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

NCT07802470 | Not Yet Recruiting

• 2 other identifiers: STU00226222R01HD120378-01
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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:

• 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.

Conditions

Stroke

Keywords

walking balance; rehabilitation robotics; walking dysfunction; chronic stroke

Outcome Measures

Primary Outcomes (3)

• Functional Gait Assessment

  The FGA is a ten-item test that evaluates dynamic balance and postural stability during gait. Each item on the test is scored from 0 (severe impairment) to 3 (normal ambulation). Total score of this test is 30, with higher score indicating better walking balance. Lowest possible score is 0.

  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)

• Lateral center of mass excursion

  The investigators will perform biomechanical laboratory assessments to make quantitative measures of changes in dynamic balance during walking. The investigators will record 3D coordinates of reflective markers placed on anatomical landmarks. These markers will be used to quantify changes in an individual's average lateral center of mass excursion occurring each stride during treadmill walking.

  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)

• Daily stepping

  The investigators will assess the amount of daily stepping in the home and community during three 1-week periods. Daily stepping will be measured and recorded using an activity monitor. HIgher number of daily stepping indicates greater physical activity levels or greater walking in the community setting.

  Pre-training assessment (Baseline), Post-training assessment (after 20 sessions, ~10 weeks from Baseline), Follow-up assessment (3 month from Post, ~6 months from Baseline)

Secondary Outcomes (14)

• 10 Meter Walk Test (10MWT)_Fast speed

  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)

• 10 Meter Walk Test (10MWT)_Preferred speed

  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)

• Activities Specific Balance Confidence (ABC) Scale

  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)

• Timed Up and Go Test (TUG)

  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)

• Berg Balance Scale (BBS)

  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)

Study Arms (2)

Experimental group

EXPERIMENTAL

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: High intensity gait training in Movement Amplification Environment

Control group

OTHER

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).

Other: High intensity gait training in natural environment

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.

Experimental group

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.

Control group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 may not qualify 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.

Sponsors & Collaborators

• Northwestern University: lead
• Edward Hines Jr. VA Hospital: collaborator

Study Sites (1)

Northwestern University

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Shamali Dusane, PT, MPT, PhD

CONTACT

(312) 503-7081; shamali.dusane@northwestern.edu

Keith Gordon, PhD, ATC, CSCS

CONTACT

(312) 503-3339; keith.gordon2@va.gov

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant Professor

Study Record Dates

• First Submitted: August 27, 2026
• First Posted: September 3, 2026
• Study Start: September 1, 2026
• Primary Completion (Estimated): August 31, 2031
• Study Completion (Estimated): August 31, 2031
• Last Updated: September 3, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share

Locations

US (1)