Upper extremity
Rehabilitation
Robot assisted therapy
Robotics
Devices
Orthosis
Lead sponsor: Thomas More Kempen
Sponsor class: OTHER
Collaborators: name: Ortho-Medico
First posted: 2017-05-15
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Phase 1: Healthy persons Phase 2: Stroke patients
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility 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

Primary outcomes:
measure: Investigate user experience by a self-composed questionnaire.
timeFrame: Up to 30 minutes at the last session
Secondary outcomes:
measure: Measure the rate of perceived exertion by the Borg scale.
timeFrame: Up to 5 minutes at the last session
measure: Investigate whether wearing the device improves functionality by the Action Research Arm Test (ARAT).
timeFrame: Up to 5 weeks (at week 1, week 2 and week 5)
Other outcomes:
Locations:
city: Edegem
country: Belgium
facility: RevArthe
state: Antwerp
city: Geel
country: Belgium
facility: Thomas More - Mobilab
state: Antwerp
city: Herentals
country: Belgium
facility: REVAlution
state: Antwerp
city: Overpelt
country: Belgium
facility: Revalidatie & MS Centrum
state: Antwerp
Study officials:
affiliation: Thomas More Kempen
name: Lieven De Maesschalck
role: PRINCIPAL_INVESTIGATOR
References: