Active Smart Wearable Orthosis for Enhanched Rehabilitation THErapy

Stroke Clinical Trial

— ARTHE  

Official title:

Usability Study of an Active Smart Wearable Orthosis for Enhanched Rehabilitation Therapy in Stroke Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03153254
• Other study ID #: S60144
• Status: Recruiting
• Phase: N/A
• Start date: September 15, 2017
• Est. completion date: September 30, 2018

Study information

• Verified date: August 2018
• Source: Thomas More Kempen
• Contact: Lieven De Maesschalck
• Phone: 014/56 23 10
• Email: lieven.demaesschalck[@]thomasmore.be
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to investigate the usability of a new upper limb robot assisted therapy device in stroke patients.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: September 30, 2018
• Est. primary completion date: September 30, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Stroke

Intervention

Device:
• Test upper limb robot assisted therapy device
During 1 session of 1/2 hour.
• Training with new upper limb robot assisted therapy device
During 2 to 5 sessions of 1/2 hour.

Locations

Country	Name	City	State
Belgium	RevArthe	Edegem	Antwerp
Belgium	Thomas More - Mobilab	Geel	Antwerp
Belgium	REVAlution	Herentals	Antwerp
Belgium	Revalidatie & MS Centrum	Overpelt	Antwerp

Sponsors (2)

Lead Sponsor	Collaborator
Thomas More Kempen	Ortho-Medico

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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)