Walking Balance Training Post-Stroke

NCT ID: NCT06090604

Last Updated: 2025-07-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 33 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-18
• Study Completion Date: 2025-05-02

Brief Summary

Stroke is one of the leading causes of disability in the United States, affecting ~795,000 people annually. Among ambulatory people with chronic stroke, impaired balance is common and substantially limits mobility (those with the poorest balance walk the least). This project will explore if a novel gait training intervention using a robotic device to amplify a person's self-generated movements can improve walking balance in people with chronic stroke. The development of effective interventions to increase walking balance among people with chronic stroke will positively impact quality of life and ability to participate in walking activities.

Detailed Description

Background: People with chronic stroke (PwCS) have substantial walking balance dysfunctions that limit independence and participation in walking activities. There is a pressing need to develop effective methods to enhance walking balance in PwCS. Interventions that amplify self-generated movements may accelerate motor learning by enhance a person's perception of movement errors. This method could potentially be applied to help PwCS improve walking balance. To this end, we have developed a cable-driven robot to create a Movement Amplification Environment (MAE) during treadmill walking. The MAE challenges walking balance by applying lateral forces to the pelvis that are proportional in magnitude to real-time lateral center of mass (COM) velocity. Our purpose is to evaluate effects of MAE training on walking balance in PwCS.

Specific Aims: Aim 1a: To quantify locomotor adaptations PwCS make to maintain walking balance in a MAE. We will evaluate the impact of the two foremost gait training variables: Gait Speed and MAE Strength. Aim 1b: To evaluate short-term changes in the ability of PwCS to control their lateral COM excursion during walking (a quantifiable walking balance measure) immediately after MAE training. Aim 2: To evaluate long-term changes in walking balance and daily walking following a 5-week high-intensity gait training intervention performed in a MAE.

Approach: Aims 1a & b: Twenty PwCS will each participate in two experiments evaluating gait biomechanics (COM dynamics and stepping patterns) during and immediately following MAE training. Aim 1a will evaluate locomotor adaptations when walking in a MAE and the effect of gait speed (slow, preferred, and fast) and MAE strength (low, medium, and high). Aim 1b will use visual feedback to challenge PwCS to control their lateral COM excursion during walking immediately before and after walking in different external conditions (No applied forces, or MAE). Outcomes will assess if short-term walking balance is enhanced immediately following MAE exposure. Aim 2: Ten PwCS will participate in 10-sessions of high intensity gait training performed in a MAE. We will assess pre- to post- changes in walking balance using clinical gait and balance measures, biomechanical assessments, and participation in daily walking (steps/day). Outcomes will assess if long-term walking balance is enhanced following MAE gait training.

Impact: Training walking balance of PwCS by amplifying their own self-generated movements is a radical departure from current practice and could substantially enhance walking balance. This study will provide a foundational understanding of how PwCS maintain walking balance in a MAE and if beneficial behaviors persist following MAE training. Successful outcomes will motivate a randomized controlled trial assessing efficacy of MAE training on walking balance in PwCS.

Conditions

Stroke

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Control of lateral COM motion during and after walking practiced in the MAE

For Aim 1a, participant's preferred and fast treadmill walking speeds will be determined followed by 2-min of baseline walking. Each participant will perform eight 2-min trials of treadmill walking 1) Null Environment: no forces, 2) MAE Low Gain: 25 Nsm-1, 3) MAE Medium Gain: 35 Nsm-1, 4) MAE High Gain: 45 Nsm-1, that will be repeated at both treadmill walking speeds. The trial order will be randomized.

For Aim 1b, we will assess participant's maximum ability to control their lateral COM motion with no forces applied, using three 21-meter walking trials with visual projections on the treadmill to provide feedback used to challenge their lateral COM motion control. Five 2-min trials in a Null environment will be followed by COM control assessment. Participants will rest and repeat the above sequence in a MAE. The order of the external environments will be randomized across participants.

Participants may participate in more than one aim (1a, 1b and 2).

Group Type: EXPERIMENTAL

High intensity gait training in a balance challenging Movement amplification environment

Intervention Type: OTHER

For Aim 2, each participant will engage in ten 45-min high-intensity gait training sessions performed in a Movement Amplification Environment (MAE). Training sessions will occur 2x/week and led by a licensed Physical Therapist. The goal of each training session is to achieve 40-min of stepping practice within a targeted range of heart rate (HR) of 70 to 80% of estimated age-predicted HR max and perceived excursion (RPE) in a MAE. Each session will begin and end with a 2.5-min warm-up and cool down, with 40-min of training using two 10-min Speed-training blocks and two 10-min Balance-training blocks. Balance training activities will include lateral maneuvers, head turns, obstacle negotiation, and backward walking. The MAE gain, training speeds and balance activities will be progressively increased within and across sessions to challenge the participant.

Interventions

High intensity gait training in a balance challenging Movement amplification environment

For Aim 2, each participant will engage in ten 45-min high-intensity gait training sessions performed in a Movement Amplification Environment (MAE). Training sessions will occur 2x/week and led by a licensed Physical Therapist. The goal of each training session is to achieve 40-min of stepping practice within a targeted range of heart rate (HR) of 70 to 80% of estimated age-predicted HR max and perceived excursion (RPE) in a MAE. Each session will begin and end with a 2.5-min warm-up and cool down, with 40-min of training using two 10-min Speed-training blocks and two 10-min Balance-training blocks. Balance training activities will include lateral maneuvers, head turns, obstacle negotiation, and backward walking. The MAE gain, training speeds and balance activities will be progressively increased within and across sessions to challenge the participant.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. 18 to 80 years of age;

2. diagnosis of hemiparetic stroke;

3. more than 6 months post-stroke;

4. ability to ambulate over ground for 10 meters with or without a single cane, and/or ankle-foot orthosis.

Exclusion Criteria

1. cognitive impairment (score of ≤22/30 on the Montreal Cognitive Assessment scale);

2. aphasia (score of ≥71/100 on the Mississippi Aphasia Screening Test);

3. excessive spasticity in lower limbs (score of > 3 on the Modified Ashworth Scale);

4. unable to tolerate 10-min. of standing;

5. enrollment in concurrent physical therapy;

6. use of braces/orthotics crossing the knee joint;

7. known pregnancy;

8. severe cardiovascular, musculoskeletal, or other neurological conditions affecting gait and balance.

9. brainstem and/or cerebellar lesion

10. perinatal stroke

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Northwestern University Feinberg School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Keith Gordon, PhD

Role: PRINCIPAL_INVESTIGATOR

Assistant Professor, Northwestern University

Locations

Northwestern University

Chicago, Illinois, United States

Countries

United States

Other Identifiers

1R21HD112813-01

Identifier Type: NIH

Identifier Source: org_study_id

View Link