Gait, Hemiplegic, Stroke
Conditions
Keywords
health literacy, balance, compliance to therapy, gait function, high intensity gait training, exoskeleton
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.
Interventions
BEHAVIORALExoskeleton mediated gait training
1 session of Forward Walking with EksoGT per week 1 session of conventional neurorehabilitation intervention per week * Transfer training * Gait training * Balance (sitting/standing; static/dynamic) * Strength * Neuromuscular re-education * Orthotics * Positioning * Caregiver education * Assistive device * Wheelchair assessment and mobility * Endurance training
BEHAVIORALHigh intensity gait training
2 sessions of High-Intensity Gait Training at a target heart rate of 60-80% of the maximum heart rate or target RPE of 15-18 * Forward stepping practice * Backwards stepping practices * Sidestepping * Stairs * Balance and compliant surface training while walking * Propulsion * Lateral balance training * Stability training * Stance control training * Limb advancement
Sponsors
Good Shepherd Rehabilitation Network
Alvernia University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Borg rating scale of Perceived Exertion | Pre-intervention, After 10 interventions (~5 weeks), After 20 interventions (~10 weeks) | 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). |
| Demographic Questionnaire | Pre-intervention | 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. |
| Newest Vital Sign (NVS) | Pre-intervention | 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. |
| Multidimensional Scale of Perceived Social Support (MSPSS) | Pre-intervention | 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. |
| Patient Health Questionnaire (PHQ-9) | Pre-intervention, After 10 interventions (~5 weeks), After 20 interventions (~10 weeks) | 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. |
| 3-Meter Backwards Walk Test (3MBWT) | Pre-intervention, After 10 interventions (~5 weeks), After 20 interventions (~10 weeks) | 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. |
| 6-Minute Walk Test | Pre-intervention, After 10 interventions (~5 weeks), After 20 interventions (~10 weeks) | 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. |
| 10-meter Walk Test | Pre-intervention, After 10 interventions (~5 weeks), After 20 interventions (~10 weeks) | 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. |
| Muscle coactivation index | Pre-intervention, After 10 interventions (~5 weeks), After 20 interventions (~10 weeks) | 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. |
| Berg Balance Scale (BBS) | Pre-intervention, After 10 interventions (~5 weeks), After 20 interventions (~10 weeks) | 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. |
| Functional Gait Assessment (FGA) | Pre-intervention, After 10 interventions (~5 weeks), After 20 interventions (~10 weeks) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient compliance | After 20 interventions (~10 weeks) | Patient attendance to physical therapy is tracked and will be measured as \>80% attendance to physical therapy. |
Countries
United States
Outcome results
None listed