Clincial feasibility of ROBERT-SAS in severely affected stroke patients

Clincial feasibility of ROBERT-SAS in severely affected stroke patients - Clincial feasibility ROBERT-SAS

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON51596

Enrollment

Registered

2022-06-22

Start date

2022-07-11

Completion date

Unknown

Last updated

2024-04-09

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

Conditions

Cerebrovascular accident Stroke

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: • Sub(acute) stroke (

Exclusion criteria

Exclusion criteria: • Premorbid disability of lower extremity • Severe cognitive impairment, unable to follow simple instructions and unable to understand Dutch. • Skin lesions at the hemiparetic leg • Progressive neurological diseases (i.e. Parkinson, dementia, etc.) • Contraindication for mobilization like lower limb fracture • Use of pacemaker • Pregnancy

Design outcomes

Primary

Measure	Time frame
The main outcome parameter is the SUS score from both the patients and the therapists.	—

Secondary

Measure	Time frame
In addition to the primary outcome, the surface EMG and resulting force will be noted with the ROBERT® -SAS system. Furthermore, the selected mode of ROBERT® -support, SAS parameter settings (including amplitude, frequency and pulse width of ES) and the treatment settings on the screen will be stored. The trajectory completion rate will be determined between the different AAN stages. Exercises specific settings such as repetitions and resistances settings, are collected. Clinical measurements like the Fugl-Meyer assessment, Motricity index and forces measured with the MRC test will be recorded over time. Furthermore, information about the clinical applicability will be gathered. This information contains information like, the settings that will be used, the movement that are trained, the time the training and set-up takes (separately timed) and lastly the training duration (in case of continuing training beyond 3 weeks) and its reasons as reported by therapists (e.g. which aspects were considered in deciding to prolong the training beyond three weeks).	—

Measure

Time frame

In addition to the primary outcome, the surface EMG and resulting force will be noted with the ROBERT® -SAS system. Furthermore, the selected mode of ROBERT® -support, SAS parameter settings (including amplitude, frequency and pulse width of ES) and the treatment settings on the screen will be stored. The trajectory completion rate will be determined between the different AAN stages. Exercises specific settings such as repetitions and resistances settings, are collected. Clinical measurements like the Fugl-Meyer assessment, Motricity index and forces measured with the MRC test will be recorded over time. Furthermore, information about the clinical applicability will be gathered. This information contains information like, the settings that will be used, the movement that are trained, the time the training and set-up takes (separately timed) and lastly the training duration (in case of continuing training beyond 3 weeks) and its reasons as reported by therapists (e.g. which aspects were considered in deciding to prolong the training beyond three weeks).

—

Countries

Netherlands

Outcome results