New Clinical Rehabilitation Approach for the Management of Falls Risks

Parkinson Disease Clinical Trial

— ReabFalls  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06175871
• Other study ID #: 2019-008
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 1, 2024
• Est. completion date: July 1, 2026

Study information

• Verified date: December 2023
• Source: Université du Québec à Chicoutimi
• Contact: Rubens da Silva, PhD
• Phone: 418 5455011
• Email: rubens.dasilva[@]uqac.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

This research program on aging to create Living Lab Sag aims at maintaining older adult's full individual and collective abilities in the Saguenay-Lac-Saint-Jean (SLSJ) region. The need for innovation and creativity aims at optimizing independence, whether for mobility, the ability to take charge of one's health, to remain at home, to have access to services, and to prevent falls in a frail and aging population. Thus, this program includes expert investigators in the areas of health, engineering and computer science, aging, neuropsychology, geriatrics, and rehabilitation/prevention within a multidisciplinary work approach for durable health for older adults in Saguenay. Living Lab Sag will be implemented based on an enriched research program, approved by the CIUSSS SLSJ (CER# 2019-008) and entitled: Development of a new clinical approach in rehabilitation for the care of older adults with a neuro-musculo-skeletal disorder and a risk of falling: Project in partnership between UQAC and the specialized geriatrics services of the CIUSSS-SLSJ. Canada census reports clearly show the demographic aging of the local population. It is predicted that people 65 years and older will comprise about 24% of the population in 2036, in Canada and Quebec. In parallel with this demographic phenomenon, 50% of Canadians live with at least one chronic disability that is often associated with advanced age, as well as with different neurological, orthopedic and cardiopulmonary degenerative diseases. Some diseases affecting the neuro-musculo-skeletal system will lead to physical disability and to a significant functional limitation in terms of balance, mobility and walking and, consequently, to an increase in the risk of falling. Falls have a significant financial effect on healthcare services. Every year, in Quebec, approximately 1/3 of people aged 65 and over will fall and, sadly, some data suggest that 424,000 people will die, worldwide, because of a fall. The present scenario also shows the importance of developing strategies to reduce the weight of falls on the healthcare system, such as the creation of Living Lab Sag where the older adults will be at the heart of the situation. With team's experience in the area, one strategy among others is the early identification of physical-functional factors leading to a fall, despite the presence of other associated extrinsic factors that are also associated with the fall (i.e., multifactor phenomenon). This identification can be realized through neurophysiological measures from valid and reliable biological signals in rehabilitation, that will help determine the neuromuscular responses associated to the level of physical frailty of the individual and his/her fall risk. However, geriatric services in general don't often have access to high-end screening tools that permit an early detection of balance problems and fall risk. Within an innovative action plan, our research program, in partnership with specialized geriatric services and researchers aims to determine the efficiency of new evaluation and intervention methods for the health of the older adults. Since 2019, this programm integrate new measures using various high-end equipment to capture biological signals enabling to perform research with patients from Hospital and patients from Parkinson Association and community local. The mission of this program is to build a new paradigm for this site while being a reference to evaluate balance/mobility and walking problems, better screen frail older adults who are at risk of falling and direct then to personalized therapy. At this time, this work will develop a longitudinal intervention study using OTAGO (PEO) exercise program. The name "OTAGO" is not an acronym, as "Otago" is a region of New Zealand located southwest of the southern island. PEO is defined by a reeducation program for strength and balance at home (or in a rehabilitation center), that is personalized, and based on conclusive data. The PEO was developed by a geriatrician (Dr. Campbell) and his team of physiotherapists in 1997, after many years of research, to identify the risks of falling and the potential interventions that could reduce these risks. The program exists worldwide but has never been tested in Québec. Although there are different fall prevention programs, conclusive data show the more frequent use of OTAGO because of its efficiency to reduce the risk of death and the incidence rate of falls over a period of one year in an aging population. This program also reduces falls by 25% according to conclusive data, which no other program in Québec and in rural areas has demonstrated until now. Finally, this program can be a cost-effective intervention for the healthcare system by reducing expenses associated to falls in rural areas, and in particular for patients in La Baie Hospital. Already used in Australia and the United States, we have yet to determine its effects in the Saguenay area. The goal is to test and show its efficiency for the fist time in the area by a random clinical trial in La Baie Hospital. This step will make it possible to advance our research program on the effective intervention plan to reduce future public healthcare expenses related to falls. The aim of this study will thus be to evaluate if the PEO, when adapted to La Baie geriatric services, is superior to conventional therapy to improve parameters of walking, balance, muscle activation, postural trunk control, mobility, force, endurance and perception of symptoms related to pain, function, fall risk and, consequently, quality of life (wellbeing), volume of medication and expenses associated to fall. In other step, the purpose is also evaluate the effect of carrying out the OTAGO exercises in an outdoor and nature modality during a feasibility study to see the impact of nature on the functional abilities of older people with neuromusculoskeletal disorders (ex. Parkinson disease).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 92
• Est. completion date: July 1, 2026
• Est. primary completion date: July 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years to 99 Years

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

Other:
• OTAGO exercises
Exercices for improvement postural control and mobility and decrease falls risks
• Conventional therapy
Exercice and education from physical therapy practice conventional from Hospital.

Locations

Country	Name	City	State
Canada	Rubens da Silva	Saguenay	Quebec

Sponsors (2)

Lead Sponsor	Collaborator
Université du Québec à Chicoutimi	Agence de la Sante et des Services Sociaux du Saguenay-Lac-Saint-Jean

Country where clinical trial is conducted

Canada, 

References & Publications (20)

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. — View Citation

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.315.7115.10 — View Citation

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 — View Citation

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.2019.01.0 — View Citation

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 — View Citation

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 Saguena — View Citation

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 — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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 20 — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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 Agi — View Citation

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- — View Citation

* Note: There are 20 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Falls Efficacy Scale-International (FES-I)	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).	change from baseline at 8 to 12 weeks
Other	Pain measures	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	change from baseline at 8 to 12 weeks
Other	Fatigue perception	Fatigue perception used BORG scale during the exercices	change from baseline at 8 to 12 weeks
Other	Frailty criteria from Fried	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).	change from baseline at 8 to 12 weeks
Other	Hoehn and Yahr Scale	The scale has been used for the staging of the functional disability associated with Parkinson's disease.	Only at baseline from Sample characterization when Parkinson was included.
Other	Cognitive status	Mini-mental state questionnaire, which was used for grading the cognitive state of patients in this study.	Only at baseline from Sample characterization.
Primary	Postural control	Measures of center of pressure (COP) from plateform of force during different balance tasks	change from baseline at 8 to 12 weeks
Primary	Walking	Gait parameters from GaitRite measurement	change from baseline at 8 to 12 weeks
Primary	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
Primary	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	Functional mobility test: TUG	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.	change from baseline at 8 to 12 weeks
Secondary	30 Second Sit to Stand Test	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.	change from baseline at 8 to 12 weeks
Secondary	maximal isometric hand grip strength	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.	change from baseline at 8 to 12 weeks
Secondary	Walking test in 10 meters	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.	change from baseline at 8 to 12 weeks
Secondary	5 times Sit-To-Stand (FTSTS)	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.	change from baseline at 8 to 12 weeks
Secondary	Numbers of falls	Self-reported falls before, during and after the study	change from baseline at 8 to 12 weeks, 6 and 12 months after

External Links

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