Cerebral Vascular AccidentHIGTNCT05650606

Inpatient Rehabilitation and Post-Discharge Outcomes With High Intensity Gait Training (HIGT) of Patients With Stroke

A study testing High Intensity Gait Training and Conventional Therapy in people with Cerebral Vascular Accident, run by Sunnyview Rehabilitation Hospital at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 to 85 years
Conditions the study is for: Cerebral Vascular Accident
What is being tested?: High Intensity Gait Training and Conventional Therapy
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 2 participants
Where: 1 siteUnited States
Study dates: 18 Mar 2023to 11 Oct 2023
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 18 to 85 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

adults (≥18 years) recovering from a unilateral cerebral infarct with resultant hemiparesis occurring less than three months prior. Patients must have an expected length of stay of at least 14 days.

Who cannot join

are older than 85 years of age have evidence of intracranial hemorrhage on head imaging
have had a brainstem, cerebellar or bilateral hemisphere stroke
are medically unstable
are pregnant
have chronic cardiorespiratory disease
on oxygen

Show all 15Show fewer

angina
unstable arrhythmias
ischemic cardiomyopathy (Ejection Fraction <50%)
unable to follow 2 steps commands accurately
neurological comorbidities that affect gait
Parkinson's
severe polyneuropathy
unable to walk at least 150 feet premorbid
dependent assistance level for transfer from a chair to a bed as assessed by physical therapy.

Trial locations and contacts

1 site in 1 country.

United States1 site

Sunnyview Rehabilitation Hospital
Schenectady, New York, 12308

Other trials in United States

About this study

Official title: Inpatient Rehabilitation and Post-Discharge Outcomes of Patients With Stroke Participating in High Intensity Gait Training

Stroke is a major cause of disability, with 2-3% of Americans reporting stroke related impairments (Tsao 2022). Following stroke, over half of Medicare patients are discharged to post-acute care facilities or receive home-based health care (Tsao 2022). Inpatient rehabilitation guidelines are lacking, with many interventions based on research of patients with chronic stroke. There is great need for randomized clinical trials during the early subacute period (Bernhardt 2017, Jordan 2021).

Clinical practice guidelines recommend high intensity gait training (HIGT) for ambulatory patients with chronic stroke (Hornby 2020). Outpatient HIGT protocols incorporating variable stepping demonstrate equivalent effectiveness to forward stepping protocols (Hornby 2019) and have yielded superior results to lower intensity therapies (Hornby 2019, Hornby 2016). Research suggests that HIGT with variable stepping is feasible during inpatient rehabilitation (Hornby 2015, Moore 2020). Pre-post studies suggest that participation in HIGT during inpatient rehabilitation yields greater improvements in walking without an increase in adverse events. (Moore 2020). Despite this, there are no randomized controlled trials evaluating HIGT in the inpatient setting.

The subacute phase of stroke recovery may be a critical time for neuroplasticity (Dromerick 2021). Not only might rehabilitation interventions be more effective when initiated earlier (Biernaskie 2004, Dromerick 2021) but because inpatient rehabilitation represents the transition from hospital to home, interventions during this timeframe have the potential to improve discharge disposition, enhance quality of life, and reduce utilization of post-discharge services.

In this randomized controlled study, investigators will determine how participation in HIGT during inpatient rehabilitation affects balance, ambulation, and quality of life after 14 and/or 21 days of inpatient rehabilitation, and 8 weeks post-discharge. Investigators will also determine if HIGT reduces health care burden with a cost-effectiveness analysis.

Conditions: Cerebral Vascular Accident
Being tested: High Intensity Gait Training, Conventional Therapy
Keywords: High Intensity Gait Training, Inpatient Rehabilitation, Health Care Burden
Medical subject headings: Stroke

What participants receive

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

High Intensity Gait TrainingOther
Physical therapy intervention for improving gait in patients post Cerebral Vascular Accident.
Conventional TherapyOther
Standard inpatient rehabilitation physical therapy treatments for Cerebral Vascular Accident.

Study groups in NCT05650606
Study group	Role	What they receive
High Intensity Gait Training	Experimental	HIGT will be performed 4-6 times per week in place of conventional physical therapy. The patient's heart rate(HR)and blood pressure(BP) will be measured throughout each session. If the HR or BP is out of the acceptable range, patients will undergo standard physical therapy for that session, and the medical team will be contacted. Target HR zones will be calculated with the Karvonen formula. The first session goal is to reach a target HR range that is 50-60% of heart rate reserve. The goal for subsequent sessions is to reach 70-80% of heart rate reserve. Rate of perceived exertion (RPE) will also be utilized. The primary therapist will design an individualized HIGT treatment program with a combination of speed dependent treadmill activities, activity-based treadmill activities, stair training, and over ground activities. The patient will be reminded during each session to ask for a rest as needed. Standing rests are preferred over sitting rests, but either may be utilized. Receives: Other: High Intensity Gait Training
Conventional	Active comparator	The conventional physical therapy sessions are what a patient would normally receive during their rehabilitation. Physical therapy sessions are usually 60-90 minutes per day for 5 days each week, and possibly one 30-minute session on a 6th day. Physical therapy sessions are focused on gait, balance, and strengthening activities to address goals related to functional mobility. Clinicians administering therapy to patients in this arm will not be given instructions on the types of therapies they administer; however, they will not be permitted to do HIGT with patients. Therapists will be permitted to use other devices such as Ekso exoskeleton, Lite Gait, Rifton Tram Body Weight Support Devices, and Electrical Stimulation devices including the XCITE and RT300. Receives: Other: Conventional Therapy

What is being measured

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

10 Meter Walk Test at Self Selected Speed
Used to assess walking speed over a short distance at the patient's chosen speed.
Measured: (Day 13-15) - (Day 1-3)
10 Meter Walk Test at Self Selected Speed
Used to assess walking speed over a short distance at the patient's chosen speed.
Measured: (Day 20-22)- (Day 1-3)
10 Meter Walk Test at Self Selected Speed
Used to assess walking speed over a short distance at the patient's chosen speed.
Measured: (Day 62 to Day 86)-(Day 14 to Day 21)
10 Meter Walk Test at Fast Speed
Used to assess walking speed over a short distance at the patient's self determined speed that is as fast as they can safely walk..
Measured: (Day 13-15) - (Day 1-3)
10 Meter Walk Test at Fast Speed
Used to assess walking speed over a short distance at the patient's self determined speed that is as fast as they can safely walk..
Measured: (Day 20-22) - (Day 1-3)
10 Meter Walk Test at Fast Speed
Used to assess walking speed over a short distance at the patient's self determined speed that is as fast as they can safely walk..
Measured: (Day 62 to Day 86)-(Day 14 to Day 21)
6 Minute Walk Test
Used to assess walking endurance and aerobic capacity. The total distance the patient walks over six minutes is recorded.
Measured: (Day 13-15) - (Day 1-3)
6 Minute Walk Test
Used to assess walking endurance and aerobic capacity. The total distance the patient walks over six minutes is recorded.
Measured: (Day 20-22) - (Day 1-3)
6 Minute Walk Test
Used to assess walking endurance and aerobic capacity. The total distance the patient walks over six minutes is recorded.
Measured: (Day 62 to Day 86)-(Day 14 to Day 21)
Stroke Impact Scale (SIS)
The Stroke Impact Scale (SIS) is a self report questionnaire that uses 9 categories to assess disability and quality of life after having had a stroke.
Measured: (Day 62 to Day 86)-(Day 14 to Day 21)
Life Space Assessment (LSA)
The LSA is a self report tool that measures frequency of independent mobility using 9 questions.
Measured: (Day 62 to Day 86)-(Day 14 to Day 21)
Cost of inpatient rehabilitation and post-discharge health care services
This will include the cost of home health care, outpatient therapies, subacute nursing facility and hospital readmissions
Measured: (Day 62 to Day 86) - (Day 1 to Day 3)

Secondary outcomes (12)

BERG Balance Scale
A 14 item scale used to assess sitting, standing, static and dynamic balance.
Measured: (Day 13-15) - (Day 1-3)
BERG Balance Scale
A 14 item scale used to assess sitting, standing, static and dynamic balance.
Measured: (Day 20-22) - (Day 1-3)
BERG Balance Scale
A 14 item scale used to assess sitting, standing, static and dynamic balance.
Measured: (Day 62 to Day 86)-(Day 14 to Day 21)
5 Times Sit to Stand
Measures functional lower extremity strength and movement patterns used to complete functional movements
Measured: (Day 13-15) - (Day 1-3)
5 Times Sit to Stand
Measures functional lower extremity strength and movement patterns used to complete functional movements
Measured: (Day 20-22) - (Day 1-3)
5 Times Sit to Stand
Measures functional lower extremity strength and movement patterns used to complete functional movements
Measured: (Day 62 to Day 86)-(Day 14 to Day 21)
Functional Ambulation Category (FAC)
A five point scale used to categorize a patient's ambulation status, ranging from independent walking outside to non-functional walking.
Measured: (Day 13-15) - (Day 1-3)
Functional Ambulation Category (FAC)
A five point scale used to categorize a patient's ambulation status, ranging from independent walking outside to non-functional walking.
Measured: (Day 20-22) - (Day 1-3)
Functional Ambulation Category (FAC)
A five point scale used to categorize a patient's ambulation status, ranging from independent walking outside to non-functional walking.
Measured: (Day 62 to Day 86)-(Day 14 to Day 21)
Assistive Device Use
Document which (if any) assistive device the patient uses for ambulation.
Measured: (Day 13-15) - (Day 1-3)
Assistive Device Use
Document which (if any) assistive device the patient uses for ambulation.
Measured: (Day 20-22) - (Day 1-3)
Assistive Device Use
Document which (if any) assistive device the patient uses for ambulation.
Measured: (Day 62 to Day 86)-(Day 14 to Day 21)

Timeline

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

18 Mar 202311 Oct 2023

First posted14 Dec 2022
Study start18 Mar 2023
Primary completion11 Oct 2023
Study completion11 Oct 2023

Why it stopped: Poor enrollment

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (10)Papers the sponsor has linked to this study.
Other trials for Cerebral Vascular AccidentStudies 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: None (open label)
Enrolment: 2 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05650606
Sponsor's protocol ID: 22-0912-1
Acronym: HIGT
Status last verified: Oct 2023
First submitted: 6 Dec 2022
Last updated: 13 Oct 2023
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Publications

Bernhardt J, Hayward KS, Kwakkel G, Ward NS, Wolf SL, Borschmann K, Krakauer JW, Boyd LA, Carmichael ST, Corbett D, Cramer SC. Agreed Definitions and a Shared Vision for New Standards in Stroke Recovery Research: The Stroke Recovery and Rehabilitation Roundtable Taskforce. Neurorehabil Neural Repair. 2017 Sep;31(9):793-799. doi: 10.1177/1545968317732668.
PubMed 28934920
Biernaskie J, Chernenko G, Corbett D. Efficacy of rehabilitative experience declines with time after focal ischemic brain injury. J Neurosci. 2004 Feb 4;24(5):1245-54. doi: 10.1523/JNEUROSCI.3834-03.2004.
PubMed 14762143
Dromerick AW, Geed S, Barth J, Brady K, Giannetti ML, Mitchell A, Edwardson MA, Tan MT, Zhou Y, Newport EL, Edwards DF. Critical Period After Stroke Study (CPASS): A phase II clinical trial testing an optimal time for motor recovery after stroke in humans. Proc Natl Acad Sci U S A. 2021 Sep 28;118(39):e2026676118. doi: 10.1073/pnas.2026676118.
PubMed 34544853
Hornby TG, Holleran CL, Leddy AL, Hennessy P, Leech KA, Connolly M, Moore JL, Straube D, Lovell L, Roth E. Feasibility of Focused Stepping Practice During Inpatient Rehabilitation Poststroke and Potential Contributions to Mobility Outcomes. Neurorehabil Neural Repair. 2015 Nov-Dec;29(10):923-32. doi: 10.1177/1545968315572390. Epub 2015 Feb 26.
PubMed 25721233
Hornby TG, Holleran CL, Hennessy PW, Leddy AL, Connolly M, Camardo J, Woodward J, Mahtani G, Lovell L, Roth EJ. Variable Intensive Early Walking Poststroke (VIEWS): A Randomized Controlled Trial. Neurorehabil Neural Repair. 2016 Jun;30(5):440-50. doi: 10.1177/1545968315604396. Epub 2015 Sep 3.
PubMed 26338433
Hornby TG, Henderson CE, Plawecki A, Lucas E, Lotter J, Holthus M, Brazg G, Fahey M, Woodward J, Ardestani M, Roth EJ. Contributions of Stepping Intensity and Variability to Mobility in Individuals Poststroke. Stroke. 2019 Sep;50(9):2492-2499. doi: 10.1161/STROKEAHA.119.026254. Epub 2019 Aug 22.
PubMed 31434543
Hornby TG, Reisman DS, Ward IG, Scheets PL, Miller A, Haddad D, Fox EJ, Fritz NE, Hawkins K, Henderson CE, Hendron KL, Holleran CL, Lynskey JE, Walter A; and the Locomotor CPG Appraisal Team. Clinical Practice Guideline to Improve Locomotor Function Following Chronic Stroke, Incomplete Spinal Cord Injury, and Brain Injury. J Neurol Phys Ther. 2020 Jan;44(1):49-100. doi: 10.1097/NPT.0000000000000303.
PubMed 31834165
Jordan N, Deutsch A. Why and How to Demonstrate the Value of Rehabilitation Services. Arch Phys Med Rehabil. 2022 Jul;103(7S):S172-S177. doi: 10.1016/j.apmr.2021.06.028. Epub 2021 Aug 15.
PubMed 34407445
Tsao CW, Aday AW, Almarzooq ZI, Alonso A, Beaton AZ, Bittencourt MS, Boehme AK, Buxton AE, Carson AP, Commodore-Mensah Y, Elkind MSV, Evenson KR, Eze-Nliam C, Ferguson JF, Generoso G, Ho JE, Kalani R, Khan SS, Kissela BM, Knutson KL, Levine DA, Lewis TT, Liu J, Loop MS, Ma J, Mussolino ME, Navaneethan SD, Perak AM, Poudel R, Rezk-Hanna M, Roth GA, Schroeder EB, Shah SH, Thacker EL, VanWagner LB, Virani SS, Voecks JH, Wang NY, Yaffe K, Martin SS. Heart Disease and Stroke Statistics-2022 Update: A Report From the American Heart Association. Circulation. 2022 Feb 22;145(8):e153-e639. doi: 10.1161/CIR.0000000000001052. Epub 2022 Jan 26.
PubMed 35078371
Moore JL, Nordvik JE, Erichsen A, Rosseland I, Bo E, Hornby TG; FIRST-Oslo Team. Implementation of High-Intensity Stepping Training During Inpatient Stroke Rehabilitation Improves Functional Outcomes. Stroke. 2020 Feb;51(2):563-570. doi: 10.1161/STROKEAHA.119.027450. Epub 2019 Dec 30.
PubMed 31884902

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

Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
Recruiting
Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
Stroke, Upper Extremity Paresis
Recruiting
Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion

All Cerebral Vascular Accident trials

Study at a glance

From the registry record, last updated by the sponsor on 13 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Inpatient Rehabilitation and Post-Discharge Outcomes of Patients With Stroke Participating in High Intensity Gait Training
ClinicalTrials.gov ID: NCT05650606
Acronym / sponsor ID: HIGT / 22-0912-1
Conditions: Cerebral Vascular Accident
Keywords: High Intensity Gait Training, Inpatient Rehabilitation, Health Care Burden
Study type: Interventional
Recruitment status: TerminatedReason stopped: Poor enrollment
Enrolment: 2 participants (actual)
Lead sponsor: Sunnyview Rehabilitation HospitalUniversity, hospital or other
Study start: 18 Mar 2023 (actual)
Primary completion: 11 Oct 2023 (actual)
Study completion: 11 Oct 2023 (actual)
First posted: 14 Dec 2022 (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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
High Intensity Gait Training	Experimental	Other: High Intensity Gait TrainingHIGT will be performed 4-6 times per week in place of conventional physical therapy. The patient's heart rate(HR)and blood pressure(BP) will be measured throughout each session. If the HR or BP is out of the acceptable range, patients will undergo standard physical therapy for that session, and the medical team will be contacted. Target HR zones will be calculated with the Karvonen formula. The first session goal is to reach a target HR range that is 50-60% of heart rate reserve. The goal for subsequent sessions is to reach 70-80% of heart rate reserve. Rate of perceived exertion (RPE) will also be utilized. The primary therapist will design an individualized HIGT treatment program with a combination of speed dependent treadmill activities, activity-based treadmill activities, stair training, and over ground activities. The patient will be reminded during each session to ask for a rest as needed. Standing rests are preferred over sitting rests, but either may be utilized.
Conventional	Active comparator	Other: Conventional TherapyThe conventional physical therapy sessions are what a patient would normally receive during their rehabilitation. Physical therapy sessions are usually 60-90 minutes per day for 5 days each week, and possibly one 30-minute session on a 6th day. Physical therapy sessions are focused on gait, balance, and strengthening activities to address goals related to functional mobility. Clinicians administering therapy to patients in this arm will not be given instructions on the types of therapies they administer; however, they will not be permitted to do HIGT with patients. Therapists will be permitted to use other devices such as Ekso exoskeleton, Lite Gait, Rifton Tram Body Weight Support Devices, and Electrical Stimulation devices including the XCITE and RT300.

Who may qualify

Ages: 18 to 85 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

adults (≥18 years) recovering from a unilateral cerebral infarct with resultant hemiparesis occurring less than three months prior. Patients must have an expected length of stay of at least 14 days.

Key exclusion criteria (15 listed)

are older than 85 years of age have evidence of intracranial hemorrhage on head imaging

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
High Intensity Gait TrainingPhysical therapy intervention for improving gait in patients post Cerebral Vascular Accident.	Other	High Intensity Gait Training
Conventional TherapyStandard inpatient rehabilitation physical therapy treatments for Cerebral Vascular Accident.	Other	Conventional

Primary outcome

10 Meter Walk Test at Self Selected Speed
Time frame: (Day 13-15) - (Day 1-3)
Used to assess walking speed over a short distance at the patient's chosen speed.
10 Meter Walk Test at Self Selected Speed
Time frame: (Day 20-22)- (Day 1-3)
Used to assess walking speed over a short distance at the patient's chosen speed.
10 Meter Walk Test at Self Selected Speed
Time frame: (Day 62 to Day 86)-(Day 14 to Day 21)
Used to assess walking speed over a short distance at the patient's chosen speed.
10 Meter Walk Test at Fast Speed
Time frame: (Day 13-15) - (Day 1-3)
Used to assess walking speed over a short distance at the patient's self determined speed that is as fast as they can safely walk..
10 Meter Walk Test at Fast Speed
Time frame: (Day 20-22) - (Day 1-3)
Used to assess walking speed over a short distance at the patient's self determined speed that is as fast as they can safely walk..
10 Meter Walk Test at Fast Speed
Time frame: (Day 62 to Day 86)-(Day 14 to Day 21)
Used to assess walking speed over a short distance at the patient's self determined speed that is as fast as they can safely walk..
6 Minute Walk Test
Time frame: (Day 13-15) - (Day 1-3)
Used to assess walking endurance and aerobic capacity. The total distance the patient walks over six minutes is recorded.
6 Minute Walk Test
Time frame: (Day 20-22) - (Day 1-3)
Used to assess walking endurance and aerobic capacity. The total distance the patient walks over six minutes is recorded.
6 Minute Walk Test
Time frame: (Day 62 to Day 86)-(Day 14 to Day 21)
Used to assess walking endurance and aerobic capacity. The total distance the patient walks over six minutes is recorded.
Stroke Impact Scale (SIS)
Time frame: (Day 62 to Day 86)-(Day 14 to Day 21)
The Stroke Impact Scale (SIS) is a self report questionnaire that uses 9 categories to assess disability and quality of life after having had a stroke.
Life Space Assessment (LSA)
Time frame: (Day 62 to Day 86)-(Day 14 to Day 21)
The LSA is a self report tool that measures frequency of independent mobility using 9 questions.
Cost of inpatient rehabilitation and post-discharge health care services
Time frame: (Day 62 to Day 86) - (Day 1 to Day 3)
This will include the cost of home health care, outpatient therapies, subacute nursing facility and hospital readmissions

12 secondary outcomes

BERG Balance Scale
Time frame: (Day 13-15) - (Day 1-3)
BERG Balance Scale
Time frame: (Day 20-22) - (Day 1-3)
BERG Balance Scale
Time frame: (Day 62 to Day 86)-(Day 14 to Day 21)
5 Times Sit to Stand
Time frame: (Day 13-15) - (Day 1-3)
5 Times Sit to Stand
Time frame: (Day 20-22) - (Day 1-3)
5 Times Sit to Stand
Time frame: (Day 62 to Day 86)-(Day 14 to Day 21)
Functional Ambulation Category (FAC)
Time frame: (Day 13-15) - (Day 1-3)
Functional Ambulation Category (FAC)
Time frame: (Day 20-22) - (Day 1-3)
Functional Ambulation Category (FAC)
Time frame: (Day 62 to Day 86)-(Day 14 to Day 21)
Assistive Device Use
Time frame: (Day 13-15) - (Day 1-3)
Assistive Device Use
Time frame: (Day 20-22) - (Day 1-3)
Assistive Device Use
Time frame: (Day 62 to Day 86)-(Day 14 to Day 21)

Results and safety

The study was stopped early (reason given: Poor enrollment). Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2023.
Background: PubMed 28934920Bernhardt J, Hayward KS, Kwakkel G, Ward NS, Wolf SL, Borschmann K, Krakauer JW, Boyd LA, Carmichael ST, Corbett D, Cramer SC. Agreed Definitions and a Shared Vision for New Standards in Stroke Recovery Research: The Stroke Recovery and Rehabilitation Roundtable Taskforce. Neurorehabil Neural Repair. 2017 Sep;31(9):793-799. doi: 10.1177/1545968317732668.
Background: PubMed 14762143Biernaskie J, Chernenko G, Corbett D. Efficacy of rehabilitative experience declines with time after focal ischemic brain injury. J Neurosci. 2004 Feb 4;24(5):1245-54. doi: 10.1523/JNEUROSCI.3834-03.2004.
Background: PubMed 34544853Dromerick AW, Geed S, Barth J, Brady K, Giannetti ML, Mitchell A, Edwardson MA, Tan MT, Zhou Y, Newport EL, Edwards DF. Critical Period After Stroke Study (CPASS): A phase II clinical trial testing an optimal time for motor recovery after stroke in humans. Proc Natl Acad Sci U S A. 2021 Sep 28;118(39):e2026676118. doi: 10.1073/pnas.2026676118.
Background: PubMed 25721233Hornby TG, Holleran CL, Leddy AL, Hennessy P, Leech KA, Connolly M, Moore JL, Straube D, Lovell L, Roth E. Feasibility of Focused Stepping Practice During Inpatient Rehabilitation Poststroke and Potential Contributions to Mobility Outcomes. Neurorehabil Neural Repair. 2015 Nov-Dec;29(10):923-32. doi: 10.1177/1545968315572390. Epub 2015 Feb 26.
Background: PubMed 26338433Hornby TG, Holleran CL, Hennessy PW, Leddy AL, Connolly M, Camardo J, Woodward J, Mahtani G, Lovell L, Roth EJ. Variable Intensive Early Walking Poststroke (VIEWS): A Randomized Controlled Trial. Neurorehabil Neural Repair. 2016 Jun;30(5):440-50. doi: 10.1177/1545968315604396. Epub 2015 Sep 3.
Background: PubMed 31434543Hornby TG, Henderson CE, Plawecki A, Lucas E, Lotter J, Holthus M, Brazg G, Fahey M, Woodward J, Ardestani M, Roth EJ. Contributions of Stepping Intensity and Variability to Mobility in Individuals Poststroke. Stroke. 2019 Sep;50(9):2492-2499. doi: 10.1161/STROKEAHA.119.026254. Epub 2019 Aug 22.
Background: PubMed 31834165Hornby TG, Reisman DS, Ward IG, Scheets PL, Miller A, Haddad D, Fox EJ, Fritz NE, Hawkins K, Henderson CE, Hendron KL, Holleran CL, Lynskey JE, Walter A; and the Locomotor CPG Appraisal Team. Clinical Practice Guideline to Improve Locomotor Function Following Chronic Stroke, Incomplete Spinal Cord Injury, and Brain Injury. J Neurol Phys Ther. 2020 Jan;44(1):49-100. doi: 10.1097/NPT.0000000000000303.
Background: PubMed 34407445Jordan N, Deutsch A. Why and How to Demonstrate the Value of Rehabilitation Services. Arch Phys Med Rehabil. 2022 Jul;103(7S):S172-S177. doi: 10.1016/j.apmr.2021.06.028. Epub 2021 Aug 15.
Background: PubMed 35078371Tsao CW, Aday AW, Almarzooq ZI, Alonso A, Beaton AZ, Bittencourt MS, Boehme AK, Buxton AE, Carson AP, Commodore-Mensah Y, Elkind MSV, Evenson KR, Eze-Nliam C, Ferguson JF, Generoso G, Ho JE, Kalani R, Khan SS, Kissela BM, Knutson KL, Levine DA, Lewis TT, Liu J, Loop MS, Ma J, Mussolino ME, Navaneethan SD, Perak AM, Poudel R, Rezk-Hanna M, Roth GA, Schroeder EB, Shah SH, Thacker EL, VanWagner LB, Virani SS, Voecks JH, Wang NY, Yaffe K, Martin SS. Heart Disease and Stroke Statistics-2022 Update: A Report From the American Heart Association. Circulation. 2022 Feb 22;145(8):e153-e639. doi: 10.1161/CIR.0000000000001052. Epub 2022 Jan 26.
Background: PubMed 31884902Moore JL, Nordvik JE, Erichsen A, Rosseland I, Bo E, Hornby TG; FIRST-Oslo Team. Implementation of High-Intensity Stepping Training During Inpatient Stroke Rehabilitation Improves Functional Outcomes. Stroke. 2020 Feb;51(2):563-570. doi: 10.1161/STROKEAHA.119.027450. Epub 2019 Dec 30.

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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.

Patricia Broschart Valenza, DPT principal investigator

Sunnyview Rehabilitation Hospital

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

Questions about this trial

What is this clinical trial studying?

A study testing High Intensity Gait Training and Conventional Therapy in people with Cerebral Vascular Accident, run by Sunnyview Rehabilitation Hospital 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 1 inclusion and 15 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: stopped early, as of the sponsor's last update on 13 Oct 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?

The study was stopped early (reason given: Poor enrollment). Results are not available in the source record.

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?

10 Meter Walk Test at Self Selected Speed (time frame: (Day 13-15) - (Day 1-3)). The study lists 12 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 NCT05650606, which also lists 10 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 13 Oct 2023.