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NCT Number: NCT07802470

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

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.

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Key information

Conditions

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

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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.

Primary outcomes

  1. 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)

    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.

  2. Lateral center of mass excursion

    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)

    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.

  3. Daily stepping

    Time frame: 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)

    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.

Secondary outcomes

  1. 10 Meter Walk Test (10MWT)_Fast speed

    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)

    The 10MWT is a simple measurement of an individuals average walking speed.

  2. 10 Meter Walk Test (10MWT)_Preferred speed

    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)

    The 10MWT is a simple measurement of an individuals average walking speed.

  3. Activities Specific Balance Confidence (ABC) Scale

    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)

    The ABC scale is a 16-item self-report measurement of an individual's confidence while performing numerous postural and ambulatory activities. Each item is rated on a scale of 0 (no confidence) to 100 (complete confidence). Overall score is calculated by adding item scores and then dividing by the total number of items. Total score is 100. Higher score indicates greater balance confidence i.e. ability to perform tasks with less or no fear of falling. Lowest possible score is 0.

  4. Timed Up and Go Test (TUG)

    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)

    The Timed Up and Go Test (TUG) assesses mobility, balance, walking ability, and fall risk. The participant sits in a chair with his/her back against the chair back. On the command "go," the patient rises from the chair, walks 3 meters at a comfortable and safe pace, turns, walks back to the chair and sits down. Time to complete the task is reported. Participant must use the same assistive device each time he/she is tested to be able to compare scores.

  5. Berg Balance Scale (BBS)

    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)

    The BBS is a 14-item measure that assesses static balance. Each item is scored on a range of 0 to 4. A total score is determined by summing scores on the all the individual items. Total score is 56. Higher score indicates better static balance. Lowest possible score is 0.

  6. 2-minute walk Test (2MWT)

    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)

    2-minute walk test (2MWT) will be used to determine cardiovascular endurance of participants based on the amount of distance walked in 2 minutes. The 2MWT demonstrated excellent relative reliability in people with stroke patients, with potential to replace the longer 6 minute walk test.

  7. Stroke Impact Scale (SIS)

    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)

    The Stroke Impact Scale (SIS) is a 59 item questionnaire used to assess the impact of stroke on a person's quality of life across 8 domains of strength, hand function, mobility, activities of daily living, communication, emotion, memory and thinking, and social participation. We will measure the potential impact of our intervention on the quality of life using SIS. This questionnaire demonstrates good reliability, validity, and sensitivity to change in mild to moderate stroke patients.

  8. Peak Lateral Center of Mass Speed

    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)

    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 peak lateral center of mass speed occurring each stride during treadmill walking.

  9. Step Width

    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)

    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 preferred step width (lateral distance between calcaneal markers) during treadmill walking.

  10. Step Length

    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)

    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 preferred step length (anterior - posterior distance between calcaneal markers) during treadmill walking.

  11. Minimum Lateral Margin of Stability (MOS)

    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)

    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 minimum lateral margin of stability (distance between a velocity weighted whole body center of mass position and the edge of the base of support) occurring each step during treadmill walking

  12. Lower-extremity joint angles during overground walking

    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)

    During over ground walking, we will calculate the frontal and sagittal plane lower-extremity joint angles to evaluate training induced changes in the paretic limb contributions.

  13. Lower-extremity joint moments during overground walking

    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)

    During over ground walking, for each gait cycle analyzed, we will identify peak joint moments (hip flexion, hip extension, knee flexion, and ankle plantarflexion) during the stance phase.

  14. Lower-extremity joint power during overground walking

    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)

    During over ground walking, for each gait cycle analyzed, we will identify peak joint positive power (hip, knee, and ankle) during the stance phase.

Study contacts

Contact information is provided by the study sponsor or research team.

Keith Gordon, PhD, ATC, CSCS

CONTACT

[email protected]

(312) 503-3339

Shamali Dusane, PT, MPT, PhD

CONTACT

[email protected]

(312) 503-7081

Sponsors and collaborators

Lead sponsor

Northwestern University

Other

Collaborators

  • Edward Hines Jr. VA Hospital

Registry information

Acronym: STABLE

Important dates

Study start
2026
Primary completion
2031
Study completion
2031
First posted
Sep 3, 2026
Registry last updated
Sep 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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