Cross sectional registry study: surveying challenges and needs in the daily lives of stroke patients with arm and hand paresis

Recruiting

• Conditions: I60; I61; I62; I63; I64; I67; I69; G81; Subarachnoid haemorrhage; Intracerebral haemorrhage

• Registration Number: DRKS00031869
• Lead Sponsor: Ottobock Healthcare Products GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-05-10
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Person had a stroke = 6 months ago.
- Person with post-stroke upper limb paresis (with little to no improvement and/or MRC strength grade =3/5).
- The person cannot satisfactorily use the paralysed arm and/or hand in activities of daily living (based on the patient's subjective assessment)

Exclusion Criteria

- Person with severe physical and/or cognitive and/or mental disorders that make participation impossible or unreasonable (i.e. MMSE score <21 (Folstein et al, 1975) and by clinical assessment).
- Person unable to follow instructions adequately
- Person unable to give consent in person
- Person with a comorbidity that precludes participation (e.g. skin defects or disease that prevents grasping objects or similar, other severe neurological disease advanced Parkinson's disease, Huntington's disease, multiple sclerosis, etc.)
- Person is pregnant
- Person does not wish to participate

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Motor impairments (measured by Motricity Index (MI), Modified Tardieu Scale (MTS), Nottingham Sensory Assessment (NSA)) and residual functions (measured by Medical Research Council (MRC) scale, grip function determined with dynamometer) of the paralyzed upper extremity after a stroke in the chronic phase.

Secondary Outcome Measures

Name	Time	Method
Cognitive and psychological everyday challenges (perceptions, needs, fears), Mini Mental State Examination (MMSE), Stroke Impact Scale version 2.0 (SIS 2.0), self-designed questionnaire) of patients after stroke; opinions, preferences, and previous experiences with splints/orthoses/technical support solutions (self-designed questionnaire) for the paretic upper extremity after a stroke and patients’ wishes or needs.