Algorithmic-Based Evaluation and Treatment Approach for Robotic Gait Training
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Complete Spinal Cord Injury
- Sponsor
- The University of Texas Health Science Center, Houston
- Enrollment
- 75
- Locations
- 1
- Primary Endpoint
- Change in over ground gait speed as assessed by the 10 Meter Walk Test without WRE
- Last Updated
- 3 years ago
Overview
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.
Investigators
Shuo-Hsiu Chang
Assistant Professor
The University of Texas Health Science Center, Houston
Eligibility Criteria
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
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
Outcomes
Primary Outcomes
Change in over ground gait speed as assessed by the 10 Meter Walk Test without WRE
Time Frame: 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 muscle activity as assessed by electromyography (EMG) during 10MWT without WRE
Time Frame: 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 energy expenditure as assessed by oxygen consumption during 10MWT without WRE
Time Frame: 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
Time Frame: 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 walking endurance as assessed by the 6 Minute Walk Test without WRE
Time Frame: 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 gait kinematics as assessed by lower extremity joint angular velocities without WRE
Time Frame: 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 muscle activity as assessed by electromyography (EMG) during 6MWT without WRE
Time Frame: 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 6MWT without WRE
Time Frame: 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.
Secondary Outcomes
- Spasticity as assessed by the Modified Ashworth Scale (MAS)(within one month before start of WRE training)
- Bone mineral density as assessed by whole body scan(within one month before start of WRE training)
- 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)
- Confidence in performing various ambulatory activities as assessed by Activities-Specific Balance Confidence Scale(within one month before start of WRE training)
- Change in muscle activity as assessed by electromyography (EMG) during 10MWT while wearing WRE(within one month before start of WRE training)
- Change in energy expenditure as assessed by oxygen consumption during 10MWT while wearing WRE(within one month before start of WRE training)
- Cognitive impairment as assessed by Folstein Mini Mental State Examination(within one month before start of WRE training)
- Lower Extremity Muscle Strength as assessed by using a force gauge such as a handheld dynamometer(within one month before start of WRE training)
- Motor recovery after stroke as assessed by Fugl-Meyer Assessment(within one month before start of WRE training)
- Over ground gait speed as assessed by the 10 Meter Walk Test while wearing WRE(within one month before start of WRE training)
- Change in walking endurance as assessed by the 6 Minute Walk Test while wearing WRE(within one month before start of WRE training)
- Range of motion for lower extremity joints as assessed by manual examination(within one month before start of WRE training)
- 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)
- Change in energy expenditure as assessed by oxygen consumption during 6MWT while wearing WRE(within one month before start of WRE training)
- 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)
- User feedback as assessed by a questionnaire(within one month before start of WRE training)
- Change in muscle activity as assessed by electromyography (EMG) during 6MWT while wearing WRE(within one month before start of WRE training)
- Change in gait kinematics as assessed by lower extremity joint excursion while wearing WRE(within one month before start of WRE training)
- Change in gait kinematics as assessed by lower extremity joint angular velocities while wearing WRE(within one month before start of WRE training)
- 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)