Acute StrokeNCT04488692

Early Functional Training in Acute Stroke Inpatient Ward

A study testing Early intervention (Mobility functional training) in people with Acute Stroke, run by Chung Shan Medical University at 1 site in Taiwan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

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. Read more about this study

Who is it for?: Ages 20 years and older
Conditions the study is for: Acute Stroke
What is being tested?: Early intervention (Mobility functional training)
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 142 participants
Where: 1 siteTaiwan
Study dates: 1 Sep 2020to 4 Mar 2022
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 20 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Taiwan1 site

Chung Shan Medical University Hospital
Taichung, 402

Other trials in Taiwan

About this study

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

Read the 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.

Conditions: Acute Stroke
Being tested: Early intervention (Mobility functional training), Sham intervention
Medical subject headings: Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT04488692
Study group	Role	What they receive
Model 1	Experimental	Participants will receive 2 sessions of functional training per day, 15-min per session. Receives: 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. Receives: Other: Early intervention (Mobility functional training); Other: Sham intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (6)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Sep 20204 Mar 2022

First posted28 Jul 2020
Study start1 Sep 2020
Primary completion4 Mar 2022
Study completion4 Mar 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (16)Papers the sponsor has linked to this study.
Other trials for Acute StrokeStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Outcomes assessor
Enrolment: 142 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04488692
Sponsor's protocol ID: CS19166
Status last verified: Oct 2022
First submitted: 21 Jul 2020
Last updated: 25 Oct 2022
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 8087974
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.
PubMed 26888985
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.
PubMed 18174489
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.
PubMed 22144725
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.
PubMed 1866749
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.
PubMed 22466792
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.
PubMed 15472114
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.
PubMed 30321906
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.
PubMed 28967376
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.
PubMed 20130401
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.
PubMed 25603539
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.
PubMed 28143920
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.
PubMed 23680682
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.
PubMed 17876069
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.
PubMed 3973842

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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INTRA-ARTERIAL MeVO TREATMENT (IMP-ACT) Within the ACT-GLOBAL Adaptive Platform Trial-NCT06352632
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All Acute Stroke trials

Study at a glance

From the registry record, last updated by the sponsor on 25 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT04488692
Acronym / sponsor ID: CS19166
Conditions: Acute Stroke
Study type: Interventional
Recruitment status: Completed
Enrolment: 142 participants (actual)
Lead sponsor: Chung Shan Medical UniversityUniversity, hospital or other
Study start: 1 Sep 2020 (actual)
Primary completion: 4 Mar 2022 (actual)
Study completion: 4 Mar 2022 (actual)
First posted: 28 Jul 2020 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Model 1	Experimental	Other: Early intervention (Mobility functional training)Participants will receive 2 sessions of functional training per day, 15-min per session.
Model 2	Active comparator	Other: Early intervention (Mobility functional training), Other: Sham interventionParticipants will receive 1 session of functional training and 1 session of sham intervention (therapist visiting and education) per day, 15-min per session.

Who may qualify

Ages: 20 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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

Key exclusion criteria (6 listed)

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,

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Early intervention (Mobility functional training)functional training focused on mobility (bed mobility, sitting balance, standing balance, and ambulation)	Other	Model 1, Model 2
Sham interventionfriendly visit and education	Other	Model 2

Primary outcome

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

6 secondary outcomes

Usual gait speed
Time frame: Baseline
Usual gait speed
Time frame: up to 2 weeks
Usual gait speed
Time frame: at 3 months post stroke
Mobility Scale for Acute Stroke (MSAS)
Time frame: Baseline
Mobility Scale for Acute Stroke (MSAS)
Time frame: up to 2 weeks
Mobility Scale for Acute Stroke (MSAS)
Time frame: at 3 months post stroke

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2022.
Background: PubMed 8087974Adams 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.
Background: PubMed 26888985Bernhardt 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.
Background: PubMed 18174489Bernhardt 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.
Background: PubMed 22144725Diserens 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.
Background: PubMed 1866749Indredavik 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.
Background: PubMed 22466792Krakauer 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.
Background: PubMed 15472114Kwakkel 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.
Background: PubMed 30321906Langhorne 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.
Background: PubMed 28967376Langhorne 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.
Background: PubMed 20130401Langhorne 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.
Background: PubMed 25603539Lee 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.
Background: PubMed 28143920Stinear 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.
Individual participant dataSharing planned: No

Related trials for Acute Stroke

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Ching-Yi Wang, PhD principal investigator

Chung Shan Medical University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Early intervention (Mobility functional training) in people with Acute Stroke, run by Chung Shan Medical University at 1 site in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Postural Assessment Scale for Stroke Patient (PASS) (time frame: Baseline). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04488692, which also lists 16 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Oct 2022.