New Clinical Rehabilitation Approach for the Management of Falls Risks

NCT06175871 | Recruiting DMC

• 1 other identifier: 2019-008
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

Brief Summary

Accidental falls in older adults are one of the world's major pubic health problem, because of their strong association with injuries and mortality rates. In Quebec, falls are responsible for a high rate of hospitalization (more than 1800 emergency department visits every day) and deaths (more than 10,000 in recent years). Preventing falls is therefore a key mission for health professionals. This research program aims to develop a new clinical approach to the rehabilitation management of the older with a neuro-musculoskeletal disorder and a risk of falling. This program is part of a new partnership project between UQAC and specialized geriatric services at the CIUSSS Saguenay-Lac-St-Jean (La Baie site). These geriatric services admit more than 400 new patients per year, representing a large pool of participants for the new program's development. Specifically, this program has 4 phases: 1) Create a clinical profile of patients in rehabilitation care from specialized geriatric services (ex: reasons for consultation, neuro-musculoskeletal disorders, rates and causes of falls, etc.); 2) to diagnose functional deficits of these patients on different dimensions of functional and physical evaluations, using standardized tests and high-tech instruments (ex: platform of force); 3) determine the effectiveness of a new exercise intervention program (OTAGO) for falls prevention; and 4) Measure client and professional team satisfaction as well as long-term impact of this new approach used to prevent falls. The most significant impact of this new program will be to reduce public health expenditure for care of older adults with balance disorder and risk for falls; and therefore, be implanted in other CIUSSS institutions from Quebec.

Conditions

Musculoskeletal Diseases; Chronic Disease; Fall Patients; Aging Problems; Postural Low Back Pain; Parkinson Disease

Keywords

Aging; Rehabilitation; Postural control; Falls; Biomechanics; Technology innovative; Prevention; Mobility

Outcome Measures

Primary Outcomes (4)

• Postural control

  Measures of center of pressure (COP) from plateform of force during different balance tasks

  change from baseline at 8 to 12 weeks

• Walking

  Gait parameters from GaitRite measurement

  change from baseline at 8 to 12 weeks

• Trunk postural control on wobble chair

  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.

  change from baseline at 8 to 12 weeks

• Machine learning-driven neuromusculoskeletal (NMS) assessment

  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.

  change from baseline at 8 to 12 weeks

Secondary Outcomes (6)

• Functional mobility test: TUG

  change from baseline at 8 to 12 weeks

• 30 Second Sit to Stand Test

  change from baseline at 8 to 12 weeks

• maximal isometric hand grip strength

  change from baseline at 8 to 12 weeks

• Walking test in 10 meters

  change from baseline at 8 to 12 weeks

• 5 times Sit-To-Stand (FTSTS)

  change from baseline at 8 to 12 weeks

Other Outcomes (6)

• Falls Efficacy Scale-International (FES-I)

  change from baseline at 8 to 12 weeks

• Pain measures

  change from baseline at 8 to 12 weeks

• Fatigue perception

  change from baseline at 8 to 12 weeks

Study Arms (2)

Otago exercises

EXPERIMENTAL

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).

Other: OTAGO exercises

Conventional physiotherapy at Hospital

ACTIVE COMPARATOR

This group will be for the conventional type of intervention already in place in geriatric services from La Baie Hospital. This therapy used for physiotherapists at site, including mobility exercices.

Other: Conventional therapy

Interventions

OTAGO exercises OTHER

Exercices for improvement postural control and mobility and decrease falls risks

Also known as: plein air et nature exercises

Otago exercises

Conventional therapy OTHER

Exercice and education from physical therapy practice conventional from Hospital.

Also known as: Physiotherapy conventional at hospital by clinicians

Conventional physiotherapy at Hospital

Eligibility Criteria

• Age: 65 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Université du Québec à Chicoutimi: lead
• Agence de la Sante et des Services Sociaux du Saguenay-Lac-Saint-Jean: collaborator

Study Sites (1)

Rubens da Silva

Saguenay, Quebec, G7H 2B1, Canada

RECRUITING

Related Publications (20)

• 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.

  PMID: 12391997 BACKGROUND

• 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.

  PMID: 26303366 BACKGROUND

• 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.

  PMID: 24484314 BACKGROUND

• 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.

  PMID: 15317981 RESULT

• 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.

  PMID: 11380764 RESULT

• 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.

  PMID: 21892675 RESULT

• 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.

  PMID: 30222769 RESULT

• 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.

  PMID: 28095084 RESULT

• 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.

  PMID: 11253156 RESULT

• 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.

  PMID: 9366737 RESULT

• 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.

  PMID: 28204770 RESULT

• 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.

  PMID: 20817938 RESULT

• 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.

  PMID: 10399508 RESULT

• 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.

  PMID: 23783372 RESULT

• 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.

  PMID: 26428907 RESULT

• 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.

  PMID: 31563376 RESULT

• 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.

  PMID: 31011080 RESULT

• 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.

  PMID: 30658312 RESULT

• 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.

  PMID: 34842716 RESULT

• 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.

  PMID: 36011629 RESULT

Related Links

• Programme d'Exercices OTAGO - Fondation de ma vie - CIUSSS-SLSJ programmes de bourse
• Profil main investigator

MeSH Terms

Conditions

Musculoskeletal Diseases; Chronic Disease; Low Back Pain; Parkinson Disease

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Sharlène Côté, MD

  CIUSSS-SLSJ (La Baie Hospital)

  STUDY CHAIR

• Julie Bouchard, PhD

  Université du Québec à Chicoutimi

  STUDY DIRECTOR

• Patrice Tremblay, PT

  CIUSSS-SLSJ (La Baie Hospital)

  STUDY CHAIR

• Rubens da Silva

  Université du Québec à Chicoutimi

  PRINCIPAL INVESTIGATOR

• Marie-Ève Langelier, MD

  Université du Québec à Chicoutimi

  STUDY CHAIR

Central Study Contacts

Rubens da Silva, PhD

CONTACT

418 5455011; rubens.dasilva@uqac.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director Physical Therapy program

Model Details: Clinical trial design

Study Record Dates

• First Submitted: November 21, 2023
• First Posted: December 19, 2023
• Study Start: July 1, 2024
• Primary Completion: July 1, 2025
• Study Completion (Estimated): July 1, 2026
• Last Updated: December 6, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)