Active Smart Wearable Orthosis for Enhanched Rehabilitation THErapy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-09-15

Study Completion Date

2018-09-30

Brief Summary

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

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Detailed Description

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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.

Conditions

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Stroke

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Phase 1: Healthy persons Phase 2: Stroke patients

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Healthy persons

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

Group Type EXPERIMENTAL

Test upper limb robot assisted therapy device

Intervention Type DEVICE

During 1 session of 1/2 hour.

Stroke patients

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

Group Type EXPERIMENTAL

Training with new upper limb robot assisted therapy device

Intervention Type DEVICE

During 2 to 5 sessions of 1/2 hour.

Interventions

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Test upper limb robot assisted therapy device

During 1 session of 1/2 hour.

Intervention Type DEVICE

Training with new upper limb robot assisted therapy device

During 2 to 5 sessions of 1/2 hour.

Intervention Type DEVICE

Other Intervention Names

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active orthosis exoskeleton active orthosis exoskeleton

Eligibility Criteria

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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

* 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

* 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:

* 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

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes