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R-1072-19

Improving anticipatory and compensatory postural responses to avoid falls after tbi
Source : Importé depuis le centre

Référence clinicaltrials.gov: NCT05268484
Traumatic Brain Injury
Recrutement possiblement ouvert
Dernière modification : 2023/12/20

Population cible

Condition médicale (spécialité visée)

Choix aire thérapeutique

Traumatic Brain Injury

Source : Importé depuis le centre

Profil des participants

Sexe(s) des participants

All

Source : Importé depuis le centre

Critères de sélection

Critères d'inclusion

INCLUSION CRITERIA FOR TRAUMATIC BRAIN INJURY:

In order to be eligible to participate in this study, I must:

Be between the ages of 18 and 70.
Have been diagnosed with a TBI by a physician and be at least 6 months post injury
Have been medically stable for 3 months prior to my most recent TBI.
Not plan to make any drastic changes to medications (as determined by study staff) for at least 4 weeks.
Be able to stand unsupported for 5 minutes.
Be willing and able to give informed consent.
Be able and willing to comply with study procedures, verbal instructions, and follow-up requirements.

INCLUSION CRITERIA FOR HEALTHY INDIVIDUALS:

In order to be eligible to participate in this study, I must:

Be between the ages of 18 and 70.
Not plan to make any drastic changes to medications for at least 4 weeks.
Not have a history of injury or disease within the last 90 days.
Be able to stand unsupported for 5 minutes.
Be willing and able to give informed consent.
Be able and willing to comply with study procedures, including follow-up requirements.

EXCLUSIONS FOR TRAUMATIC BRAIN INJURY:

I must NOT:

Have severe cardiac disease such as heart attack or moderate or severe congestive heart failure.
Have a pre-existing condition resulting in significant disruption in alignment or function of the lower limb during standing.
Have any additional orthopedic, neuromuscular, or neurological conditions that would interfere with my balance.
Have had a penetrating TBI (a penetrating TBI is when an item or object goes through the skull to damage the brain).
Have any previously diagnosed history of balance problems prior to TBI.
Be able to stand without the ankle foot orthosis (AFO).
Have fluctuating blood pressure.
Be on any medication that may affect my balance, strength, or muscle coordination (e.g. Botox).
Be currently enrolled in another research study that is likely to affect participation in this research study.

EXCLUSIONS FOR HEALTHY INDIVIDUALS:

I must NOT:

Have a history of injury to my lower limbs in the past 90 days.
Have severe cardiac disease such as heart attack or moderate or severe congestive heart failure.
Have a pre-existing condition resulting in significant disruption in alignment or function of the lower limb during standing.
Have any additional medical conditions that affect my bones, muscles, or nerves that would interfere with my movement or my ability to feel touch or pain.
Have difficulty following or responding to commands that would limit my study participation.
Be currently enrolled in another research study that is likely to affect participation in this research study.

Source : Importé depuis le centre

Thérapie ou Intervention proposée

Cohortes
Nom Condition médicale Traitement État du recrutement
TBI Intervention Group Donnée non disponible Participants will participate in 16 anticipatory postural adjustments (APA) and compensatory postural adjustments (CPA) training sessions using the Neurocom Balance Platform. Each session will last for 1 hour. During the APA portion, a visual cue on the front screen in the form of a countdown timer showing the remaining seconds to the onset of the upcoming perturbation. This information will allow an opportunity for the participant to adjust their posture to handle the upcoming perturbation in the best possible way and also train them to anticipate upcoming disturbances and execute corrective motor outputs. This will ensure the generation of APA in a consistent and repetitive manner. In CPA, after a 5 second pause, the platform will oscillate at 1 Hz, with a constant amplitude, in the anterior-posterior direction for 50 seconds, followed by an additional 5 second quiet period. The participant will wear a safety harness at all times and a spotter will be present at all times.
  • Inconnu
  • TBI Control Group Donnée non disponible No intervention is provided
  • Inconnu
  • Healthy Control Donnée non disponible No intervention is provided
  • Inconnu
  • TBI Intervention Group
    État du recrutement
    unknown
    TBI Control Group
    État du recrutement
    unknown
    Healthy Control
    État du recrutement
    unknown
    Données à jour depuis : 20 décembre 2023

    Description de l'étude

    Résumé de l'étude

    The purpose of this study is to assess a balance training program to see if it can be helpful to avoid falls in people who have had traumatic brain injuries (TBIs).

    The study will include 3 groups: TBI Intervention group , TBI Control Group, and healthy control group.

    TBI Intervention group - These individuals will participate in 16 anticipatory postural adjustments (APA) and compensatory postural adjustments (CPA) training sessions using the Neurocom Balance Platform. Each session will last for 1 hour. During the APA portion, participants will be provided with a visual cue on the front screen in the form of a countdown timer showing the remaining seconds to the onset of the upcoming perturbation. This information will allow an opportunity for the participant to adjust their posture to handle the upcoming perturbation in the best possible way and also train them to anticipate upcoming disturbances and execute corrective motor outputs. In CPA, after a 5 second pause, the platform will oscillate at 1 Hz, with a constant amplitude, in the anterior-posterior direction for 50 seconds, followed by an additional 5 second quiet period. The participant will wear a safety harness at all times and a spotter will be present at all times.

    TBI Control Group- They do not receive any intervention. healthy control group- They do not receive any intervention.

    All three groups will participate in two data collection sessions: Baseline and follow-up.

    At baseline and follow-up, we will collect functional, clinical, biomechanical, and physiological metrics.

    During training and data collection, a spotter will be present at all times to prevent falls and participants will be allowed as much rest as needed by them..

    Source : Importé depuis le centre

    Sites

    Centres participants


    Dernière modification : 20 décembre 2023
    Données à jour depuis : 22 mars
    Origine des données : clinicaltrials.gov
    Référence clinicaltrials.gov: NCT05268484