Treatment Trials

30 Clinical Trials for Various Conditions

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COMPLETED
A Digital Resilience Intervention for Emergency Medical Service Workers
Description

Emergency medical service (EMS) workers (i.e., ambulance service providers) experience triple the risk for anxiety, depression, and posttraumatic stress disorder (PTSD) compared to the general U.S. population. These mental disorders impact health and well-being across the life course. Thus, there is a critical need for interventions targeting key risk factors that can reduce EMS workers' mental health risk. Chronic stress represents such a risk factor and is a routine feature of the EMS profession due to the demands of providing emergency medical care. Self-Reflective Resilience-Recovery Activity Promotion Training (SRR-RAPT) promotes finding positive meaning in stressors by building self-awareness of the coping and regulatory responses used to manage them; evaluating those responses; adapting them based upon their perceived effectiveness; and developing a plan for managing similar stressors in the future based on what can be learned from the current situation. In addition to prompting self-monitoring and active reflection on stressors and coping responses, SRR-RAPT encourages practicing recovery activities that permit a person's stressor induced strain level to return to baseline. The primary objective of the current study is to evaluate the feasibility, acceptability, and adoptability of SRR-RAPT among EMS personnel. A secondary objective was to examine the intervention's effect on hypothesized mechanisms of action predicted to vary in response to the intervention, as well as consider the intervention's ability to reduce mental health symptoms. It is hypothesized that the intervention will be associated with more positive meaning made, adaptive self-reflection, recovery activities, and recovery experiences, as well as lower levels of mental health symptoms.

RECRUITING
Contingency Management for Recovery Oriented Activities at Recovery Houses
Description

In this study, the investigators will implement contingency management at rural recovery houses, where individuals with substance use disorders reside. Contingency management is a behavioral intervention in which participants receive incentives (rewards) when they complete planned tasks that are consistent with their recovery efforts. House staff members will also participate in this study and will be trained to provide contingency management to residents. The investigators will compare recovery houses that implement contingency management to matched houses that do not, and the main outcomes will be engagement in the planned activities and retention in the recovery houses. Participants will receive contingency management for up to 12 weeks and follow-up will occur 6 months post-treatment.

RECRUITING
The Effect of the Menstrual Cycle on Immune Cell Activity and Recovery After Resistance Exercise
Description

The goal of this observational study is to learn how the menstrual cycle affects immune cell activation, recruitment, and recovery responses after resistance exercise in healthy, resistance-trained women aged 18-40. The main questions it aims to answer are: Does the menstrual cycle influence neutrophil recruitment and adhesion after resistance exercise? Does the menstrual cycle affect markers of muscle damage and functional recovery? Researchers will compare three menstrual phases (early follicular, late follicular, and mid-luteal) to see if immune responses and recovery outcomes differ across these phases. Participants will: Complete resistance exercise protocols across three different menstrual cycle phases. Provide blood samples to assess immune cell activation and muscle damage markers. Track sleep, mood, and recovery with questionnaires and wear an accelerometer.

COMPLETED
Study to Assess the Safety, Tolerability, and Effects of CHI-202 to Support Recovery From Physical Activity
Description

The study is designed as a proof of concept, single-center, randomized, double-blind, placebo controlled study to assess the safety and efficacy of CHI-202 (cannabinoids and other ingredients) compared to placebo in the treatment of Delayed Onset Muscle Soreness (DOMS).

ENROLLING_BY_INVITATION
Understanding Perinatal Spinal Cord Injury
Description

The purpose of this study is to deepen our understanding of children who have a cervical spinal cord injury obtained in utero or at birth and examine the effects of tailored activity-based recovery training (ABRT) in combination with transcutaneous spinal cord stimulation (scTS). This is a within subjects, pre-post design study. Neurophysiological, sensorimotor, and autonomic assessments will occur pre, interim, and post 40 sessions of ABRT in conjunction with scTs.

RECRUITING
Water-based Activity to Enhance Recovery in Long COVID-19
Description

This two-year study will evaluate the feasibility and safety of an exercise + cognitive training program to improve neurological symptoms of long-COVID. This is a two-phased trial: 1) an exercise phase and 2) a cognitive training phase. The exercise phase will be an aquatic based exercise program. A combination exercise + memory training programs designed for persons with cognitive impairment have significantly improved memory more than other single intervention groups (exercise only, cognitive training only) and given the success of combination training programs with healthy adults, it is important to adapt these programs for persons with neurological symptoms of long-COVID.

Conditions
ACTIVE_NOT_RECRUITING
Addressing Arm Non-use by Encouraging Idle-time Activity During Early Recovery from Stroke
Description

This project evaluates the feasibility of using custom wearable technology and associated procedures to increase activity of the more-involved upper extremity during the earliest stages of recovery from stroke by increasing the amount of therapeutic exercise during idle-time. The proposed research is relevant to public health because it takes steps to mitigate a significant problem in physical rehabilitation using low-cost technology to motivate and monitor idle-time exercise without adding significantly to clinician workloads. The project aligns with the NICHD / NCMRR Research Plan on Rehabilitation by exploiting a mobile health (mHealth) and sensor-based approach to promote health and wellness through participant-engaged, data-driven, individualized care.

Conditions
COMPLETED
Health and Recovery Program in Increasing Physical Activity Level in Stage IA-IIIA Endometrial Cancer Survivors
Description

This randomized phase II trial studies how well a health and recovery program works in increasing physical activity level in stage IA-IIIA endometrial cancer survivors. Health and recovery program which includes exercise counseling, Fitbit tracker, and phone or email/text communication may increase the level of physical activity in endometrial cancer survivors and promote and maintain behavior change at a lower cost.

NOT_YET_RECRUITING
Effects of Personalized Exercise Prescriptions Through Mobile Health on Physical Activity and Health Outcomes in the Cancer Survivors
Description

Participation in regular physical activity is vital to a healthy lifestyle. Research has shown that regular participation in physical activity among cancer survivors is not only able to improve health outcomes, but is also related to their quality of life. As we live in an age of technology, health wearables and smartphone apps might be one novel manner by which to help cancer survivors increase physical activity as well as improve health outcomes. Yet, the effectiveness of wearable and app as a tool for health promotion among cancer survivors is largely unstudied. The purpose of this study is to evaluate the effectiveness of a personalized m-health intervention via fitness wearable (Fitbit Inspire 3) exercise app (sFitRx) on physical activity, weight, quality of life, individual beliefs, and emotions among cancer survivors.

NOT_YET_RECRUITING
The Effects of Repeated Operational Stress and Limited Recovery on Resilience Capacity
Description

This longitudinal study will examine the effects of repeated bouts of operational stress and limited recovery on integrated MPS, whole-body protein balance, iron absorption, and aerobic performance. Following baseline characterization measures, active adults (n=24) representative of normal weight phenotype (NW; n=12) and overweight phenotype (OW; n=12) will complete a 48h balance phase preceding two rounds of repeated 72h energy deficit exposure each immediately followed by a 48h recovery phase. NW cutoff will be defined ≤ 22% body fat for males and ≤ 32% body fat for females. OW cutoff will be defined as \>22% body fat for males and \>32% body fat for females. These body composition cutoffs are informed by the maximum allowable percent body fat standards outlined in current Army Regulation 600-9. Additional details for determining % body fat are outlined in the experimental procedures section of the protocol.

RECRUITING
Implementation of IVS3 for Upper Limb Motor Recovery
Description

This study measures participant satisfaction and upper extremity function in outpatients with chronic stroke when exposed to the IVS3 device. Investigators hypothesize that treatment with the IVS3 device will be feasible and tolerable for use in the outpatient setting.

RECRUITING
At-home Walking Cadence Functional Assessment and Recovery Trajectory for Older Adults Undergoing Major Surgery
Description

This is a prospective observational study looking at gait-cadence in older adults who are scheduled to have major abdominal surgery at the University of Chicago. The objective of the study is to evaluate whether gait-cadence, as measured from a patient's mobile device at-home, can provide an accurate assessment of a patient's functional status prior to major abdominal surgery and identify patients at risk of poor functional outcomes.

Conditions
RECRUITING
Activity Restrictions After Inguinal Hernia Repair
Description

This research is intended to be a pilot study to identify differences in outcomes for varied lifting and physical activity precautions following surgical repair of single-sided inguinal hernias. The researchers hypothesize that when given the autonomy to return to activity at the patient's discretion, convalescence will decrease in comparison to a control group given specific precautions to refrain from lifting and strenuous activity. Specific aims include differences in convalescence and surgical outcomes for each group, i.e. rates of complications, hernia recurrence, physical activity assessments pre and postop, and quality of life outcomes.

Conditions
RECRUITING
Hand and Arm Motor Recovery Via Non-invasive Electrical Spinal Cord Stimulation After Stroke
Description

The recovery from a stroke is often incomplete. It is the leading cause of acquired permanent disability in the adult population. Persistent functional loss of the hand and arm contributes significantly to disability. However, the current standard of care to treat hand and arm movements are inadequate. There is an urgent need for innovative and effective therapies for recovery of the upper limb after stroke. Growing evidence shows that electrical spinal cord stimulation, combined with activity-dependent rehabilitation, enables voluntary movement of paralyzed muscles in some neurologic disorders, such as spinal cord injury. The investigators hypothesize that spinal networks that lost control after stroke can be activated by non-invasive electrical stimulation of the spinal cord to improve functional recovery. The aims of the study are: 1. to determine the improvements in hand and arm function that result from the combined application of non-invasive spinal stimulation and activity-based rehabilitation. Surface electrodes placed over the skin of the neck will be used for non-invasive electrical stimulation of the spinal cord. Functional task practice will be used for activity-dependent rehabilitation, 2. to evaluate long-lasting benefits to hand and arm function that persist beyond the period of spinal stimulation.

COMPLETED
Predictors of Recovery and the App-Facilitated Tele-Rehabilitation (AFTER) Program for COVID-19 Survivors
Description

The aim of this study is to investigate the feasibility (safety, adherence) and initial efficacy (physical function and patient reported outcomes) of a multicomponent tele-rehabilitation program during COVID-19 recovery of patients who have been hospitalized due to COVID-19.

RECRUITING
Stroke Rehabilitation, Functional Recovery, and Cost-effectiveness
Description

The investigators will determine the client and non-client variables associated with discharge to an inpatient rehabilitation facility vs. skilled nursing facility in individuals' post-stroke. The investigators will determine how these variables are associated with short-term (discharge from facility) and long-term (6-months post-stroke) function and quality of life.

Conditions
TERMINATED
Improving Hand Recovery With Neuromodulation in Tetraplegia
Description

This study will examine a form of non-invasive brain stimulation applied with intensive therapy of the arm and hand. The goal of the study is to determine if arm and hand function can be improved in people with incomplete cervical spinal cord injury (neck spinal cord injury, tetraplegia). Participants will be assigned to receive either active or inactive non-invasive brain stimulation.

COMPLETED
Transcranial Direct Current Stimulation for Post-stroke Motor Recovery
Description

This research study is to find out if brain stimulation at different dosage level combined with an efficacy-proven rehabilitation therapy can improve arm function. The stimulation technique is called transcranial direct current stimulation (tDCS). The treatment uses direct currents to stimulate specific parts of the brain affected by stroke. The adjunctive rehabilitation therapy is called "modified Constraint-Induced Movement Therapy" (mCIMT). During this therapy the subject will wear a mitt on the hand of the arm that was not affected by a stroke and force to use the weak arm. The study will test 3 different doses of brain stimulation in combination with mCIMT to find out the most promising one.

TERMINATED
Activity-Dependent Transspinal Stimulation in SCI
Description

Robotic gait training is often used with the aim to improve walking ability in individuals with Spinal Cord Injury. However, robotic gait training alone may not be sufficient. This study will compare the effects of robotic gait training alone to robotic gait training combined with either low-frequency or high-frequency non-invasive transspinal electrical stimulation. In people with motor-incomplete SCI, a series of clinical and electrical tests of nerve function will be performed before and after 20 sessions of gait training with or without stimulation.

COMPLETED
Transforming Recovery Through Exercise and Community
Description

The primary aim of this study is to develop a feasible, acceptable, and effective multilevel physical activity (PA) intervention that addresses both individual and interpersonal factors that can be easily scalable and delivered in the context of a methadone clinic. To do so, the investigators will train methadone maintenance treatment (MMT) patients who are already engaging in PA at public health recommended levels to deliver a group-based PA intervention to physically inactive MMT patients at a large community-based methadone clinic. Through the development of interpersonal relationships and social support, the investigators expect that MMT peers who have successfully navigated challenges associated with PA in this population (i.e. depression, smoking, triggers for drug use in environment) will help physically inactive MMT patients increase self-efficacy and motivation for initiating and sustaining PA.

COMPLETED
Patient Ambulation in Post-Op Recovery
Description

The purpose of this study is to create a platform that accurately measures and reports patient physical activity before a procedure, during the hospital stay, and after discharge from the hospital.

COMPLETED
Examination of Balance, Vestibular, and Ocular Functions and Activity Following Concussion
Description

Previous research and position statements have outlined the necessity of balance and gait testing in the post-concussion evaluation of athletes. However, many of the currently available balance testing techniques lack objectivity and sensitivity to the effects of concussion. Such balance impairments may exist following concussion due to disruption of vestibular and/or ocular motor systems. However, no clinically feasible tools have been longitudinally examined to detect gait balance control deficits or to investigate how vestibular or motor dysfunction may lead to gait imbalance. Additionally, participation in physical and cognitive activities post-concussion may affect recovery. While limited evidence exists to support this notion, further investigation is necessary to improve clinical management recommendations. The proposed study will allow for the examination of tools which add value to post-concussion clinical evaluations and study-related outcomes will enhance the understanding of dynamic balance control and vestibular/ocular motor recovery, and their potential for implementation into concussion management protocols.

COMPLETED
The Study of Physical Activity Rewards After Knee Surgery
Description

The objectives of this research are to conduct a proof of concept randomized controlled trial with 200 patients undergoing primary total knee replacement (TKR) at Brigham and Women's Hospital (BWH). The trial will compare levels of physical activity in subjects in the behavioral and economic interventions versus "Usual Care" post TKR.

COMPLETED
EEG Studies of Induction and Recovery From Propofol Induced General Anesthesia
Description

The purpose of this study is to investigate how the commonly used anesthetic drug propofol works in the brain to produce loss of consciousness. While under general anesthesia your brain waves will be measured using electroencephalogram (EEG). On a separate day, the patient's brain will be imaged using magnetic resonance imaging (MRI).

TERMINATED
Esmolol Infusion During Laminectomy: Effect on Quality of Recovery
Description

The purpose of this study is to evaluate the effects of esmolol, a drug which is commonly administered during surgery to help control blood pressure and heart rate, on postoperative pain levels and requirements for pain medication.

Conditions
COMPLETED
Promoting Physical Activity After Colorectal Cancer
Description

Colorectal cancer is the third most common cancer in the U.S. and if detected early, has a favorable prognosis. Colorectal cancer survivors report increased fatigue, low vigor, impaired physical functioning and disturbances in body esteem. However, the group is relatively understudied and the potential benefits of increased physical activity to their recovery have not been examined. This study focuses on enhancing recovery by offering a home-based physical activity program to patients who have completed treatment for colorectal cancer. This study will test the efficacy of the physical activity intervention using a randomized controlled design among 134 patients who have completed treatment for colorectal cancer in the past 2 years. Outcomes will include physical activity behavior, fitness, vigor, fatigue, physical functioning, and body esteem among participants at baseline, 3 (posttreatment), 6 and 12 months. We will also track intervention costs and conduct exploratory analyses of moderators and mediators of change to help guide the future development of physical activity interventions to enhance recovery from colorectal cancer.

RECRUITING
Does Style of Pre-sedation Instructions Improve Patient Outcomes in Ambulatory Anesthesia for Oral and Maxillofacial Surgery?
Description

This randomized controlled trial aims to evaluate the impact of a brief guided visualization exercise on anesthesia-related outcomes in oral and maxillofacial surgery in patients scheduled for ambulatory anesthesia in the oral and maxillofacial surgery clinic. Researchers will compare these patients, who will receive the guided visualization exercise in addition to standardized pre-operative instructions, to patients who will only receive the standardized pre-operative instructions. The following outcomes will be measured for both groups: * A seven-point Anesthesia Experience Survey * Face-Legs-Activity-Cry-Consolability (FLACC) scores at three points in time during the anesthetic - during local anesthesia, during surgery, and fifteen minutes after surgery has concluded * Amount of medications used during the sedation * Length of sedation

COMPLETED
Noninvasive VNS to Facilitate Excitability in Motor Cortex
Description

Transcranial Magnetic Stimulation (TMS) positively influences motor rehabilitation in stroke recovery. Transcutaneous auricular vagus nerve stimulation (taVNS) has shown effects on cortical plasticity. We investigate whether combination of TMS and taVNS is more effective at motor cortex excitability than either modality alone.

COMPLETED
The Effects of Head Trauma on Collegiate Athletes
Description

Recently, researchers and clinicians have examined many different forms of concussion testing aimed to assess if a brain injury has occurred and to what degree it affects the individual being tested. Due to the multifaceted and complex presentation of concussive injuries and the unknown effects of repeated head trauma, it is unlikely that a single test of physiological or behavioral function will reflect the full range of injury-related damages from a concussive event or from a series of cumulative head traumas, as well as the injury response within brain tissue. However, by combining a variety of objective assessments which may detect structural and functional alterations following head trauma into a single study, a clearer understanding of the multi-faceted presentation resulting from head trauma may be identified. The identification of biomarkers and the utilization of objective and clinically feasible tools will provide a method to assess three domains across multiple systems affected by head trauma: 1) the prognostic value of initial concussion assessments to identify injury severity and factors responsible for prolonged recovery, 2) the temporal window of recovery and potential vulnerability of brain tissue post-injury, and 3) the long-term alterations associated with repeated head trauma exposure.

RECRUITING
Multi-functional Neuroprosthetic System for Restoration of Motor Function in Spinal Cord Injury
Description

This study is to evaluate the use of a fully implanted device for providing hand function, reach, and trunk function to individuals with cervical spinal cord injury. Funding Sources: FDA OOPD NIH NINDS