Skip to main content
OpenTrials
Completed

NCT Number: NCT04488692

Early Functional Training in Acute Stroke Inpatient Ward

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Acute Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Stroke Vascular Diseases

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chung Shan Medical University Hospital

Taichung, 402, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Early intervention (Mobility functional training)

Other

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

Sham intervention

Other

friendly visit and education

Primary outcomes

  1. Postural Assessment Scale for Stroke Patient (PASS)

    Time frame: Baseline

    The total score range is 0 to 36 points. Higher score indicate better performance.

  2. Postural Assessment Scale for Stroke Patient (PASS)

    Time frame: up to 2 weeks

    The total score range is 0 to 36 points. Higher score indicate better performance.

  3. Postural Assessment Scale for Stroke Patient (PASS)

    Time frame: at 3 months post stroke

    The total score range is 0 to 36 points. Higher score indicate better performance.

  4. Barthel index (BI)

    Time frame: Baseline

    The total score range is 0 to 100 points. Higher score indicate better performance.

  5. Barthel index (BI)

    Time frame: up to 2 weeks

    The total score range is 0 to 100 points. Higher score indicate better performance.

  6. Barthel index (BI)

    Time frame: at 3 months post stroke

    The total score range is 0 to 100 points. Higher score indicate better performance.

Secondary outcomes

  1. Usual gait speed

    Time frame: Baseline

    meters per second. Higher score indicate better performance.

  2. Usual gait speed

    Time frame: up to 2 weeks

    meters per second. Higher score indicate better performance.

  3. Usual gait speed

    Time frame: at 3 months post stroke

    meters per second. Higher score indicate better performance.

  4. Mobility Scale for Acute Stroke (MSAS)

    Time frame: Baseline

    The total score range is 6 to 36 points. Higher score indicate better performance.

  5. Mobility Scale for Acute Stroke (MSAS)

    Time frame: up to 2 weeks

    The total score range is 6 to 36 points. Higher score indicate better performance.

  6. Mobility Scale for Acute Stroke (MSAS)

    Time frame: at 3 months post stroke

    The total score range is 6 to 36 points. Higher score indicate better performance.

Sponsors and collaborators

Lead sponsor

Chung Shan Medical University

Other

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Jul 28, 2020
Registry last updated
Oct 25, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.