Armed4Stroke: Allied Rehabilitation using Medical Devices for Stroke

Phase 2

Completed

Conditions: acquired brain injury
stroke
10007963

Registration Number: NL-OMON55636

Lead Sponsor: Vrije Universiteit Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 72

Inclusion Criteria

Inclusion criteria for the patient will be:
1) < 3 months after stroke (excluding subarachnoid haemorrhage)
2) 18 years or older
3) Written informed consent
4) Able to understand the Dutch language (on sufficient level to understand
instructions and complete the questionnaires)
5) Knowing and able to appoint a caregiver who he/she wants to participate in
the programme (with a maximum of two caregivers)
6) Living independently before the stroke
7) Living at home or planned to be discharged home
8) being able to follow instructions (a MoCA score > 21 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

For both patient and caregiver: a serious comorbidity that interferes with
participation

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Mobility domain of the self-reported health status following the Stroke Impact<br /><br>Scale (SIS version 3.0).</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary objectives are to assess the added value of the Armed4Stroke on<br /><br>- The length of inpatient stay in those patients that start the CME<br /><br>intervention during inpatient rehabilitation.<br /><br>- Preparedness for Caregiving Scale<br /><br>- Functional outcomes, such as walking speed and distance, balance and the<br /><br>level of independency during Activities of Daily Living (ADL)<br /><br>- Psychosocial measures, such as self-efficacy and anxiety and depression of<br /><br>patient and caregiver and quality of live. </p><br>