Algorithmic-Based Evaluation and Treatment Approach for Robotic Gait Training

Multiple Sclerosis Clinical Trial

Official title:

Algorithmic-Based Evaluation and Treatment Approach for Robotic Gait Training

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03057652
• Other study ID #: HSC-MS-15-0923
• Status: Recruiting
• Phase: N/A
• Start date: March 2016
• Est. completion date: December 2023

Study information

• Verified date: May 2022
• Source: The University of Texas Health Science Center, Houston
• Contact: Shuo-Hsiu Chang, PT, PhD
• Phone: 713-799-7016
• Email: shuo-hsiu.chang[@]uth.tmc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 75
• Est. completion date: December 2023
• Est. primary completion date: December 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acquired Brain Injury
• Brain Injuries
• Complete Spinal Cord Injury
• Incomplete Spinal Cord Injury
• Multiple Sclerosis
• Spinal Cord Injuries
• Wounds and Injuries

Intervention

Device:
• ReWalk
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.
• EKSO
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.
• REX
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.

Locations

Country	Name	City	State
United States	TIRR Memorial Hermann	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
The University of Texas Health Science Center, Houston

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in over ground gait speed as assessed by the 10 Meter Walk Test without WRE	The 10 Meter Walk Test (10MWT) will assess subject's self-selected gait speed.	within one week before start of WRE training, within 2 weeks after start of WRE training
Primary	Change in walking endurance as assessed by the 6 Minute Walk Test without WRE	The 6 Minute Walk Test (6MWT) assesses the distance walked in 6 minutes.	within one week before start of WRE training, within 2 weeks after start of WRE training
Primary	Change in muscle activity as assessed by electromyography (EMG) during 10MWT without WRE	Surface EMG sensors will be placed on the skin of subjects' lower extremities during 10MWT.	within one week before start of WRE training, within 2 weeks after start of WRE training
Primary	Change in muscle activity as assessed by electromyography (EMG) during 6MWT without WRE	Surface EMG sensors will be placed on the skin of subjects' lower extremities during 6MWT.	within one week before start of WRE training, within 2 weeks after start of WRE training
Primary	Change in energy expenditure as assessed by oxygen consumption during 10MWT without WRE	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.	within one week before start of WRE training, within 2 weeks after start of WRE training
Primary	Change in energy expenditure as assessed by oxygen consumption during 6MWT without WRE	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.	within one week before start of WRE training, within 2 weeks after start of WRE training
Primary	Change in gait kinematics as assessed by lower extremity joint excursion without WRE	Infrared light emitting diode markers will be attached to bilateral lower extremities. The marker data will be recorded using motion capture system.	within one week before start of WRE training, within 2 weeks after start of WRE training
Primary	Change in gait kinematics as assessed by lower extremity joint angular velocities without WRE	Infrared light emitting diode markers will be attached to bilateral lower extremities. The marker data will be recorded using motion capture system.	within one week before start of WRE training, within 2 weeks after start of WRE training
Secondary	Bone mineral density as assessed by whole body scan	Subjects will undergo whole body bone scan according to standardized protocols.	within one month before start of WRE training
Secondary	Cognitive impairment as assessed by Folstein Mini Mental State Examination	Folstein Mini Mental State Examination provides information about orientation, attention, learning, calculation, delayed recall, and construction.	within one month before start of WRE training
Secondary	Lower Extremity Muscle Strength as assessed by using a force gauge such as a handheld dynamometer	We will measure lower extremity muscle strength using a force gauge such as a handheld dynamometer.	within one month before start of WRE training
Secondary	Spasticity as assessed by the Modified Ashworth Scale (MAS)	The Modified Ashworth Scale will be used to measure spasticity in lower limb.	within one month before start of WRE training
Secondary	Range of motion for lower extremity joints as assessed by manual examination	Range of joint motion of bilateral hip, knee and ankle joints. Subject will lie down on an examination table.	within one month before start of WRE training
Secondary	Stability during the maximum distance an individual can reach forward from a seated position as assessed by Modified Functional Reach (MFR)	Assesses a patient's stability by measuring the maximum distance an individual can reach forward from a seated position.	within one month before start of WRE training
Secondary	Walking ability in ambulatory individuals with SC as assessed by Spinal Cord Injury Functional Ambulation Inventory (SCI-FAI):	Assesses functional walking ability in ambulatory individuals with SCI.	within one month before start of WRE training
Secondary	Amount of physical assistance needed for walking following paralysis resulted from SCI as assessed by Walking Index of Spinal Cord Injury (WISCI-II)	This test is performed by SCI population.	within one month before start of WRE training
Secondary	Motor recovery after stroke as assessed by Fugl-Meyer Assessment	Evaluates and measures recovery in post-stroke hemiplegic individuals.	within one month before start of WRE training
Secondary	Confidence in performing various ambulatory activities as assessed by Activities-Specific Balance Confidence Scale	Measure of confidence in performing various ambulatory activities without falling or experiencing a sense of unsteadiness. This is performed in ABI and MS population.	within one month before start of WRE training
Secondary	User feedback as assessed by a questionnaire	A questionnaire will be administered to allow participants to provide feedback regarding their experiences during intervention.	within one month before start of WRE training
Secondary	Over ground gait speed as assessed by the 10 Meter Walk Test while wearing WRE	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.	within one month before start of WRE training
Secondary	Change in walking endurance as assessed by the 6 Minute Walk Test while wearing WRE	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.	within one month before start of WRE training
Secondary	Change in muscle activity as assessed by electromyography (EMG) during 10MWT while wearing WRE	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.	within one month before start of WRE training
Secondary	Change in muscle activity as assessed by electromyography (EMG) during 6MWT while wearing WRE	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.	within one month before start of WRE training
Secondary	Change in energy expenditure as assessed by oxygen consumption during 10MWT while wearing WRE	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.	within one month before start of WRE training
Secondary	Change in energy expenditure as assessed by oxygen consumption during 6MWT while wearing WRE	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.	within one month before start of WRE training
Secondary	Change in gait kinematics as assessed by lower extremity joint excursion while wearing WRE	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.	within one month before start of WRE training
Secondary	Change in gait kinematics as assessed by lower extremity joint angular velocities while wearing WRE	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.	within one month before start of WRE training
Secondary	Change in H-reflex of soleus muscle as assessed by electromyography (EMG)	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.	within one week before start of WRE training, within 2 weeks after start of WRE training