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

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON22517
Enrollment
12
Registered
2014-04-04
Start date
2014-04-01
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stroke, Beroerte

Interventions

Subjects will be recommended to exercise 180 minutes per week (6 days, 30 minutes/day) with the SCRIPT2 system at home, during 6 weeks. They will train their arm and hand using games via a patient use

Sponsors

Roessingh Research and Development b.v.
Lead Sponsor

Eligibility

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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).

Contacts

Public ContactSharon Nijenhuis

Roessingh Research and Development P.O. Box 310

s.nijenhuis@rrd.nl+31 (0)53 4875766

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)