Post-stroke active-actuated arm/hand training at home

Recruiting

Conditions: Stroke, Beroerte

Registration Number: NL-OMON22517

Lead Sponsor: Roessingh Research and Development b.v.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 12

Inclusion Criteria

1. Patients with an unilateral ischemic or hemorrhagic stroke, between 6 and 12 months post-stroke
2. Between 18 and 80 years of age
3. Clinically diagnosed with central paresis of the arm and/or hand as a result of stroke, but with
A. 15° active elbow flexion
B. ¼ range of active finger flexion (PIP/DIP)
4. Ability to complete measurements and training sessions
5. Discharged from medical centre
6. Living at home and have internet access
7. Having a carer who is co-resident or closely involved in their care
8. A fair cognitive level: ability to read and understand the Dutch language, and ability to understand and follow instructions
9. Patients should fit the device: 5-95% size of hand and body shape
10. Written informed consent to participate in the study

Exclusion Criteria

1. Patients who are not eligible to join normal rehabilitation (psychological issues, patients with near complete paralysis etc.)
2. 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
3. Severe sensory deficits from the involved limb
4. Severe neglect
5. Visual impairments (that cannot be corrected with glasses or contact lenses to within normal or near normal limits)
6. Cognitive impairment.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main study parameters are outcomes related to user acceptance, including usability, satisfaction, motivation and compliance (Training duration, Intrinsic Motivation Inventory, System Usability Scale, and a semi-structured interview about user experience).

Secondary Outcome Measures

Name	Time	Method
Measures to examine general motor function, perceived use and participation (The Action Research Arm Test (ARAT), the upper extremity part of the Fugl-Meyer (FM) test, Motor Activity Log (MAL), the Stroke Impact Scale (SIS), an adapted version of the Nine Hole Peg Test NHPT) and kinematics).