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Post-stroke arm/hand training at home.

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON29571
Enrollment
20
Registered
2012-10-19
Start date
2013-01-01
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, CVA, beroerte

Interventions

During six weeks, the chronic stroke patients will receive either 18 one hour sessions, plus additional training when desired, of technology assisted arm and hand home training (experimental group), o

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 receive additional therapy of the affected arm/wrist/hand during participation of the study; 2. Patients who are not eligible to join normal rehabilitation (psychological issues, patients with near complete paralysis etc.); 3. 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; 4. Severe sensory deficits from the involved limb; 5. Severe neglect; 6. Visual impairments (that cannot be corrected with glasses or contact lenses to within normal or near normal limits); 7. Cognitive impairment.

Design outcomes

Primary

MeasureTime frame
Main study parameters are outcomes related to user acceptance, including usability, satisfaction, motivation and compliance (Intrinsic Motivation Inventory, System Usability Scale, Qualitative interview about experience of use).

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, the Box & Blocks test (BBT), Motor Activity Log (MAL), the Stroke Impact Scale (SIS), kinematics and EMG).

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)