Algorithmic-Based Evaluation and Treatment Approach for Robotic Gait Training

The University of Texas System (UT)

Status: Unknown

Conditions: Complete Spinal Cord Injury; Incomplete Spinal Cord Injury; Multiple Sclerosis; Acquired Brain Injury

Treatments: Device: ReWalk; Device: REX; Device: EKSO

Study type: Interventional

Funder types: Other

Identifiers

NCT03057652

HSC-MS-15-0923

Details and patient eligibility

About

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.

Enrollment: 75 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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75 participants in 6 patient groups

ReWalk, then EKSO, then REX

Experimental group

Description:

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.

Treatment:

Device: ReWalk

Device: REX

Device: EKSO

ReWalk, then REX, then EKSO

Experimental group

Description:

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.

Treatment:

Device: ReWalk

Device: REX

Device: EKSO

EKSO, then ReWalk, then REX

Experimental group

Description:

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.

Treatment:

Device: ReWalk

Device: REX

Device: EKSO

EKSO, then REX, then ReWalk

Experimental group

Description:

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.

Treatment:

Device: ReWalk

Device: REX

Device: EKSO

REX, then EKSO, then ReWalk

Experimental group

Description:

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.

Treatment:

Device: ReWalk

Device: REX

Device: EKSO

REX, then ReWalk, then EKSO

Experimental group

Description:

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.

Treatment:

Device: ReWalk

Device: REX

Device: EKSO