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NCT06343415
The goal of this randomised cross-over feasibility trial is to investigate two intensive robot-assisted training therapies in the early rehabilitation phase after acquired brain injury and disorders of consciousness. The main questions it aims to answer are: * Is the protocol feasible concerning inclusion in the study? * Is the protocol feasible concerning protocol completion? Participants will randomly be assigned to either five days of robot-assisted gait training (GAIT), two days of pause, then five days of robot-assisted step training (STEP) or vice versa. The investigators will explore and compare safety events, physiological measures and physical activity levels, behavioural measures, and functional disability outcomes. Further, the investigators report intervention and technical parameters in detail.
NCT04860973
A non-blinded randomised controlled feasibility study of weighted blankets to help agitation and disturbed sleep after brain injury. This is a single centre study based in a community hospital in the UK. Outcomes centre on determining the feasibility and acceptability of the study taking place in an NHS setting.
NCT07386314
The overall objective of the study is to compare upper limb cognitive and motor rehabilitation programs delivered via tele-rehabilitation and in-person, in order to evaluate their overall impact on the rehabilitation process of subjects with GCA outcomes at the end of the subacute phase.
NCT07378592
The aim of this project is to prepare adults with acquired brain injuries for on-road driving by using the driving simulator and increase participant's comfort level, confidence, and independence within their occupation of driving. The occupational therapy faculty are interested in identifying the impact driving simulation training has on individuals with acquired brain injuries and how it prepares them for on-road driving. We hope that the information from this project will help us gather information on how driving simulation training improves pre-driving skills related to comfort, confidence, and independence.
NCT06464549
Assessment of consciousness and attention in individuals with severe Acquired Brain Injury (sABI) is crucial for planning rehabilitation, but it is often hindered by coexisting sensory-motor and/or cognitive-behavioural disorders. This project aims at evaluating the value of spontaneous eye blinking features to assess patients' attentional abilities and to distinguish patients with unresponsive wakefulness syndrome (UWS) from those in minimally conscious state (MCS). Patients will undergo an EEG-EOG recording at rest and during an auditory oddball task. Eye blinking features on EOG will be analysed and compared to that of healthy individuals. A machine-learning-based algorithm using blinking features for the diagnosis of patients with sABI will be studied and validated preliminarily. This project will help to stratify patients with sABI using easy-to-detect clinical markers, supporting clinicians' decision-making about patient's management. Additionally, blinking patterns related to residual attentional abilities in patients emerged from disorders of consciousness will be investigated.
NCT07303075
Children and young people with acquired brain injury (ABI) commonly experience long-term emotional, behavioural, and participation difficulties that can affect quality of life for both them and their families. Parents and caregivers also often experience high levels of stress and reduced wellbeing. Despite these needs, family-centred psychological interventions remain limited. Acceptance and Commitment Therapy (ACT) is a values-focused cognitive-behavioural approach designed to increase psychological flexibility and has shown promise for children with long-term health conditions and for parents of children with ABI, but it has not been directly evaluated as a joint therapeutic approach for children with ABI and their parents. This study (Family CARE-ABI) evaluates the feasibility, acceptability, and preliminary effectiveness of delivering ACT simultaneously to a young person aged 11-18 with an ABI and their parent/guardian. Up to six dyads will be recruited. The study uses a non-concurrent, multiple-baseline, single-case experimental design in which dyads are randomised to begin a 12-week ACT intervention after either a 3- or 4-week baseline period. Sessions (up to 12, one hour each) are delivered via Microsoft Teams by a trainee clinical psychologist under specialist supervision. Therapy integrates the DNA-V model of ACT-developed for young people-with ABI-specific psychoeducation and skills practice tailored to each dyad's needs. Outcome measures include mental health and wellbeing (Outcome Rating Scale), psychological flexibility (CompACT or AFQ-Y8), symptoms of anxiety and depression (GAD-7, PHQ-9, or RCADS-25), community participation (CASP/CASP-Y), and needs after ABI (MANTIC). Measures are collected at baseline, post-intervention, and 12-week follow-up, with weekly wellbeing ratings throughout participation. Therapeutic alliance (SRS) is obtained after each intervention session. All dyads will also take part in separate qualitative interviews exploring their experiences of the intervention and its impact. Safety is closely monitored, including assessment of distress, adverse events, and any safeguarding concerns. Participation is voluntary, and dyads may withdraw at any time without affecting usual care. Data are stored securely and anonymised for analysis. The study aims to generate early evidence regarding whether family-centred ACT may support psychological wellbeing, flexibility, and participation for young people with ABI and their parents, and to inform future intervention development and larger-scale trials.
NCT04930822
The Bioness Integrated Therapy System (BITS) (Bioness Inc. Valencia, CA) Touch Screen is an FDA approved device comprised of an interactive touchscreen and diverse program options to challenge patients through the use of visual motor activities, visual and auditory processing, cognitive skills, and endurance training. The purpose of this study is to enroll a small group of adults currently undergoing inpatient rehabilitation, who were admitted for an acute neurological event and present with an acute neurological visual field impairment. The primary objective is to compare any increase in visual field awareness using a prescribed regimen consisting of conventional vision exercises compared with a regimen using BITS touch screen technology. Participants will be alternately assigned into "A" and "B" groups upon enrollment. The control group "A" will be prescribed conventional (table top, pen and paper) vision interventions provided by an occupational therapist and will receive pre- and post- assessment of visual field awareness. Treatment group "B" will include a prescribed regimen with use of BITS touch screen technology. Group B participants will receive the same pre- and post- assessment of visual field awareness as Group A participants. The hypothesis is that incorporation of the BITS touch screen technology, being more interactive, will result in better outcomes for visual field awareness. This is an unblinded quasi-randomized control trial that will determine best treatment intervention for visual field impairment. Safety will be measured by the number of reported adverse events. The study period will include 6 sessions per participant, conducted at one site, with the objective of enrolling at least 30 participants to have 15 participants in each study group.
NCT06774287
Rationale: Acquired brain injury (ABI) often results in memory deficits that can have a big impact on social and vocational functioning of patients. Rehabilitation treatment of memory dysfunction consists of optimizing memory performance by using effective compensation strategies. Several effective memory-strategy training programs have been developed. However, these often contain labor-intensive treatment protocols that are possibly an overtreatment of ABI patients with relatively mild memory impairments. On the other hand there is a sprawl of commercial computerized cognitive training programs or 'brain games' available that claim to restore memory function. However, research has repeatedly shown that treatment effects of available brain games do not generalize to daily life functioning. With the shortcomings of current memory treatment programs in mind, the investigators developed a combined computerized and face-to-face training of memory strategies, which consists of a shortened traditional face-to-face treatment combined with an innovative Brain Game based on compensation strategies instead of restorative training. This is a promising cost-effective intervention that provides the possibility of repeated practice at home to train compensatory strategies in a safe and imaginative digital environment. The hypothesis is the strategy training will promote generalization, also after rehabilitation ends. Objective: The primary objective is the evaluation of the potential positive effect of the combined computerized and face-to-face memory treatment on effective memory strategy use and reducing subjective memory failures in ABI patients with memory deficits in the chronic phase of acquired brain injury (\>3 months after injury). Study design: The study will be a multiple-baseline across individuals single-case experimental design (SCED). Three patients will receive treatment as usual and three patients will receive a shortened treatment combined with the game, which will be referred to as the 'Karman Line memory strategy training'. Study population: The study population consists of patients referred for outpatient cognitive rehabilitation. Participants eligible for the study must have memory deficits and complaints due to Acquired Brain Injury (ABI) of nonprogressive nature (i.e. TBI, stroke), with a minimum time post-onset of 3 months. Age has to be between 18 and 75 and participants have to live independently at home. Memory deficits will be assessed by neuropsychological examination, memory complaints will be assessed by the Everyday Memory Questionnaire-Revised (EMQ-R). In one year six to eight participants will be recruited. Intervention: The Karman Line memory strategy training consists of six weekly treatment sessions under the guidance of a therapist. The protocol is a shortened version of an existing memory strategy training (treatment as usual), which contains ten sessions. In the sessions, patients get information about memory and memory strategies and learn to apply those to their personal treatment goals. Inbetween the sessions, the participant will work on personal memory goals and practice the strategies by playing the corresponding levels of the memory game at home. Main study parameters/endpoints: The main study parameter is the three most commonly reported memory complaints selected from the 13-item scale of the EMQ-R. The primary outcome measure is not the EMQ-R, but a personalized set of measurement VAS-scales for each patient. Secondary study parameters include the impact of memory problems on activities and participation, the achievement of personalized treatment goals, objective strategy use, objective memory functioning, metacognitions about memory and measures of feasibility by patients and practitioners. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: The burden in the study consists of participating in repeated measurements, therapy sessions, and homework assignments. All tests and methods that are used are non-invasive and not stressful for the patient. All tests and tasks will be based on widely-used validated and reliable paper-pencil or computer tasks. Treatment is non-invasive and scarcely stressful: a therapist will always be present and assess the patient's burden and eventually take appropriate measures such as inserting a resting break.
NCT05897593
Factors related to successful rehabilitation in acquired brain injury (ABI) are often directly related to adherence; for instance, dosage, frequency, and intensity can burden the patient regarding time and motivational factors. Regarding salience, patients may lose interest or find a traditional intervention boring after a few sessions. It is well documented that nonadherence not only impacts rehabilitation for patients but can also further prolong treatment, and increase hospital and clinician costs, in addition to a higher prevalence of future comorbidities. Additionally, the same factors that are related to can impact adherence are also related to neuroplasticity. Therefore, strategies that improve patient adherence can significantly help optimize patient care and treatment outcomes for those with ABI. The gamification of rehabilitation therapies using augmented reality (AR) may help promote adherence. Gamification of rehabilitation therapy can make mass practice required in rehabilitation therapies seemingly fun and more personally engaging for the patient. Additionally, the experience achieved through AR can further promote salience and be customizable to individual patient requirements. As AR systems are now highly portable, cost-effective, and relatively simple to utilize, they can provide an excellent opportunity to provide more engaging rehabilitation approaches compared to standard care alone. AR gamification of rehabilitation may increase adherence by shifting patients' perspectives of therapy as tedious, boring, or a hassle, to a fun and engaging game that ultimately helps their recovery processes. The GlenXRose AR-delivered ABI program (developed by the Cognitive Projections Lab, University of Alberta) has been created in collaboration with the Glenrose Rehabilitation Hospital with the overall goal of increasing patient adherence, treatment outcomes, and satisfaction with ABI rehabilitation therapy. The proposed studies are to investigate the feasibility of implementing this technology alongside routine clinical care, obtaining clinician feedback, examining associated financial costs, and continuing to examine the effect of the GlenXRose AR ABI-therapies on patient adherence and clinical outcomes, compared to traditional clinical care alone.
NCT06804486
Exercise and physical activity in children with pediatric acquired brain injury
NCT07119827
This study aims to evaluate the potential effects of premorbid personality on the short- and long-term global cognitive recovery in patients with severe acquired brain injury (sABI) or stroke. The secondary aims are to assess the effects of premorbid personality on the sort- and long-term recovery in autonomy (disability), cognitive functions, psycho-behavioral functioning, motor skills, and social participation. Evaluate the incidence of premorbid personality alterations. Investigate personality changes 12-18 months after the neurological event.
NCT06800040
The purpose of this study is to assess the feasibility, acceptability, and effectiveness of a 6-week group-based memory training program for individuals experiencing memory problems after acquired brain injury (ABI). Memory impairment is a prevalent consequence of neurological disorders like stroke, traumatic brain injury (TBI), anoxia, brain tumours, or brain infections, collectively termed acquired brain injury (ABI). While memory rehabilitation has shown promise in improving cognitive function in ABI patients, individualised treatments can be resource-intensive and not readily accessible to all in need. The program "Group-Based Memory Rehabilitation to Improve Memory for Everyday Tasks" offers an evidence-based, group-based intervention. Previous studies have demonstrated its efficacy in enhancing everyday memory function, including increased use of memory strategies, achievement of memory-related goals, and improvements in learning ability, both in the subacute and chronic phase post-injury. Furthermore, recent investigations have shown comparable efficacy when delivering the program through telehealth platforms (video conferencing). The investigators have meticulously translated and adapted the memory program to suit Norwegian conditions. As far as the investigators are aware, this is the first time the program has undergone translation and adaptation for Norwegian speakers. This study aims to evaluate the memory program's feasibility, acceptability, and effectiveness in a Norwegian context, aiming to support its implementation in local health services. Both physical face-to-face groups as well as telehealth delivery through videoconferencing will be evaluated. Telehealth delivery will be utilised to overcome geographical barriers and enhance accessibility for patients residing in rural or remote areas in Northern Norway, where rehabilitation services are recognized as an unmet need. A total of five groups will be run during 2025 and 2026. Three of the three groups will be digital via videoconferencing.
NCT06952595
Increasing the amount of exercises completed has been shown to help recovery for people after a brain injury. This study will explore if providing extra training of exercises prescribed to a patient and carer team, will allow more practice of these exercises, better abilities to move and balance, and to assess if carer confidence changes with doing this. It is a repeated case design in the in-patient acute Neurosciences setting at the Norfolk and Norwich University Hospital NHS Trust (NNUH).
NCT06930963
Children with cerebral palsy (CP) or an acquired brain injury (ABI) are often prescribed ankle-foot orthoses (AFOs) to correct impairments of muscles and/or to prevent contractures and bony deformities. The impact of AFOs on gait, and to a lesser extent on gross motor function (GMF), has been investigated. Yet, little is known about their impact on the quality of movement. This study aims to examine how AFOs influence both the quality and capacity of daily functional activities in these children.
NCT06895226
Exercise and physical activity in adults with acquired brain injury
NCT05729165
Severe Acquired Brain Injury (sABI), with a more or less prolonged state of coma, generally causes disruption of the physiological modes of swallowing and feeding and the physiological abilities of communication and phonation. There is broad agreement in the scientific literature for early intervention by the entire rehabilitation team. In the specific case of swallowing and phonatory function, speech therapist intervention is indicated with the goal of restoring the automatic and voluntary movements of the muscles involved in the performance of the previously mentioned functions. Speech-language treatment of buccal structures, sensation, motor and praxie is recommended in conjunction with other types of approaches (dietary modifications, compensation techniques, postural modifications). In the acute and early subacute phase of patients with sABI with a vigilance level of less than 4 according to the Levels of Cognitive Functioning scale, alterations in bucco-linguo-facial structures and swallowing can be observed that prevent the execution of a correct motor pattern of phonation and swallowing. For this reason, passive and/or active stimulation aimed at restoring sensitivity, strength, and movement coordination of the bucco-linguo-facial and laryngeal muscles is necessary to rehabilitate the prerequisites for the initiation of feeding, to restore adequate afferents, and to stimulate communication. A careful search of the literature shows that over the past decade many studies in the rehabilitation field have sought to understand the effects of local vibration therapy at various levels of the central nervous system and the possible benefits in neurorehabilitation. From a speech therapy perspective, there are only three studies on the area of dysphonia in cases of upper laryngeal nerve palsy, combining traditional treatment with the use of Novafon®, a sound wave medical device used for Local Vibrational Therapy. The results show greater improvements in vocal function and voice quality when classical treatment is combined with Local Vibrational Therapy. These studies conclude by affirming the need for further research with a larger sample size to analyze the potential effectiveness of Novafon® applied to the recovery of vocal cord paralysis.
NCT05777499
Aim: Investigate whether patients undergoing specialist rehabilitation after complex neurological injury show different functional outcomes if music therapy is included in their rehabilitation program compared to usual care. Background: Patients with complex needs following a brain, spinal cord, and/or peripheral nerve injury often require a period of specialist neurorehabilitation. This involves multiple therapy disciplines, led by a Consultant in Rehabilitation Medicine, Neurology, or Neuropsychiatry. Although music therapy is suggested to enhance neuroplasticity and recovery in patients with brain injury, it is not routinely commissioned in clinical care due to a lack of supportive evidence. Hypothesis: Patients undergoing music therapy in addition to complex specialist rehabilitation show better functional outcomes compared to usual care. Number of participants: 75, aged 16-80 years. Methods: Patients undergo baseline assessments and are randomised to MUSIC or CONTROL Therapy. Both arms receive 1-3 additional therapy sessions per week, matched for duration and number, total 15 hours. After approximately 10-weeks intervention, assessments are repeated. All participants then have access to music therapy until they are discharged from Neurorehabilitation Unit (NRU), with additional qualitative data collection using semi-structured interviews, field notes, staff reports, staff stress surveys, and broader ecological observations. Duration for Participants: From consent to discharge from NRU. Primary Outcome: Change in Functional Independence Measure+Functional Assessment Measure (FIM+FAM), Northwick Park Dependency Scale (NWPDS), and Barthel Activities of Daily Living pre and post 15 hours intervention. Secondary Outcome: Change in quality of life (Flourishing Scale), psychological distress (Hospital Anxiety and Depression Scale, Depression Intensity Scale Circles), social interaction (Sickness Impact Profile Social Interaction Subscale), well-being (WHO Well-Being Index), and communication (Communication Outcomes After Stroke Scale), pre and post 15 hours intervention. Mean difference in well-being (WHO Well-Being Index) throughout the intervention period between music therapy and control therapy groups. Mean difference in post-intervention pain and mood visual analogue scores between music therapy and control therapy groups.
NCT06510023
A study measuring rewards sensitivity in individuals with acquired brain injury at an acute rehabilitation level.
NCT04016961
This study evaluates the addition of therapy dogs in inpatient physical and occupational therapy. Data will be collected across 10 PT and 10 OT sessions, half of which will incorporate a therapy dog.
NCT05472363
This research study is being done to look at the safety and diagnostic benefit of conducting an TMS(transcranial magnetic stimulation)-EEG measured before and after a brief experimental stimulation session using investigational devices repetitive TMS or transcranial direct current stimulation (tDCS).