Clinical trial NCT03057652: Algorithmic-Based Evaluation and Treatment Approach for Robotic Gait Training
Official title: Algorithmic-Based Evaluation and Treatment Approach for Robotic Gait Training
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Complete Spinal Cord Injury
Incomplete Spinal Cord Injury
Acquired Brain Injury
Multiple Sclerosis
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
First posted: 2017-02-20
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
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.
Primary purpose: TREATMENT

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.


Eligibility 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) 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 ABI such as SCI, MS, TBI, CP
* Decreased range of motion or contractures in legs (\>10° at hips, knees or ankles)
* Inability to tolerate standing due to cardiovascular issues or orthostatic hypotension
* Pressure sores, impaired skin integrity
* Uncontrolled spasticity (≥3 on Modified Ashworth Scale)
* Colostomy
* Severe comorbidities: active infections, heart, lung, or circulatory conditions
* Unresolved deep vein thrombosis

Multiple Sclerosis (MS) Inclusion Criteria:

* Male or non-pregnant female
* ≥18 years of age
* Chronic (\> 6 mo post) injury
* Diagnosis of multiple sclerosis
* 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
* Able to achieve adequate fit within exoskeleton
* Intact skin on all surfaces in contact with device and load bearing surfaces
* Cognitively intact and able to follow directions and demonstrate learning capability

Multiple Sclerosis (MS) Exclusion Criteria:

* Pregnancy
* Spinal instability
* Non-English speaking
* Unhealed limb or pelvic fractures or any condition restricting weight bearing in limbs
* Decreased range of motion or contractures in legs (\>10° at hips, knees or ankles)
* Inability to tolerate standing due to cardiovascular issues or orthostatic hypotension
* Uncontrolled autonomic dysreflexia
* Unresolved deep vein thrombosis
* Pressure sores, impaired skin integrity
* Uncontrolled spasticity (≥3 on Modified Ashworth Scale)
* Colostomy
* Severe comorbidities: active infections, heart, lung, or circulatory conditions\[23,24\]
* Diagnosis of other neurological injury other than MS such as CVA, SCI, ABI, CP
* MS Relapse in 3 months prior to recruitment

Able Bodied Inclusion Criteria:

* Male or non-pregnant female
* ≥18 years of age
* Weight \<220 pounds
* Cognitively intact and able to follow directions and demonstrate learning capability\[23\]
* Healthy individuals with no history or diagnosis of neurological injury
* Sufficient range of motion to attain normal, reciprocal gait pattern, and transition from normal sit to stand or stand to sit
* Able to achieve adequate fit within exoskeleton
* Intact skin on all surfaces in contact with device and load bearing surfaces
* Ability to perform informed consent\[24\]

Able Bodied Exclusion Criteria:

* Pregnancy
* Spinal instability
* Non-English speaking
* Unhealed limb or pelvic fractures or any condition restricting weight bearing in limbs
* Diagnosis of neurological injury such as CVA, SCI, ABI, CP, MS
* Decreased range of motion or contractures in legs (\>10° at hips, knees or ankles)
* Severe comorbidities: active infections, heart, lung, or circulatory conditions
* Colostomy

Primary outcomes:
measure: Change in over ground gait speed as assessed by the 10 Meter Walk Test without WRE
timeFrame: within one week before start of WRE training, within 2 weeks after start of WRE training
measure: Change in walking endurance as assessed by the 6 Minute Walk Test without WRE
timeFrame: within one week before start of WRE training, within 2 weeks after start of WRE training
measure: Change in muscle activity as assessed by electromyography (EMG) during 10MWT without WRE
timeFrame: within one week before start of WRE training, within 2 weeks after start of WRE training
measure: Change in muscle activity as assessed by electromyography (EMG) during 6MWT without WRE
timeFrame: within one week before start of WRE training, within 2 weeks after start of WRE training
measure: Change in energy expenditure as assessed by oxygen consumption during 10MWT without WRE
timeFrame: within one week before start of WRE training, within 2 weeks after start of WRE training
measure: Change in energy expenditure as assessed by oxygen consumption during 6MWT without WRE
timeFrame: within one week before start of WRE training, within 2 weeks after start of WRE training
measure: Change in gait kinematics as assessed by lower extremity joint excursion without WRE
timeFrame: within one week before start of WRE training, within 2 weeks after start of WRE training
measure: Change in gait kinematics as assessed by lower extremity joint angular velocities without WRE
timeFrame: within one week before start of WRE training, within 2 weeks after start of WRE training
Secondary outcomes:
measure: Bone mineral density as assessed by whole body scan
timeFrame: within one month before start of WRE training
measure: Cognitive impairment as assessed by Folstein Mini Mental State Examination
timeFrame: within one month before start of WRE training
measure: Lower Extremity Muscle Strength as assessed by using a force gauge such as a handheld dynamometer
timeFrame: within one month before start of WRE training
measure: Spasticity as assessed by the Modified Ashworth Scale (MAS)
timeFrame: within one month before start of WRE training
measure: Range of motion for lower extremity joints as assessed by manual examination
timeFrame: within one month before start of WRE training
measure: Stability during the maximum distance an individual can reach forward from a seated position as assessed by Modified Functional Reach (MFR)
timeFrame: within one month before start of WRE training
measure: Walking ability in ambulatory individuals with SC as assessed by Spinal Cord Injury Functional Ambulation Inventory (SCI-FAI):
timeFrame: within one month before start of WRE training
measure: Amount of physical assistance needed for walking following paralysis resulted from SCI as assessed by Walking Index of Spinal Cord Injury (WISCI-II)
timeFrame: within one month before start of WRE training
measure: Motor recovery after stroke as assessed by Fugl-Meyer Assessment
timeFrame: within one month before start of WRE training
measure: Confidence in performing various ambulatory activities as assessed by Activities-Specific Balance Confidence Scale
timeFrame: within one month before start of WRE training
measure: User feedback as assessed by a questionnaire
timeFrame: within one month before start of WRE training
measure: Over ground gait speed as assessed by the 10 Meter Walk Test while wearing WRE
timeFrame: within one month before start of WRE training
measure: Change in walking endurance as assessed by the 6 Minute Walk Test while wearing WRE
timeFrame: within one month before start of WRE training
measure: Change in muscle activity as assessed by electromyography (EMG) during 10MWT while wearing WRE
timeFrame: within one month before start of WRE training
measure: Change in muscle activity as assessed by electromyography (EMG) during 6MWT while wearing WRE
timeFrame: within one month before start of WRE training
measure: Change in energy expenditure as assessed by oxygen consumption during 10MWT while wearing WRE
timeFrame: within one month before start of WRE training
measure: Change in energy expenditure as assessed by oxygen consumption during 6MWT while wearing WRE
timeFrame: within one month before start of WRE training
measure: Change in gait kinematics as assessed by lower extremity joint excursion while wearing WRE
timeFrame: within one month before start of WRE training
measure: Change in gait kinematics as assessed by lower extremity joint angular velocities while wearing WRE
timeFrame: within one month before start of WRE training
measure: Change in H-reflex of soleus muscle as assessed by electromyography (EMG)
timeFrame: within one week before start of WRE training, within 2 weeks after start of WRE training
Other outcomes:
Locations:
city: Houston
country: United States
facility: TIRR Memorial Hermann
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Shuo-Hsiu Chang, PT, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Zhu F, Kern M, Fowkes E, Afzal T, Contreras-Vidal JL, Francisco GE, Chang SH. Effects of an exoskeleton-assisted gait training on post-stroke lower-limb muscle coordination. J Neural Eng. 2021 Jun 4;18(4). doi: 10.1088/1741-2552/abf0d5.