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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

No Placebo-Only Group

Summary

This trial tests if high intensity walking exercises during the initial phase of stroke recovery in rehab centers can improve walking, balance, and quality of life. It also checks if this approach is cost-effective and reduces healthcare needs after discharge.

Eligible Conditions

Stroke

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

10 Meter Walk Test at Fast Speed

10 Meter Walk Test at Self Selected Speed

6 Minute Walk Test

+3 more

Secondary study objectives

5 Times Sit to Stand

Assistive Device Use

BERG Balance Scale

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

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