Feasibility of Supervised Care & Rehabilitation Involving Personal Tele-robotics for arm/hand function of chronic stroke patients

Completed

Conditions: Cerebrovascular accident
Stroke
10007963

Registration Number: NL-OMON39741

Lead Sponsor: Revalidatiecentrum Het Roessingh

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 20

Inclusion Criteria

• Patients with an unilateral ischemic or hemorrhagic stroke, between 6 months and 5 years post-stroke
• Between 18 and 80 years of age
• Clinically diagnosed with central paresis of the arm and/or hand as a result of stroke, but with:
- 15° active elbow flexion
- * range of active finger flexion (PIP/DIP)
• Ability to complete measurements and training sessions
• Discharged from medical centre
• Living at home and have internet access
• Having a carer who is co-resident or closely involved in their care
• A fair cognitive level: ability to read and understand the Dutch language, and ability to understand and follow instructions
• Patients should fit the device: 5-95% size of hand and body shape
• Written informed consent to participate in the study.

Exclusion Criteria

• Patients who are not eligible to join normal rehabilitation (psychological issues, patients with near complete paralysis etc.)
• Other severe co-morbidities, like cardiovascular, neurological, orthopaedic or rheumatoid impairments (incl. pain affecting use of the upper extremity) before stroke that may interfere with task performance
• Severe sensory deficits from the involved limb
• Severe neglect
• Visual impairments (that cannot be corrected with glasses or contact lenses to within normal or near normal limits)
• Cognitive impairments

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Main study parameters are outcomes related to user acceptance, including<br /><br>usability, satisfaction, motivation and compliance (Intrinsic Motivation<br /><br>Inventory, System Usability Scale, Qualitative interview about experience of<br /><br>use).</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Measures to examine general motor function, perceived use and participation<br /><br>(The Action Research Arm Test (ARAT), the upper extremity part of the<br /><br>Fugl-Meyer (FM) test, the Box & Blocks test (BBT), Motor Activity Log (MAL),<br /><br>the Stroke Impact Scale (SIS), kinematics and EMG).</p><br>