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High Intensity Gait Training for Stroke (HIGT Trial)

N/A

Waitlist Available

Led By Patricia Broschart Valenza, DPT

Research Sponsored by Sunnyview Rehabilitation Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up (day 62 to day 86)-(day 14 to day 21)

Awards & highlights

HIGT Trial Summary

This trial will evaluate if high intensity gait training during early subacute inpatient rehabilitation can improve balance, ambulation and quality of life after stroke, and reduce health care burden.

Eligible Conditions

Stroke

HIGT Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ (day 62 to day 86)-(day 14 to day 21)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~(day 62 to day 86)-(day 14 to day 21)

This trial's timeline: 3 weeks for screening, Varies for treatment, and (day 62 to day 86)-(day 14 to day 21) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

10 Meter Walk Test at Fast Speed

10 Meter Walk Test at Self Selected Speed

6 Minute Walk Test

+3 more

Secondary outcome measures

5 Times Sit to Stand

Assistive Device Use

BERG Balance Scale

+1 more

HIGT Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: High Intensity Gait TrainingExperimental Treatment1 Intervention

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.

Group II: ConventionalActive Control1 Intervention

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.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Sunnyview Rehabilitation HospitalLead Sponsor

3 Previous Clinical Trials

342 Total Patients Enrolled

3 Trials studying Stroke

342 Patients Enrolled for Stroke

Patricia Broschart Valenza, DPTPrincipal InvestigatorSunnyview Rehabilitation Hospital

Media Library

High Intensity Gait Training Clinical Trial Eligibility Overview. Trial Name: NCT05650606 — N/A

Stroke Research Study Groups: High Intensity Gait Training, Conventional

Stroke Clinical Trial 2023: High Intensity Gait Training Highlights & Side Effects. Trial Name: NCT05650606 — N/A

High Intensity Gait Training 2023 Treatment Timeline for Medical Study. Trial Name: NCT05650606 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are participants aged 25 and over eligible to enroll in this experiment?

"To qualify for this trial, participants must fall between 18 and 85 years old. Separately, 38 clinical trials are active and open to minors while 1012 studies focus on those aged 65 or older."

Answered by AI

Are recruitment efforts for this clinical trial currently underway?

"According to clinicaltrials.gov, this trial is not actively recruiting participants at the moment. This study was initially posted on January 1st 2023 and last updated December 6th 2022. However, there are numerous other medical studies that are open for recruitment right now – 1049 in total!"

Answered by AI

What kind of individuals are most suitable to be involved in this medical research?

"This medical trial is accepting 144 applicants who have experienced a single stroke in the past three months and are between 18-85 years of age. Eligible candidates should display hemiparesis due to unilateral cerebral infarct, with an anticipated hospital stay of at least two weeks."

Answered by AI

What are the main objectives of this investigation?

"The primary outcome measured during this trial (from Day 62 to Day 86 and from Day 14 to 21) is the 10 Meter Walk Test at Fast Speed. The research team will also be evaluating Functional Ambulation Category, BERG Balance Scale, and 5 Times Sit to Stand as secondary outcomes when gauging patient progress."

Answered by AI

Recent research and studies

Neurorehabilitation and Neural RepairJournal

Variable Intensive Early Walking Poststroke (VIEWS)

Hornby, T. George, Carey L. Holleran, Patrick W. Hennessy, Abigail L. Leddy, Mark Connolly, Jaclyn Camardo, Jane Woodward, Gordhan Mahtani, Linda Lovell, and Elliot J. Roth. 2015. “Variable Intensive Early Walking Poststroke (VIEWS)”. Neurorehabilitation and Neural Repair. SAGE Publications. doi:10.1177/1545968315604396.

StrokeJournal

Contributions of Stepping Intensity and Variability to Mobility in Individuals Poststroke

Hornby, T. George, Christopher E. Henderson, Abbey Plawecki, Emily Lucas, Jennifer Lotter, Molly Holthus, Gabrielle Brazg, et al.. 2019. “Contributions of Stepping Intensity and Variability to Mobility in Individuals Poststroke”. Stroke. Ovid Technologies (Wolters Kluwer Health). doi:10.1161/strokeaha.119.026254.

clinicaltrials.govStudy

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

Patricia Broschart Valenza 2023. "Inpatient Rehabilitation and Post-Discharge Outcomes With High Intensity Gait Training (HIGT) of Patients With Stroke". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05650606.