Terminé

Standard Vestibular Rehabilitation Training (VRT) vs. Sensory Kinetics Balance System (SKBS) + VRT on Balance and Functional Outcomes in the Mild Traumatic Brain Injury (mTBI) Population.

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Ce qui est testé

Sensory Kinetics Balance System

+ Traditional Vestibular Rehabilitation

Dispositif médicalAutre
Qui peut participer

Maladies du cerveau+5

+ Traumatismes crâniens

+ Maladies du système nerveux central

De 18 à 75 ans
+17 critères d'éligibilité
Voir tous les critères d'éligibilité
Comment se déroule l'étude

Étude thérapeutique

Interventionnel
Date de début : janvier 2012
Voir le détail du protocole

Résumé

Sponsor principalShirley Ryan AbilityLab
Dernière mise à jour : 4 avril 2016
Issu d'une base de données validée par les autorités. Revendiquer en tant que partenaire

Date de début de l'étude : 1 janvier 2012

Date à laquelle le premier participant a commencé l'étude.

Traumatic brain injury (TBI) occurs when physical trauma causes temporary or permanent neurological damage. In some cases, symptoms can continue over time and contribute to disability. Dizziness and vertigo are associated with nearly all reported studies of mild Traumatic Brain Injury (mTBI) and are a significant and functionally limiting component of the overall disability. TBI is one of the many risks faced by military personnel in combat activities . In a RAND Corporation survey of service members who had been deployed to Iraq or Afghanistan, 19% reported probable TBI. Dizziness and vertigo are associated with nearly all reported studies of mTBI and are a significant and debilitating component of the overall disability. mTBI are currently caused by both blast and impact injuries resulting in variable disabilities . Overt symptoms may include balance and spatial disorientation problems (vertigo) related to vestibular dysfunction, vision disturbances, inner-ear edema, and/or other sensory integration deficits. Treatment of this particular population group has several challenges which include: 1) difficulty with early and specific injury assessment 2) the determination of appropriate return-to-duty measures 3) selection of effective individualized balance rehabilitation and treatment tools 4) Prolonged length of rehabilitation and uncertain measureable endpoints. The group is also highly variable in the nature and extent of balance deficits and cognitive and / or related psychological impairments. It appears that almost all subjects with mTBI show some susceptibility to vestibular or vestibular/ocular disorders. After assessment of disequilibrium, rehabilitation is often a course of remedial physical therapy (PT). To affect change in mobility by standard physical therapy, sensory and motor systems are "habituated" through exercise, with hope of rehabilitating the system and "compensating" by instructing the patient to alter skill sets associated with a task. Compensation (without immediate sensory feedback) is problematic and prone to patient (and caregiver) interpretation and error, because it may not address the underlying problems and may not have long term therapeutic benefits. There is also a very limited pool of PTs who specialize in the treatment of neurological problems resulting from brain injuries. Individual vestibular rehabilitation treatment programs are designed by these specialist PTs who also monitor and participate in each patient's recovery. This approach is labor intensive, time consuming (up to 14 weeks of therapy is often needed) and some patients do not recover fully . The overall objective of this research effort is to use novel combinations of multi-modal sensory guided feedback (especially tactile) and traditional vestibular rehabilitation to retrain military personnel suffering balance disorders as a result of mTBI. The investigators therapeutic goal is to test technology that will return the patient, in the shortest period of time, to a level of balance performance consistent with return to the community and/or military duty. The sense of touch is intrinsically linked with the neuro-motor channel, both at the reflex and higher cognitive regions, which makes it uniquely tied to orientation and localization. Vibrotactile arrays are therefore intuitive and are an effective sensory feedback pathway. Recent research has also demonstrated that tactile cueing yield significantly faster and more accurate performance than comparable spatial auditory cues. Further research has demonstrated this finding is relatively stable across a variety of body orientations, even when spatial translation is required and under physiological stress. Over a Phase I SBIR and current Phase II effort, Engineering Acoustics Inc. has developed the Sensory Kinetics (SK) Balance System. In the SK system, patients move on a force platform (see Figure 1) while movement and posture data is interpreted by advanced software a mapped to a wearable vibrotactile belt array and visual display. Vibrotactile cueing provides continuous and instantaneous feedback to the patient that compliments their postural and mobility decisions. The investigators believe that vibrotactile feedback can greatly increase spatial awareness and consequently mobility. Further, the ability of the brain to re-organize and relearn functional movement activities provides an intriguing potential pathway for the retention of learned functional mobility strategies.Vibrotactile cueing involves short duration bursts of mechanical vibration from actuators, or tactors, that are mounted within a torso worn belt. The person's position is measured and calculated using a force plate sensor and camera sensors. The computerized system is then used as part of physical therapy balance training to improve the patient's balance and potentially reduce their risk of falling.

Sponsor principalShirley Ryan AbilityLab
Dernière mise à jour : 4 avril 2016
Issu d'une base de données validée par les autorités. Revendiquer en tant que partenaire

Protocole

Cette section fournit des détails sur le plan de l'étude, y compris la manière dont l'étude est conçue et ce qu'elle évalue.
Détails du design

31 participants à inclure

Nombre total de participants que l'essai clinique vise à recruter.

Traitement

Cette étude teste un ou plusieurs traitements pour évaluer leur efficacité contre une maladie ou un problème de santé spécifique. L'objectif est de voir si un nouveau médicament ou une thérapie fonctionne mieux, ou provoque moins d'effets secondaires que les options existantes.



Éligibilité

Les chercheurs recherchent des patients correspondant à une certaine description appelée critères d'éligibilité : état de santé général ou traitements antérieurs du patient.
Conditions
Critères

Tout sexe

Le sexe biologique des participants éligibles à s'inscrire.

De 18 à 75 ans

Tranche d'âge des participants éligibles à participer.

Volontaires sains non autorisés

Indique si les individus en bonne santé et ne présentant pas la condition étudiée peuvent participer.

Conditions

Pathologie

Maladies du cerveauTraumatismes crâniensMaladies du système nerveux centralTraumatisme crânio-cérébralMaladies du système nerveuxBlessures et lésionsTraumatisme du système nerveuxBlessures Cérébrales Traumatiques

Critères

6 critères d'inclusion nécessaires pour participer
Able to sit unaided for two minutes

Able to stand independently with or without a cane, or with no more than moderate assistance from the physical therapist/researcher

Adults 18 years-75 years old

Mild to moderate Traumatic Brain Injury

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11 critères d'exclusion empêchent la participation
A diagnosis of

Amputees

Associated high-level stroke or spinal cord injury

Mini Mental Status Exam score of less than 24 and/or Cognitive Log score of less than 25

Voir plus de critères

Plan de l'étude

Découvrez tous les traitements administrés dans cette étude, leur description détaillée et ce qu'ils impliquent.
Groupes de traitement
Objectifs de l'étude

2 groupes d'intervention sont désignés dans cette étude

Cette étude ne comporte pas de groupe placebo. 

Groupes de traitement

Groupe I

Expérimental
Subjects will be randomized in to one of two groups. The group that will receive training on the SKBS device along with traditional vestibular and balance training.

Groupe II

Comparateur actif
Traditional vestibular rehabilitation will include VOT exercises that will work toward increasing the gain of the system as well as walking, balance re-training, and functional mobility.

Objectifs de l'étude

Objectifs principaux

Objectifs secondaires

Centres d'étude

Ce sont les hôpitaux, cliniques ou centres de recherche où l'essai est conduit. Vous pouvez trouver le site le plus proche de vous ainsi que son statut.

Cette étude comporte 1 site

Rehabilitation Institute of Chicago

Chicago, United StatesOuvrir Rehabilitation Institute of Chicago dans Google Maps
Terminé1 Centres d'Étude