Early Functional Training in Acute Stroke Inpatient Ward

October 22, 2022 updated by: Ching-Yi Wang, Chung Shan Medical University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

142

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taichung, Taiwan, 402
        • Chung Shan Medical University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Model 1
Participants will receive 2 sessions of functional training per day, 15-min per session.
Other: Early intervention (Mobility functional training)
functional training focused on mobility (bed mobility, sitting balance, standing balance, and ambulation)
ACTIVE_COMPARATOR: Model 2
Participants will receive 1 session of functional training and 1 session of sham intervention (therapist visiting and education) per day, 15-min per session.
Other: Early intervention (Mobility functional training)
functional training focused on mobility (bed mobility, sitting balance, standing balance, and ambulation)
Other: Sham intervention
friendly visit and education

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postural Assessment Scale for Stroke Patient (PASS)
Time Frame: Baseline
The total score range is 0 to 36 points. Higher score indicate better performance.
Baseline
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.
up to 2 weeks
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.
at 3 months post stroke
Barthel index (BI)
Time Frame: Baseline
The total score range is 0 to 100 points. Higher score indicate better performance.
Baseline
Barthel index (BI)
Time Frame: up to 2 weeks
The total score range is 0 to 100 points. Higher score indicate better performance.
up to 2 weeks
Barthel index (BI)
Time Frame: at 3 months post stroke
The total score range is 0 to 100 points. Higher score indicate better performance.
at 3 months post stroke

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Usual gait speed
Time Frame: Baseline
meters per second. Higher score indicate better performance.
Baseline
Usual gait speed
Time Frame: up to 2 weeks
meters per second. Higher score indicate better performance.
up to 2 weeks
Usual gait speed
Time Frame: at 3 months post stroke
meters per second. Higher score indicate better performance.
at 3 months post stroke
Mobility Scale for Acute Stroke (MSAS)
Time Frame: Baseline
The total score range is 6 to 36 points. Higher score indicate better performance.
Baseline
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.
up to 2 weeks
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.
at 3 months post stroke

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chung Shan Medical University

Investigators

  • Principal Investigator: Ching-Yi Wang, PhD, Chung Shan Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 1, 2020

Primary Completion (ACTUAL)

March 4, 2022

Study Completion (ACTUAL)

March 4, 2022

Study Registration Dates

First Submitted

July 21, 2020

First Submitted That Met QC Criteria

July 23, 2020

First Posted (ACTUAL)

July 28, 2020

Study Record Updates

Last Update Posted (ACTUAL)

October 25, 2022

Last Update Submitted That Met QC Criteria

October 22, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CS19166

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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