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

Phase 1

• Conditions: G81.9; G82.2; Hemiplegia, unspecified; Paraplegia, unspecified

• Registration Number: DRKS00022136
• Lead Sponsor: Schön Klinik Bad Aibling SE & Co. KG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-06-08
• Study Completion: 2020-09-22
• Results First Posted: 2023-08-12
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 12

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

neurological or neuropsychological exclusion criteria:
- severe spasticity > Modified Ashwort Scale 3
- severe Neglect
- diagnosed Dementia
- <6 Points in the orientation-subscale of the Mini-Mental-Status-test (with deviations from +-1 day concerning the precise date not leading to deduction of Points)
- epilepsy

orthopaedic exclusion criteria:
- instable or not load-stable fractures
- fixated contractures of the affected Joints (e.g. painful shoulder)
- severe instability/subluxation (>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)

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
sability Evaluation (questionnaire after having completed 5 therapy sessions with the robot)<br><br>The questionnaire for patients includes:<br>- device subscale of the QUEST<br>- satisfaction with device subscale of OPUS<br>- presence questionnaire (Regenbrecht & Schubert)<br>- NASA-TLX<br>- Treatment experience questionnaire (TEQ)<br><br>The questionnaire for therapists includes:<br>- device subscale of the QUEST<br>- System Usability Scale<br>- User experience questionnaire short (UEQ-S)<br>- technical Affinity questionnaire (TA-EG)<br><br>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 Outcome Measures

Name	Time	Method
Feasibility, usage documentation of technical and safety aspects, Evaluation of the range of motion assessment of the robot