Early Functional Training in Acute Stroke Inpatient Ward

Not Applicable

Completed

• Conditions: Acute Stroke
• Interventions: Other: Early intervention (Mobility functional training); Other: Sham intervention

• Registration Number: NCT04488692
• Lead Sponsor: Chung Shan Medical University

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.

Study Timeline

• Study First Submitted: 2020-07-21
• Study First Submitted QC: 2020-07-23
• Study First Posted: 2020-07-28
• Study Start: 2020-09-01
• Primary Completion: 2022-03-04
• Study Completion: 2022-03-04
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-22
• Last Update Posted: 2022-10-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 142

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Model 2	Early intervention (Mobility functional training)	Participants will receive 1 session of functional training and 1 session of sham intervention (therapist visiting and education) per day, 15-min per session.
Model 1	Early intervention (Mobility functional training)	Participants will receive 2 sessions of functional training per day, 15-min per session.
Model 2	Sham intervention	Participants will receive 1 session of functional training and 1 session of sham intervention (therapist visiting and education) per day, 15-min per session.

Primary Outcome Measures

Name	Time	Method
Postural Assessment Scale for Stroke Patient (PASS)	at 3 months post stroke	The total score range is 0 to 36 points. Higher score indicate better performance.
Barthel index (BI)	at 3 months post stroke	The total score range is 0 to 100 points. Higher score indicate better performance.

Secondary Outcome Measures

Name	Time	Method
Usual gait speed	at 3 months post stroke	meters per second. Higher score indicate better performance.
Mobility Scale for Acute Stroke (MSAS)	at 3 months post stroke	The total score range is 6 to 36 points. Higher score indicate better performance.

Trial Locations

Locations (1)

Chung Shan Medical University Hospital; 🇨🇳 Taichung, Taiwan