Early Functional Training in Acute Stroke Inpatient Ward

Acute Stroke Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04488692
• Other study ID #: CS19166
• Status: Completed
• Phase: N/A
• Start date: September 1, 2020
• Est. completion date: March 4, 2022

Study information

• Verified date: October 2022
• Source: Chung Shan Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 142
• Est. completion date: March 4, 2022
• Est. primary completion date: March 4, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Stroke
• Stroke

Intervention

Other:
• Early intervention (Mobility functional training)
functional training focused on mobility (bed mobility, sitting balance, standing balance, and ambulation)
• Sham intervention
friendly visit and education

Locations

Country	Name	City	State
Taiwan	Chung Shan Medical University Hospital	Taichung

Sponsors (1)

Lead Sponsor	Collaborator
Chung Shan Medical University

Country where clinical trial is conducted

Taiwan, 

References & 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. — View Citation

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. Erratum in: Neurology. 2017 Jul 4;89(1):107. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Epub 2004 Oct 7. Review. — View Citation

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:CD006187. doi: 10.1002/14651858.CD006187.pub3. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Sundseth A, Thommessen B, Rønning 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. — View Citation

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. Epub 2007 Sep 17. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 16 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postural Assessment Scale for Stroke Patient (PASS)	The total score range is 0 to 36 points. Higher score indicate better performance.	Baseline
Primary	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
Primary	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
Primary	Barthel index (BI)	The total score range is 0 to 100 points. Higher score indicate better performance.	Baseline
Primary	Barthel index (BI)	The total score range is 0 to 100 points. Higher score indicate better performance.	up to 2 weeks
Primary	Barthel index (BI)	The total score range is 0 to 100 points. Higher score indicate better performance.	at 3 months post stroke
Secondary	Usual gait speed	meters per second. Higher score indicate better performance.	Baseline
Secondary	Usual gait speed	meters per second. Higher score indicate better performance.	up to 2 weeks
Secondary	Usual gait speed	meters per second. Higher score indicate better performance.	at 3 months post stroke
Secondary	Mobility Scale for Acute Stroke (MSAS)	The total score range is 6 to 36 points. Higher score indicate better performance.	Baseline
Secondary	Mobility Scale for Acute Stroke (MSAS)	The total score range is 6 to 36 points. Higher score indicate better performance.	up to 2 weeks
Secondary	Mobility Scale for Acute Stroke (MSAS)	The total score range is 6 to 36 points. Higher score indicate better performance.	at 3 months post stroke