Multiple Sclerosis Clinical Trial
Algorithmic-Based Evaluation and Treatment Approach for Robotic Gait Training
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
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