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Early Functional Training in Acute Stroke Inpatient Ward

Primary Purpose

Acute Stroke

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Early intervention (Mobility functional training)
Sham intervention
Sponsored by
Chung Shan Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Stroke

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Chung Shan Medical University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Model 1

Model 2

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
July 21, 2020
Last Updated
October 22, 2022
Sponsor
Chung Shan Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT04488692
Brief Title
Early Functional Training in Acute Stroke Inpatient Ward
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
September 1, 2020 (Actual)
Primary Completion Date
March 4, 2022 (Actual)
Study Completion Date
March 4, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chung Shan Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Stroke

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
142 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Model 1
Arm Type
Experimental
Arm Description
Participants will receive 2 sessions of functional training per day, 15-min per session.
Arm Title
Model 2
Arm Type
Active Comparator
Arm 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.
Intervention Type
Other
Intervention Name(s)
Early intervention (Mobility functional training)
Intervention Description
functional training focused on mobility (bed mobility, sitting balance, standing balance, and ambulation)
Intervention Type
Other
Intervention Name(s)
Sham intervention
Intervention Description
friendly visit and education
Primary Outcome Measure Information:
Title
Postural Assessment Scale for Stroke Patient (PASS)
Description
The total score range is 0 to 36 points. Higher score indicate better performance.
Time Frame
Baseline
Title
Postural Assessment Scale for Stroke Patient (PASS)
Description
The total score range is 0 to 36 points. Higher score indicate better performance.
Time Frame
up to 2 weeks
Title
Postural Assessment Scale for Stroke Patient (PASS)
Description
The total score range is 0 to 36 points. Higher score indicate better performance.
Time Frame
at 3 months post stroke
Title
Barthel index (BI)
Description
The total score range is 0 to 100 points. Higher score indicate better performance.
Time Frame
Baseline
Title
Barthel index (BI)
Description
The total score range is 0 to 100 points. Higher score indicate better performance.
Time Frame
up to 2 weeks
Title
Barthel index (BI)
Description
The total score range is 0 to 100 points. Higher score indicate better performance.
Time Frame
at 3 months post stroke
Secondary Outcome Measure Information:
Title
Usual gait speed
Description
meters per second. Higher score indicate better performance.
Time Frame
Baseline
Title
Usual gait speed
Description
meters per second. Higher score indicate better performance.
Time Frame
up to 2 weeks
Title
Usual gait speed
Description
meters per second. Higher score indicate better performance.
Time Frame
at 3 months post stroke
Title
Mobility Scale for Acute Stroke (MSAS)
Description
The total score range is 6 to 36 points. Higher score indicate better performance.
Time Frame
Baseline
Title
Mobility Scale for Acute Stroke (MSAS)
Description
The total score range is 6 to 36 points. Higher score indicate better performance.
Time Frame
up to 2 weeks
Title
Mobility Scale for Acute Stroke (MSAS)
Description
The total score range is 6 to 36 points. Higher score indicate better performance.
Time Frame
at 3 months post stroke

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ching-Yi Wang, PhD
Organizational Affiliation
Chung Shan Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chung Shan Medical University Hospital
City
Taichung
ZIP/Postal Code
402
Country
Taiwan

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
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8087974
Citation
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Early Functional Training in Acute Stroke Inpatient Ward

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