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A Multidimensional Inpatient Balance Training Class to Improve Functional Outcomes in Rehabilitation Inpatients With ABI

11 avril 2017 mis à jour par: Marian Cayer, University of British Columbia
Many survivors of acquired brain injury (ABI) suffer from decreased balance and increased risks of falls. Previous studies indicate that balance training improves balance, reduces falls, and increases walking speed and balance confidence. The purpose of this study is to determine if a multidimensional balance training based on the FallProof(TM) approach achieves better improvements in balance and walking performance than the current practice . Participants will be assigned to: 1)a task-oriented circuit training balance class (current practice), or 2) balance training class based on the FallProof(TM) approach. Standardized tests will determine if participating in balance training helps improve balance, walking speed and balance confidence.

Aperçu de l'étude

Description détaillée

The purpose of this pilot research study is to determine if a balance training (BT) class based on the FallProof(TM) approach achieves better balance and mobility outcomes than the current practice. The FallProof's approach focuses on multiple components of balance impairment including multisensory, postural strategy and centre of gravity control training. Current practice is a task-oriented circuit training balance class.

ABI survivors may have muscle weakness, decreased coordination and sensory loss, which contribute to reduced balance, difficulty with functional mobility and activities of daily living. Balance control provides the foundation for a person's ability to stand, walk and function independently. Previous studies indicate that balance training (BT) improves balance, reduces falls, increases walking speed and balance self-efficacy for ABI patients .The Ottawa Panel Evidence-Based Clinical Practice Guidelines for ABI Rehabilitation supported the use of BT based on the research evidence. Interventions such as task-oriented training, multisensory training, trunk control training and perceptual exercises demonstrate positive effect on balance and mobility outcomes. To our knowledge, there are few studies that have examined a multidimensional approach to BT.

A systematic review concluded that exercises performed for 20-60 minutes, 3-4 times a week for 6-12 weeks can improve balance in ABI patients. However, Treacy et al demonstrated that inpatient BT for just 2 weeks can improve balance compared to a control group who received traditional exercise interventions.

At GF Strong Rehabilitation Center (GFS), the usual care provided to the ambulatory ABI patients consists of individualized one to one physiotherapy treatment, as well as a high level BT class. Currently, this BT class is a circuit training class that focuses on task-oriented gait exercises. FallProof balance training is a group- based approach that includes multisensory, postural strategy, centre of gravity control and gait pattern training. It was originally developed for older adults with impaired balance; but there is no research on the effectiveness of this approach for ABI patients. The FallProof approach has been introduced to the low level and intermediate level BT class at GFS, for ABI patients with sever and moderate balance impairments. These classes received positive feedback from patients and therapists. Patients reported improved functional mobility and confidence after attending the class. However, there was no functional outcome measurements collected to compare the effectiveness of the previous class and the new FallProof class. We plan to modify the current circuit training high level balance class with the FallProof approach in the spring of 2017. Before introducing the FallProof class, we would like to collect outcome measures with the current BT class for three months, and then collect collect data with the new class for comparison. We would like to determine if a multidimensional group based BT treatment approach is more effective at improving functional outcomes compared to the current practice.

Type d'étude

Interventionnel

Inscription (Anticipé)

20

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 2G9
        • GF Strong Rehabilitation Center

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

16 ans à 69 ans (Enfant, Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

Inclusion Criteria:

  1. inpatients admitted to GFS with a diagnosis of ABI;
  2. medical stability
  3. has the cognitive ability to understand and follow instructions and participate in a class setting
  4. a Berg Balance Score of ≥52;
  5. able to walk independently with or without a mobility aid.

Exclusion Criteria:

1) unable to attend class in a group setting and/or unable to follow instructions.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Non randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Comparateur actif: Control Balance Training (BT) class
Group based circuit training class, 30 minute session, twice a week for three weeks
Circuit training class with 11 stations, including: step-ups, ball kicking, balance beam, sit to stand, walk and carry, tandem walking, walking over a mat, walking up a ramp, walking at different speeds, speed walk, dual task walking.
Expérimental: Fallproof Balance Training (BT) class
Group based balance training class based on the FallProof(TM) approach, 30 minute session , twice a week for three weeks
There are four categories of exercises in this approach including: center of gravity control training (e.g. multi-directional weight shifts in standing, standing with altered base of support), multisensory training (e.g. standing on compliant surfaces, eyes open/closed), postural strategy training (e.g. resisted perturbation to facilitate ankle, hip or step strategy), and gait pattern variation training (e.g. walking with altered base of support , walking over and around obstacles). Each training category will be allocated 5 minutes with two exercises in each category. An additional 5 minutes will be allotted for games to challenge balance (balloon volleyball, pass the potato, circle soccer).There will be opportunity for group discussion and observational learning.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Community Balance and Mobility Scale (CB & M)
Délai: after attending balance class for 3 weeks
A performance measure composed of 13 challenging tasks. Item scores range from 0 to 5 and reflect progressive task difficulty. All tasks performed without ambulation aides.
after attending balance class for 3 weeks

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Timed Up and Go Test (TUG)
Délai: after attending balance class for 3 weeks
Timing how long it takes for patient to rise from a chair, walks 3 meters at a comfortable and safe pace, turns, walks back to the chair and sits down.
after attending balance class for 3 weeks
4 meters Gait Speed Test (GST)
Délai: after attending balance class for 3 weeks
Measure time (in seconds) that it takes the patient to walk 4 meters. The patient should be at their usual speed during the entire 4 meter timed area. Use a 6 meter path, with the central 4 meters as the timed area. Patient may use any walking aid.
after attending balance class for 3 weeks
Falls Efficacy Scale (FES)
Délai: after attending balance class for 3 weeks
A 10-item questionnaire for patients to rate their confidence in their ability to perform 10 daily tasks without falling as an indicator of how one's fear of falling impacts physical performance. Each item is rated from 1 ("very confident") to 10 ("not confident at all").
after attending balance class for 3 weeks

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Les enquêteurs

  • Chercheur principal: Marian Cayer, BSc, Vancouver Coastal Health

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Anticipé)

10 avril 2017

Achèvement primaire (Anticipé)

30 novembre 2017

Achèvement de l'étude (Anticipé)

30 décembre 2017

Dates d'inscription aux études

Première soumission

31 mars 2017

Première soumission répondant aux critères de contrôle qualité

11 avril 2017

Première publication (Réel)

12 avril 2017

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

12 avril 2017

Dernière mise à jour soumise répondant aux critères de contrôle qualité

11 avril 2017

Dernière vérification

1 avril 2017

Plus d'information

Termes liés à cette étude

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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