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

Primary Purpose

Brain Injuries, Traumatic, Cerebrovascular Trauma, Acute Brain Injuries

Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Control Balance Training (BT) class
Fallproof Balance Training (BT) class
Sponsored by
University of British Columbia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Brain Injuries, Traumatic

Eligibility Criteria

16 Years - 69 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • GF Strong Rehabilitation Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Control Balance Training (BT) class

Fallproof Balance Training (BT) class

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Timed Up and Go Test (TUG)
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.
4 meters Gait Speed Test (GST)
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.
Falls Efficacy Scale (FES)
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").

Full Information

First Posted
March 31, 2017
Last Updated
April 11, 2017
Sponsor
University of British Columbia
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1. Study Identification

Unique Protocol Identification Number
NCT03110237
Brief Title
A Multidimensional Inpatient Balance Training Class to Improve Functional Outcomes in Rehabilitation Inpatients With ABI
Official Title
A Multidimensional Inpatient Balance Training Class to Improve Functional Outcomes in Rehabilitation Inpatients With ABI
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Unknown status
Study Start Date
April 10, 2017 (Anticipated)
Primary Completion Date
November 30, 2017 (Anticipated)
Study Completion Date
December 30, 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of British Columbia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Injuries, Traumatic, Cerebrovascular Trauma, Acute Brain Injuries

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control Balance Training (BT) class
Arm Type
Active Comparator
Arm Description
Group based circuit training class, 30 minute session, twice a week for three weeks
Arm Title
Fallproof Balance Training (BT) class
Arm Type
Experimental
Arm Description
Group based balance training class based on the FallProof(TM) approach, 30 minute session , twice a week for three weeks
Intervention Type
Other
Intervention Name(s)
Control Balance Training (BT) class
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Fallproof Balance Training (BT) class
Intervention Description
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.
Primary Outcome Measure Information:
Title
Community Balance and Mobility Scale (CB & M)
Description
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.
Time Frame
after attending balance class for 3 weeks
Secondary Outcome Measure Information:
Title
Timed Up and Go Test (TUG)
Description
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.
Time Frame
after attending balance class for 3 weeks
Title
4 meters Gait Speed Test (GST)
Description
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.
Time Frame
after attending balance class for 3 weeks
Title
Falls Efficacy Scale (FES)
Description
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").
Time Frame
after attending balance class for 3 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
69 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sophia Zhao, MPT
Phone
604-734-1313
Ext
2549
Email
sophia.zhao@vch.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Marian Cayer, BSc
Phone
604-734-1313
Ext
2110
Email
marian.cayer@vch.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marian Cayer, BSc
Organizational Affiliation
Vancouver Coastal Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
GF Strong Rehabilitation Center
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 2G9
Country
Canada
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sophia Si Cong Zhao, MPT
Phone
604-734-1313
Ext
2549
Email
sophia.zhao@vch.ca

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
24756870
Citation
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.
Results Reference
background
Citation
Winter D. A.B.C.(Anatomy, Biomechanics and Control) of Balance During Standing and Walking. Waterloo: Waterloo Biomechanics; 1995.
Results Reference
background
Citation
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/
Results Reference
background
PubMed Identifier
20716987
Citation
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.
Results Reference
background
PubMed Identifier
22089406
Citation
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.
Results Reference
background
PubMed Identifier
16939981
Citation
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.
Results Reference
background
Citation
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.
Results Reference
background
PubMed Identifier
8503751
Citation
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.
Results Reference
background
PubMed Identifier
15482247
Citation
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.
Results Reference
background
PubMed Identifier
18780882
Citation
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.
Results Reference
background
PubMed Identifier
18955424
Citation
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.
Results Reference
background
PubMed Identifier
21504955
Citation
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.
Results Reference
background
PubMed Identifier
9442992
Citation
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.
Results Reference
background
PubMed Identifier
12971704
Citation
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.
Results Reference
background
PubMed Identifier
14966713
Citation
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.
Results Reference
background
PubMed Identifier
25758408
Citation
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.
Results Reference
background
PubMed Identifier
21623303
Citation
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.
Results Reference
background
PubMed Identifier
16084820
Citation
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.
Results Reference
background
PubMed Identifier
15706542
Citation
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.
Results Reference
background
PubMed Identifier
17008340
Citation
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.
Results Reference
background
PubMed Identifier
17767814
Citation
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.
Results Reference
background
PubMed Identifier
21221120
Citation
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.
Results Reference
background
PubMed Identifier
19786420
Citation
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.
Results Reference
background
PubMed Identifier
10588538
Citation
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.
Results Reference
background
PubMed Identifier
17378232
Citation
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.
Results Reference
background
PubMed Identifier
19675123
Citation
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.
Results Reference
background

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

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