Algorithmic-Based Evaluation and Treatment Approach for Robotic Gait Training
NCT ID: NCT03057652
Last Updated: 2022-05-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
75 participants
INTERVENTIONAL
2016-03-31
2023-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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ReWalk, then EKSO, then REX
Subjects will be asked to complete a screening visit, baseline and post assessment for each intervention training (ReWalk, EKSO, REX) and up to 15 training sessions per 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.
ReWalk, then REX, then EKSO
Subjects will be asked to complete a screening visit, baseline and post assessment for each intervention training (ReWalk, EKSO, REX) and up to 15 training sessions per 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.
EKSO, then ReWalk, then REX
Subjects will be asked to complete a screening visit, baseline and post assessment for each intervention training (ReWalk, EKSO, REX) and up to 15 training sessions per 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.
EKSO, then REX, then ReWalk
Subjects will be asked to complete a screening visit, baseline and post assessment for each intervention training (ReWalk, EKSO, REX) and up to 15 training sessions per 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.
REX, then EKSO, then ReWalk
Subjects will be asked to complete a screening visit, baseline and post assessment for each intervention training (ReWalk, EKSO, REX) and up to 15 training sessions per 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.
REX, then ReWalk, then EKSO
Subjects will be asked to complete a screening visit, baseline and post assessment for each intervention training (ReWalk, EKSO, REX) and up to 15 training sessions per 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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* ≥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
* 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
* 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
* 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\[24\]
Exclusion Criteria
* 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
* 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
* 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
* 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
18 Years
ALL
Yes
Sponsors
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The University of Texas Health Science Center, Houston
OTHER
Responsible Party
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Shuo-Hsiu Chang
Assistant Professor
Principal Investigators
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Shuo-Hsiu Chang, PT, PhD
Role: PRINCIPAL_INVESTIGATOR
The University of Texas Health Science Center, Houston
Locations
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TIRR Memorial Hermann
Houston, Texas, United States
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Other Identifiers
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HSC-MS-15-0923
Identifier Type: -
Identifier Source: org_study_id
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