Active Smart Wearable Orthosis Using Painted EMG Electrodes for Home Based Therapy With Augmentative Feedback
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Thomas More Kempen
- Enrollment
- 10
- Locations
- 2
- Primary Endpoint
- Active range of motion of the elbow joint
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Supportive Care
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 85 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Active range of motion of the elbow joint
Time Frame: Change from baseline active range of motion of the elbow joint at 8 weeks and 12 weeks
The maximum range of motion to flexion and extension of the elbow joint that the person can achieve independently
Passive range of motion of the elbow joint
Time Frame: Change from baseline passive range of motion of the elbow joint at 8 weeks and 12 weeks
The maximum range of motion to flexion and extension of the elbow joint of the test person that can be achieved by the assessor.
Modified Ashworth Scale
Time Frame: Change from baseline Modified Ashworth Scale at 8 weeks and 12 weeks
Spasticity measurement
Fugl-Meyer test upper limb section
Time Frame: Change from baseline Fugl-Meyer test upper limb section at 8 weeks and 12 weeks
Stroke specific, performance based impairment index. Applied to determine disease severity and describe motor recovery.
Medical research council score
Time Frame: Change from baseline Medical research council score at 8 weeks and 12 weeks
Muscle strength assessment
Secondary Outcomes
- ABILHAND questionnaire(Change from baseline ABILHAND questionnaire score at 8 weeks and 12 weeks)
- Functional independence measure(Change from baseline Functional independence measure score at 8 weeks and 12 weeks)
- Stroke impact scale(Change from baseline Stroke impact scale score at 8 weeks and 12 weeks)
- Intrinsic motivation inventory(Change from baseline Intrinsic motivation inventory score at 8 weeks and 12 weeks)
Investigators
Lore Van de Perre
Study principal investigator
Thomas More Kempen