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- Essai clinique NCT03110237
A Multidimensional Inpatient Balance Training Class to Improve Functional Outcomes in Rehabilitation Inpatients With ABI
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
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
Inscription (Anticipé)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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British Columbia
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Vancouver, British Columbia, Canada, V5Z 2G9
- GF Strong Rehabilitation Center
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- inpatients admitted to GFS with a diagnosis of ABI;
- medical stability
- has the cognitive ability to understand and follow instructions and participate in a class setting
- a Berg Balance Score of ≥52;
- 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
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 |
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Comparateur actif: Control Balance Training (BT) class
Group based circuit training class, 30 minute session, twice a week for three weeks
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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.
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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
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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.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Community Balance and Mobility Scale (CB & M)
Délai: after attending balance class for 3 weeks
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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.
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after attending balance class for 3 weeks
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Timed Up and Go Test (TUG)
Délai: after attending balance class for 3 weeks
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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.
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after attending balance class for 3 weeks
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4 meters Gait Speed Test (GST)
Délai: after attending balance class for 3 weeks
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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.
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after attending balance class for 3 weeks
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Falls Efficacy Scale (FES)
Délai: after attending balance class for 3 weeks
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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").
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after attending balance class for 3 weeks
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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Marian Cayer, BSc, Vancouver Coastal Health
Publications et liens utiles
Publications générales
- Lubetzky-Vilnai A, Kartin D. The effect of balance training on balance performance in individuals poststroke: a systematic review. J Neurol Phys Ther. 2010 Sep;34(3):127-37. doi: 10.1097/NPT.0b013e3181ef764d.
- Bonan IV, Yelnik AP, Colle FM, Michaud C, Normand E, Panigot B, Roth P, Guichard JP, Vicaut E. Reliance on visual information after stroke. Part II: Effectiveness of a balance rehabilitation program with visual cue deprivation after stroke: a randomized controlled trial. Arch Phys Med Rehabil. 2004 Feb;85(2):274-8. doi: 10.1016/j.apmr.2003.06.016.
- Karthikbabu S, Nayak A, Vijayakumar K, Misri Z, Suresh B, Ganesan S, Joshua AM. Comparison of physio ball and plinth trunk exercises regimens on trunk control and functional balance in patients with acute stroke: a pilot randomized controlled trial. Clin Rehabil. 2011 Aug;25(8):709-19. doi: 10.1177/0269215510397393. Epub 2011 Apr 19.
- van Hedel HJ, Wirz M, Dietz V. Assessing walking ability in subjects with spinal cord injury: validity and reliability of 3 walking tests. Arch Phys Med Rehabil. 2005 Feb;86(2):190-6. doi: 10.1016/j.apmr.2004.02.010.
- Tyson S, Connell L. The psychometric properties and clinical utility of measures of walking and mobility in neurological conditions: a systematic review. Clin Rehabil. 2009 Nov;23(11):1018-33. doi: 10.1177/0269215509339004. Epub 2009 Sep 28.
- Yelnik AP, Le Breton F, Colle FM, Bonan IV, Hugeron C, Egal V, Lebomin E, Regnaux JP, Perennou D, Vicaut E. Rehabilitation of balance after stroke with multisensorial training: a single-blind randomized controlled study. Neurorehabil Neural Repair. 2008 Sep-Oct;22(5):468-76. doi: 10.1177/1545968308315996.
- Pollock A, Baer G, Campbell P, Choo PL, Forster A, Morris J, Pomeroy VM, Langhorne P. Physical rehabilitation approaches for the recovery of function and mobility following stroke. Cochrane Database Syst Rev. 2014 Apr 22;2014(4):CD001920. doi: 10.1002/14651858.CD001920.pub3.
- Winter D. A.B.C.(Anatomy, Biomechanics and Control) of Balance During Standing and Walking. Waterloo: Waterloo Biomechanics; 1995.
- Annabel McDermott, OT; Nicol Korner-Bitensky, PhD OT; Norine Foley, BASc; Mark Speechley, PhD; Nancy M. Salbach, PhD, PT; Maxim Ben Yakov, BSc. PT; Robert Teasell, MD. (2012). Balance Training. Retrieved from http://www.strokengine.ca/intervention/balance-training/
- An M, Shaughnessy M. The effects of exercise-based rehabilitation on balance and gait for stroke patients: a systematic review. J Neurosci Nurs. 2011 Dec;43(6):298-307. doi: 10.1097/JNN.0b013e318234ea24.
- Ottawa Panel; Khadilkar A, Phillips K, Jean N, Lamothe C, Milne S, Sarnecka J. Ottawa panel evidence-based clinical practice guidelines for post-stroke rehabilitation. Top Stroke Rehabil. 2006 Spring;13(2):1-269. doi: 10.1310/3TKX-7XEC-2DTG-XQKH.
- Lindsay MP, Gubitz G, Bayley M, Hill MD, Davies-Schinkel C, Singh S, and Phillips S. Canadian Best Practice Recommendations for Stroke Care (Update 2010). On behalf of the Canadian Stroke Strategy Best Practices and Standards Writing Group. 2010; Ottawa, Ontario Canada: Canadian Stroke Network.
- Richards CL, Malouin F, Wood-Dauphinee S, Williams JI, Bouchard JP, Brunet D. Task-specific physical therapy for optimization of gait recovery in acute stroke patients. Arch Phys Med Rehabil. 1993 Jun;74(6):612-20. doi: 10.1016/0003-9993(93)90159-8.
- McClellan R, Ada L. A six-week, resource-efficient mobility program after discharge from rehabilitation improves standing in people affected by stroke: placebo-controlled, randomised trial. Aust J Physiother. 2004;50(3):163-7. doi: 10.1016/s0004-9514(14)60154-9.
- Alptekin N, Gok H, Geler-Kulcu D, Dincer G. Efficacy of treatment with a kinaesthetic ability training device on balance and mobility after stroke: a randomized controlled study. Clin Rehabil. 2008 Oct-Nov;22(10-11):922-30. doi: 10.1177/0269215508090673. Erratum In: Clin Rehabil. 2008 Feb;23(2):189.
- Sackley CM, Lincoln NB. Single blind randomized controlled trial of visual feedback after stroke: effects on stance symmetry and function. Disabil Rehabil. 1997 Dec;19(12):536-46. doi: 10.3109/09638289709166047.
- Morioka S, Yagi F. Effects of perceptual learning exercises on standing balance using a hardness discrimination task in hemiplegic patients following stroke: a randomized controlled pilot trial. Clin Rehabil. 2003 Sep;17(6):600-7. doi: 10.1191/0269215503cr654oa.
- Treacy D, Schurr K, Lloyd B, Sherrington C. Additional standing balance circuit classes during inpatient rehabilitation improved balance outcomes: an assessor-blinded randomised controlled trial. Age Ageing. 2015 Jul;44(4):580-6. doi: 10.1093/ageing/afv019. Epub 2015 Mar 10.
- Rose DJ. Reducing the risk of falls among older adults: the Fallproof Balance and Mobility Program. Curr Sports Med Rep. 2011 May-Jun;10(3):151-6. doi: 10.1249/JSR.0b013e31821b1984.
- Ng SS, Hui-Chan CW. The timed up & go test: its reliability and association with lower-limb impairments and locomotor capacities in people with chronic stroke. Arch Phys Med Rehabil. 2005 Aug;86(8):1641-7. doi: 10.1016/j.apmr.2005.01.011.
- Howe JA, Inness EL, Venturini A, Williams JI, Verrier MC. The Community Balance and Mobility Scale--a balance measure for individuals with traumatic brain injury. Clin Rehabil. 2006 Oct;20(10):885-95. doi: 10.1177/0269215506072183.
- van Hedel HJ, Wirz M, Dietz V. Standardized assessment of walking capacity after spinal cord injury: the European network approach. Neurol Res. 2008 Feb;30(1):61-73. doi: 10.1179/016164107X230775.
- Scivoletto G, Tamburella F, Laurenza L, Foti C, Ditunno JF, Molinari M. Validity and reliability of the 10-m walk test and the 6-min walk test in spinal cord injury patients. Spinal Cord. 2011 Jun;49(6):736-40. doi: 10.1038/sc.2010.180. Epub 2011 Jan 11.
- Hellstrom K, Lindmark B. Fear of falling in patients with stroke: a reliability study. Clin Rehabil. 1999 Dec;13(6):509-17. doi: 10.1191/026921599677784567.
- Medley A, Thompson M, French J. Predicting the probability of falls in community dwelling persons with brain injury: a pilot study. Brain Inj. 2006 Dec;20(13-14):1403-8. doi: 10.1080/02699050601082057.
- Wirz M, Muller R, Bastiaenen C. Falls in persons with spinal cord injury: validity and reliability of the Berg Balance Scale. Neurorehabil Neural Repair. 2010 Jan;24(1):70-7. doi: 10.1177/1545968309341059. Epub 2009 Aug 12.
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Anticipé)
Achèvement primaire (Anticipé)
Achèvement de l'étude (Anticipé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
- Maladies cardiovasculaires
- Maladies vasculaires
- Troubles cérébrovasculaires
- Maladies du cerveau
- Maladies du système nerveux central
- Maladies du système nerveux
- Traumatisme crânio-cérébral
- Traumatisme, système nerveux
- Lésions cérébrales
- Blessures et Blessures
- Lésions cérébrales, traumatiques
- Traumatisme cérébrovasculaire
Autres numéros d'identification d'étude
- H16-02866
Plan pour les données individuelles des participants (IPD)
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Informations sur les médicaments et les dispositifs, documents d'étude
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Essais cliniques sur Lésions cérébrales, traumatiques
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Kessler FoundationInstituto Vocacional Enrique Díaz de León A.C., Guadalajara, MexicoRecrutementTBI (Traumatic Brain Injury) ou MS (Sclérose en Plaques)États-Unis, Espagne
Essais cliniques sur Control Balance Training (BT) class
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University of BernForel Clinic; Clinic Südhang; Psychiatric Center MuensingenComplété