Early Functional Training in Acute Stroke Inpatient Ward

The Effect of Two Models of an Early Intervention Program on Functional Recovery at Three Months to Acute Stroke Patients: A Randomized Controlled Trial

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04488692

Enrollment

142

Registered

2020-07-28

Start date

2020-09-01

Completion date

2022-03-04

Last updated

2022-10-25

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

Conditions

Acute Stroke

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.

Interventions

OTHEREarly intervention (Mobility functional training)

functional training focused on mobility (bed mobility, sitting balance, standing balance, and ambulation)

OTHERSham intervention

friendly visit and education

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Postural Assessment Scale for Stroke Patient (PASS)	Baseline	The total score range is 0 to 36 points. Higher score indicate better performance.
Barthel index (BI)	Baseline	The total score range is 0 to 100 points. Higher score indicate better performance.

Secondary

Measure	Time frame	Description
Usual gait speed	Baseline	meters per second. Higher score indicate better performance.
Mobility Scale for Acute Stroke (MSAS)	Baseline	The total score range is 6 to 36 points. Higher score indicate better performance.

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026