Stroke
Conditions
Keywords
Upper extremity, Rehabilitation, Robot assisted therapy, Robotics, Devices, Orthosis, clinical outcome
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.
Interventions
During 8 weeks, 3 times a week, 1 hour therapy sessions with the device
Sponsors
Thomas More Kempen
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Modified Ashworth Scale | Change from baseline Modified Ashworth Scale at 8 weeks and 12 weeks | Spasticity measurement |
| Fugl-Meyer test upper limb section | 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 | Change from baseline Medical research council score at 8 weeks and 12 weeks | Muscle strength assessment |
| 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 | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Functional independence measure | Change from baseline Functional independence measure score at 8 weeks and 12 weeks | Assessment of physical and cognitive disability, focusing on the burden of care. |
| Stroke impact scale | Change from baseline Stroke impact scale score at 8 weeks and 12 weeks | Questionnaire evaluating how stroke has impacted the person's health and life. |
| Intrinsic motivation inventory | Change from baseline Intrinsic motivation inventory score at 8 weeks and 12 weeks | Multidimensional measurement device intended to assess participants' subjective experience related to a target activity in laboratory experiments. |
| ABILHAND questionnaire | Change from baseline ABILHAND questionnaire score at 8 weeks and 12 weeks | Questionnaire-based assessment of manual ability |
Countries
Belgium
Contacts
Primary ContactLore Van de Perre, MSc
Outcome results
None listed