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.
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 Type
INTERVENTIONAL
Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Enrollment
10
During 8 weeks, 3 times a week, 1 hour therapy sessions with the device
Thomas More Kempen
Geel, Antwepen, Belgium
Fugl-Meyer test upper limb section
Stroke specific, performance based impairment index. Applied to determine disease severity and describe motor recovery.
Time frame: Change from baseline Fugl-Meyer test upper limb section at 8 weeks and 12 weeks
Medical research council score
Muscle strength assessment
Time frame: Change from baseline Medical research council score at 8 weeks and 12 weeks
Active range of motion of the elbow joint
The maximum range of motion to flexion and extension of the elbow joint that the person can achieve independently
Time frame: Change from baseline active range of motion of the elbow joint at 8 weeks and 12 weeks
Passive range of motion of the elbow joint
The maximum range of motion to flexion and extension of the elbow joint of the test person that can be achieved by the assessor.
Time frame: Change from baseline passive range of motion of the elbow joint at 8 weeks and 12 weeks
Modified Ashworth Scale
Spasticity measurement
Time frame: Change from baseline Modified Ashworth Scale at 8 weeks and 12 weeks
ABILHAND questionnaire
Questionnaire-based assessment of manual ability
Time frame: Change from baseline ABILHAND questionnaire score at 8 weeks and 12 weeks
Functional independence measure
Assessment of physical and cognitive disability, focusing on the burden of care.
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Time frame: Change from baseline Functional independence measure score at 8 weeks and 12 weeks
Stroke impact scale
Questionnaire evaluating how stroke has impacted the person's health and life.
Time frame: Change from baseline Stroke impact scale score at 8 weeks and 12 weeks
Intrinsic motivation inventory
Multidimensional measurement device intended to assess participants' subjective experience related to a target activity in laboratory experiments.
Time frame: Change from baseline Intrinsic motivation inventory score at 8 weeks and 12 weeks