New Clinical Rehabilitation Approach for the Management of Falls Risks (ReabFalls)
Development of a New Clinical Rehabilitation Approach for the Management of Elderly People With a Neuromusculoskeletal Disorder and a Risk of Falls: a Partnership Project Between UQAC and the Specialized Geriatric Services of CIUSSS-SLSJ
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Detailed Description
Study Type
Study Type
Enrollment (Actual)
Enrollment
Phase
Phase
- Not Applicable
Contacts and Locations
Study Contact
Study Contact
- Name: Rubens da Silva, PhD
- Phone Number: 1361 418 5455011
- Email: rubens.dasilva@uqac.ca
Study Locations
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-
Quebec
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Saguenay, Quebec, Canada, G7H 2B1
- Rubens da Silva
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-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Admitted to La Baie Hospital rehabilitation services; or
- Admitted to the waiting list for geriatric services at La Baie Hospital; or
- Older adults from the communityé
- Age 65 and over
- Able-bodied adult with minimal autonomy to perform fall-prevention tests and exercises.
- Have at least one neuro-musculo-skeletal disorders and risk of falls
Exclusion Criteria:
- Cancer
- Red flags (infection, tumor, etc.)
- Severe psychiatric disorders
- Palliative care
- Congenital spinal deformity (spondylolysis, intervertebral fusions)
- Severe systemic syndromes or diseases that may prevent tests and exercises from being performed.
- Stroke - very acute phase (1 week) and this until medial hemodynamic stability.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
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Experimental: Otago exercises
OTAGO program - based on very specific exercises for balance, force, and muscular endurance as well as on education about the risk of falling.
The program is considered as "home care" (exercises to be done at home) but will be done as a group and with supervision, at CIUSSS or from outdoor and nature intervention (recreactional parks).
OTAGO session lasts for 30-40 minutes and will be done twice a week at sites with progression.
The program is comprised of 5 muscle strengthening exercises and 12 postural balance exercises.
Participants will also be invited to walk 2 times per week for 30 minutes (can be divided into shorter periods, for example 3 blocs of 10 minutes) from outdoor sites or recrative parks.
According to each person's strength and mobility, exercises will be increased with the use of free weights (for example during squats) and/or by increasing the number of repetitions.
Total duration of the program will be 3 months (i.e., a duration adapted to the site).
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Exercices for improvement postural control and mobility and decrease falls risks
Other Names:
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What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Postural control
Time Frame: change from baseline at 8 to 12 weeks
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Measures of center of pressure (COP) from plateform of force during different balance tasks
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change from baseline at 8 to 12 weeks
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Walking
Time Frame: change from baseline at 8 to 12 weeks
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Gait parameters from GaitRite measurement
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change from baseline at 8 to 12 weeks
|
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Trunk postural control on wobble chair
Time Frame: change from baseline at 8 to 12 weeks
|
This test measures trunk postural balance during a sitting balance task on an unstable chair where only lumbar spine movements are allowed to restore balance.
Briefly, the base of the chair consists of a pivot at its center and four springs that can be arranged and fixed at a distance varying between 6.0 and 21 cm from the center, allowing the system's level of stability to be varied.
The system allows only forward/backward and lateral tilting.
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change from baseline at 8 to 12 weeks
|
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Machine learning-driven neuromusculoskeletal (NMS) assessment
Time Frame: change from baseline at 8 to 12 weeks
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Adapt and integrate existing machine learning algorithms (e.g., pose detection, body reconstruction) to create an NMS assessment framework using smartphone cameras.
Image and video recording will be done with three smartphone cameras, positioned on tripods at different angles to the participants.
The initial use of multiple cameras is crucial for gathering multi-dimensional data and will allow us to evaluate the effect of camera angle, and the number of cameras, on the accuracy and reliability of the analyses.
Various scales will be placed within the recording space, serving as reference points for future camera calibration.
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change from baseline at 8 to 12 weeks
|
Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Functional mobility test: TUG
Time Frame: change from baseline at 8 to 12 weeks
|
To assess mobility.
Equipment: A stopwatch.
Directions: Patients wear their regular footwear and can use a walking aid, if needed.
Begin by having the patient sit back in a standard arm chair and identify a line 3 meters, or 10 feet away, on the floor.
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change from baseline at 8 to 12 weeks
|
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30 Second Sit to Stand Test
Time Frame: change from baseline at 8 to 12 weeks
|
The 30CST is a measurement that assesses functional lower extremity strength in older adults.
It is part of the Fullerton Functional Fitness Test Battery.
This test was developed to overcome the floor effect of the 5 or 10 repetition sit to stand test in older adults.
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change from baseline at 8 to 12 weeks
|
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maximal isometric hand grip strength
Time Frame: change from baseline at 8 to 12 weeks
|
Jamar dynamometer to assess maximal isometric hand grip strength and frailty criteria.
3 trials of maximal contraction up 5 seconds.
The best value was retained and corrected by body mass index from Fried classification.
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change from baseline at 8 to 12 weeks
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Walking test in 10 meters
Time Frame: change from baseline at 8 to 12 weeks
|
Walking speed executed in 10 meter walking test. 2 trials and the best value in time seconds was retained for analysis.
The Fried criteria by 4,75 meters was also used to measure time in seconds from this distance (14 feet) and normalized by heigth and weigth.
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change from baseline at 8 to 12 weeks
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5 times Sit-To-Stand (FTSTS)
Time Frame: change from baseline at 8 to 12 weeks
|
If the 30 second sit to stand test was not applied for some patients, we used also this test which it measures the amount of time it takes for a patient to sit and stand five times in succession with arms folded across their chest.
2 trials were applied in this test and the best time in seconds used for analysis.
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change from baseline at 8 to 12 weeks
|
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Numbers of falls
Time Frame: change from baseline at 8 to 12 weeks, 6 and 12 months after
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Self-reported falls before, during and after the study
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change from baseline at 8 to 12 weeks, 6 and 12 months after
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Other Outcome Measures
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Falls Efficacy Scale-International (FES-I)
Time Frame: change from baseline at 8 to 12 weeks
|
The Falls Efficacy Scale-International (FES-I) is a short, easy to administer tool that measures the level of concern about falling during social and physical activities inside and outside the home whether or not the person actually does the activity.
The level of concern is measured on a four point Likert scale (1=not at all concerned to 4=very concerned).
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change from baseline at 8 to 12 weeks
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Pain measures
Time Frame: change from baseline at 8 to 12 weeks
|
Pain measurement was applied with the Brain pain inventory (BPI) questionnaire.
The interference items were now presented with 0-10 scales, with 0=no interference and 10=interferes completely
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change from baseline at 8 to 12 weeks
|
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Fatigue perception
Time Frame: change from baseline at 8 to 12 weeks
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Fatigue perception used BORG scale during the exercices
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change from baseline at 8 to 12 weeks
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Frailty criteria from Fried
Time Frame: change from baseline at 8 to 12 weeks
|
The presence of frailty criteria according to Fried was assessed with self-report questions and two physical tests from five characteristics : 1) Low physical activity (to capture history of sedentary behavior or activity: ex.
Do you get any physical exercise for the sake of exercising?
How often do you leave your house?); 2) fatigue (complaint of exhaustion with normal activity such as walking outside, climbing stairs: ex.
I felt that everything I did was an effort in the last week?); 3) weight loss (unintentional weight loss 10 lbs. or more in past year or more than 5% in past year); 4) weakness (grip strength evaluated with manual dynamometer; in average <30 kg for men and <18 kg for women, but data is normalized by body mass index); 5) slowness or slow walking speed (usual gait speed over 4.57 meters (15 feet); ex.
>6.5 seconds, dependent of height).
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change from baseline at 8 to 12 weeks
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Hoehn and Yahr Scale
Time Frame: Only at baseline from Sample characterization when Parkinson was included.
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The scale has been used for the staging of the functional disability associated with Parkinson's disease.
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Only at baseline from Sample characterization when Parkinson was included.
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Cognitive status
Time Frame: Only at baseline from Sample characterization.
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Mini-mental state questionnaire, which was used for grading the cognitive state of patients in this study.
|
Only at baseline from Sample characterization.
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Collaborators and Investigators
Sponsor
Sponsor
Collaborators
Collaborators
Investigators
Investigators
- Study Chair: Sharlène Côté, MD, CIUSSS-SLSJ (La Baie Hospital)
- Study Director: Julie Bouchard, PhD, Université du Québec à Chicoutimi
- Study Chair: Patrice Tremblay, PT, CIUSSS-SLSJ (La Baie Hospital)
- Principal Investigator: Rubens da Silva, Université du Québec à Chicoutimi
- Study Chair: Marie-Ève Langelier, MD, Université du Québec à Chicoutimi
Publications and helpful links
General Publications
- Campbell AJ, Robertson MC, Gardner MM, Norton RN, Tilyard MW, Buchner DM. Randomised controlled trial of a general practice programme of home based exercise to prevent falls in elderly women. BMJ. 1997 Oct 25;315(7115):1065-9. doi: 10.1136/bmj.315.7115.1065.
- Fried LP, Tangen CM, Walston J, Newman AB, Hirsch C, Gottdiener J, Seeman T, Tracy R, Kop WJ, Burke G, McBurnie MA; Cardiovascular Health Study Collaborative Research Group. Frailty in older adults: evidence for a phenotype. J Gerontol A Biol Sci Med Sci. 2001 Mar;56(3):M146-56. doi: 10.1093/gerona/56.3.m146.
- Poquet N, Lin C. The Brief Pain Inventory (BPI). J Physiother. 2016 Jan;62(1):52. doi: 10.1016/j.jphys.2015.07.001. Epub 2015 Aug 21. No abstract available.
- Vieira ER, Da Silva RA, Severi MT, Barbosa AC, Amick Iii BC, Zevallos JC, Martinez IL, Chaves PHM. Balance and Gait of Frail, Pre-Frail, and Robust Older Hispanics. Geriatrics (Basel). 2018 Jul 18;3(3):42. doi: 10.3390/geriatrics3030042.
- Thomas S, Mackintosh S, Halbert J. Does the 'Otago exercise programme' reduce mortality and falls in older adults?: a systematic review and meta-analysis. Age Ageing. 2010 Nov;39(6):681-7. doi: 10.1093/ageing/afq102. Epub 2010 Sep 4.
- Barry E, Galvin R, Keogh C, Horgan F, Fahey T. Is the Timed Up and Go test a useful predictor of risk of falls in community dwelling older adults: a systematic review and meta-analysis. BMC Geriatr. 2014 Feb 1;14:14. doi: 10.1186/1471-2318-14-14.
- Fuzhong L, McAuley E, Fisher KJ, Harmer P, Chaumeton N, Wilson NL. Self-efficacy as a mediator between fear of falling and functional ability in the elderly. J Aging Health. 2002 Nov;14(4):452-66. doi: 10.1177/089826402237178.
- Jiang X, Cooper J, Porter MM, Ready AE. Adoption of Canada's Physical Activity Guide and Handbook for Older Adults: impact on functional fitness and energy expenditure. Can J Appl Physiol. 2004 Aug;29(4):395-410. doi: 10.1139/h04-025.
- Guideline for the prevention of falls in older persons. American Geriatrics Society, British Geriatrics Society, and American Academy of Orthopaedic Surgeons Panel on Falls Prevention. J Am Geriatr Soc. 2001 May;49(5):664-72. No abstract available.
- Woolcott JC, Khan KM, Mitrovic S, Anis AH, Marra CA. The cost of fall related presentations to the ED: a prospective, in-person, patient-tracking analysis of health resource utilization. Osteoporos Int. 2012 May;23(5):1513-9. doi: 10.1007/s00198-011-1764-1. Epub 2011 Sep 3.
- Oliveira MR, Vieira ER, Gil AWO, Fernandes KBP, Teixeira DC, Amorim CF, da Silva RA. One-legged stance sway of older adults with and without falls. PLoS One. 2018 Sep 17;13(9):e0203887. doi: 10.1371/journal.pone.0203887. eCollection 2018.
- Vieira ER, Tappen R, Gropper SS, Severi MT, Engstrom G, de Oliveira MR, Barbosa AC, da Silva RA. Changes on Walking During Street Crossing Situations and on Dorsiflexion Strength of Older Caribbean Americans After an Exercise Program: A Pilot Study. J Aging Phys Act. 2017 Oct 1;25(4):525-532. doi: 10.1123/japa.2016-0231. Epub 2017 Sep 14.
- Shubert TE, Smith ML, Goto L, Jiang L, Ory MG. Otago Exercise Program in the United States: Comparison of 2 Implementation Models. Phys Ther. 2017 Feb 1;97(2):187-197. doi: 10.2522/ptj.20160236.
- Derouesne C, Poitreneau J, Hugonot L, Kalafat M, Dubois B, Laurent B. [Mini-Mental State Examination:a useful method for the evaluation of the cognitive status of patients by the clinician. Consensual French version]. Presse Med. 1999 Jun 12;28(21):1141-8. French.
- Jones SE, Kon SS, Canavan JL, Patel MS, Clark AL, Nolan CM, Polkey MI, Man WD. The five-repetition sit-to-stand test as a functional outcome measure in COPD. Thorax. 2013 Nov;68(11):1015-20. doi: 10.1136/thoraxjnl-2013-203576. Epub 2013 Jun 19.
- da Silva RA, Vieira ER, Carvalho CE, Oliveira MR, Amorim CF, Neto EN. Age-related differences on low back pain and postural control during one-leg stance: a case-control study. Eur Spine J. 2016 Apr;25(4):1251-7. doi: 10.1007/s00586-015-4255-9. Epub 2015 Oct 1.
- Oliveira MR, Vieira ER, Gil AWO, Teixeira DC, Amorim CF, da Silva RA. How many balance task trials are needed to accurately assess postural control measures in older women? J Bodyw Mov Ther. 2019 Jul;23(3):594-597. doi: 10.1016/j.jbmt.2019.04.004. Epub 2019 Apr 12.
- da Silva RA, Vieira ER, Leonard G, Beaulieu LD, Ngomo S, Nowotny AH, Amorim CF. Age- and low back pain-related differences in trunk muscle activation during one-legged stance balance task. Gait Posture. 2019 Mar;69:25-30. doi: 10.1016/j.gaitpost.2019.01.016. Epub 2019 Jan 11.
- Dallaire M, Gagnon G, Fortin E, Nepton J, Severn AF, Cote S, Smaili SM, Goncalves de Oliveira Araujo HA, de Oliveira MR, Ngomo S, Bouchard J, da Silva RA. The Impact of Parkinson's Disease on Postural Control in Older People and How Sex can Mediate These Results: A Systematic Review. Geriatrics (Basel). 2021 Oct 29;6(4):105. doi: 10.3390/geriatrics6040105.
- de Lima MDCC, Dallaire M, Tremblay C, Nicole A, Fortin E, Maluf IC, Nepton J, Severn AF, Tremblay P, Cote S, Bouchard J, da Silva RA. Physical and Functional Clinical Profile of Older Adults in Specialized Geriatric Rehabilitation Care Services in Saguenay-Quebec: A Retrospective Study at La Baie Hospital. Int J Environ Res Public Health. 2022 Aug 13;19(16):9994. doi: 10.3390/ijerph19169994.
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Actual)
Primary Completion
Study Completion (Actual)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Synucleinopathies
- Pain
- Neurologic Manifestations
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Pathologic Processes
- Disease Attributes
- Neurodegenerative Diseases
- Movement Disorders
- Parkinsonian Disorders
- Basal Ganglia Diseases
- Back Pain
- Pathological Conditions, Signs and Symptoms
- Signs and Symptoms
- Parkinson Disease
- Musculoskeletal Diseases
- Low Back Pain
- Chronic Disease
Other Study ID Numbers
Other Study ID Numbers
- 2019-008
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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