Clinical trial NCT06478680: Comparing Effects of Conventional Neurorehabilitation with Exoskeleton with High-intensity Gait Training
Official title: Comparing Effects of Conventional Neurorehabilitation with Exoskeleton with High-intensity Gait Training on Gait, Balance, and Depression Following Stroke and the Impact of Social Determinants of Health and Depression on Patients' Adherence to Physical Therapy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stroke
Gait, Hemiplegic
Keywords: health literacy
balance
compliance to therapy
gait function
high intensity gait training
exoskeleton
Lead sponsor: Alvernia University
Sponsor class: OTHER
Collaborators: name: Good Shepherd Rehabilitation Network
First posted: 2024-06-27
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: Inclusion Criteria:

* 18 years of age or older
* English or Spanish-speaking
* A diagnosis of stroke (intracerebral hemorrhage or acute ischemic stroke)
* Referred to Good Shepherd Rehabilitation Outpatient Physical Therapy Clinic

Exclusion Criteria:

* Unable to follow 1-step commands
* \> 220 pounds (100 kg)
* Height \< 5'0" or \> 6'4"
* Unable to take a few steps with assistance
* A score of ≥ 50/56 on Berg Balance Scale (BBS)
* A score of ≥ 26/30 on Functional Gait Assessment (FGA)
* Resting blood pressure \>180/110 mmHg
* Resting heart rate \> 120 bpm
* Severe cardiac disease (New York Heart Association Classification IV)
* Severe spasticity (Modified Ashworth score \> 3)
* Unstable spine or unhealed pelvic/limb fractures
* Active heterotrophic ossification impacting lower extremity range of motion
* Significant lower or upper extremity contractures
* Inability to achieve neutral ankle dorsiflexion with 12° of knee flexion
* Pregnancy
* Colostomy
* Poor skin integrity in areas in contact with the EksoGTTM
* Unresolved deep vein thrombosis
* Lower limb prosthesis or amputation
* Leg length discrepancies \> 0.5 inches for upper legs, 0.75 inches for lower legs
* ROM restrictions preventing normal, reciprocal gait
* Inability to stand for \> 3 minutes due to pain or orthostatic hypotension
* Pusher syndrome
* Cortical blindness

Primary outcomes:
measure: Demographic Questionnaire
timeFrame: Pre-intervention
measure: Newest Vital Sign (NVS)
timeFrame: Pre-intervention
measure: Multidimensional Scale of Perceived Social Support (MSPSS)
timeFrame: Pre-intervention
measure: Patient Health Questionnaire (PHQ-9)
timeFrame: Pre-intervention, After 10 interventions (~5 weeks), After 20 interventions (~10 weeks)
measure: 3-Meter Backwards Walk Test (3MBWT)
timeFrame: Pre-intervention, After 10 interventions (~5 weeks), After 20 interventions (~10 weeks)
measure: 6-Minute Walk Test
timeFrame: Pre-intervention, After 10 interventions (~5 weeks), After 20 interventions (~10 weeks)
measure: 10-meter Walk Test
timeFrame: Pre-intervention, After 10 interventions (~5 weeks), After 20 interventions (~10 weeks)
measure: Muscle coactivation index
timeFrame: Pre-intervention, After 10 interventions (~5 weeks), After 20 interventions (~10 weeks)
measure: Berg Balance Scale (BBS)
timeFrame: Pre-intervention, After 10 interventions (~5 weeks), After 20 interventions (~10 weeks)
measure: Functional Gait Assessment (FGA)
timeFrame: Pre-intervention, After 10 interventions (~5 weeks), After 20 interventions (~10 weeks)
measure: Borg rating scale of Perceived Exertion
timeFrame: Pre-intervention, After 10 interventions (~5 weeks), After 20 interventions (~10 weeks)
Secondary outcomes:
measure: Patient compliance
timeFrame: After 20 interventions (~10 weeks)
Other outcomes:
Locations:
city: Allentown
country: United States
facility: Good Shepherd Rehabilitation
state: Pennsylvania
Study officials:
affiliation: Alvernia University
name: Soo Yeon Sun, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Good Shepherd Rehabilitation Network
name: Kelley Limbauan, PT, DPT, NCS
role: PRINCIPAL_INVESTIGATOR
References: