Algorithmic-Based Evaluation and Treatment Approach for Robotic Gait Training

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