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Search / Trial NCT03153254

Active Smart Wearable Orthosis for Enhanched Rehabilitation THErapy

Launched by THOMAS MORE KEMPEN · May 12, 2017

Trial Information

Current as of July 21, 2025

Unknown status

Keywords

Upper Extremity Rehabilitation Robot Assisted Therapy Robotics Devices Orthosis

ClinConnect Summary

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 sho...

Gender

ALL

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

About Thomas More Kempen

Thomas More Kempen is a reputable clinical trial sponsor committed to advancing healthcare through innovative research and development. With a focus on delivering high-quality clinical trials, the organization collaborates with academic institutions, healthcare professionals, and industry partners to facilitate the evaluation of new therapies and medical technologies. Leveraging its expertise in regulatory compliance and patient safety, Thomas More Kempen strives to contribute to the improvement of patient outcomes and the enhancement of medical knowledge, ensuring that studies are conducted with the utmost integrity and ethical standards.

Locations

Edegem, Antwerp, Belgium

Geel, Antwerp, Belgium

Herentals, Antwerp, Belgium

Overpelt, Antwerp, Belgium

Patients applied

0 patients applied

Trial Officials

Lieven De Maesschalck

Principal Investigator

Thomas More Kempen

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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