NCT04488692

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
142

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 21, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 28, 2020

Completed
1 month until next milestone

Study Start

First participant enrolled

September 1, 2020

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 4, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 4, 2022

Completed
Last Updated

October 25, 2022

Status Verified

October 1, 2022

Enrollment Period

1.5 years

First QC Date

July 21, 2020

Last Update Submit

October 22, 2022

Conditions

Acute Stroke

Outcome Measures

Primary Outcomes (6)

  • Postural Assessment Scale for Stroke Patient (PASS)

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

    Baseline

  • Postural Assessment Scale for Stroke Patient (PASS)

    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)

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

    at 3 months post stroke

  • Barthel index (BI)

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

    Baseline

  • Barthel index (BI)

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

    up to 2 weeks

  • Barthel index (BI)

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

    at 3 months post stroke

Secondary Outcomes (6)

  • Usual gait speed

    Baseline

  • Usual gait speed

    up to 2 weeks

  • Usual gait speed

    at 3 months post stroke

  • Mobility Scale for Acute Stroke (MSAS)

    Baseline

  • Mobility Scale for Acute Stroke (MSAS)

    up to 2 weeks

  • +1 more secondary outcomes

Study Arms (2)

Model 1

EXPERIMENTAL

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

Other: Early intervention (Mobility functional training)

Model 2

ACTIVE COMPARATOR

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)Other: Sham intervention

Interventions

Early intervention (Mobility functional training)OTHER

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

Model 1Model 2
Sham interventionOTHER

friendly visit and education

Model 2

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patient with acute ischemic stroke / ICH
  • referred for early rehabilitation,
  • aged 20 years or more,

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chung Shan Medical University Hospital

Taichung, 402, Taiwan

Location

Related Publications (16)

  • Adams HP Jr, Brott TG, Crowell RM, Furlan AJ, Gomez CR, Grotta J, Helgason CM, Marler JR, Woolson RF, Zivin JA, et al. Guidelines for the management of patients with acute ischemic stroke. A statement for healthcare professionals from a special writing group of the Stroke Council, American Heart Association. Circulation. 1994 Sep;90(3):1588-601. doi: 10.1161/01.cir.90.3.1588. No abstract available.

    PMID: 8087974BACKGROUND

  • Bernhardt J, Churilov L, Ellery F, Collier J, Chamberlain J, Langhorne P, Lindley RI, Moodie M, Dewey H, Thrift AG, Donnan G; AVERT Collaboration Group. Prespecified dose-response analysis for A Very Early Rehabilitation Trial (AVERT). Neurology. 2016 Jun 7;86(23):2138-45. doi: 10.1212/WNL.0000000000002459. Epub 2016 Feb 17.

    PMID: 26888985BACKGROUND

  • Bernhardt J, Dewey H, Thrift A, Collier J, Donnan G. A very early rehabilitation trial for stroke (AVERT): phase II safety and feasibility. Stroke. 2008 Feb;39(2):390-6. doi: 10.1161/STROKEAHA.107.492363. Epub 2008 Jan 3.

    PMID: 18174489BACKGROUND

  • Diserens K, Moreira T, Hirt L, Faouzi M, Grujic J, Bieler G, Vuadens P, Michel P. Early mobilization out of bed after ischaemic stroke reduces severe complications but not cerebral blood flow: a randomized controlled pilot trial. Clin Rehabil. 2012 May;26(5):451-9. doi: 10.1177/0269215511425541. Epub 2011 Dec 2.

    PMID: 22144725BACKGROUND

  • Indredavik B, Bakke F, Solberg R, Rokseth R, Haaheim LL, Holme I. Benefit of a stroke unit: a randomized controlled trial. Stroke. 1991 Aug;22(8):1026-31. doi: 10.1161/01.str.22.8.1026.

    PMID: 1866749BACKGROUND

  • Krakauer JW, Carmichael ST, Corbett D, Wittenberg GF. Getting neurorehabilitation right: what can be learned from animal models? Neurorehabil Neural Repair. 2012 Oct;26(8):923-31. doi: 10.1177/1545968312440745. Epub 2012 Mar 30.

    PMID: 22466792BACKGROUND

  • Kwakkel G, van Peppen R, Wagenaar RC, Wood Dauphinee S, Richards C, Ashburn A, Miller K, Lincoln N, Partridge C, Wellwood I, Langhorne P. Effects of augmented exercise therapy time after stroke: a meta-analysis. Stroke. 2004 Nov;35(11):2529-39. doi: 10.1161/01.STR.0000143153.76460.7d. Epub 2004 Oct 7.

    PMID: 15472114BACKGROUND

  • Langhorne P, Collier JM, Bate PJ, Thuy MN, Bernhardt J. Very early versus delayed mobilisation after stroke. Cochrane Database Syst Rev. 2018 Oct 16;10(10):CD006187. doi: 10.1002/14651858.CD006187.pub3.

    PMID: 30321906BACKGROUND

  • Langhorne P, Wu O, Rodgers H, Ashburn A, Bernhardt J. A Very Early Rehabilitation Trial after stroke (AVERT): a Phase III, multicentre, randomised controlled trial. Health Technol Assess. 2017 Sep;21(54):1-120. doi: 10.3310/hta21540.

    PMID: 28967376BACKGROUND

  • Langhorne P, Stott D, Knight A, Bernhardt J, Barer D, Watkins C. Very early rehabilitation or intensive telemetry after stroke: a pilot randomised trial. Cerebrovasc Dis. 2010;29(4):352-60. doi: 10.1159/000278931. Epub 2010 Jan 30.

    PMID: 20130401BACKGROUND

  • Lee KB, Lim SH, Kim KH, Kim KJ, Kim YR, Chang WN, Yeom JW, Kim YD, Hwang BY. Six-month functional recovery of stroke patients: a multi-time-point study. Int J Rehabil Res. 2015 Jun;38(2):173-80. doi: 10.1097/MRR.0000000000000108.

    PMID: 25603539BACKGROUND

  • Stinear CM, Byblow WD, Ackerley SJ, Smith MC, Borges VM, Barber PA. Proportional Motor Recovery After Stroke: Implications for Trial Design. Stroke. 2017 Mar;48(3):795-798. doi: 10.1161/STROKEAHA.116.016020. Epub 2017 Jan 31.

    PMID: 28143920BACKGROUND

  • Sundseth A, Thommessen B, Ronning OM. Early mobilization after acute stroke. J Stroke Cerebrovasc Dis. 2014 Mar;23(3):496-9. doi: 10.1016/j.jstrokecerebrovasdis.2013.04.012. Epub 2013 May 13.

    PMID: 23680682BACKGROUND

  • Verheyden G, Nieuwboer A, De Wit L, Thijs V, Dobbelaere J, Devos H, Severijns D, Vanbeveren S, De Weerdt W. Time course of trunk, arm, leg, and functional recovery after ischemic stroke. Neurorehabil Neural Repair. 2008 Mar-Apr;22(2):173-9. doi: 10.1177/1545968307305456. Epub 2007 Sep 17.

    PMID: 17876069BACKGROUND

  • Wade DT, Wood VA, Hewer RL. Use of hospital resources by acute stroke patients. J R Coll Physicians Lond. 1985 Jan;19(1):48-52. No abstract available.

    PMID: 3973842BACKGROUND

  • Xu T, Yu X, Ou S, Liu X, Yuan J, Chen Y. Efficacy and Safety of Very Early Mobilization in Patients with Acute Stroke: A Systematic Review and Meta-analysis. Sci Rep. 2017 Jul 26;7(1):6550. doi: 10.1038/s41598-017-06871-z.

    PMID: 28747763BACKGROUND

MeSH Terms

Conditions

Stroke

Interventions

Early Intervention, Educational

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Child Health ServicesCommunity Health ServicesHealth ServicesHealth Care Facilities Workforce and ServicesPreventive Health Services

Study Officials

  • Ching-Yi Wang, PhD

    Chung Shan Medical University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 21, 2020

First Posted

July 28, 2020

Study Start

September 1, 2020

Primary Completion

March 4, 2022

Study Completion

March 4, 2022

Last Updated

October 25, 2022

Record last verified: 2022-10

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)