Acquired Brain Injury, Complete Spinal Cord Injury, Incomplete Spinal Cord Injury, Multiple Sclerosis
Conditions
Brief summary
The purpose of this study is to develop an algorithmic-based evaluation and treatment approach for wearable robotic exoskeleton (WRE) gait training for patients with neurological conditions.
Interventions
DEVICEReWalk
ReWalk is a type of wearable robotic exoskeleton (WRE). Subjects will be randomly assigned the order of participation in the exoskeleton devices. ReWalk training sessions will be scheduled for one hour to include don/doff of device, sit to stand, standing balance and walking. ReWalk phase will require 2 hours pre and 2 hours post training for outcome measurement assessments, plus a minimum of 5 training sessions, with the possibility of up to 15 training sessions to reach a minimal assistance level. The total time commitment for each subject will range from 14-20 weeks and cover 27-72 hours.
DEVICEEKSO
EKSO is a type of wearable robotic exoskeleton (WRE). Subjects will be randomly assigned the order of participation in the exoskeleton devices. EKSO training sessions will be scheduled for one hour to include don/doff of device, sit to stand, standing balance and walking. EKSO phase will require 2 hours pre and 2 hours post training for outcome measurement assessments, plus a minimum of 5 training sessions, with the possibility of up to 15 training sessions to reach a minimal assistance level. The total time commitment for each subject will range from 14-20 weeks and cover 27-72 hours.
DEVICEREX
REX is a type of wearable robotic exoskeleton (WRE). Subjects will be randomly assigned the order of participation in the exoskeleton devices. REX training sessions will be scheduled for one hour to include don/doff of device, sit to stand, standing balance and walking. REX phase will require 2 hours pre and 2 hours post training for outcome measurement assessments, plus a minimum of 5 training sessions, with the possibility of up to 15 training sessions to reach a minimal assistance level. The total time commitment for each subject will range from 14-20 weeks and cover 27-72 hours.
Sponsors
The University of Texas Health Science Center, Houston
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Each of the participants will receive training with each of the 3 wearable robotic exoskeletons (WRE) examined in this study, and the order of receipt will be randomized.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Spinal Cord Injury Inclusion Criteria: * Male or non-pregnant female * ≥18 years of age * Chronic (\> 6 mo post) injury * Diagnosis of spinal cord injury * Able to achieve adequate fit within exoskeleton * Sufficient range of motion to attain normal, reciprocal gait pattern, and transition from normal sit to stand or stand to sit * Weight \<220 pounds * Intact skin on all surfaces in contact with device and load bearing surfaces * Ability to perform informed consent * Cognitively intact and able to follow directions and demonstrate learning capability Spinal Cord Injury
Exclusion criteria
* Pregnancy * Spinal instability * Non-English speaking * Unhealed limb or pelvic fractures or any condition restricting weight bearing in limbs * Diagnosis of other neurological injury other than SCI such as CVA, MS, ABI, CP * Uncontrolled spasticity (≥3 on Modified Ashworth Scale)\[21\] * Colostomy * Decreased range of motion or contractures in legs (\>10° at hips, knees or ankles) * Uncontrolled autonomic dysreflexia * Unresolved deep vein thrombosis * Inability to tolerate standing due to cardiovascular issues or orthostatic hypotension * Severe comorbidities: active infections, heart, lung, or circulatory conditions * Pressure sores, impaired skin integrity Acquired Brain Injury(ABI) Inclusion Criteria: * Male or non-pregnant female * ≥18 years of age * Chronic (\> 6 mo post) injury * Able to achieve adequate fit within exoskeleton * Ability to perform informed consent * Sufficient range of motion to attain normal, reciprocal gait pattern, and transition from normal sit to stand or stand to sit * Weight \<220 pounds * Intact skin on all surfaces in contact with device and load bearing surfaces * Cognitively intact and able to follow directions and demonstrate learning capability Acquired Brain Injury(ABI)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in over ground gait speed as assessed by the 10 Meter Walk Test without WRE | within one week before start of WRE training, within 2 weeks after start of WRE training | The 10 Meter Walk Test (10MWT) will assess subject's self-selected gait speed. |
| Change in walking endurance as assessed by the 6 Minute Walk Test without WRE | within one week before start of WRE training, within 2 weeks after start of WRE training | The 6 Minute Walk Test (6MWT) assesses the distance walked in 6 minutes. |
| Change in muscle activity as assessed by electromyography (EMG) during 10MWT without WRE | within one week before start of WRE training, within 2 weeks after start of WRE training | Surface EMG sensors will be placed on the skin of subjects' lower extremities during 10MWT. |
| Change in muscle activity as assessed by electromyography (EMG) during 6MWT without WRE | within one week before start of WRE training, within 2 weeks after start of WRE training | Surface EMG sensors will be placed on the skin of subjects' lower extremities during 6MWT. |
| Change in energy expenditure as assessed by oxygen consumption during 10MWT without WRE | within one week before start of WRE training, within 2 weeks after start of WRE training | Oxygen consumption will be calculated on a breath-by-breath basis measured by a portable metabolic system (Cosmed K4b2). This task will be performed during the 10MWT. |
| Change in gait kinematics as assessed by lower extremity joint excursion without WRE | within one week before start of WRE training, within 2 weeks after start of WRE training | Infrared light emitting diode markers will be attached to bilateral lower extremities. The marker data will be recorded using motion capture system. |
| Change in energy expenditure as assessed by oxygen consumption during 6MWT without WRE | within one week before start of WRE training, within 2 weeks after start of WRE training | Oxygen consumption will be calculated on a breath-by-breath basis measured by a portable metabolic system (Cosmed K4b2). This task will be performed during the 6MWT. |
| Change in gait kinematics as assessed by lower extremity joint angular velocities without WRE | within one week before start of WRE training, within 2 weeks after start of WRE training | Infrared light emitting diode markers will be attached to bilateral lower extremities. The marker data will be recorded using motion capture system. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Bone mineral density as assessed by whole body scan | within one month before start of WRE training | Subjects will undergo whole body bone scan according to standardized protocols. |
| Cognitive impairment as assessed by Folstein Mini Mental State Examination | within one month before start of WRE training | Folstein Mini Mental State Examination provides information about orientation, attention, learning, calculation, delayed recall, and construction. |
| Lower Extremity Muscle Strength as assessed by using a force gauge such as a handheld dynamometer | within one month before start of WRE training | We will measure lower extremity muscle strength using a force gauge such as a handheld dynamometer. |
| Spasticity as assessed by the Modified Ashworth Scale (MAS) | within one month before start of WRE training | The Modified Ashworth Scale will be used to measure spasticity in lower limb. |
| Range of motion for lower extremity joints as assessed by manual examination | within one month before start of WRE training | Range of joint motion of bilateral hip, knee and ankle joints. Subject will lie down on an examination table. |
| Stability during the maximum distance an individual can reach forward from a seated position as assessed by Modified Functional Reach (MFR) | within one month before start of WRE training | Assesses a patient's stability by measuring the maximum distance an individual can reach forward from a seated position. |
| Walking ability in ambulatory individuals with SC as assessed by Spinal Cord Injury Functional Ambulation Inventory (SCI-FAI): | within one month before start of WRE training | Assesses functional walking ability in ambulatory individuals with SCI. |
| Amount of physical assistance needed for walking following paralysis resulted from SCI as assessed by Walking Index of Spinal Cord Injury (WISCI-II) | within one month before start of WRE training | This test is performed by SCI population. |
| Motor recovery after stroke as assessed by Fugl-Meyer Assessment | within one month before start of WRE training | Evaluates and measures recovery in post-stroke hemiplegic individuals. |
| Confidence in performing various ambulatory activities as assessed by Activities-Specific Balance Confidence Scale | within one month before start of WRE training | Measure of confidence in performing various ambulatory activities without falling or experiencing a sense of unsteadiness. This is performed in ABI and MS population. |
| User feedback as assessed by a questionnaire | within one month before start of WRE training | A questionnaire will be administered to allow participants to provide feedback regarding their experiences during intervention. |
| Over ground gait speed as assessed by the 10 Meter Walk Test while wearing WRE | within one month before start of WRE training | The 10 Meter Walk Test (10MWT) will assess subject's self-selected gait speed. After WRE training has been completed, subjects will perform 10MWT while ambulating in the WRE. |
| Change in walking endurance as assessed by the 6 Minute Walk Test while wearing WRE | within one month before start of WRE training | The 6 Minute Walk Test (6MWT) assesses the distance walked in 6 minutes. After WRE training has been completed, subjects will perform 6MWT while ambulating in the WRE. |
| Change in muscle activity as assessed by electromyography (EMG) during 10MWT while wearing WRE | within one month before start of WRE training | Surface EMG sensors will be placed on the skin of subjects' lower extremities during 10MWT. After WRE training has been completed, subjects will be assessed by EMG during the 10MWT while ambulating in the WRE. |
| Change in muscle activity as assessed by electromyography (EMG) during 6MWT while wearing WRE | within one month before start of WRE training | Surface EMG sensors will be placed on the skin of subjects' lower extremities during 6MWT. After WRE training has been completed, subjects will be assessed by EMG during the 6MWT while ambulating in the WRE. |
| Change in energy expenditure as assessed by oxygen consumption during 10MWT while wearing WRE | within one month before start of WRE training | Oxygen consumption will be calculated on a breath-by-breath basis measured by a portable metabolic system (Cosmed K4b2). This task will be performed during the 10MWT. After WRE training has been completed, oxygen consumption will be assessed in subjects during the 10MWT while ambulating in the WRE. |
| Change in energy expenditure as assessed by oxygen consumption during 6MWT while wearing WRE | within one month before start of WRE training | Oxygen consumption will be calculated on a breath-by-breath basis measured by a portable metabolic system (Cosmed K4b2). This task will be performed during the 6MWT. After WRE training has been completed, oxygen consumption will be assessed in subjects during the 10MWT while ambulating in the WRE. |
| Change in gait kinematics as assessed by lower extremity joint excursion while wearing WRE | within one month before start of WRE training | Infrared light emitting diode markers will be attached to bilateral lower extremities. The marker data will be recorded using motion capture system. After WRE training has been completed, subjects will be assessed while ambulating in the WRE. |
| Change in gait kinematics as assessed by lower extremity joint angular velocities while wearing WRE | within one month before start of WRE training | Infrared light emitting diode markers will be attached to bilateral lower extremities. The marker data will be recorded using motion capture system. After WRE training has been completed, subjects will be assessed while ambulating in the WRE. |
| Change in H-reflex of soleus muscle as assessed by electromyography (EMG) | within one week before start of WRE training, within 2 weeks after start of WRE training | The tibialis nerve will be stimulated, and the size of each H-reflex will be measured as the peak-to-peak amplitude of the non-rectified EMG trace. |
Countries
United States
Contacts
Primary ContactShuo-Hsiu Chang, PT, PhD
Backup ContactRuta Paranjape, MS, CCRP
Outcome results
None listed