What this study is
The goal of this clinical trial is to learn if a treadmill gait training performed with a new robotic device will improve walking balance and everyday participation in walking activities for adults who have had a stroke. The main questions it aims to answer are:
1. Does treadmill gait training performed with a new robotic device that challenges their walking balance improve a person's balance and steadiness while walking? 2. Does treadmill gait training performed with a new robotic device help people with stroke walk better and take more steps in their daily lives? We will compare the new robotic training (which uses a cable device to gently pull the participant side-to-side to challenge their balance) to standard high-intensity treadmill training (where no extra pulling forces are applied) to see if combination of high intensity treadmill training in a balance challenging environment works better for stroke recovery specifically for walking balance.
Participants will:
- Complete 20 sessions of high-intensity walking training on a treadmill
- Undergo special walking and balance tests at the Human Agility laboratory 4 different times: before the training, halfway through the training (after 10 sessions), at the end of the training (after 20 sessions), and 3 months after training is completed.
- Have their daily walking activity (steps per day) tracked to measure improvements at home and in the community.
What's being tested
- High intensity gait training in Movement Amplification Environment
Intervention · OTHER
Participants will participate in a 20-session, gait training intervention performed in a Movement Amplification Environment, conducted twice a week. A licensed physical therapist will lead gait training sessions using a large commercial treadmill - belt width 1.39 m (Tuff Tread, Willis, TX). To prevent falls, participants will wear a trunk harness attached to a passive overhead safety support. Before the training beings, participants' vitals and their rate of perceived exertion (RPE) will be assessed. Participants will wear a polar heart rate (HR) monitor to record training intensity and a StepWatch5 activity monitor to measure the number of steps. Every training session will begin and end with a 2.5-minute warmup and cool down respectively. The 40-minute body of the training session will be divided into four 10-minute segments: two of the 10-minute segments will consist of Speed and two of Balance. Target heart rate during these periods will be between 70 and 85% of HRmax.
- High intensity gait training in natural environment
Intervention · OTHER
Participants will participate in a 20-session gait training intervention conducted twice a week. A licensed physical therapist will lead gait training sessions using a large commercial treadmill - belt width 1.39 m (Tuff Tread, Willis, TX). To prevent falls, participants will wear a trunk harness attached to a passive overhead safety support. Before the training beings, participants' vitals and their rate of perceived exertion (RPE) will be assessed. Participants will wear a polar heart rate (HR) monitor to record training intensity and a StepWatch5 activity monitor to measure the number of steps. Every training session will begin and end with a 2.5-minute warmup and cool down respectively. The 40-minute body of the training session will be divided into four 10-minute segments: two of the 10-minute segments will consist of Speed and two of Balance. Target heart rate during these periods will be between 70 and 85% of HRmax.
Study details
- Sponsor
- Northwestern University
- Conditions
- Stroke
- Enrolling
- 50 people
- Starts
- 2026-09-01
- Est. completion
- 2031-08-31
- Design
- Single-blind, randomized, parallel groups
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years – 80 YearsSex ALLHealthy volunteers Not acceptedYou may qualify if
- 18 to 80 years of age;
- Diagnosis of hemiparetic stroke;
- More than 6 months post-stroke;
- Ability to ambulate over ground for 10 meters with no physical assistance, use of unilateral assistive devices, such as a single cane, and use of braces that do not cross the knee joint, such as an ankle-foot orthosis, are permitted;
- Passive range of motion of the legs within functional limits and not restricting the ability to engage in locomotor training and; medically stable with medical clearance from physician to participate.
You can't join if
- Cognitive impairment (score ≤22/30 on the Montreal Cognitive Assessment scale);
- Aphasia (score ≥71/100 on the Mississippi Aphasia Screening Test);
- Excessive spasticity in lower limbs (score >3 on the Modified Ashworth Scale);
- Unable to tolerate 10-min. of standing;
- Enrollment in concurrent physical therapy;
- Use of orthotics crossing the knee joint;
- Known pregnancy; and; severe cardiovascular, musculoskeletal or other neurological conditions affecting gait and balance.
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openNorthwestern University
Chicago, Illinois, United States
- Shamali Dusane · Contact(312) 503-7081shamali.dusane@northwestern.edu
Study team
Sponsor
Northwestern University
Study ID STU00226222
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.