Deze pagina is automatisch vertaald en de nauwkeurigheid van de vertaling kan niet worden gegarandeerd. Raadpleeg de Engelse versie voor een brontekst.

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

11 april 2017 bijgewerkt door: 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.

Studie Overzicht

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Verwacht)

20

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

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

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

16 jaar tot 69 jaar (Kind, Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Niet-gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Actieve vergelijker: 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.
Experimenteel: 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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Community Balance and Mobility Scale (CB & M)
Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Timed Up and Go Test (TUG)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Onderzoekers

  • Hoofdonderzoeker: Marian Cayer, BSc, Vancouver Coastal Health

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Verwacht)

10 april 2017

Primaire voltooiing (Verwacht)

30 november 2017

Studie voltooiing (Verwacht)

30 december 2017

Studieregistratiedata

Eerst ingediend

31 maart 2017

Eerst ingediend dat voldeed aan de QC-criteria

11 april 2017

Eerst geplaatst (Werkelijk)

12 april 2017

Updates van studierecords

Laatste update geplaatst (Werkelijk)

12 april 2017

Laatste update ingediend die voldeed aan QC-criteria

11 april 2017

Laatst geverifieerd

1 april 2017

Meer informatie

Termen gerelateerd aan deze studie

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

Klinische onderzoeken op Hersenletsel, traumatisch

Klinische onderzoeken op Control Balance Training (BT) class

Abonneren