Health and Financial Impact on the Use of a Personal Exoskeleton in the Home and Community: a Case Study

Обзор

The goal of this clinical trial is to examine the long-term use of a personal overground robotic exoskeleton in subjects with spinal cord injury. The main aims of this study include: 1. Determine patterns of personal overground robotic exoskeleton use over 12 months. 2. Examine the impact of personal overground robotic exoskeleton use on health outcomes over 12 months. These will include: 1. Objective health - heart rate, physical activity, sleep behavior, body temperature, body-mass index, and bone density 2. Medical status - rehospitalization, infection frequency, pressure injury, falls, fractures, medication (type/dose) 3. Function - bowel function, bladder function, pain, spasticity, quality of life, mental health, social participation 3. Determine healthcare expenditure over 12 months Participants and their support person(s) will be trained on using a personal robotic exoskeleton in their home and community. Once they complete training, they will use the exoskeleton as they wish (ie, no requirement to use the device a certain number of times per week) and data collection will begin.

Подробное описание

This prospective observational study will recruit and enroll individuals with SCI. These individuals will be part of a convenience sample due to employment or volunteer work with Ekso Bionics. They will be own or have access to an Indego Personal exoskeleton for home use. The parallel mixed methods design will allow for quantitative and qualitative data collected concurrently and integrated with equal consideration. Eligible individuals will be identified through work with representatives at Ekso Bionics for device acquisition and set up of training. Individuals who acquire a personal device will be screened for eligibility (criteria detailed below) and qualifying patients will be approached to participate. Upon providing consent, participants will complete quantitative and qualitative assessments over 12 months. Assessments will be conducted on five occasions: (1) baseline, (2) 1-month post-enrollment, (3) 3-months post-enrollment, (4) 6-months post-enrollment, and (5) 12-months post-enrollment. All study specific assessments will be completed by trained assessors. Quantitative and qualitative assessments will be completed by a physical therapist or other member of the research staff with necessary training. Time commitment for each participant at each assessment is 60 to 90 minutes.

Additionally, participants will be fitted for and provided at study enrollment with a wearable medical monitoring device for continuous tracking over 12-months. Study staff will provide each participant with a personal device account, to be set up using a premade study email, during enrollment. These emails will be generated utilizing a unique identifier feature which allows a single email to be suffixed with a unique identifier (e.g., study email account: "EksoIndegoStudy@gmail.com", participant S001 Wearable sensor account: "EksoIndegoStudy+S001@gmail.com"). Each account will be linked to a research data collection platform at Ekso Bionics. Ekso Bionics will collect necessary data from the wearable sensors including: heart rate, physical activity, sleep data, stress scores, weight, and profile information. To maintain blinding of potential health data, we will use the 1st of the birth month for each participant, so activity levels based on age can still be calculated appropriately. Data from the wearable device will be retrieved from the manufacturer cloud-based storage. All data is available for export by study staff either individually or as batch data, including all de-identified participant data in one file.

No specific intervention will take place during this observational study. However, each will have access to an Ekso Indego Personal device for home and community use. The Ekso Indego Personal (Indego) is a wearable powered exoskeleton device that actively assists individuals to stand and walk; these are individuals with walking impairments resulting from lower extremity weakness or paralysis due to spinal cord injury. Unique in design, the Indego consists of five (5) snap-together components (the lumbar/hip section, right and left upper leg sections, and right and left lower leg sections). The hip component houses a rechargeable battery pack, while each upper leg component houses two motors as well as embedded sensors and controllers. The Ekso Indego Personal incorporates powered movement of both hip and knee joints, in addition to built-in ankle-foot-orthoses (AFOs) at both ankle joints, which provide ankle support and stability, and also transfers the weight of the exoskeleton to the ground. The Ekso Indego Personal requires use of a stability aid, such as a rolling walker or set of forearm crutches. Once acquired, participants will complete device training and utilize their personal Ekso Indego exoskeleton according to their individual preferences with their certified support person.

Assessments will include: brief usage survey, 1-1 focused interview on device usage, device data, objective health data captured by wearable health monitor, self-reported BMI, bone mineral density, medical status questionnaire, Modified International SCI Lower Urinary Tract Function Basic Data Set, Modified International SCI Bowl Function Basic Data Set, pain questionnaire, Penn Spasm Frequency Scale, quality of life questionnaire, General Anxiety Disorder-7, Craig Handicap Assessment And Reporting Technique, health encounters survey, 1-1 focused interview on healthcare encounters, and medical records review.

Вмешательства

• Устройство Overground Robotic Exoskeleton
  Participants will have received training on their personal exoskeleton device prior to data collection. There is no required use dosage of the Ekso Indego Personal for this observational study.

Первичные конечные точки

• Change in sessions recorded and provided by the exoskeleton device across study timepoints [Срок оценки: baseline, 1-month post-enrollment, 3-months post-enrollment, 6-months post-enrollment, and 12-months post-enrollment.]
• Change in time spent walking recorded and provided by the exoskeleton device across study timepoints [Срок оценки: baseline, 1-month post-enrollment, 3-months post-enrollment, 6-months post-enrollment, and 12-months post-enrollment.]
• Change in walking time recorded and provided by the exoskeleton device across study timepoints [Срок оценки: baseline, 1-month post-enrollment, 3-months post-enrollment, 6-months post-enrollment, and 12-months post-enrollment.]
• Change in usage metrics as reported by user [Срок оценки: baseline, 1-month post-enrollment, 3-months post-enrollment, 6-months post-enrollment, and 12-months post-enrollment.]
• Change in medical health status, assessed by interview and written questions based on the SCI Model Systems form II, between all timepoints in study [Срок оценки: baseline, 1-month post-enrollment, 3-months post-enrollment, 6-months post-enrollment, and 12-months post-enrollment.]
• Change in bladder function between 5 timepoints using the Modified International SCI Lower Urinary Tract Function Basic Data set [Срок оценки: baseline, 1-month post-enrollment, 3-months post-enrollment, 6-months post-enrollment, and 12-months post-enrollment.]
• Change in bowel function between 5 timepoints using the Modified International SCI Bowel Function Basic Data set [Срок оценки: baseline, 1-month post-enrollment, 3-months post-enrollment, 6-months post-enrollment, and 12-months post-enrollment.]
• Changes in pain between 5 timepoints in study measured by questions from SCI Model Systems Form II [Срок оценки: baseline, 1-month post-enrollment, 3-months post-enrollment, 6-months post-enrollment, and 12-months post-enrollment.]
• Changes in spasticity from baseline to 4 other timepoints in study measured by Penn Spasm Frequency Scale [Срок оценки: baseline, 1-month post-enrollment, 3-months post-enrollment, 6-months post-enrollment, and 12-months post-enrollment.]
• Change in quality of life assessed by the SCI Model Systems form II SCI-QOL and Satisfaction with Life scale from baseline to 4 other time points during study [Срок оценки: baseline, 1-month post-enrollment, 3-months post-enrollment, 6-months post-enrollment, and 12-months post-enrollment.]

Вторичные конечные точки (7)

• Changes in heart rate measured by wearable health monitoring device from baseline to study completion [Срок оценки: Through study completion, 1 year]
• Change in sleep behavior over the duration of the 12-months using a wearable health monitoring device [Срок оценки: Through study completion, 1 year]
• Change in body temperature over the duration of the 12-months using a wearable health monitoring device [Срок оценки: Through study completion, 1 year]
• Changes in body mass index (BMI) at 5 time points during the study based on self reported height and weight [Срок оценки: baseline, 1-month post-enrollment, 3-months post-enrollment, 6-months post-enrollment, and 12-months post-enrollment.]
• Change in bone mineral density (BMD) will be assessed using dual-energy x-ray absorptiometry (DXA) at baseline and conclusion of the study with comparison of z scores assessed. [Срок оценки: baseline and 12-months post-enrollment]
• Changes in heart rate during exercise sessions using Indego from baseline to 12-month post enrollment [Срок оценки: Through study completion, 1 year]
• Change in number of steps per day over the duration of the 12-months using a wearable health monitoring device [Срок оценки: Through study completion, 1 year]

Критерии участия

Критерии включения

• Femur lengths from 14.5" to 19" (35.5cm to 47 cm)
• Healthy bone density
• Height from 5'1" to 6'3" (1.5 to 1.9 m)
• Seated hip width ≤ 16.6" (42.2 cm)
• Sufficient upper extremity strength to manage approved stability aids
• Weight 250 lbs or less
• Availability of a support person able to complete training and be present during all Indego sessions

Критерии исключения

• Cognitive impairments resulting in inability to follow directions
• Colostomy bag
• Diminished standing tolerance caused by orthostatic hypotension
• Heterotopic ossification
• Hip or knee contractures greater than 10° or ankle contractures greater than 5°
• History of severe neurological injuries other than SCI (multiple sclerosis, --cerebral palsy, amyotrophic lateral sclerosis, traumatic brain injury, etc).
• Lower limb prothesis
• Poor skin integrity in areas in contact with the device
• Pregnancy
• Psychiatric conditions that may interfere with proper operation of the device
• Severe concurrent medical diseases: infections, circulatory, heart or lung, pressure sores
• Severe or uncontrolled spasticity (Modified Ashworth 4)
• Spinal instability or spinal orthotics
• Uncontrolled autonomic dysreflexia
• Uncontrolled hypertension or hypotension
• Unhealed limb or pelvic fractures
• Unresolved deep vein thrombosis
• Any condition which in the opinion of a medical doctor prevents the user from using the device

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

США · 1 центр

• Ekso Bionics, Inc. — San Rafael

Публикации

• Gorman PH, Forrest GF, Asselin PK, Scott W, Kornfeld S, Hong E, Spungen AM. The Effect of Exoskeletal-Assisted Walking on Spinal Cord Injury Bowel Function: Results from a Randomized Trial and Comparison to Other Physical Interventions. J Clin Med. 2021 Mar 2;10(5):964. doi: 10.3390/jcm10050964. PMID 33801165
• Baunsgaard CB, Nissen UV, Brust AK, Frotzler A, Ribeill C, Kalke YB, Leon N, Gomez B, Samuelsson K, Antepohl W, Holmstrom U, Marklund N, Glott T, Opheim A, Penalva JB, Murillo N, Nachtegaal J, Faber W, Biering-Sorensen F. Exoskeleton gait training after spinal cord injury: An exploratory study on secondary health conditions. J Rehabil Med. 2018 Sep 28;50(9):806-813. doi: 10.2340/16501977-2372. PMID 30183055
• Priebe MM, Sherwood AM, Thornby JI, Kharas NF, Markowski J. Clinical assessment of spasticity in spinal cord injury: a multidimensional problem. Arch Phys Med Rehabil. 1996 Jul;77(7):713-6. doi: 10.1016/s0003-9993(96)90014-3. PMID 8670001
• Hsieh JT, Wolfe DL, Miller WC, Curt A; SCIRE Research Team. Spasticity outcome measures in spinal cord injury: psychometric properties and clinical utility. Spinal Cord. 2008 Feb;46(2):86-95. doi: 10.1038/sj.sc.3102125. Epub 2007 Oct 2. PMID 17909559
• Krogh K, Emmanuel A, Perrouin-Verbe B, Korsten MA, Mulcahey MJ, Biering-Sorensen F. International spinal cord injury bowel function basic data set (Version 2.0). Spinal Cord. 2017 Jul;55(7):692-698. doi: 10.1038/sc.2016.189. Epub 2017 Feb 14. PMID 28195229
• Biering-Sorensen F, Kennelly M, Kessler TM, Linsenmeyer T, Pannek J, Vogel L, Wyndaele JJ. International Spinal Cord Injury Lower Urinary Tract Function Basic Data Set (version 2.0). Spinal Cord Ser Cases. 2018 Jul 6;4:60. doi: 10.1038/s41394-018-0090-7. eCollection 2018. PMID 30002915
• Shackleton C, Evans R, West S, Derman W, Albertus Y. Robotic Walking to Mitigate Bone Mineral Density Decline and Adverse Body Composition in Individuals With Incomplete Spinal Cord Injury: A Pilot Randomized Clinical Trial. Am J Phys Med Rehabil. 2022 Oct 1;101(10):931-936. doi: 10.1097/PHM.0000000000001937. Epub 2021 Dec 6. PMID 34864766
• Abdelrahman S, Ireland A, Winter EM, Purcell M, Coupaud S. Osteoporosis after spinal cord injury: aetiology, effects and therapeutic approaches. J Musculoskelet Neuronal Interact. 2021 Mar 1;21(1):26-50. PMID 33657753

Идентификаторы

NCT: NCT07030322 · 1385701

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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