Algorithmic-Based Evaluation and Treatment Approach for Robotic Gait T

Algorithmic-Based Evaluation and Treatment Approach for Robotic Gait Training

Status unknownNot a drug-phase studyMS (type not specified)NCT03057652

What it found

Paper found, not read

A paper reports the results; we have not read it yet. See Papers below.

What was tested

Treatment tested

  • ReWalk
  • EKSO
  • REX

What it measured

Main measures

  • Change in over ground gait speed as assessed by the 10 Meter Walk Test without WRE

    within one week before start of WRE training, within 2 weeks after start of WRE training

    Walking and mobility

  • Change in walking endurance as assessed by the 6 Minute Walk Test without WRE

    within one week before start of WRE training, within 2 weeks after start of WRE training

    Walking and mobility

  • Change in muscle activity as assessed by electromyography (EMG) during 10MWT without WRE

    within one week before start of WRE training, within 2 weeks after start of WRE training

  • Change in muscle activity as assessed by electromyography (EMG) during 6MWT without WRE

    within one week before start of WRE training, within 2 weeks after start of WRE training

    Walking and mobility

  • Change in energy expenditure as assessed by oxygen consumption during 10MWT without WRE

    within one week before start of WRE training, within 2 weeks after start of WRE training

  • Change in energy expenditure as assessed by oxygen consumption during 6MWT without WRE

    within one week before start of WRE training, within 2 weeks after start of WRE training

    Walking and mobility

  • Change in gait kinematics as assessed by lower extremity joint excursion without WRE

    within one week before start of WRE training, within 2 weeks after start of WRE training

    Walking and mobility

  • Change in gait kinematics as assessed by lower extremity joint angular velocities without WRE

    within one week before start of WRE training, within 2 weeks after start of WRE training

    Walking and mobility

Other measures (20)

  • Bone mineral density as assessed by whole body scan

    within one month before start of WRE training

  • Cognitive impairment as assessed by Folstein Mini Mental State Examination

    within one month before start of WRE training

    Thinking and memory

  • Lower Extremity Muscle Strength as assessed by using a force gauge such as a handheld dynamometer

    within one month before start of WRE training

    Physical function

  • Spasticity as assessed by the Modified Ashworth Scale (MAS)

    within one month before start of WRE training

    Spasticity

  • Range of motion for lower extremity joints as assessed by manual examination

    within one month before start of WRE training

  • Stability during the maximum distance an individual can reach forward from a seated position as assessed by Modified Functional Reach (MFR)

    within one month before start of WRE training

  • Walking ability in ambulatory individuals with SC as assessed by Spinal Cord Injury Functional Ambulation Inventory (SCI-FAI):

    within one month before start of WRE training

    Walking and mobility

  • Amount of physical assistance needed for walking following paralysis resulted from SCI as assessed by Walking Index of Spinal Cord Injury (WISCI-II)

    within one month before start of WRE training

    Walking and mobility

  • Motor recovery after stroke as assessed by Fugl-Meyer Assessment

    within one month before start of WRE training

  • Confidence in performing various ambulatory activities as assessed by Activities-Specific Balance Confidence Scale

    within one month before start of WRE training

    Walking and mobility

Who could take part

MS (type not specified) · 18 and over

Show the full criteria

Inclusion 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

Exclusion criteria

Not separately supplied in the registry.

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

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.

Papers

Loading reviews and guidelines…

History

    1. Started

      Mar 2016

    2. Main results due

      Dec 2023

    3. Finished

      Dec 2023

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