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

Stroke Clinical Trial

— ARTHE  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01723046
• Other study ID #: IWT120278
• Status: Not yet recruiting
• Phase: N/A
• First received: October 30, 2012
• Last updated: December 10, 2012
• Start date: February 2013
• Est. completion date: September 2014

Study information

• Verified date: December 2012
• Source: Thomas More Kempen
• Contact: Lore Van de Perre, MSc
• Phone: +32 14 56 23 10
• Email: lore.van.de.perre[@]khk.be
• Is FDA regulated: No
• Health authority: Belgium: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 10
• Est. completion date: September 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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 Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Stroke

Intervention

Device:
• Training with new upper limb robot assisted therapy device
During 8 weeks, 3 times a week, 1 hour therapy sessions with the device

Locations

Country	Name	City	State
Belgium	Thomas More Kempen	Geel	Antwepen

Sponsors (1)

Lead Sponsor	Collaborator
Thomas More Kempen

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	Medical research council score	Muscle strength assessment	Change from baseline Medical research council score at 8 weeks and 12 weeks	No
Primary	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	No
Primary	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	No
Primary	Modified Ashworth Scale	Spasticity measurement	Change from baseline Modified Ashworth Scale at 8 weeks and 12 weeks	No
Secondary	ABILHAND questionnaire	Questionnaire-based assessment of manual ability	Change from baseline ABILHAND questionnaire score at 8 weeks and 12 weeks	No
Secondary	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	No
Secondary	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	No
Secondary	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	No