Physical Therapy for Traumatic Brain Injury (B-HIST Trial)
Palo Alto (17 mi)Overseen byCandy Tefertiller, DPT, PhD
Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: Craig Hospital
No Placebo Group
Prior Safety Data
Trial Summary
What is the purpose of this trial?This study will explore whether the types and intensity of the interventions being delivered will yield measurable cognitive benefits in addition to improved mobility and balance.
The study evaluates three therapeutic approaches to improve mobility and balance after traumatic brain injury (TBI): Conventional Gait and Balance Training, high intensity step training, and high intensity step training with virtual reality.
Is High Intensity Step Training a promising treatment for traumatic brain injury?The research articles suggest that various physical therapy methods, like treadmill training and circuit training, show promise in improving movement and balance in people with traumatic brain injury. High Intensity Step Training, which focuses on intense physical activity, could also be promising because it aims to improve similar aspects of movement and balance.12458
What safety data exists for high-intensity physical therapy in traumatic brain injury treatment?The available research indicates that high-intensity physical therapy, including aerobic exercise and rapid-resisted training, is generally safe for individuals with traumatic brain injury (TBI). Studies have shown no adverse events in trials involving aerobic exercise and rapid-resisted elliptical training for TBI patients. These interventions have been associated with improvements in cardiorespiratory fitness, balance, and mood symptoms without reported safety concerns. However, adherence to exercise protocols remains a challenge, and further research is needed to optimize these interventions for TBI patients.4791011
What data supports the idea that Physical Therapy for Traumatic Brain Injury is an effective treatment?The available research shows that physical therapy, including high-intensity training and other exercise programs, can be effective for people with traumatic brain injury (TBI). For example, a study on rapid-resisted elliptical training found improvements in balance, sleep quality, and mood in adults with TBI. Another case report on home-based circuit training for a teenager with severe TBI showed better walking speed, energy use, and self-perception after just four weeks. These findings suggest that physical therapy can help improve various aspects of life for those with TBI, making it a promising treatment option.13456
Do I have to stop taking my current medications for this trial?The trial protocol does not specify whether you need to stop taking your current medications. However, you must be medically cleared for high intensity step training by a physician, which might involve reviewing your medications.
Eligibility Criteria
This trial is for adults who've had a traumatic brain injury (TBI) and are experiencing slower walking speeds. They should be within six months post-injury, weigh under 298 pounds, be shorter than 6'2", able to walk ten feet with minimal assistance, and have completed initial inpatient rehab for TBI. Those with uncontrolled health issues or participating in other trials can't join.Treatment Details
The study tests three methods to improve mobility after TBI: standard gait and balance training; high intensity step training (HIST); and HIST combined with virtual reality. It aims to see if these treatments also enhance cognitive functions alongside physical abilities like balance.
3Treatment groups
Experimental Treatment
Active Control
Group I: High Intensity Step Training with Virtual Reality (HISTVR)Experimental Treatment1 Intervention
The third arm combines virtual reality with HIST, designed to increase cortical excitability while concurrently activating the neuromuscular system.
Group II: High Intensity Step Training (HIST)Experimental Treatment1 Intervention
High Intensity Step Training (HIST) focuses on the repetition of stepping at higher cardiovascular intensities and yielding a greater number of steps per training session.
Group III: Conventional Gait and Balance Training (CGBT)Active Control1 Intervention
The current approach for walking retraining, Conventional Gait and Balance Training (CGBT) focuses on walking training in a variety of conditions, obstacle management training, functional independence training, strength training, and standing dynamic balance training.
Find a clinic near you
Research locations nearbySelect from list below to view details:
Craig HospitalEnglewood, CO
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Who is running the clinical trial?
Craig HospitalLead Sponsor
References
Gait rehabilitation with body weight-supported treadmill training for a blast injury survivor with traumatic brain injury. [2014]Research supports the use of body weight-supported treadmill training (BWSTT) in patients with hemi-paresis and may show promise as a gait training and neuromuscular re-education intervention in the blast-injured, traumatic brain injury (TBI) population. The purpose of this case study is to document the use BWSTT and goal-directed therapy in the improvement of gait quality, gait speed and maximum distance ambulated in a blast injury survivor with TBI.
[Physical therapy for persons with traumatic brain injury]. [2018]Traumatic brain injury is a major public health problem and may result in significant impairment of an individual's physical, cognitive, and psychosocial functioning. Therefore, special attention must be paid to physical therapy that plays an important role in early rehabilitation. Physical therapists have the opportunity to apply various scales and tests for assessment of the functional status of patients with traumatic brain injury and effectiveness of physical therapy: Functional Independence Measure, Disability Rating Scale, Barthel Index, Glasgow Coma Scale, Glasgow Outcome Scale, Rancho Los Amigos Scale, Mini-Mental State Examination, etc. This review presents the analysis of morbidity and mortality after traumatic brain injury, possibilities to assess patients' functional status, characteristics of physical therapy, and factors influencing the efficiency of physical therapy. Complications such as contractures, spasticity, sleep disturbances, impaired balance, as well as the attention and behavior disorders, lack of motivation, depression make difficulties in application of physical therapy and rehabilitation for the persons with traumatic brain injury.
Physical exercise ameliorates deficits induced by traumatic brain injury. [2012]The extent and depth of traumatic brain injury (TBI) remains a major determining factor together with the type of structural insult and its location, whether mild, moderate or severe, as well as the distribution and magnitude of inflammation and loss of cerebrovascular integrity, and the eventual efficacy of intervention. The influence of exercise intervention in TBI is multiple, ranging from anti-apoptotic effects to the augmentation of neuroplasticity. Physical exercise diminishes cerebral inflammation by elevating factors and agents involved in immunomodulatory function, and buttresses glial cell, cerebrovascular, and blood-brain barrier intactness. It provides unique non-pharmacologic intervention that incorporate different physical activity regimes, whether dynamic or static, endurance or resistance. Physical training regimes ought necessarily to be adapted to the specific demands of diagnosis, type and degree of injury and prognosis for individuals who have suffered TBI.
Effects of a rapid-resisted elliptical training program on motor, cognitive and neurobehavioral functioning in adults with chronic traumatic brain injury. [2023]This small clinical trial utilized a novel rehabilitation strategy, rapid-resisted elliptical training, in an effort to increase motor, and thereby cognitive, processing speed in ambulatory individuals with traumatic brain injury (TBI). As an initial step, multimodal functional abilities were quantified and compared in 12 ambulatory adults with and 12 without TBI. After the baseline assessment, the group with TBI participated in an intensive 8-week daily exercise program using an elliptical trainer and was reassessed after completion and at an 8-week follow-up. The focus of training was on achieving a fast movement speed, and once the target was reached, resistance to motion was increased in small increments to increase intensity of muscle activation. Primary outcomes were: High-Level Mobility Assessment Tool (HiMAT), instrumented balance tests, dual-task (DT) performance and neurobehavioral questionnaires. The group with TBI had poorer movement excursion during balance tests and poorer dual-task (DT) performance. After training, balance reaction times improved and were correlated with gains in the HiMAT and DT. Sleep quality also improved and was correlated with improved depression and learning. This study illustrates how brain injury can affect multiple linked aspects of functioning and provides preliminary evidence that intensive rapid-resisted training has specific positive effects on dynamic balance and more generalized effects on sleep quality in TBI.
Home-based circuit training program for an adolescent female with severe traumatic brain injury: A case report. [2018]Adolescents with traumatic brain injury (TBI) are often discharged from physical therapy (PT) services without transitioning into exertional conditioning programs. Active participation in physical activities with peers at school is essential to achieve a sense of accomplishment and acceptance. Factors such as reduced aerobic fitness and residual gait impairments can lead to limited participation and peer interaction. The purpose of this case report was to describe the impact of home-based circuit training (HBCT) focusing on strength and balance on gait speed (GS), energy expenditure, and functional performance in a 17-year-old female with severe TBI. The participant sustained a TBI from a motor vehicle crash. Although she was ambulatory and independent with the basic activities of daily living following two years of rehabilitation, she presented with activity limitations and participation restrictions at school. The participant performed a 4-week HBCT program developed by a school physical therapist that focused on strength and balance. At the end of 4 weeks, improvements were observed in 6 MWT (change = 79.7 m), GS (change = 0.22 m/s), and the COPM scores (performance score change = 2.8, satisfaction score change = 2.2, MCID = 2). Improvements in functional performance, gait speed, and self-perception of occupational performance were observed following 4-week HBCT. Future clinical trials on short duration, HBCT program for children and young adults with TBI are recommended in order to establish effectiveness of HBCT.
Feasibility of single session high-intensity interval training utilizing speed and active recovery to push beyond standard practice post-stroke. [2022]Improvement in overground walking speed reduces dependency and is a central focus in post-stroke rehabilitation. Previous studies have shown that high-intensity interval training (HIT) can significantly improve functional and health-related outcomes in neurologically health individuals more so than traditional approaches. Emerging evidence suggests the same may be true post-stroke.
A proof-of-concept trial of a community-based aerobic exercise program for individuals with traumatic brain injury. [2021]Objective: To assess the feasibility of conducting an aerobic exercise training study in a community setting for individuals with traumatic brain injury (TBI)Methods: This is a prospective, randomized, and controlled study. Nine participants (three moderate-to-severe and six mild TBI) were randomized to a community-based 3-month individualized aerobic exercise training program (AET). Seven participants (four moderate-to-severe, three mild TBI) were randomized to a stretching and toning program (SAT). Cardiorespiratory fitness (CRF) level was assessed with peak oxygen uptake (VO2peak) testing.Results: After 3 months of training, the AET trended toward improved VO2peak when compared with the SAT group (8% vs - 4%, p = .059) with a large effect size of 1.27. Only 50% of participants in the AET group completed more than 70% of the assigned exercise sessions. No adverse events were reported. Both the AET and SAT groups reported small improvements in self-reported mood symptoms, including depression, anxiety, and anger.Conclusions: It is feasible to conduct an exercise training study and improve CRF for persons with TBI in community settings with structured exercise protocols. However, exploring methods to enhance adherence is crucial for future exercise clinical trials to improve brain health in this population.
Feasibility of a rhythmic auditory stimulation gait training program in community-dwelling adults after TBI: A case report. [2021]Traumatic brain injury has multiple impacts on gait including decreased speed and increased gait variability. Rhythmic auditory stimulation (RAS) gait training uses the rhythm and timing structure of music to train and ultimately improve slow and variable walking patterns.
The timeframe for safe resumption of high-level mobility following traumatic brain injury is currently unknown: a systematic review. [2022]To examine the safety of high-level mobility (HLM) prescription in the early sub-acute phase of recovery following moderate-to-extremely severe traumatic brain injury (TBI) with specific focus on provocation of concussion-like symptoms.
Physical exercise for people with mild traumatic brain injury: A systematic review of randomized controlled trials. [2022]Recent research recommends physical exercise rather than rest following a mild traumatic brain injury (mTBI).
An At-Home, Virtually Administered Graded Exertion Protocol for Use in Concussion Management: Preliminary Evaluation of Safety and Feasibility for Determining Clearance to Return to High-Intensity Exercise in Healthy Youth and Children With Subacute Concussion. [2023]Graded exertion testing (GXT) is an important tool for concussion management, as it is used to personalize post-concussion exercise prescription and return athletes to sport. However, most GXT requires expensive equipment and in-person supervision. Our objective was to assess the safety and feasibility of the Montreal Virtual Exertion (MOVE) protocol, a no-equipment, virtually compatible GXT, in healthy children and children with subacute concussion. The MOVE protocol consists of seven stages of bodyweight and plyometric exercises performed for 60 sec each. Twenty healthy (i.e., non-concussed) children completed the MOVE protocol virtually over Zoom Enterprise. Next, 30 children with subacute concussion (median: 31.5 days post-injury) were randomized to the MOVE protocol or Buffalo Concussion Treadmill Test (BCTT), which increases the incline or speed of the treadmill every minute until maximum exertion. Out of an abundance of caution, all concussed participants completed the MOVE protocol in an in-person clinical space. However, the test evaluator was stationed in a different room within the clinic and administered the MOVE protocol using Zoom Enterprise software to mimic telehealth conditions. Safety and feasibility outcomes were recorded throughout GXT, including heart rate, rate of perceived exertion (RPE), and symptom outcomes. No adverse events were recorded, and all feasibility criteria were successfully met in healthy youth and youth with concussion. Among concussed youth, increases in heart rate (MOVE: 82.4 ± 17.9 bpm, BCTT: 72.1 ± 23.0 bpm; t(28) = 1.36, p = 0.18), RPE (MOVE: 5.87 ± 1.92, BCTT: 5.07 ± 2.34, t(28) = 1.02, p = 0.32), and overall symptom presentation were similar between the MOVE and BCTT protocols. The MOVE protocol is a safe and feasible GXT in healthy youth and youth with subacute concussion. Future studies should assess the fully virtual administration of the MOVE in children with concussion, MOVE protocol tolerability in children with acute concussion, and whether the MOVE protocol can be used to guide individualized exercise prescription.