NCT03110237

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 31, 2017

Completed
10 days until next milestone

Study Start

First participant enrolled

April 10, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 12, 2017

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2017

Completed
Last Updated

April 12, 2017

Status Verified

April 1, 2017

Enrollment Period

8 months

First QC Date

March 31, 2017

Last Update Submit

April 11, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • Community Balance and Mobility Scale (CB & M)

    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

Secondary Outcomes (3)

  • Timed Up and Go Test (TUG)

    after attending balance class for 3 weeks

  • 4 meters Gait Speed Test (GST)

    after attending balance class for 3 weeks

  • Falls Efficacy Scale (FES)

    after attending balance class for 3 weeks

Study Arms (2)

Control Balance Training (BT) class

ACTIVE COMPARATOR

Group based circuit training class, 30 minute session, twice a week for three weeks

Other: Control Balance Training (BT) class

Fallproof Balance Training (BT) class

EXPERIMENTAL

Group based balance training class based on the FallProof(TM) approach, 30 minute session , twice a week for three weeks

Other: Fallproof Balance Training (BT) class

Interventions

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.

Control Balance Training (BT) class

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.

Fallproof Balance Training (BT) class

Eligibility Criteria

Age16 Years - 69 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

GF Strong Rehabilitation Center

Vancouver, British Columbia, V5Z 2G9, Canada

Location

Related Publications (26)

  • 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.

    PMID: 24756870BACKGROUND
  • Winter D. A.B.C.(Anatomy, Biomechanics and Control) of Balance During Standing and Walking. Waterloo: Waterloo Biomechanics; 1995.

    BACKGROUND
  • 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/

    BACKGROUND
  • 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.

    PMID: 20716987BACKGROUND
  • 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.

    PMID: 22089406BACKGROUND
  • 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.

    PMID: 16939981BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    PMID: 8503751BACKGROUND
  • 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.

    PMID: 15482247BACKGROUND
  • 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.

    PMID: 18780882BACKGROUND
  • 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.

    PMID: 18955424BACKGROUND
  • 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.

    PMID: 21504955BACKGROUND
  • 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.

    PMID: 9442992BACKGROUND
  • 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.

    PMID: 12971704BACKGROUND
  • 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.

    PMID: 14966713BACKGROUND
  • 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.

    PMID: 25758408BACKGROUND
  • 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.

    PMID: 21623303BACKGROUND
  • 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.

    PMID: 16084820BACKGROUND
  • 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.

    PMID: 15706542BACKGROUND
  • 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.

    PMID: 17008340BACKGROUND
  • 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.

    PMID: 17767814BACKGROUND
  • 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.

    PMID: 21221120BACKGROUND
  • 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.

    PMID: 19786420BACKGROUND
  • 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.

    PMID: 10588538BACKGROUND
  • 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.

    PMID: 17378232BACKGROUND
  • 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.

    PMID: 19675123BACKGROUND

MeSH Terms

Conditions

Brain Injuries, TraumaticCerebrovascular TraumaBrain Injuries

Interventions

Artifacts

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and InjuriesCerebrovascular DisordersVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

  • Marian Cayer, BSc

    Vancouver Coastal Health

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sophia Zhao, MPT

CONTACT

Marian Cayer, BSc

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 31, 2017

First Posted

April 12, 2017

Study Start

April 10, 2017

Primary Completion

November 30, 2017

Study Completion

December 30, 2017

Last Updated

April 12, 2017

Record last verified: 2017-04

Data Sharing

IPD Sharing
Will not share

Locations