Early Functional Training in Acute Stroke Inpatient Ward

Chung Shan Medical University

Status: Completed

Conditions: Acute Stroke

Treatments: Other: Sham intervention; Other: Early intervention (Mobility functional training)

Study type: Interventional

Funder types: Other

Identifiers

NCT04488692

CS19166

Details and patient eligibility

About

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.

Full 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.

Enrollment: 142 patients

Sex: All

Ages: 20+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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142 participants in 2 patient groups

Model 1

Experimental group

Description:

Participants will receive 2 sessions of functional training per day, 15-min per session.

Treatment:

Other: Early intervention (Mobility functional training)

Model 2

Active Comparator group

Description:

Participants will receive 1 session of functional training and 1 session of sham intervention (therapist visiting and education) per day, 15-min per session.

Treatment:

Other: Early intervention (Mobility functional training)

Other: Sham intervention