Feasibility of the Supervised Care & Rehabilitation Involving Personal Tele-Robotics active-actuated arm/hand training system at home after chronic stroke

Completed

Conditions: Cerebrovascular accident
Stroke
10007963

Registration Number: NL-OMON41182

Lead Sponsor: Revalidatiecentrum Het Roessingh

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 12

Inclusion Criteria

* Patients with an unilateral ischemic or haemorrhagic 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 movement (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 (Training duration,<br /><br>Intrinsic Motivation Inventory, System Usability Scale, and a semi-structured<br /><br>interview about user experience). </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, Motor Activity Log (MAL), the Stroke Impact Scale (SIS),<br /><br>adapted Nine Hole Peg Test (NHPT) and kinematics). </p><br>