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Armed4Stroke: Allied Rehabilitation using caregiver MEDiated Exercises for Stroke

Armed4Stroke: Allied Rehabilitation using caregiver MEDiated Exercises for Stroke

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON22043
Enrollment
72
Registered
2018-12-11
Start date
2019-09-02
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, telerehabilitation, caregiver mediated exercises

Interventions

The Armed4Stroke program consists of eight weeks of complementary exercise therapy done with a caregiver, supported by tele-rehabilitation, next to the usual therapy. Complementary exercise therapy:

Sponsors

Amsterdam UMC
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Inclusion criteria for the patient will be: 1) 20 points) 9) Sufficiently motivated for CME Inclusion criteria for the caregiver: 1) 18 years or older 2) Written informed consent 3) Able to understand the Dutch language (on sufficient level to understand instructions and complete the questionnaires) 4) Sufficiently motivated for CME 5) Medically stable and physically able to perform the exercises together with the patient.

Exclusion criteria

Exclusion criteria: Exclusion criteria for both patient and caregiver will be a serious comorbidity that interferes with participation. To determine suitability of patient and partner, one exercise session with a trained therapist will be scheduled prior randomisation. The therapist will check the inclusion/exclusion criteria and judge if the exercises can be done adequately and safely.

Design outcomes

Primary

MeasureTime frame
Mobility domain of the Stroke Impact Scale (SIS version 3.0), which measures self-reported health status.

Secondary

MeasureTime frame
For the patient: 1) Length of inpatient stay, for those patients that will be included during inpatient rehabilitation. 2) Self-reported health status, measured by the other domains of the Stroke Impact Scale and the Rivermead Mobility Index (RMI) 3) Extended Activities of daily living, measured by the Nottingham Extended ADL (NEADL). 4) Quality of life, measured with the EQ-5D. 5) Self-efficacy, measured by the stroke self-efficacy questionnaire. 6) Walking ability, assessed with Functional Ambulation Categories, the 10 metre walking speed and an instrumental 6 minute walking test using the MOX activity monitor. 7) Functional outcome, measured by Modified Rankin Scale (MRS) 8) Balance, assessed with the Berg Balance Scale (BBS) 9) Strength of the lower limb, assessed with the Motricity Index (MI). 10) The amount of daily activity during one week (MOX Activity monitor) 11) Community Ambulation Questionnaire. For the caregiver: 1) The experienced strain of the caregiver measured by the Caregiver Strain Index. (CSI). 2) Quality of life, measured with the CarerQOL. For both: 1) Care Transition Measure, short version CTM-4 2) Emotional functioning, measured with the Hospital Anxiety and Depression Scale (HADS) and Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety and Depression item banks, 3) Fatigue, measured by the Fatigue Severity Scale. 4) Self-efficacy, measured by the General Self-Efficacy Scale (GSES). 5) Family functioning, measured by the general functioning subscale of the McMaster Family Assessment Device (FAD).

Contacts

Public ContactRinske Nijland

Postbus 58271

r.nijland@reade.nl020-6071931

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)