Early Functional Training in Acute Stroke Inpatient Ward

NCT ID: NCT04488692

Last Updated: 2022-10-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

142 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-01

Study Completion Date

2022-03-04

Brief Summary

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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

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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.

Conditions

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Acute Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Model 1

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

Group Type EXPERIMENTAL

Early intervention (Mobility functional training)

Intervention Type OTHER

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

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.

Group Type ACTIVE_COMPARATOR

Early intervention (Mobility functional training)

Intervention Type OTHER

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

Sham intervention

Intervention Type OTHER

friendly visit and education

Interventions

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Early intervention (Mobility functional training)

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

Intervention Type OTHER

Sham intervention

friendly visit and education

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chung Shan Medical University

OTHER

Sponsor Role lead

Responsible Party

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Ching-Yi Wang

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ching-Yi Wang, PhD

Role: PRINCIPAL_INVESTIGATOR

Chung Shan Medical University

Locations

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Chung Shan Medical University Hospital

Taichung, , Taiwan

Site Status

Countries

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Taiwan

References

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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.

Reference Type BACKGROUND
PMID: 8087974 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26888985 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18174489 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22144725 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 1866749 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22466792 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15472114 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30321906 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28967376 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20130401 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25603539 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28143920 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23680682 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17876069 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 3973842 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28747763 (View on PubMed)

Other Identifiers

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CS19166

Identifier Type: -

Identifier Source: org_study_id

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