Clinical trial NCT06090604: Walking Balance Training Post-Stroke
Official title: Movement Amplification Training to Enhance Walking Balance Post-Stroke
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stroke
Keywords: Stroke
Balance control
Walking dysfunction
Lead sponsor: Northwestern University Feinberg School of Medicine
Sponsor class: OTHER
First posted: 2023-10-19
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Minimum average lateral center of mass (COM) excursion
timeFrame: 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.
measure: Minimum lateral margin of stability
timeFrame: 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.
measure: 10 Meter Walk Test (10MWT)
timeFrame: 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.
measure: Timed Up and Go (TUG)
timeFrame: 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.
measure: Berg Balance Scale (BBS)
timeFrame: 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.
measure: Activities-specific Balance Confidence (ABC) Scale
timeFrame: 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.
measure: Dynamic Gait Index (DGI)
timeFrame: 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.
measure: 6 minute walk test (6WMT)
timeFrame: 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.
measure: Stepping Activity in the Home and Community
timeFrame: 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:
measure: Step length
timeFrame: 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.
measure: Step width
timeFrame: 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.
measure: Heart rate
timeFrame: 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.
measure: Blood pressure
timeFrame: 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.
measure: Exertion
timeFrame: 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.
measure: Number of steps taken during training session
timeFrame: For Aim 2, the total number of steps during training will be collected after each of the 10 training session over 5 weeks. Each training session will be one hour long.
measure: Chedoke-McMaster Stroke Assessment (CMSA) scale
timeFrame: For both Aims 1 and 2, CMSA scale will be collected at session 1 to determine participants stroke recovery. This session will be two hours long.
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
Study officials:
affiliation: Assistant Professor, Northwestern University
name: Keith Gordon, PhD
role: PRINCIPAL_INVESTIGATOR
References: