Walking Balance Training Post-Stroke

NCT06090604 | Completed

• 1 other identifier: 1R21HD112813-01
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke

Keywords

Stroke; Balance control; Walking dysfunction

Outcome Measures

Primary Outcomes (9)

• Minimum average lateral center of mass (COM) excursion

  Minimum average lateral COM excursion occurring during 5 consecutive gait cycles will be calculated as our metric of ability to control lateral COM motion during walking

  For Aim 1, COM excursion will be calculated at session 1 and after a week on session 2. For Aim 2, COM excursion will be calculated at session 1 and after 5 weeks of training at session 12. Each of these sessions will be two hours long.

• Minimum lateral margin of stability

  Minimum lateral margin of stability is the distance between the lateral extrapolated center of mass (XCOM) and the base of support (BOS), approximated as the lateral position of the 5th metatarsal marker on the side of the last initial contact. Minimum MOS is identified during stance phase of each step. Extrapolated center of mass (XCOM) position is calculated using: XCOM= COM + COM\* √ l/g

  For Aim 1, margin of stability will be calculated at session 1 and after a week on session 2. For Aim 2, margin of stability will be calculated at session 1 and after 5 weeks of training at session 12. Each of these sessions will be two hours long.

• 10 Meter Walk Test (10MWT)

  10MWT is a simple measurement of an individual's average walking speed measured at self-selected speed (instruction: "walk at your normal comfortable pace") and fastest-possible speed (instruction: "as fast as you safely can").

  For Aim 1, 10MWT will be performed at session 1 to determine baseline functional status. For Aim 2, 10MWT will be performed at session 1 and after 5 weeks of training at session 12. Each of these sessions will be two hours long.

• Timed Up and Go (TUG)

  TUG is used to assess functional mobility, walking balance, and fall risk. It is a quick, valid, reliable and widely used clinical performance based measure in individuals post-stroke. While there is no time limit to the TUG test, more time taken to finish the task indicates poor balance and greater fall-risk.

  For Aim 1, TUG will be performed at session 1 to determine baseline functional status. For Aim 2, TUG will be performed at session 1 and after 5 weeks of training at session 12. Each of these sessions will be two hours long.

• Berg Balance Scale (BBS)

  BBS is a 14-item measure that assesses static balance with excellent validity and reliability in individuals post-stroke. The total score for this test is 56. Minimum score is 0 and maximum score is 56. Higher scores indicate better balance and lower fall-risk, while lower scores indicate poor balance and increased fall-risk.

  For Aim 1, BBS will be performed at session 1 to determine baseline functional status. For Aim 2, BBS will be performed at session 1 and after 5 weeks of training at session 12. Each of these sessions will be two hours long.

• Activities-specific Balance Confidence (ABC) Scale

  ABC scale is a self-reported measure of an individual's confidence while performing specific postural and ambulatory activities. The ABC is a reliable and valid measure of balance confidence in individuals post-stroke. The total score for ABC scale is 1600. Minimum score is 0 and maximum score is 1600. Higher scores indicate better balance confidence, while lower scores indicate poor balance confidence.

  For Aim 1, ABC will be performed at session 1 to determine baseline functional status. For Aim 2, ABC will be performed at session 1 and after 5 weeks of training at session 12. Each of these sessions will be two hours long.

• Dynamic Gait Index (DGI)

  DGI is an eight item test that assesses gait, balance and fall risk during usual steady-state walking and walking during more challenging tasks. The total score for this test is 24. Minimum score is 0 and maximum score is 24. Higher scores indicate better walking balance, while lower scores indicate poor walking balance.

  For Aim 1, DGI will be performed at session 1 to determine baseline functional status. For Aim 2, DGI will be performed at session 1 and after 5 weeks of training at session 12. Each of these sessions will be two hours long.

• 6 minute walk test (6WMT)

  6MWT is a sub-maximal exercise test used to assess aerobic capacity and endurance. The distance covered during 6 minutes of walking indicate participants exercise tolerance. The vitals measures before and after the 6MWT indicate the cardiovascular and respiratory response to exercise.

  For Aim 2, 6WMT will be performed at session 1 and after 5 weeks of training at session 12. Each of these sessions will be two hours long.

• Stepping Activity in the Home and Community

  The amount of daily stepping in the home and community taken per day averaged across the 7-day collection periods before and after training will be assessed for Aim 2. Daily stepping will be measured and recorded using a StepWatch4 (Modus, Edmonds, WA) activity monitor. The microprocessor-based accelerometer will be worn around the ankle during all waking hours (except bathing) for the duration of the stepping assessment period.

  For Aim 2, the stepping activity will be assessed for a period of one week after session 1 and session 12 (post 5 weeks of training). Participants will be asked to wear the monitor during all waking hours.

Secondary Outcomes (7)

• Step length

  For Aim 1, step length will be performed at session 1 and after a week on session 2. For Aim 2, step length will be calculated at session 1 and after 5 weeks of training at session 12. Each of these sessions will be two hours long.

• Step width

  For Aim 1, step width will be performed at session 1 and after a week on session 2. For Aim 2, step width will be calculated at session 1 and after 5 weeks of training at session 12. Each of these sessions will be two hours long.

• Heart rate

  For Aim 2, heart rate will be collected before and after each of the 10 one hour long training sessions over 5 weeks. Vitals will be collected at session 1 and after 5 weeks of training at session 12. Both these sessions will be two hours long.

• Blood pressure

  For Aim 2, blood pressure will be collected before and after each of the 10 one hour long training sessions over 5 weeks. Vitals will be collected at session 1 and after 5 weeks of training at session 12. Both these sessions will be two hours long.

• Exertion

  For Aim 2, participants level of exertion will be collected throughout the 10 training sessions over 5 weeks. Each training session will be one hour long.

Study Arms (1)

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

EXPERIMENTAL

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).

Other: High intensity gait training in a balance challenging Movement amplification environment

Interventions

High intensity gait training in a balance challenging Movement amplification environment 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.

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

Eligibility Criteria

• Age: 18 Years - 85 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 or without a single cane, and/or ankle-foot orthosis.

You may not qualify if:

• cognitive impairment (score of ≤22/30 on the Montreal Cognitive Assessment scale);
• aphasia (score of ≥71/100 on the Mississippi Aphasia Screening Test);
• excessive spasticity in lower limbs (score of \> 3 on the Modified Ashworth Scale);
• unable to tolerate 10-min. of standing;
• enrollment in concurrent physical therapy;
• use of braces/orthotics crossing the knee joint;
• known pregnancy;
• severe cardiovascular, musculoskeletal, or other neurological conditions affecting gait and balance.
• brainstem and/or cerebellar lesion
• perinatal stroke

Sponsors & Collaborators

• Northwestern University Feinberg School of Medicine: lead

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

Study Officials

• Keith Gordon, PhD

  Assistant Professor, Northwestern University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 18, 2023
• First Posted: October 19, 2023
• Study Start: August 18, 2023
• Primary Completion: May 2, 2025
• Study Completion: May 2, 2025
• Last Updated: July 8, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After completion of the study
• Access Criteria: Data will be publicly available.

Locations

US (1)