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.
- Training with new upper limb robot assisted therapy device Device
Other Names: active orthosis; exoskeleton Intervention Desc: During 8 weeks, 3 times a week, 1 hour therapy sessions with the device ARM 1: Kind: Experimental Label: Training with the device Description: Training with new upper limb robot assisted therapy device
- Masking: Single Blind (Outcomes Assessor)
- Purpose: Supportive Care
- Endpoint: Efficacy Study
- Intervention: Single Group Assignment
|Type||Measure||Time Frame||Safety Issue|
|Primary||Fugl-Meyer test upper limb section||Change from baseline Fugl-Meyer test upper limb section at 8 weeks and 12 weeks||No|
|Primary||Medical research council score||Change from baseline Medical research council score at 8 weeks and 12 weeks||No|
|Primary||Active range of motion of the elbow joint||Change from baseline active range of motion of the elbow joint at 8 weeks and 12 weeks||No|
|Primary||Passive range of motion of the elbow joint||Change from baseline passive range of motion of the elbow joint at 8 weeks and 12 weeks||No|
|Primary||Modified Ashworth Scale||Change from baseline Modified Ashworth Scale at 8 weeks and 12 weeks||No|
|Secondary||ABILHAND questionnaire||Change from baseline ABILHAND questionnaire score at 8 weeks and 12 weeks||No|
|Secondary||Functional independence measure||Change from baseline Functional independence measure score at 8 weeks and 12 weeks||No|
|Secondary||Stroke impact scale||Change from baseline Stroke impact scale score at 8 weeks and 12 weeks||No|
|Secondary||Intrinsic motivation inventory||Change from baseline Intrinsic motivation inventory score at 8 weeks and 12 weeks||No|
- Thomas More Kempen Lead