Impact of More Frequent PT Services

NCT04778475 | Completed Results

• 2 other identifiers: 001086355P20GM109040
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine what amount of physical therapy is beneficial in the hospital setting after suffering a stroke. This study involves research. The investigators propose to enroll 150 individuals with acute stroke admitted to MUSC over the next 12 months and randomize them into increased frequency and usual care PT treatment groups. This study will be designed as a randomized control trial. If a patient agrees to participate, they will be assigned (at random) to either a treatment group which will receive more frequent therapy services or to the control group which will receive the "standard" amount of therapy services currently provided in the hospital setting (\~3-5 times per week). By studying the balance, walking and success of patients in the treatment group compared with the control group- the researchers hope to better understand the effect of more frequent physical therapy services on your independence post stroke.

Conditions

Mobility Limitation; Physical Disability; Stroke, Acute

Outcome Measures

Primary Outcomes (4)

• Change in Score of Postural Assessment Stroke Scale (PASS)

  The scale measures 12 items of balance in sitting, lying and standing with increasing amounts of difficulty. It consists of a 4 point scale, measured from 0 to 3 with scores that range from 0-36. Patients with a lower score have a more severe impairment, and patients with a higher score have a less severe impairment.

  From date of hospital admission up until 90 day post hospital discharge follow up

• Change in Modified Rankin Scale

  The scale is a questionnaire that asks patients about their ability to perform activities of daily living (ADL's) taking into account their physical, mental, and speech performance. On admission the questionnaire focuses on their ability to perform ADL's prior to their stroke. At discharge and at 90 days follow up post discharge, the questionnaire focuses on their ability to perform ADL's at that time point. It is scored from 0 to 5. Patients with a lower score have a less severe impairment, and patients with a higher score have a more severe impairment.

  From date of hospital admission up until 90 days post hospital discharge follow up

• Change in Activity Measure for Post-Acute Care (AMPAC) Score

  The scale measures basic mobility in the hospital setting including moving around in bed, getting out of bed, sitting and standing, moving from a bed to a chair, walking, and going up and down stairs. It consists of a 4 point scale measured from 1 to 4 with scores that range from 6 to 24. Patients with a lower score have a more severe impairment, and patients with a higher score have a less severe impairment.

  From date of hospital admission up until 90 day post hospital discharge follow up

• Mean Length of Stay

  Average hospitalization (measured in days)

  From hospital admission to hospital discharge

Secondary Outcomes (3)

• Change in National Institutes of Health Stroke Scale (NIHSS) Score

  From date of hospital admission up until 90 day post hospital discharge follow up

• Mean National Institute of Health Stroke Scale Score (NIHSS)

  within 24 hours of hospital admission to stroke service

• Mean Modified Rankin Scale Score

  Within 24 hours of hospital admission

Study Arms (2)

Group A

EXPERIMENTAL

The treatment group will receive increased frequency of PT services within the first 3-5 days of admission, followed by daily PT services for the duration of their inpatient stay.

Other: Intensive therapy

Group B

ACTIVE COMPARATOR

The control group will receive standard care of PT services 3-5 times per week during their hospitalization.

Other: Standard of care therapy

Interventions

Intensive therapy OTHER

PT services twice a day for 3-5 days and then daily for the remainder of hospital stay

Group A

Standard of care therapy OTHER

PT services 3-5 times a week for 15 to 30 minutes

Group B

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Acute stroke
• NIH score of 2-15 with motor involvement
• Age \</=80yo
• Medical stability for increased therapy services( determined by Stroke Service NP)

You may not qualify if:

• Inability or unwillingness of subject or legal guardian/representative to give -informed consent
• Medical instability or cerebral perfusion dependence, requiring bed rest
• Pregnancy (noted in chart)
• Inmates (noted in chart)
• COVID-19 infection (PCR positive labs)
• Dialysis (noted in chart \& performed while inpatient)

Sponsors & Collaborators

• Medical University of South Carolina: lead
• National Institutes of Health (NIH): collaborator
• National Institute of General Medical Sciences (NIGMS): collaborator

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29414, United States

Location

Related Publications (19)

• O'Donnell MJ, Chin SL, Rangarajan S, Xavier D, Liu L, Zhang H, Rao-Melacini P, Zhang X, Pais P, Agapay S, Lopez-Jaramillo P, Damasceno A, Langhorne P, McQueen MJ, Rosengren A, Dehghan M, Hankey GJ, Dans AL, Elsayed A, Avezum A, Mondo C, Diener HC, Ryglewicz D, Czlonkowska A, Pogosova N, Weimar C, Iqbal R, Diaz R, Yusoff K, Yusufali A, Oguz A, Wang X, Penaherrera E, Lanas F, Ogah OS, Ogunniyi A, Iversen HK, Malaga G, Rumboldt Z, Oveisgharan S, Al Hussain F, Magazi D, Nilanont Y, Ferguson J, Pare G, Yusuf S; INTERSTROKE investigators. Global and regional effects of potentially modifiable risk factors associated with acute stroke in 32 countries (INTERSTROKE): a case-control study. Lancet. 2016 Aug 20;388(10046):761-75. doi: 10.1016/S0140-6736(16)30506-2. Epub 2016 Jul 16.

  PMID: 27431356 BACKGROUND

• Langhorne P, de Villiers L, Pandian JD. Applicability of stroke-unit care to low-income and middle-income countries. Lancet Neurol. 2012 Apr;11(4):341-8. doi: 10.1016/S1474-4422(12)70024-8. Epub 2012 Mar 19.

  PMID: 22441195 BACKGROUND

• Peiris CL, Taylor NF, Shields N. Extra physical therapy reduces patient length of stay and improves functional outcomes and quality of life in people with acute or subacute conditions: a systematic review. Arch Phys Med Rehabil. 2011 Sep;92(9):1490-500. doi: 10.1016/j.apmr.2011.04.005.

  PMID: 21878220 BACKGROUND

• 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: 26888985 BACKGROUND

• Sorbello D, Dewey HM, Churilov L, Thrift AG, Collier JM, Donnan G, Bernhardt J. Very early mobilisation and complications in the first 3 months after stroke: further results from phase II of A Very Early Rehabilitation Trial (AVERT). Cerebrovasc Dis. 2009;28(4):378-83. doi: 10.1159/000230712. Epub 2009 Jul 30.

  PMID: 19641313 BACKGROUND

• 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: 18174489 BACKGROUND

• Bernhardt J, English C, Johnson L, Cumming TB. Early mobilization after stroke: early adoption but limited evidence. Stroke. 2015 Apr;46(4):1141-6. doi: 10.1161/STROKEAHA.114.007434. Epub 2015 Feb 17. No abstract available.

  PMID: 25690544 BACKGROUND

• Bernhardt J, Dewey H, Collier J, Thrift A, Lindley R, Moodie M, Donnan G. A Very Early Rehabilitation Trial (AVERT). Int J Stroke. 2006 Aug;1(3):169-71. doi: 10.1111/j.1747-4949.2006.00044.x. No abstract available.

  PMID: 18706042 BACKGROUND

• AVERT Trial Collaboration group. Efficacy and safety of very early mobilisation within 24 h of stroke onset (AVERT): a randomised controlled trial. Lancet. 2015 Jul 4;386(9988):46-55. doi: 10.1016/S0140-6736(15)60690-0. Epub 2015 Apr 16.

  PMID: 25892679 BACKGROUND

• Verheyden G, Nieuwboer A, De Wit L, Feys H, Schuback B, Baert I, Jenni W, Schupp W, Thijs V, De Weerdt W. Trunk performance after stroke: an eye catching predictor of functional outcome. J Neurol Neurosurg Psychiatry. 2007 Jul;78(7):694-8. doi: 10.1136/jnnp.2006.101642. Epub 2006 Dec 18.

  PMID: 17178824 BACKGROUND

• Morgan P. The relationship between sitting balance and mobility outcome in stroke. Aust J Physiother. 1994;40(2):91-6. doi: 10.1016/S0004-9514(14)60455-4.

  PMID: 25025319 BACKGROUND

• Smith MC, Barber PA, Stinear CM. The TWIST Algorithm Predicts Time to Walking Independently After Stroke. Neurorehabil Neural Repair. 2017 Oct-Nov;31(10-11):955-964. doi: 10.1177/1545968317736820. Epub 2017 Nov 1.

  PMID: 29090654 BACKGROUND

• Veerbeek JM, Van Wegen EE, Harmeling-Van der Wel BC, Kwakkel G; EPOS Investigators. Is accurate prediction of gait in nonambulatory stroke patients possible within 72 hours poststroke? The EPOS study. Neurorehabil Neural Repair. 2011 Mar-Apr;25(3):268-74. doi: 10.1177/1545968310384271. Epub 2010 Dec 26.

  PMID: 21186329 BACKGROUND

• Arias-Fernandez P, Romero-Martin M, Gomez-Salgado J, Fernandez-Garcia D. Rehabilitation and early mobilization in the critical patient: systematic review. J Phys Ther Sci. 2018 Sep;30(9):1193-1201. doi: 10.1589/jpts.30.1193. Epub 2018 Sep 4.

  PMID: 30214124 BACKGROUND

• Adler J, Malone D. Early mobilization in the intensive care unit: a systematic review. Cardiopulm Phys Ther J. 2012 Mar;23(1):5-13.

  PMID: 22807649 BACKGROUND

• 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: 28747763 BACKGROUND

• Sullivan JE, Crowner BE, Kluding PM, Nichols D, Rose DK, Yoshida R, Pinto Zipp G. Outcome measures for individuals with stroke: process and recommendations from the American Physical Therapy Association neurology section task force. Phys Ther. 2013 Oct;93(10):1383-96. doi: 10.2522/ptj.20120492. Epub 2013 May 23.

  PMID: 23704035 BACKGROUND

• Benaim C, Perennou DA, Villy J, Rousseaux M, Pelissier JY. Validation of a standardized assessment of postural control in stroke patients: the Postural Assessment Scale for Stroke Patients (PASS). Stroke. 1999 Sep;30(9):1862-8. doi: 10.1161/01.str.30.9.1862.

  PMID: 10471437 BACKGROUND

• Farrelly S, Boan AD, Hartnett J, Monsch E, Hartis A, Bowden M, Kautz S, Holmstedt C. Frequent Error Augmentation Training in Physical Therapy Post Stroke. J Acute Care Phys Ther. 2024 Jul;15(3):65-76. doi: 10.1097/jat.0000000000000237. Epub 2024 Jun 21.

  PMID: 39493729 DERIVED

MeSH Terms

Conditions

Mobility Limitation; Stroke

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Limitations and Caveats

This was a single center trial at an academic medical institution certified as a Comprehensive Stroke Center, thus results may not be generalizable to other community or non-tertiary care settings. The treating PTs were not blinded to group allocation, as PT staff were part of the study team. The sample size was relatively limited, with unequal treatment group assignment as well as some imbalance with respect to stroke subtype and baseline outcome measures on admission.

Results Point of Contact

• Title: Sinead Farrelly DPT
• Organization: Medical University of South Carolina

farrelsi@musc.edu

843-792-3069

Study Officials

• Christine Holmstedt, DO

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Neurology and Emergency Medicine

Study Record Dates

• First Submitted: February 23, 2021
• First Posted: March 3, 2021
• Study Start: June 30, 2021
• Primary Completion: October 14, 2022
• Study Completion: October 14, 2022
• Last Updated: December 18, 2023
• Results First Posted: December 18, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)