Therapeutic Effects of a New Upper Limb Robot Assisted Therapy Device for Persons After Stroke (ARTHE)

Active Smart Wearable Orthosis Using Painted EMG Electrodes for Home Based Therapy With Augmentative Feedback

The purpose of this pilot study is to investigate the clinical effects of a new upper limb robot assisted therapy device that is linked to a virtual therapy environment in patients with stroke.

Study Overview

• Status: Unknown
• Conditions: Stroke
• Intervention / Treatment: 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 clinical effects of using a new upper arm RAT device for upper arm rehabilitation in patients with stroke is investigated. Myo-electrical signals will serve as input for the device, assisting the user in flexion and extension of the elbow. The device is coupled to a virtual environments, creating a stimulating therapy environment.

• Study Type: Interventional
• Enrollment (Anticipated): 10
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lore Van de Perre, MSc; Phone Number: +32 14 56 23 10; Email: lore.van.de.perre@khk.be

Study Locations

• Belgium
  • Antwepen
    • Geel, Antwepen, Belgium, 2440
      • Thomas More Kempen
      • Contact: Lore Van de Perre, MSc; Phone Number: +32 14 56 23 10; Email: lore.van.de.perre@khk.be
      • Contact: Peter Karsmakers, PhD; Phone Number: +32 14 56 23 10; Email: peter.karsmakers@khk.be
      • Principal Investigator: Lore Van de Perre, MSc
      • Sub-Investigator: Roy Sevit, MSc
      • Sub-Investigator: Koen Janssens, MSc
      • Sub-Investigator: Peter Karsmakers, PhD
      • Sub-Investigator: Louis Peeraer, Prof.PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients with stroke, more than three months post onset
• No or moderate spasticity in the upper limb (maximum score of 3 on Modified Ashworth Scale)
• Observable voluntary muscle activity in biceps and triceps muscle of the affected upper limb (minimal score of 1 on the Medical research council score)
• Able to sit on a chair with adequate trunk stability
• Able to follow verbal instructions
• Able to communicate verbal information to the researchers

Exclusion Criteria:

• Patients who are medically unstable
• Cognitive disorders impeding the intervention
• Visual disorders impeding the intervention
• Subluxation of the shoulder joint
• Pusher syndrome

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Training with the device; Training with new upper limb robot assisted therapy device	Device: Training with new upper limb robot assisted therapy device; During 8 weeks, 3 times a week, 1 hour therapy sessions with the device; Other Names: exoskeleton; active orthosis
No Intervention: Control group; The control group is treated with conventional therapy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fugl-Meyer test upper limb section	Stroke specific, performance based impairment index. Applied to determine disease severity and describe motor recovery.	Change from baseline Fugl-Meyer test upper limb section at 8 weeks and 12 weeks
Medical research council score	Muscle strength assessment	Change from baseline Medical research council score at 8 weeks and 12 weeks
Active range of motion of the elbow joint	The maximum range of motion to flexion and extension of the elbow joint that the person can achieve independently	Change from baseline active range of motion of the elbow joint at 8 weeks and 12 weeks
Passive range of motion of the elbow joint	The maximum range of motion to flexion and extension of the elbow joint of the test person that can be achieved by the assessor.	Change from baseline passive range of motion of the elbow joint at 8 weeks and 12 weeks
Modified Ashworth Scale	Spasticity measurement	Change from baseline Modified Ashworth Scale at 8 weeks and 12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ABILHAND questionnaire	Questionnaire-based assessment of manual ability	Change from baseline ABILHAND questionnaire score at 8 weeks and 12 weeks
Functional independence measure	Assessment of physical and cognitive disability, focusing on the burden of care.	Change from baseline Functional independence measure score at 8 weeks and 12 weeks
Stroke impact scale	Questionnaire evaluating how stroke has impacted the person's health and life.	Change from baseline Stroke impact scale score at 8 weeks and 12 weeks
Intrinsic motivation inventory	Multidimensional measurement device intended to assess participants' subjective experience related to a target activity in laboratory experiments.	Change from baseline Intrinsic motivation inventory score at 8 weeks and 12 weeks

Collaborators and Investigators

• Sponsor: Thomas More Kempen
• Investigators: Principal Investigator: Lore Van de Perre, MSc, Thomas More Kempen

Study record dates

Study Major Dates

• Study Start: February 1, 2013
• Primary Completion (Anticipated): July 1, 2014
• Study Completion (Anticipated): September 1, 2014

Study Registration Dates

• First Submitted: October 30, 2012
• First Submitted That Met QC Criteria: November 5, 2012
• First Posted (Estimate): November 7, 2012

Study Record Updates

• Last Update Posted (Estimate): December 11, 2012
• Last Update Submitted That Met QC Criteria: December 10, 2012
• Last Verified: December 1, 2012

More Information

Terms related to this study

• Keywords: Rehabilitation; Upper extremity; Robotics; clinical outcome; 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: IWT120278