Active Smart Wearable Orthosis for Enhanched Rehabilitation THErapy (ARTHE)

Thomas More Kempen

Status: Unknown

Conditions: Stroke

Treatments: Device: Test upper limb robot assisted therapy device; Device: Training with new upper limb robot assisted therapy device

Study type: Interventional

Funder types: Other

Identifiers

NCT03153254

S60144

Details and patient eligibility

About

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

Full 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

Healthy persons

Experimental group

Description:

Test upper limb robot assisted therapy device. During 1 session of 1/2 hour.

Treatment:

Device: Test upper limb robot assisted therapy device

Stroke patients

Experimental group

Description:

Training with new upper limb robot assisted therapy device. During 2 to 5 sessions of 1/2 hour.

Treatment:

Device: Training with new upper limb robot assisted therapy device