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RobExReha - robotic rehabilitation system with augmented reality for the upper limb for diagnosis and therapy - a usability and feasibility study

RobExReha - robotic rehabilitation system with augmented reality for the upper limb for diagnosis and therapy - a usability and feasibility study - RobExReha

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
DRKS
Registry ID
DRKS00022136
Enrollment
12
Registered
2020-06-08
Start date
2020-07-31
Completion date
Unknown
Last updated
2025-04-07

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

Conditions

G81.9 G82.2

Interventions

Group 1: therapy with the RobExReha robot (Five 30-minute sessions within two weeks)
subsequently usability evaluation with a questionnaire Group 2: the comparison is made using the evaluation of a Usability questionnaire from 13 patients who trained with the ArmeoPower or ArmeoSpring

Sponsors

Schön Klinik Bad Aibling SE & Co. KG
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: - paresis of the Right upper limb (due to practicability, in this phase of the project only one side is considered); severity of paresis: MRC 1-3 possible exemplary diagnoses: ischemic or haemorraghic Apoplex, cerebrovascular diseases, Guillan-Barré-Syndrom, spinal cord injuries, multiple sklerosis, Encephalomyelitis disseminata - age >= 18 years - preserved speaking comprehension and ability to communicate - ability to and medical approval to sit upright for at least 45 minutes and to pay Attention to the therapy - normal or accordingly corrected vision

Exclusion criteria

Exclusion criteria: neurological or neuropsychological exclusion criteria: - severe spasticity > Modified Ashwort Scale 3 - severe Neglect - diagnosed Dementia - 2 lateral fingers) of the shoulder further exclusion criteria: - open skin defects or fresh sutures at the contact Points to the elbow-orthosis or the HoloLens - existing legal care - Body weight >105 kg - Wheel distance of the wheelchair wheels not between 480 and 700 mm - length of the upper arm not between 250 and 400 mm - user of active implantable device sensitive to electromagnetic Radiation (e.g. heart Pacemaker)

Design outcomes

Primary

MeasureTime frame
Usability Evaluation (questionnaire after having completed 5 therapy sessions with the robot) The questionnaire for patients includes: - device subscale of the QUEST - satisfaction with device subscale of OPUS - presence questionnaire (Regenbrecht & Schubert) - NASA-TLX - Treatment experience questionnaire (TEQ) The questionnaire for therapists includes: - device subscale of the QUEST - System Usability Scale - User experience questionnaire short (UEQ-S) - technical Affinity questionnaire (TA-EG) the operating time as part of the system's usability is assessed with a transcribed Video protocol of the respective 5th therapy session of each patient.

Secondary

MeasureTime frame
Feasibility, usage documentation of technical and safety aspects, Evaluation of the range of motion assessment of the robot

Countries

Germany

Contacts

Public ContactAlexandra de Crignis

Schön Klinik Bad Aibling SE & Co. KG

acrignis@schoen-klinik.de+49 8061 903-1957

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 8, 2026