Covid 19 Clinical Trials

	Name (Synonyms)	Correlation
drug3116	WebEx Physical Activity Program Wiki	0.45
drug711	Collection of odour samples Wiki	0.45
drug2377	ReWalk 6.0 Wiki	0.45
drug1904	Non-Heated Vest Wiki	0.45
drug1231	Heated Vest Wiki	0.45

Correlated MeSH Terms (2)

	Name (Synonyms)	Correlation
D014947	Wounds and Injuries NIH	0.26
D001930	Brain Injuries, NIH	0.15

Correlated HPO Terms (0)

	Name (Synonyms)	Correlation

There are 5 clinical trials

Clinical Trials

1 CSP #2003 - Exoskeleton Assisted-Walking in Persons With SCI: Impact on Quality of Life

Background Veterans with spinal cord injury (SCI) have many adverse secondary medical and quality of life (QOL) changes as a result of immobilization. Veterans with SCI who have completed rehabilitation after injury and are unable to ambulate receive a wheelchair as standard of care (SOC) for mobility. Powered exoskeletons are a technology that has recently become available as an alternate form of mobility by providing an external framework for support and computer controlled motorized hip and knee joints to assist with over ground ambulation.

NCT02658656 Spinal Cord Injury Device: ReWalk 6.0

MeSH:Spinal Cord Injuries

Primary Outcomes

Description: The Veterans RAND 36 Item Health Survey (VR-36) is a brief, generic, multi-use, self-administered health survey comprised of 36 items. The instrument is primarily used to measure health related quality of life, to estimate disease burden and to evaluate disease-specific impact on general and selected populations. The items on the questionnaire correspond to eight principal health domains including general health perceptions, physical functioning, role limitations due to physical and emotional problems, bodily pain, energy-fatigue, social functioning and mental health. The outcome in this study is the score from the Mental Health Component Summary (MCS) of the VR-36, which measures the vitality, social functioning, role-emotional, and mental health of the participant.

Measure: Mental Health Component Summary (MCS) of the Veterans Rand-36 (VR-36)

Time: Change from Baseline Assessment to 4 Months Post Intervention

Description: The Spinal Cord Injury - Quality of Life (SCI-QOL) measurement tool was developed to assess patient reported outcome measures in persons with SCI. It is comprised of four broad domains of physical-medical health, emotional health, social participation, and physical functioning. Primary Outcome #2 will be a sum of the scores on the Bladder Management Difficulties, Bowel Management Difficulties, and Pain Interference item banks within the Physical-Medical Health domain.

Measure: The sum T-score for the SCI-QOL Physical Medical Health domain (three item banks of Bladder Management Difficulties, Bowel Management Difficulties, and Pain Interference)

Time: Change from Baseline Assessment to 4 Months Post Intervention

Secondary Outcomes

Description: Total body fat mass as measured by DXA (Dual energy X-Absorptiometry) scan.

Measure: Total Body Fat Mass (Kg)

Time: Change from Baseline Assessment to 4 Months Post Intervention

2 Developing a Feedback-Controlled Heated Vest to Address Thermoregulatory Dysfunction in Persons With Spinal Cord Injury

Persons with higher levels of spinal cord injury (above the 2nd thoracic vertebrae; tetraplegia) are unable to maintain normal core body temperature (Tcore) when exposed to cool environments. In persons with tetraplegia, even limited exposure to cool temperatures may cause Tcore to approach hypothermic values and impair cognitive performance. Conversely, an increase in Tcore from subnormal to normal range may improve cognitive performance. Prior work has shown that cool seasonal temperatures have an adverse effect on personal comfort and the ability to perform vital daily activities of self-care in persons with tetraplegia. Interventions that address the vulnerability to hypothermia are limited. A self-regulating heated vest designed specifically for persons with tetraplegia is a novel and promising strategy to address this problem. By more effectively maintaining Tcore, the vest can decrease the adverse impact of cool temperatures on comfort, quality of life, and performance of vital daily tasks for Veterans with tetraplegia during the cooler seasons.

NCT03662308 Spinal Cord Injuries Device: Heated Vest Device: Non-Heated Vest

MeSH:Spinal Cord Injuries Wounds and Injuries

Primary Outcomes

Description: Tcore will be continuously monitored throughout baseline and thermal challenge periods (with heated & non-heated vests) by a TX-2 Rectal probe and Iso-Thermex Multichannel Thermometer (Columbus Instruments, Columbus, OH). The probe will be placed 10 cm beyond the anal sphincter.

Measure: Change in Core Body Temperature (Tcore)

Time: Visits 2 & 3 (subjects with tetraplegia only): Continuously throughout baseline & Thermal Challenge (2 hrs) periods. The change in Tcore from baseline to the end of Thermal Challenge will be determined.

Description: The cognitive battery will be administered once at BL and once after Thermal Challenge in persons with tetraplegia only (Visits 2 & 3). Testing conditions will be identical, quiet, and distraction-free. Wechsler Adult Intelligence Scale-Fourth Edition (WAIS-IV): Subjects will be asked to repeat 2-9 numbers forward, backward and in ascending order to assess attention, processing speed, and working memory. Each assessment requires 10 min.

Measure: Change in Cognitive Performance: WAIS-IV

Time: Visits 2 & 3 (subjects with tetraplegia only): At the end baseline (at 15 min) & end of Thermal Challenge (at 120 min) periods. The change in cognitive performance from baseline to the end of Thermal Challenge will be determined.

Description: Delayed Recall section of the Montreal Cognitive Assessment (MoCA): Subjects will be asked to repeat 5 simple words immediately and then recall them after a 5-minute delay to assess working memory. Each assessment requires 6 min.

Measure: Change in Cognitive Performance: Delayed Recall

Description: Stroop Color and Word: Subjects will be asked to read words of colors, colors of fonts to assess attention and processing speed; color of fonts of words which describe conflicting colors to assess response inhibition (executive functioning). Subjects will practice each of the assessments for approximately 10 seconds prior to the actual test to ensure understanding of the instructions. Each assessment requires 4 min.

Measure: Change in Cognitive Performance: Stroop

Secondary Outcomes

Description: Thermal Comfort will be measured every 10 minutes throughout BL and thermal challenge periods by the Zhang 6-point thermal comfort scale: +3 (very comfortable), +2 (comfortable), +1 (just comfortable), -1 (just uncomfortable), -2 (uncomfortable), and -3 (very uncomfortable). A greater frequency of +1, +2, and +3 scores are considered more desirable than -1, -2, and -3 scores during the Thermal Challenge. Each assessment requires only the time needed for the subject to respond (typically less than 10 seconds).

Measure: Change in Thermal Comfort (TC)

Time: Visits 1, 2, & 3 (all subjects): During baseline & every 10 minutes throughout Thermal Challenge (2 hrs). The change in TC from baseline to the end of Thermal Challenge will be determined.

Other Outcomes

Description: Skin thermocouples (TX-4 Skin Surface probes, Columbus Instruments, Columbus, OH) will be taped to 12 sites on the anterior trunk. Tsk data will be collected continuously throughout the baseline (BL) and Thermal Challenge periods. All areas under the vest will have skin temperatures less than or equal to 39 degrees C.

Measure: Change in Skin Temperature (Tsk) under the heated vest

Time: Visits 2 & 3 (all subjects): Continuously throughout baseline (15 min) & Thermal Challenge (2 hrs) periods. The change in Tsk from baseline to the end of Thermal Challenge will be determined.

Description: Thermal sensation will be measured on the Zhang 9-point Thermal Sensation scale: +4 (very hot), +3 (hot), +2 (warm), +1 (slightly warm), 0 (neutral), -1 (slightly cool), -2 (cool), -3 (cold), and -4 (very cold). TS should be no greater than "warm" this would include identification of "hot spots". Each assessment requires only the time needed for the subject to respond (typically less than 10 seconds).

Measure: Change in Thermal Sensation (TS)

Time: Visit 1 (able-bodied subjects only): During baseline & every 10 minutes throughout Thermal Challenge (2 hrs). The change in TS from baseline to the end of Thermal Challenge will be determined.

3 Improving Activity Engagement Among Persons With SCI During COVID-19

During the current COVID-19 pandemic many spinal cord injury (SCI) rehabilitation services are limited to emergency management, leaving those living in the community without access to services. Unfortunately, this can lead to negative effects including increase in emotional distress, feelings of isolation, and decreased activity engagement. Due to their limited mobility and greater likelihood of respiratory illness it is imperative to provide alternative forms of activity engagement to reduce their risk for secondary complications. Physical activity has been demonstrate to have numerous benefits for individuals with SCI ranging from enhanced health through prevention of secondary complications to improved subjective well-being. The current study proposes to provide an online physical activity program through web-based videoconferencing to person with SCI to improve overall wellbeing and activity engagement. The program will consist of six weeks of twice-weekly, 45-minute sessions in which an experienced fitness instructor (i.e., wheelchair aerobics) with lived experience and a Kinesiology graduate student will lead online sessions. The sessions will be comprised of a 10-minute warm-up phase, a 25-minute aerobic phase and a 10-minute cool-down phase that will incorporate upper-extremity flexibility exercises and guided meditation. In all cases, remote (i.e., in-home) participant monitoring of physiological signals will be conducted by the instructor to ensure safety of participants. Once the program has been completed, participants will be asked to complete self-report questionnaires related to acceptability, feasibility, and limited effectiveness. Participants will also be asked to complete a brief semi-structured interview examining barriers and facilitators of the program. Participant feedback from the interviews will be used to further develop of the program to meet the needs of the population and develop sustainable approaches for access to care in the community setting through collaborations with community partners (SCI Ontario, National SCI Alliance, Ontario Neurotrauma Foundation). Ultimately, the proposed project aims to improve overall wellbeing and access to health care service for those with SCI during the COVID-19 quarantine.

NCT04408287 Spinal Cord Injuries Other: WebEx Physical Activity Program

MeSH:Spinal Cord Injuries

Primary Outcomes

Description: Treatment Satisfaction Questionnaire

Measure: Treatment Satisfaction

Time: 6 weeks

Secondary Outcomes

Description: Spinal Cord Injury - Quality of Life Short Form

Measure: Ability to Participate in Social Roles and Activities

Time: Baseline, 6 weeks, and at 3 month follow-up

Description: Spinal Cord Injury - Quality of Life Short Form

Measure: Fatigue

Time: Baseline, 6 weeks, and at 3 month follow-up

Description: Spinal Cord Injury - Quality of Life Short Form

Measure: Satisfaction with Social Roles and Activities

Time: Baseline, 6 weeks, and at 3 month follow-up

Description: Spinal Cord Injury - Quality of Life Short Form

Measure: Positive Affect and Well-Being

Time: Baseline, 6 weeks, and at 3 month follow-up

Description: Spinal Cord Injury - Quality of Life Short Form

Measure: Pain Interference

Time: Baseline, 6 weeks, and at 3 month follow-up

Description: Spinal Cord Injury - Quality of Life Short Form

Measure: Resilience

Time: Baseline, 6 weeks, and at 3 month follow-up

Description: Spinal Cord Injury - Quality of Life Short Form

Measure: Self-Esteem

Time: Baseline, 6 weeks, and at 3 month follow-up

Other Outcomes

Description: Fear of COVID-19 Scale

Measure: Fear of COVID-19 Scale

Time: Baseline, 6 weeks, and at 3 month follow-up

4 Tracking Needs of Persons With a Spinal Cord Injury (SCI) During the COVID-19 Pandemic

Persons with spinal cord injury (PwSCI) are at a greater risk for major health conditions and poorer health outcomes than persons without spinal cord injury (SCI). They often experience a great deal of health needs both on a physiological level as well as a psychosocial level. PwSCI frequently require supports and services to be able to live independently within the community. These services and supports are sometimes difficult to access within the community when the country is operating under regular capacity, in current times with the global COVID-19 pandemic, the challenges for obtaining and accessing supports and services will become much greater. The proposed project aims to identify the specific needs during this time of crisis and to provide referrals and resources to ameliorate those needs by surveying PwSCI in the St. Louis region. The project also hopes to determine if these persons experience isolation during shelter at home orders. PwSCI, who the investigators serve or have served in the past, will be contacted via phone or e-mail once a month for six months and asked to complete a questionnaire that will allow the investigators to track the participant's needs during the COVID-19 pandemic.

NCT04422769 Spinal Cord Injuries

MeSH:Spinal Cord Injuries Wounds and Injuries

Primary Outcomes

Description: Instrumental Support refers to the perception that people in one's social network are available to provide material or functional aid in completing daily tasks (such as making meals or providing transportation) if needed. This self-report measure for adults (ages 18 and above) is an 8-item calibrated scale.This study will use the measure to determine if people's instrumental support changes during a pandemic.

Measure: NIH Toolbox Instrumental Support Survey - change in instrumental support

Time: Initial, 3 month and 6 month

Secondary Outcomes

Description: A scale designed to measure one's subjective feelings of loneliness as well as feelings of social isolation. Participants rate each of the 3 items as hardly ever, some of the time, or often. This study will use the measure to determine if people feel socially isolated during a pandemic.

Measure: UCLA 3-item Loneliness Scale - change in social isolation

Time: Initial, 3 month and 6 month

5 COVID-19 and Disability: The Impact of a Societal Lockdown on Those With Spinal Cord and Brain Injuries

Document and evaluate the impact of societal restrictions due to the pandemic on SCI- and ABI-related disability and functional impairments, and the resultant effects on psychological wellbeing, physical wellbeing and quality of life for those with SCI/ABI.

NCT04426071 Brain Injuries Stroke Spinal Cord Injuries