Mobility LimitationNCT04778475
Impact of More Frequent PT Services
A study testing Intensive therapy in people with Mobility Limitation and Physical Disability, run by Medical University of South Carolina at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Mobility Limitation, Physical Disability, Stroke, Acute
- What is being tested?
- Intensive therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Jun 2021to 14 Oct 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Acute stroke
- NIH score of 2-15 with motor involvement
- Age </=80yo
- Medical stability for increased therapy services( determined by Stroke Service NP)
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
Medical University of South Carolina
Charleston, South Carolina, 29414
About this study
Official title: Impact of Intense Physical Therapy on Functional Mobility Outcomes in the Acute Stroke Population (<24 Hours Post-stroke)
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.
Read the detailed description
Early mobilization is a widely accepted pillar of acute hospital therapy services. In most populations, early mobility is regarded as safe, feasible, and yields positive results. A considerable amount of clinical and scientific literature has evaluated and upheld the positive effect of early mobility on patient safety, ICU delirium, duration of mechanical ventilation, hospital length of stay, functional mobility, ambulation ability, and mortality. However, most of the research in the field of early mobilization has focused on intensive care patients with multiple medical comorbidities.
The consideration of an acute stroke diagnosis in relation to the approach of acute care PT and "early mobility" is limited. The AVERT trial was novel in opening the doors to considering physical therapy's approach to acute stroke care on these dedicated stroke units, critical since earlier research surmised that complications of immobility could be estimated to account for as many as 51% of death in the first 30 days post stroke. The results of the AVERT trial, however, raised concern that very early mobilization may cause changes in cerebral blood flow and blood pressure leading to worsened stroke outcomes, increased mortality and increased rate of falls during early mobility.
From the publication of the AVERT trial, there has been a rise in clinical interest regarding the correlation of early mobility and improved functional outcomes post stroke. The majority of physical therapy studies in the acute stroke population have only examined the optimal time to begin mobilization post admission to the hospital. This project proposes the idea that patients with acute stroke may not be able to tolerate an extensive early mobility program. Instead, patients may benefit from shorter more frequent bouts of therapy early in their recovery to focus on specific areas such as seated postural control, motor recruitment strategies, and transfer training delivered in separate sessions. The investigators hypothesize that the approach of shorter, more frequent bouts of quality therapy services will negate the post stroke fatigue factor. Thus, allowing patients to progress functional mobility with improved tolerance to therapy sessions, frequent repetition, as well as implementation of motor learning principles to ensure carryover by providing distributed over massed practice. The research in the field of neuroplasticity and neuro rehabilitation illustrates the importance of high intensity, repetitive and aggressive approaches for motor recovery, however, most of this research has been performed in the subacute stroke population.
Rather than decreasing the time to upright mobility, it may be beneficial to examine the effect of short bouts of more frequent mobilization in these patients, within the early stages of their hospitalization. If, as assumed, a prolonged duration of upright sitting posture has a negative effect on cerebral blood flow10 it may be possible to gain the positive effects of early mobility by continuing to provide PT services while combating the negative effects of cerebral perfusion by returning all patients to a supine position in bed following therapy services within the first 24 hours of acute stroke. This study aims to examine the approach of increased frequency of physical therapy services as a way to gain the benefits of the publicized early mobility approach, while weighing the concerns raised by previous trials and decreasing amount of time left upright to combat negative effects of cerebral perfusion on the ischemic penumbra. As part of this study, there will be an experimental group of participants who will receive PT sessions twice a day for the first three out of five days of admission, followed by daily treatment sessions at an intensity of at least 20-50-minute bouts. This group will be compared to a group of control participants who will receive standard PT services 3-5x/wk (on average 8-23 minutes/session) while in the acute hospital setting. Outcomes of interest include average length of stay, discharge disposition, Postural Assessment Stroke Scale \& Modified Rankin Scale scores, and rate of readmission at 30 days. There is a critical need to evaluate how the mobilization approach of patients with acute stroke during their hospitalization impacts their discharge disposition, length of stay, and future functional outcomes
- Conditions
- Mobility Limitation, Physical Disability, Stroke, Acute
- Being tested
- Intensive therapy, Standard of care therapy
- Medical subject headings
- Mobility Limitation, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intensive therapyOther
PT services twice a day for 3-5 days and then daily for the remainder of hospital stay
Standard of care therapyOther
PT services 3-5 times a week for 15 to 30 minutes
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Standard of care therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: From date of hospital admission up until 90 day post hospital discharge follow up
Mean Length of Stay
Average hospitalization (measured in days)
Measured: From hospital admission to hospital discharge
Secondary outcomes (3)
Change in National Institutes of Health Stroke Scale (NIHSS) Score
The scale measures the severity of symptoms associated with patient's stroke. It assesses the severity of impairments related to stroke. The impairments are graded on a 3-4 point scale with scores that range from 0-42. Patients with a higher score have a more severe impairment, and patients with a lower score have a less severe impairment.
Measured: From date of hospital admission up until 90 day post hospital discharge follow up
Mean National Institute of Health Stroke Scale Score (NIHSS)
The scale measures the severity of symptoms associated with patient's stroke. It assesses the severity of impairments related to stroke. The impairments are graded on a 3-4 point scale with scores that range from 0-42. Patients with a higher score have a more severe impairment, and patients with a lower score have a less severe impairment.
Measured: within 24 hours of hospital admission to stroke service
Mean Modified Rankin Scale Score
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 day follow up 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.
Measured: Within 24 hours of hospital admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2021
- Study start30 Jun 2021
- Primary completion14 Oct 2022
- Study completion14 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (19)Papers the sponsor has linked to this study.
- Other trials for Mobility LimitationStudies of the same condition, open and under way.
- More trials run by Medical University of South CarolinaThe sponsor's other registered studies.
- 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
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute of General Medical Sciences (NIGMS)
- Responsible party
- Principal investigator, Christine Holmstedt, Medical University of South Carolina
- Investigators
- Christine Holmstedt, DO, Principal investigator, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04778475
- Sponsor's protocol ID
- 00108635
- Other IDs
- 5P20GM109040
- Status last verified
- Nov 2023
- First submitted
- 23 Feb 2021
- Last updated
- 18 Dec 2023
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 27431356Langhorne 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.
PubMed 22441195Peiris 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.
PubMed 21878220Bernhardt 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 26888985Sorbello 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.
PubMed 19641313Bernhardt 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 18174489Bernhardt 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.
PubMed 25690544Bernhardt 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.
PubMed 18706042AVERT 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.
PubMed 25892679Verheyden 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.
PubMed 17178824Morgan 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.
PubMed 25025319Smith 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.
PubMed 29090654Veerbeek 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.
PubMed 21186329Arias-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.
PubMed 30214124Adler J, Malone D. Early mobilization in the intensive care unit: a systematic review. Cardiopulm Phys Ther J. 2012 Mar;23(1):5-13.
PubMed 22807649
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Intense Physical Therapy on Functional Mobility Outcomes in the Acute Stroke Population (<24 Hours Post-stroke)
- ClinicalTrials.gov ID
- NCT04778475
- Acronym / sponsor ID
- 00108635
- Conditions
- Mobility Limitation, Physical Disability, Stroke, Acute
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute of General Medical Sciences (NIGMS)
- Study start
- 30 Jun 2021 (actual)
- Primary completion
- 14 Oct 2022 (actual)
- Study completion
- 14 Oct 2022 (actual)
- First posted
- 3 Mar 2021 (actual)
- Results
- Posted 18 Dec 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Early mobilization is a widely accepted pillar of acute hospital therapy services. In most populations, early mobility is regarded as safe, feasible, and yields positive results. A considerable amount of clinical and scientific literature has evaluated and upheld the positive effect of early mobility on patient safety, ICU delirium, duration of mechanical ventilation, hospital length of stay, functional mobility, ambulation ability, and mortality. However, most of the research in the field of early mobilization has focused on intensive care patients with multiple medical comorbidities.
The consideration of an acute stroke diagnosis in relation to the approach of acute care PT and "early mobility" is limited. The AVERT trial was novel in opening the doors to considering physical therapy's approach to acute stroke care on these dedicated stroke units, critical since earlier research surmised that complications of immobility could be estimated to account for as many as 51% of death in the first 30 days post stroke. The results of the AVERT trial, however, raised concern that very early mobilization may cause changes in cerebral blood flow and blood pressure leading to worsened stroke outcomes, increased mortality and increased rate of falls during early mobility.
From the publication of the AVERT trial, there has been a rise in clinical interest regarding the correlation of early mobility and improved functional outcomes post stroke. The majority of physical therapy studies in the acute stroke population have only examined the optimal time to begin mobilization post admission to the hospital. This project proposes the idea that patients with acute stroke may not be able to tolerate an extensive early mobility program. Instead, patients may benefit from shorter more frequent bouts of therapy early in their recovery to focus on specific areas such as seated postural control, motor recruitment strategies, and transfer training delivered in separate sessions. The investigators hypothesize that the approach of shorter, more frequent bouts of quality therapy services will negate the post stroke fatigue factor. Thus, allowing patients to progress functional mobility with improved tolerance to therapy sessions, frequent repetition, as well as implementation of motor learning principles to ensure carryover by providing distributed over massed practice. The research in the field of neuroplasticity and neuro rehabilitation illustrates the importance of high intensity, repetitive and aggressive approaches for motor recovery, however, most of this research has been performed in the subacute stroke population.
Rather than decreasing the time to upright mobility, it may be beneficial to examine the effect of short bouts of more frequent mobilization in these patients, within the early stages of their hospitalization. If, as assumed, a prolonged duration of upright sitting posture has a negative effect on cerebral blood flow10 it may be possible to gain the positive effects of early mobility by continuing to provide PT services while combating the negative effects of cerebral perfusion by returning all patients to a supine position in bed following therapy services within the first 24 hours of acute stroke. This study aims to examine the approach of increased frequency of physical therapy services as a way to gain the benefits of the publicized early mobility approach, while weighing the concerns raised by previous trials and decreasing amount of time left upright to combat negative effects of cerebral perfusion on the ischemic penumbra. As part of this study, there will be an experimental group of participants who will receive PT sessions twice a day for the first three out of five days of admission, followed by daily treatment sessions at an intensity of at least 20-50-minute bouts. This group will be compared to a group of control participants who will receive standard PT services 3-5x/wk (on average 8-23 minutes/session) while in the acute hospital setting. Outcomes of interest include average length of stay, discharge disposition, Postural Assessment Stroke Scale \& Modified Rankin Scale scores, and rate of readmission at 30 days. There is a critical need to evaluate how the mobilization approach of patients with acute stroke during their hospitalization impacts their discharge disposition, length of stay, and future functional outcomes
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Other: Intensive therapyThe 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. |
| Group B | Active comparator | Other: Standard of care therapyThe control group will receive standard care of PT services 3-5 times per week during their hospitalization. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Acute stroke
- NIH score of 2-15 with motor involvement
- Age </=80yo
- Medical stability for increased therapy services( determined by Stroke Service NP)
Key exclusion criteria (6 listed)
- 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)
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 |
|---|---|---|
| Intensive therapyPT services twice a day for 3-5 days and then daily for the remainder of hospital stay | Other | Group A |
| Standard of care therapyPT services 3-5 times a week for 15 to 30 minutes | Other | Group B |
Primary outcome
Change in Score of Postural Assessment Stroke Scale (PASS)
Time frame: From date of hospital admission up until 90 day post hospital discharge follow up
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.
Change in Modified Rankin Scale
Time frame: From date of hospital admission up until 90 days post hospital discharge follow up
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.
Change in Activity Measure for Post-Acute Care (AMPAC) Score
Time frame: From date of hospital admission up until 90 day post hospital discharge follow up
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.
Mean Length of Stay
Time frame: From hospital admission to hospital discharge
Average hospitalization (measured in days)
3 secondary outcomes
Change in National Institutes of Health Stroke Scale (NIHSS) Score
Time frame: From date of hospital admission up until 90 day post hospital discharge follow up
Mean National Institute of Health Stroke Scale Score (NIHSS)
Time frame: within 24 hours of hospital admission to stroke service
Mean Modified Rankin Scale Score
Time frame: Within 24 hours of hospital admission
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 27431356O'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.
- Background: PubMed 22441195Langhorne 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.
- Background: PubMed 21878220Peiris 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.
- 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 19641313Sorbello 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.
- 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 25690544Bernhardt 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.
- Background: PubMed 18706042Bernhardt 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.
- Background: PubMed 25892679AVERT 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.
- Background: PubMed 17178824Verheyden 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.
- Background: PubMed 25025319Morgan 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.
- Background: PubMed 29090654Smith 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.
- Individual participant dataSharing planned: No
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Joint Osteoarthritis, Atherosclerosis of the Distal Arteries, Without Gangrene
Recruiting
Brain Stimulation Effects on Orientation and Mobility Skills in Adults With Vision Impairment
Retinitis Pigmentosa (RP), Rod Cone Dystrophy
RecruitingObservational study
Effectiveness and Safety of OSTENIL® TENDON in the Treatment of Pain and Restricted Mobility in Tendon Disorders
Tendinopathy
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.
Christine Holmstedt, DO principal investigator
Medical University of South Carolina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intensive therapy in people with Mobility Limitation and Physical Disability, run by Medical University of South Carolina at 1 site in United States.
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 4 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 18 Dec 2023. 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 United States. 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?
Yes. Results are posted in the registry (first posted 18 Dec 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in Score of Postural Assessment Stroke Scale (PASS) (time frame: From date of hospital admission up until 90 day post hospital discharge follow up). The study lists 4 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 NCT04778475, which also lists 19 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 18 Dec 2023.