Gait Stability After Stroke (AdaptGait)
Influence of Added Tasks and Different Environmental Conditions on Gait Stability After Stroke
The study will investigate gait stability in individuals post-stroke compared with age- and sex-matched healthy adults. Participants will undergo laboratory-based walking assessments under different environmental conditions, including level walking, uphill and downhill walking, and unexpected slip perturbations, with and without added cognitive, postural, and load-carrying tasks. The primary outcome measures will be the Margin of Stability (MOS), step width, and step width variability.
Study Overview
Status
Conditions
Detailed Description
: The study will recruit 20-30 adults post-stroke and an equal number of healthy controls. Participants post-stroke will be recruited after discharge from their regular rehabilitation. Participants will complete a single assessment session involving walking on a instrumented dual-belt treadmill mounted on a Stewart platform while secured with a safety harness. Walking conditions will include level, inclined, declined, and slip-perturbed walking, as well as walking combined with serial subtraction, head turning, or backpack carrying. Three-dimensional motion capture, force measurements, and surface electromyography will be used to quantify gait biomechanics and neuromuscular responses. The effects of environmental conditions and added tasks on gait stability, balance control, and fall risk will be compared between groups to identify biomechanical and neuromuscular markers associated with increased fall susceptibility after stroke.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Katja Groleger Sršen, MD, PhD
- Phone Number: +386 1 4758283
- Email: katja.groleger@ir-rs.si
Study Locations
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Ljubljana, Slovenia, 1000
- University Rehabilitation Institute, Republic of Slovenia
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria - stroke group:
- Discharge from regular rehabilitation
- First unilateral ischemic or hemorrhagic stroke affecting one of the cerebral hemispheres
- More than 3 months post-stroke
- Mini-Mental State Examination score ≥24 or cognitive ability to participate in the study
- Ability to walk independently in the community without a walking aid
- Moderate to mild balance impairment (Mini-BESTest score 16-25)
- Sufficient cognitive and physical ability to participate
- Ability to walk on a treadmill in intervals for up to 30 altogether
Inclusion Criteria - healthy control group:
- Age- and sex-matched to participants with stroke
- Mini-BESTest score ≥ 16
- Sufficient cognitive and physical ability to participate
- Ability to walk on a treadmill in intervals for up to 30 altogether
Exclusion Criteria (both groups):
- Musculoskeletal impairments affecting gait or balance
- Severe cardiovascular disease or heart failure (NYHA Class III-IV)
- Other neurological disorders
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Post-stroke patients
Adults with unilateral stroke (>3 months post-stroke) will undergo assessment of gait stability and balance responses during treadmill walking under different environmental conditions (level, uphill, downhill, and slip-perturbed walking) and added tasks (serial subtraction, head turning, and backpack carrying). |
Level treadmill walking Uphill treadmill walking Downhill treadmill walking Slip-perturbed treadmill walking Added task: serial subtraction Added task: head turning Added task: backpack carrying |
|
Active Comparator: Control group: healthy control participants
Age- and sex-matched healthy adults will undergo the same assessment protocol as the post-stroke patients, i.e., assessment of gait stability and balance responses during treadmill walking under different environmental conditions (level, uphill, downhill, and slip-perturbed walking) and added tasks (serial subtraction, head turning, and backpack carrying). |
Level treadmill walking Uphill treadmill walking Downhill treadmill walking Slip-perturbed treadmill walking Added task: serial subtraction Added task: head turning Added task: backpack carrying |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Margin of Stability (MOS)
Time Frame: During the intervention (periprocedurally)
|
Margin of stability in the anteroposterior and mediolateral directions calculated from kinematic and kinetic gait data during walking under different environmental conditions and added tasks, expressed in cm (more is better) |
During the intervention (periprocedurally)
|
|
Step Width
Time Frame: During the intervention (periprocedurally)
|
Mean step width measured during walking under different environmental conditions and added tasks, expressed in cm (less is better) |
During the intervention (periprocedurally)
|
|
Step Width Variability
Time Frame: During the intervention (periprocedurally)
|
Variability of step width calculated across consecutive gait cycles during walking under different environmental conditions and added tasks, , expressed as coeffcient of variation (less is better) |
During the intervention (periprocedurally)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Spatiotemporal Gait Parameter 1: Cadence
Time Frame: During the intervention (periprocedurally)
|
Gait cadence (in steps/min; less is better) measured using the instrumented treadmill |
During the intervention (periprocedurally)
|
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Spatiotemporal Gait Parameter 2: Step Length
Time Frame: During the intervention (periprocedurally)
|
Gait step length (in cm, more is better) measured using the instrumented treadmill |
During the intervention (periprocedurally)
|
|
Spatiotemporal Gait Parameter 3: Stance Time
Time Frame: During the intervention (periprocedurally)
|
Gait stance time (in s, less is better) measured using the instrumented treadmill |
During the intervention (periprocedurally)
|
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Spatiotemporal Gait Parameter 4: Swing Time
Time Frame: During the intervention (periprocedurally)
|
Gait swing time (in cm, more is better) measured using the instrumented treadmill |
During the intervention (periprocedurally)
|
|
Kinetic Variable 1: Ground Reaction Force
Time Frame: During the intervention (periprocedurally)
|
Ground reaction force in antero-posterior direction (in N; less is better) measured using the instrumented treadmill |
During the intervention (periprocedurally)
|
|
Kinetic Variable 2: Center-of-pressure Movement
Time Frame: During the intervention (periprocedurally)
|
Center-of-pressure movement in antero-posterior and medio-lateral direction (in cm; less is better) measured using the instrumented treadmill |
During the intervention (periprocedurally)
|
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Kinetic Variable 3: Velocity
Time Frame: During the intervention (periprocedurally)
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Velocity in antero-posterior and medio-lateral direction (in cm/s; smaller is better) measured using the instrumented treadmill |
During the intervention (periprocedurally)
|
Collaborators and Investigators
Investigators
- Principal Investigator: Metka Močilar, MSc PT, University Rehabilitation Institute, Republic of Slovenia
- Study Director: Urška Puh, PT, PhD, University Rehabilitation Institute, Republic of Slovenia
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- URIS202602
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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