Walking Fatigability and Brain Activity in People With Multiple Sclerosis

Condition(s) studied

Study summary

Walking fatigability is a motor impairment happening in approximately 43.5% of people with multiple sclerosis (pwMS). Walking fatigability is defined as a decrease in 10% of distance walked, comparing the first minute with the last minute of the 6-minute walking test (6MWT), which one may call distance walking fatigability. More recently, our research group has found that walking fatigability manifests also in terms of gait quality, with different gait characteristics affected from patient to patient, suggesting that different gait profiles might be observed for walking fatigability. One possible explanation for the walking fatigability motor impairment is the lower capacity or neural reserve of pwMS to sustain optimal levels of cortical activity to either maintain performance (i.e., distance walked) or gait quality.

The study proposes two research questions. Both part A and B are observational studies.

The study includes 70 pwMS and 30 healthy controls. The study consists of 3 tests. The clinical assessment session will be composed of responses to different questionnaires, while parts A and B comprehend walking overground (part A) or on fixed-speed treadmill (part B).

Part A Session 1 (1 hour and 30minutes, including equipment preparation and rest time).

First, anthropometric characteristics and measurements of force, spasticity, cognition, walking speed, and performance foot tap test will be performed. For cortical activity measurement of the prefrontal cortex, supplementary motor area, premotor cortex, and primary motor cortex, a functional Nears-infrared Spectroscopy (fNIRS) will be positioned in the participant\'s head. Wearable sensors will be positioned in a pre-defined body position for the measurement of gait characteristics. Both gait characteristics and cortical brain activation will be measured concomitantly during fast and comfortable speed short walking (10 trials of 15 seconds with 25-30 seconds standing still resting periods between trials, in a block design) before and after and during a prolonged walking (6-minute walking test (6MWT)) protocols. A resting period of 20 minutes will be provided to the participants before the beginning of the 6MWT.

Part B. Participants who participated in Part A will be invited to participate in Part B. This study also consists of a single visit that is 1 hour and 30 minutes long (preparation and assessment included). The participants will be asked to walk on an immersive treadmill in two fixed-speed conditions (relative to 80% and 50% of the Timed 25-foot Walking test) while infrared cameras will record the reflective markers position. Forty minutes of rest will be provided to the participants between the fixed-speed conditions.

Eligibility

Primary outcome measure(s)

• Range of Motion (hip, knee and ankle joints) during the gait cycle — Day 2 and day 3
  The angle of the hip, knee, and ankle joints in the sagittal (flexion-extension), coronal (adduction-abduction), and transversal (rotation) plans during the gait cycle
• Toe-Off angle — Day 2 and day 3
  The plantar flexion of the foot in the last moment of contact of the feet with the floor
• Foot Strike angle — Day 2 and day 3
  The dorsiflexion of the feet in the heel strike
• Relative concentration of oxyhemoglobin and deoxyhemoglobin — Day 2
  The cortical brain activation will be obtained through functional near-infrared spectroscopy (fNIRS). The fNIRS measures the relative concentration of oxyhemoglobin and deoxyhemoglobin in the brain tissue, more specifically, in the brain cortex. The following brain regions will be measured: * Frontopolar cortex (Broadman area 10) * Dorsolateral prefrontal cortex (Broadman 9 and 46) * Primary motor cortex (Broadman area 4) * Supplementary motor area (Broadman area 6) * Premotor cortex (Broadman area 6)
• Gait Speed — Day 2 and day 3
  The anteroposterior distance, divided by the gait cycle duration (two subsequent heel strikes of the same leg).
• Cadence — Day 2 and day 3
  Number of steps made per minute (both legs)
• Step Duration — Day 2 and day 3
  The duration from the heel strike of a leg with the heel strike of the contralateral leg
• Step Duration variability — Day 2 and day 3
  The coefficient of variation calculated from the step duration variable
• Ground reaction force — Day 3
  It is the amount of force produced against the floor by a person. It will measured in the three directions: vertical, anteroposterior, and medial-lateral.
• Fatigability index — Day 2 and day 3
  A fatigability index will be applied for all gait parameters for the 6-minute walking test and the treadmill walking listed in accordance with the following sentence: fatigability index: ((gait parameters at minute n- gait parameter at minute 1)/gait parameter at minute 1)\*100.
• Perception of gait quality change (PGQC) — Day 2 and day 3
  It is a questionnaire to measure the capacity of the person to perceive changes in his/her gait after walking for a prolonged time. Here, this questionnaire is asked after the 6-minute walking test (6MWT). The questionnaire is in a Likert-type score, ranging from -3 (very much worse) to 3 (very much improved).
• Distance walked index (DWI) — Day 2
  The distance walked index (DWI) will be applied to the distance walked in each minute of the 6-minute walking test using the following formula: DWI(%) = ((distance walked at minute n- distance walked at minute 1)/ distance walked at minute 1)\*100
• 6-minutes walking test — Day 2
  The total distance and the distance walked, in meters, minute-by-minute will be recorded during the 6-minutes walking test.

Trial sites (3)

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