Clinical trial NCT04488692: Early Functional Training in Acute Stroke Inpatient Ward
Official title: The Effect of Two Models of an Early Intervention Program on Functional Recovery at Three Months to Acute Stroke Patients: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Stroke
Lead sponsor: Chung Shan Medical University
Sponsor class: OTHER
First posted: 2020-07-28
Enrollment: 142
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To investigate the difference between two models of an early intervention program (focused on mobility function) in the functional recovery 3 months post stroke in a group of patients with acute ischemic stroke while in acute inpatient ward hospitalization.

Detailed description: Patients with acute stroke admit into an acute inpatient ward who meet study criteria and provide institutional-reviewed consent form will be randomly assigned into either model 1 or model 2 of an early functional training program. Participants in model 1 group will receive 2 sessions of functional training per day whereas those in model 2 group will receive 1 session of functional training and 1 session of friendly visit and education per day. The following outcomes will be measured at admission, at discharge and at 3 months post stroke: Barthel index (BI), Postural Assessment Scale for Stroke (PASS), Mobility Scale for Acute Stroke (MASA), and usual gait speed (UGS). The rater is blinded to participants' group membership.

Eligibility criteria: Inclusion Criteria:

* patient with acute ischemic stroke / ICH
* referred for early rehabilitation,
* aged 20 years or more,

Exclusion Criteria:

* able to walk independently and safely at admission,
* unable to understand three simple comments,
* unable to recovery even with appropriate medical management,
* serious condition require ICU care,
* terminal illness for hospice care,
* waiting to transfer to long term care facilities

Primary outcomes:
measure: Postural Assessment Scale for Stroke Patient (PASS)
timeFrame: Baseline
measure: Postural Assessment Scale for Stroke Patient (PASS)
timeFrame: up to 2 weeks
measure: Postural Assessment Scale for Stroke Patient (PASS)
timeFrame: at 3 months post stroke
measure: Barthel index (BI)
timeFrame: Baseline
measure: Barthel index (BI)
timeFrame: up to 2 weeks
measure: Barthel index (BI)
timeFrame: at 3 months post stroke
Secondary outcomes:
measure: Usual gait speed
timeFrame: Baseline
measure: Usual gait speed
timeFrame: up to 2 weeks
measure: Usual gait speed
timeFrame: at 3 months post stroke
measure: Mobility Scale for Acute Stroke (MSAS)
timeFrame: Baseline
measure: Mobility Scale for Acute Stroke (MSAS)
timeFrame: up to 2 weeks
measure: Mobility Scale for Acute Stroke (MSAS)
timeFrame: at 3 months post stroke
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: Chung Shan Medical University Hospital
Study officials:
affiliation: Chung Shan Medical University
name: Ching-Yi Wang, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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