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StrokeSTABLENCT07802470

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

A study testing High intensity gait training in Movement Amplification Environment and High intensity gait training in natural environment in people with Stroke, run by Northwestern University at 1 site in United States.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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: 1. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Stroke
What is being tested?
High intensity gait training in Movement Amplification Environment and High intensity gait training in natural environment
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteUnited States
Study dates
1 Sep 2026to 31 Aug 2031
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

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

United States1 site
  • Northwestern University

    Chicago, Illinois, 60611

    Shamali Dusane, (312) 503-7081, shamali.dusane@northwestern.edu

Other trials in United States

About this study

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.
Read more

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.
Conditions
Stroke
Being tested
High intensity gait training in Movement Amplification Environment, High intensity gait training in natural environment
Keywords
walking balance, rehabilitation robotics, walking dysfunction, chronic stroke
Medical subject headings
Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • High intensity gait training in Movement Amplification EnvironmentOther

    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 environmentOther

    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 groups in NCT07802470
Study groupRoleWhat they receive
Experimental groupExperimentalParticipants 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.
Receives: Other: High intensity gait training in Movement Amplification Environment
Control groupOtherParticipants 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).
Receives: Other: High intensity gait training in natural environment

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 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. 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.

    Measured: 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)

  3. 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.

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

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

    Measured: 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. 10 Meter Walk Test (10MWT)_Preferred speed

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

    Measured: 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)

  3. Activities Specific Balance Confidence (ABC) Scale

    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.

    Measured: 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)

  4. Timed Up and Go Test (TUG)

    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.

    Measured: 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)

  5. Berg Balance Scale (BBS)

    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.

    Measured: 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)

  6. 2-minute walk Test (2MWT)

    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.

    Measured: 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)

  7. Stroke Impact Scale (SIS)

    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.

    Measured: 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)

  8. Peak Lateral Center of Mass Speed

    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.

    Measured: 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)

  9. Step Width

    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.

    Measured: 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. Step Length

    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.

    Measured: 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)

  11. Minimum Lateral Margin of Stability (MOS)

    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

    Measured: 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)

  12. Lower-extremity joint angles during overground walking

    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.

    Measured: 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)

  13. Lower-extremity joint moments during overground walking

    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.

    Measured: 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)

  14. Lower-extremity joint power during overground walking

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

    Measured: 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)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Sep 2026
  2. Study start1 Sep 2026 (estimated)
  3. Primary completion31 Aug 2031 (estimated)
  4. Study completion31 Aug 2031 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07802470
Sponsor's protocol ID
STU00226222
Other IDs
R01HD120378-01
Acronym
STABLE
Status last verified
Sep 2026
First submitted
27 Aug 2026
Last updated
3 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes

Questions about this trial

What is this clinical trial studying?

A study testing High intensity gait training in Movement Amplification Environment and High intensity gait training in natural environment in people with Stroke, run by Northwestern University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 3 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Shamali Dusane, PT, MPT, PhD ((312) 503-7081, shamali.dusane@northwestern.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the 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)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2026.

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