Stroke Training to Advance Balance During Locomotor Experiences (STABLE) Trial

Conditions

• Stroke

Eligibility Criteria

Sex

ALL

Age

18 Years - 80 Years

Healthy Volunteers

Not accepted

Interventions

• High intensity gait training in Movement Amplification Environment — 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 — 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

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.

Key Dates

First listed

Sep 3, 2026

Start date

Sep 1, 2026

Status verified

Sep 2026

Primary completion

Aug 31, 2031

Completion

Aug 31, 2031

Study Design

Enrollment

50 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Experimental group
  Participants randomized to the Experimental group will perform 20 sessions of high intensity gait training within the movement amplification environment. To create the movement amplification environment, the investigators have constructed a cable-driven robot, the Agility Trainer. The Agility Trainer applies small forces to the pelvis that increase the difficulty to maintain forward walking.
• Other: Control group
  Participants randomized to the Control group will perform 20 sessions of high intensity gait training in a natural environment without forces applied (no movement amplification environment).

Primary Outcome Measure

Functional Gait Assessment [ Time Frame: Pre-training assessment (Baseline), Mid-training assessment (after 10 sessions, ~5 weeks from Baseline), Post-training assessment (after 20 sessions, ~10 weeks from Baseline), Follow-up assessment (3 month from Post, ~6 months from Baseline) ]

Central Contacts

• Shamali Dusane, PT, MPT, PhD
  (312) 503-7081
  [email protected]
• Keith Gordon, PhD, ATC, CSCS
  (312) 503-3339
  [email protected]

Locations (1)

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