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

Thomas More Kempen

Status: Unknown

Conditions: Stroke

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

Study type: Interventional

Funder types: Other

Identifiers

NCT01723046

IWT120278

Details and patient eligibility

About

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.

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 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.

Enrollment: 10 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: Single Blind

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10 participants in 2 patient groups

Training with the device

Experimental group

Description:

Training with new upper limb robot assisted therapy device

Treatment:

Device: Training with new upper limb robot assisted therapy device

Control group

No Intervention group

Description:

The control group is treated with conventional therapy.