Dataset Information

Remotely Supervised Home-Based Intensive Exercise Intervention to Improve Balance, Functional Mobility, and Physical Activity in Survivors of Moderate or Severe Traumatic Brain Injury: Protocol for a Mixed Methods Study.

ABSTRACT:

Background

Traumatic brain injury (TBI) may impact an individual physically, cognitively, socially, and emotionally. Poor balance, reduced mobility, and low daily physical activity often will require ongoing physical rehabilitation intervention. However, face-to-face specialized physiotherapy is not always accessible for individuals living in rural settings.

Objective

We will answer four questions: (1) What is the feasibility of a remotely supervised, home-based, intensive exercise intervention with survivors of moderate and severe TBI? (2) Does the frequency of remote supervision have an impact on the feasibility of completing a home-based intensive exercise program? (3) Does the frequency of remote supervision impact balance, functional mobility, and physical activity? (4) What is the lived experience of remote supervision for both survivors and caregivers?

Methods

Four participants will complete two intensive, 4-week (five days per week) home-based exercise interventions remotely supervised via synchronous videoconference. Each exercise intervention will have a goal of 160 to 300 repetitions or 60 minutes of tailored exercises to promote neuroplasticity and be defined as an intensive home-based exercise intervention. An alternating single-subject design will allow for the comparison between two frequencies of remote supervision, once weekly and five times weekly. Daily repeated outcome measures, pre- and postintervention outcome measures, and 1-month follow-up outcome measures will be collected to explore the effect on feasibility and physical variables. Daily outcome measures include step count and Five Times Sit-to-Stand test. Pre-post measures include assessment of quiet stance and the Community Balance and Mobility Scale. A semistructured interview will be completed at the end of each intervention segment to document the lived experience of both survivors and their study partners. Finally, five questionnaires will be used to understand the overall experience: the Mayo-Portland Adaptability Inventory-4 Participation Index, Satisfaction With Life Scale, Fall Efficacy Scale-International, Interpersonal Behavior Questionnaire, and System Usability Scale. Data will be analyzed following traditional single-subject methods of analysis.

Results

Ethics approval was received from both the Bruyère Research Institute and University of Ottawa review boards in March 2019. Recruitment is underway.

Conclusions

The proposed intervention is complex in nature due to the involvement of multiple technology sources and the inclusion of a complex dyad (survivors and caregivers) in a community setting. This type of research is timely given that alternative methods of physical intervention delivery are needed to facilitate gains in balance, mobility, physical activity among TBI survivors with limited access to clinical care, and the quality of the patients' experience.

International registered report identifier (irrid)

PRR1-10.2196/14867.

SUBMITTER: O'Neil J

PROVIDER: S-EPMC6812480 | biostudies-literature | 2019 Oct

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Remotely Supervised Home-Based Intensive Exercise Intervention to Improve Balance, Functional Mobility, and Physical Activity in Survivors of Moderate or Severe Traumatic Brain Injury: Protocol for a Mixed Methods Study.

O'Neil Jennifer J Egan Mary M Marshall Shawn S Bilodeau Martin M Pelletier Luc L Sveistrup Heidi H

JMIR research protocols 20191009 10

<h4>Background</h4>Traumatic brain injury (TBI) may impact an individual physically, cognitively, socially, and emotionally. Poor balance, reduced mobility, and low daily physical activity often will require ongoing physical rehabilitation intervention. However, face-to-face specialized physiotherapy is not always accessible for individuals living in rural settings.<h4>Objective</h4>We will answer four questions: (1) What is the feasibility of a remotely supervised, home-based, intensive exercis ...[more]

PMID: 31599733

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Project description:BackgroundCurrently, there are no FDA approved therapies for persistent post-traumatic headache (PPTH) secondary to traumatic brain injury (TBI). As such neither headache nor TBI specialists have an effective means to manage PPTH. Thus, the objective of the present pilot trial was to evaluate the feasibility and preliminary efficacy of a four-week at-home remotely supervised transcranial direct current stimulation (RS-tDCS) intervention for veterans with PPTH.MethodsTwenty-five (m = 46.6 ± 8.7 years) veterans with PPTH were randomized into two groups and received either active (n = 12) or sham (n = 13) RS-tDCS, with anodal stimulation over left dlPFC and cathodal over occipital pole. Following a four-week baseline, participants completed 20-sessions of active or sham RS-tDCS with real-time video monitoring over a period of four-weeks. Participants were assessed again at the end of the intervention and at four-weeks post-intervention. Primary outcomes were overall adherence rate (feasibility) and change in moderate-to-severe headache days per month (efficacy). Secondary outcomes were changes in total number of headache days, and PPTH-related functional outcomes.ResultsAdherence rate was high with 88% of participants (active = 10/12; sham = 12/13) fully completing tDCS interventions. Importantly, there was no significant difference in adherence between active and sham groups (p = 0.59). Moderate-to-severe headache days were significantly reduced within the active RS-tDCS group (p = 0.004), compared to sham during treatment (-2.5 ± 3.5 vs. 2.3 ± 3.4), and 4-week follow-up (-3.9 ± 6.4 vs. 1.2 ± 6.5). Total number of headache days was significantly reduced within the active RS-tDCS (p = 0.03), compared to sham during-treatment (-4.0 ± 5.2 vs. 1.5 ± 3.8), and 4-week follow-up (-2.1 ± 7.2 vs. -0.2 ± 4.4).ConclusionThe current results indicate our RS-tDCS paradigm provides a safe and effective means for reducing the severity and number of headache days in veterans with PPTH. High treatment adherence rate and the remote nature of our paradigm indicate RS-tDCS may be a feasible means to reduce PPTH, especially for veterans with limited access to medical facilities.Clinical Trial Registration: ClinicalTrials.gov, identifier [NCT04012853].

Project description:ObjectiveThis study aims to explore the feasibility, safety, and effectiveness of home exercise prehabilitation on a new social platform for remote guidance to optimize the physical function of patients with end-stage renal disease awaiting kidney transplantation and provide scientific guidance on home prehabilitation exercises for patients awaiting kidney transplantation.MethodsThe subjects of this randomized clinical trial were randomly divided into the test and control groups. The control group maintained their exercise habits, while the trial group was given a 12-week personalized home prehabilitation exercise prescription (aerobic exercise + functional resistance exercise + flexibility exercise) on a new social platform with remote guidance. The participants' physical and cardiorespiratory fitness, quality of life, and psychological functioning were assessed before and after the intervention. The 6-min walk test (6MWT) walking distance and its percentage of attainment, the handgrip, the 5 repetition-sit-to-stand test, and the 4-m gait speed were used as primary outcome indicators, while the Short Form Health Survey SF-36 (health survey summary table) and the Hospital Anxiety and Depression scale were used as the secondary outcome indicators.ResultsAfter 12 weeks of intervention, the changes in the 6MWT measured distance (+ 44.9 ± 40.2, P = 0.001) and the percentage of 6MWT measured distance achieved (+ 6.8 ± 5.7, P = 0.001), the handgrip (+ 2.7 ± 4.3, P = 0.028), the 5-sit-to-stand test (-1.1 ± 1.4, P = 0.005), and the 4-m walking speed (-0.3 ± 0.4, P < 0.001) of the test group (n = 21) improved significantly. In the control group (n = 16), the changes in the 6MWT measured distance (-13.1 ± 57.2), the 6MWT measured distance attainment percentage (-2.1 ± 9.1), the handgrip (-0.1 ± 2.5), the 5-sit-to-stand test value (0.6 ± 2.2), and the 4-m walking speed (0.2 ± 0.5) showed no significant difference. No significant improvement in anxiety, depression, and SF-36 was noted in both the test and control groups.ConclusionThe remote coaching of home exercise pre-habilitation on a new social platform significantly improves the physical and cardiopulmonary fitness of patients with end-stage renal disease awaiting kidney transplantation. This treatment is safe and feasible in this population.

Project description:BackgroundSeveral studies have reported that using the Wii™ Balance Board can provide added value regarding balance (re-)training in neurological diseases. However, for the large group of mobile older stroke survivors, there is no evidence regarding the feasibility of an unsupervised Wii™ Balance Board training in the home setting. The aim of this study was to investigate the feasibility of a home-based Wii™ balance training for these patients and to identify methodological challenges for randomised controlled trials in the future.MethodsWe conducted a pilot randomised controlled trial with two intervention arms in participants' homes. Mobile stroke survivors (aged 60 years or above; 12 weeks after discharge from hospital) received a 6-week (once per week) supervised balance training at the study centre, followed by a 6-week (three times per week) unsupervised balance training at home. We used the Nintendo Wii™ Balance Board for one intervention arm and conventional balance exercises for the other intervention arm. Feasibility was assessed by recruiting rates, appropriateness of assessments regarding sensitivity to changes and acceptance of the intervention by the participants.ResultsIn two German hospital stroke units, 349 stroke survivors were screened over a period of 6 months, 91 were eligible and 52 were interested. Twelve weeks after discharge, 14 participants agreed and 11 completed the intervention (7 men and 4 women, mean age 74 years). The Berg Balance Scale and Dynamic Gait Index showed ceiling effects already at baseline measure. The participants in both intervention arms evaluated the unsupervised training positively and feasible for self-application. No falls or injuries occurred over the intervention period, while the required scope of the exercises could largely be achieved.ConclusionsIn this pilot study, the recruitment of participants and the chosen assessments were not satisfactory due to selection bias and corresponding ceiling effects. However, the two home-based balance interventions proved feasible for mobile older stroke survivors with low functional limitations.Trial registrationClinicalTrials.gov, NCT02251470. Registered 29 September 2014.

Project description:BackgroundTranscranial direct current stimulation (tDCS) is a non-invasive brain stimulation technique that has been shown to improve common symptoms of neurological disorders like depressed mood, fatigue, motor deficits and cognitive dysfunction. tDCS requires daily treatment sessions in order to be effective. We developed a remotely supervised tDCS (RS-tDCS) protocol for participants with multiple sclerosis (MS) to increase accessibility of tDCS, reducing clinician, patient, and caregiver burden. The goal of this protocol is to facilitate home use for larger trials with extended treatment periods. In this study we determine the generalizability of RS-tDCS paired with cognitive training (CT) by testing its feasibility in participants with Parkinson's disease (PD).MethodsFollowing the methods in our MS protocol development, we enrolled sixteen participants (n = 12 male, n = 4 female; mean age 66 years) with PD to complete ten open-label sessions of RS-tDCS paired with CT (2.0 mA × 20 min) at home under the remote supervision of a trained study technician. Tolerability data were collected before, during, and after each individual session. Baseline and follow-up measures included symptom inventories (fatigue and sleep) and cognitive assessments.ResultsRS-tDCS was feasible and tolerable for patients with PD, with at-home access leading to high protocol compliance. Side effects were mostly limited to mild sensations of transient itching and burning under the electrode sites. Similar to prior finding sin MS, we found preliminary efficacy for improvement of fatigue and cognitive processing speed in PD.ConclusionsRS-tDCS paired with CT is feasible for participants with PD to receive at home treatment. Signals of benefit for reduced fatigue and improved cognitive processing speed are consistent across the PD and MS samples. RS-tDCS can be generalized to provide tDCS to a range of patients with neurologic disorders for at-home rehabilitation.Trial registrationClinicalTrials.gov Identifier: NCT02746705 . Registered April 21st 2016.

Dataset Information

Remotely Supervised Home-Based Intensive Exercise Intervention to Improve Balance, Functional Mobility, and Physical Activity in Survivors of Moderate or Severe Traumatic Brain Injury: Protocol for a Mixed Methods Study.

Background

Objective

Methods

Results

Conclusions

International registered report identifier (irrid)

Publications

Remotely Supervised Home-Based Intensive Exercise Intervention to Improve Balance, Functional Mobility, and Physical Activity in Survivors of Moderate or Severe Traumatic Brain Injury: Protocol for a Mixed Methods Study.

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