Comparing Effects of Conventional Neurorehabilitation With Exoskeleton With High-intensity Gait Training
NCT Number: NCT06478680
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Stroke|Gait, Hemiplegic
Interventions: BEHAVIORAL: Exoskeleton mediated gait training|BEHAVIORAL: High intensity gait training
Sponsor: Alvernia University
Collaborators: Good Shepherd Rehabilitation Network
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 62
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-08-15
Completion Date: 2025-12-30

Summary:
The purpose of this research is to compare improvements between the rehab intervention with walking practice using the robotic exoskeleton versus walking practice that is vigorous enough to keep participants' heart rate over a certain target level during physical therapy sessions. Investigators want to compare improvements in your walking function and mental health that occur after 20 interventions. The study also aims to evaluate if participants' mental health, social support, and health literacy affect attendance at physical therapy sessions.

Primary Outcome Measures: Demographic Questionnaire, Questions include age, sex, date of birth, race/ethnicity, total income during T the past 12 months, main occupation and when was the last work, language at home, marital status, education level, and if they take any antidepressants., Pre-intervention|Newest Vital Sign (NVS), The NVS is a 6-question screening tool that identifies participants' risk of low or limited health literacy (HL) based on interpreting an ice cream nutrition label., Pre-intervention|Multidimensional Scale of Perceived Social Support (MSPSS), The Multidimensional Scale of Perceived Social Support is a 12-item self-administered scale that measures social support. The total score for the MSPSS ranges from 12 to 84, with higher scores indicating higher levels of perceived social support., Pre-intervention|Patient Health Questionnaire (PHQ-9), The PHQ-9 is a self-administered depression screening tool with nine items. It has been reported that the PHQ-9 is the best-performing tool for screening for post-stroke depression., Pre-intervention, After 10 interventions (~5 weeks), After 20 interventions (~10 weeks)|3-Meter Backwards Walk Test (3MBWT), The 3MBWT measures the time (in seconds) it takes for a participant to walk 3 meters backward, hence assessing a backward gait speed. Backward gait speed is used to evaluate neuromuscular control, proprioception, protective reflexes, fall risk, and balance. Use of assistive devices will be documented., Pre-intervention, After 10 interventions (~5 weeks), After 20 interventions (~10 weeks)|6-Minute Walk Test, The 6MWT assesses participants' aerobic capacity/endurance by recording the distance (in meters) that the participants walk in 6 minutes. Assistive devices may be used and will be documented., Pre-intervention, After 10 interventions (~5 weeks), After 20 interventions (~10 weeks)|10-meter Walk Test, The 10mWT assesses walking speed in meters/second (m/s) over a short distance (10m). Two trials are administered at the patient's comfortable walking speed, followed by 2 trials at their fast walking speed, per Physical Therapist's instruction. The 2 trials for each speed are then averaged and the 2 gait speeds (preferred and fast) are documented in m/s. Assistive devices may be used, and will be documented., Pre-intervention, After 10 interventions (~5 weeks), After 20 interventions (~10 weeks)|Muscle coactivation index, Muscle coactivation index will be calculated based on the EMG signals from 8 leg muscles (bilateral tibialis anterior, medial gastrocnemius, rectus femoris, medial hamstring). Surface electromyographic recordings will be conducted during forward and backward walking tests., Pre-intervention, After 10 interventions (~5 weeks), After 20 interventions (~10 weeks)|Berg Balance Scale (BBS), The Berg Balance Scale is a 14-item clinician-rated measure that assesses static and balance in sitting and standing. It has a maximum score of 56 points. Each item is scored on a 5-point scale from 0 to 4, with 0 indicating the subject is unable to perform the task and 4 being the highest score., Pre-intervention, After 10 interventions (~5 weeks), After 20 interventions (~10 weeks)|Functional Gait Assessment (FGA), The FGA is used to assess postural stability during walking and assesses an individual's ability to perform multiple motor tasks while walking. The Functional Gait Assessment (FGA) is scored on a 4-point ordinal scale ranging from 0-3, with 0 indicating severe impairment and 3 indicating normal ambulation. The total score is calculated by summing all the items and ranges from 0-30, with lower scores indicating greater impairment., Pre-intervention, After 10 interventions (~5 weeks), After 20 interventions (~10 weeks)|Borg rating scale of Perceived Exertion, The Borg Rating Scale of Perceived Exertion will be measured in all participants at the completion of 6 minute walk test. It measures exertion on a scale of 0 (no exertion or resting) to 10 (pushing oneself to the max)., Pre-intervention, After 10 interventions (~5 weeks), After 20 interventions (~10 weeks)
Secondary Outcome Measures: Patient compliance, Patient attendance to physical therapy is tracked and will be measured as \>80% attendance to physical therapy., After 20 interventions (~10 weeks)