Clinical trial NCT01723046: Therapeutic Effects of a New Upper Limb Robot Assisted Therapy Device for Persons After Stroke
Official title: Active Smart Wearable Orthosis Using Painted EMG Electrodes for Home Based Therapy With Augmentative Feedback
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stroke
Keywords: Upper extremity
Rehabilitation
Robot assisted therapy
Robotics
Devices
Orthosis
clinical outcome
Lead sponsor: Thomas More Kempen
Sponsor class: OTHER
First posted: 2012-11-07
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Fugl-Meyer test upper limb section
timeFrame: Change from baseline Fugl-Meyer test upper limb section at 8 weeks and 12 weeks
measure: Medical research council score
timeFrame: Change from baseline Medical research council score at 8 weeks and 12 weeks
measure: Active range of motion of the elbow joint
timeFrame: Change from baseline active range of motion of the elbow joint at 8 weeks and 12 weeks
measure: Passive range of motion of the elbow joint
timeFrame: Change from baseline passive range of motion of the elbow joint at 8 weeks and 12 weeks
measure: Modified Ashworth Scale
timeFrame: Change from baseline Modified Ashworth Scale at 8 weeks and 12 weeks
Secondary outcomes:
measure: ABILHAND questionnaire
timeFrame: Change from baseline ABILHAND questionnaire score at 8 weeks and 12 weeks
measure: Functional independence measure
timeFrame: Change from baseline Functional independence measure score at 8 weeks and 12 weeks
measure: Stroke impact scale
timeFrame: Change from baseline Stroke impact scale score at 8 weeks and 12 weeks
measure: Intrinsic motivation inventory
timeFrame: Change from baseline Intrinsic motivation inventory score at 8 weeks and 12 weeks
Other outcomes:
Locations:
city: Geel
country: Belgium
facility: Thomas More Kempen
state: Antwepen
Study officials:
affiliation: Thomas More Kempen
name: Lore Van de Perre, MSc
role: PRINCIPAL_INVESTIGATOR
References: