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Randomised controlled trial assessing the effect of a technology-assisted gait and balance training on mobility in older people after hip fracture: study protocol.

ABSTRACT: INTRODUCTION:Deficits in balance and walking ability are relevant risk factors for falls during ageing. Moreover, falls are a risk factor for future falls, strongly associated with adverse health outcomes, such as fear of falling or fractures, particularly, hip fracture. For this reason, the development of prevention tools and innovative rehabilitation strategies is one of the main objectives in geriatrics. Effective interventions to promote hip recovery after hip fracture are characterised by intensive and repetitive movements. One treatment approach is to increase the number of steps during the rehabilitation sessions and to improve the balance and the endurance of the patients in the use of technological devices. METHODS AND ANALYSIS:This randomised controlled trial aimed to evaluate an innovative rehabilitation treatment of elderly patients with hip fractures. A total of 195 patients with hip fractures will be recruited and randomly divided into three groups: traditional rehabilitation programme, traditional rehabilitation programme plus TYMO system and traditional rehabilitation programme plus Walker View. Assessments will be performed at baseline, at the end of treatment, at 6 months, and at 1?and 2 years after the end of the treatment. Only subjects hospitalised 4?weeks prior to the beginning of the study will be taken into consideration. Twenty treatment sessions will be conducted, divided into three training sessions per week, for 7 weeks. The technological intervention group will carry out 30?min sessions of traditional therapy and 20?min of treatment with a technological device. The control group will perform traditional therapy sessions, each lasting 50?min. The primary outcomes are risk of falling, gait performance and fear of falling. ETHICS AND DISSEMINATION:The study was approved by the Istituto di Ricerca e Cura a Carattere Scientifica, Istituto Nazionale Ricovero e Cura Anziani Ethics Committee, with identification code number 19?014. Trial results will be submitted for publication in journals and conferences. TRIAL REGISTRATION NUMBER:NCT04095338.

SUBMITTER: Maranesi E

PROVIDER: S-EPMC7299027 | biostudies-literature | 2020 Jun

REPOSITORIES: biostudies-literature

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Randomised controlled trial assessing the effect of a technology-assisted gait and balance training on mobility in older people after hip fracture: study protocol.

Maranesi Elvira E Riccardi Giovanni Renato GR Lattanzio Fabrizia F Di Rosa Mirko M Luzi Riccardo R Casoni Elisa E Rinaldi Nadia N Baldoni Renato R Di Donna Valentina V Bevilacqua Roberta R

BMJ open 20200615 6

<h4>Introduction</h4>Deficits in balance and walking ability are relevant risk factors for falls during ageing. Moreover, falls are a risk factor for future falls, strongly associated with adverse health outcomes, such as fear of falling or fractures, particularly, hip fracture. For this reason, the development of prevention tools and innovative rehabilitation strategies is one of the main objectives in geriatrics. Effective interventions to promote hip recovery after hip fracture are characteri ...[more]

PMID: 32546491

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Project description:(1) Background: Parkinson's Disease (PD) is one of the most common causes of disability among older individuals. The advanced stages of PD are usually characterized by postural instability and, as a consequence, falls. Those are among the main factors that determine the quality of life, as well as the morbidity and mortality of a person with PD. In the field of PD rehabilitation, robotics is also rapidly gaining ground. As a primary aim, we evaluate the acceptability of the technology integrated intervention, using the Psychosocial Impact of Assistive Devices Scale (PIADS), in order to analyze the attitude of the participants towards the Tymo® system. As a secondary outcome, we assess the result of the rehabilitation treatment integrated with the Tymo® system on several patient's features. (2) Methods: We studied a population of 16 patients with Parkinson's Disease. Each recruited subject completed 10 treatment sessions, organized as two training sessions per week, for 5 weeks. The intervention included 30 min of traditional therapy and 20 min of technological treatment with a robotic system. PIADS is composed of three subscales (Competence subscale, Adaptability subscale, Self-esteem subscale) ranging from -3 to +3, reflecting, respectively, a negative or positive feeling towards the device. (3) Results: The Competence subscale, measuring feelings of competence and usefulness, obtained a score of 1.24 (SD = 0.78). The score of Adaptability subscale, indicating a willingness to try out new things and to take risks, was 1.83 (SD = 0.65). Finally, the Self-esteem subscale, indicating feelings of emotional health and happiness, reached a score of 1.31 (SD = 0.72). Moreover, statistical analysis reveals a significant effect on balance performance after intervention. (4) Conclusions: This feasibility study represents a starting point in the use of technology in the rehabilitation pathway of patients affected by Parkinson's Disease. In fact, our results suggest that a standard therapy combined with an innovative treatment using Tymo® may be accepted by PD patients, which may benefit especially from preserving balance.

Project description:Motor functions are deteriorated by aging. Some conditions may magnify this deterioration. This study examined whether hemodialysis (HD) process would negatively impact gait and balance beyond diabetes condition among mid-age adults (48⁻64 years) and older adults (65+ years). One hundred and ninety-six subjects (age = 66.2 ± 9.1 years, body-mass-index = 30.1 ± 6.4 kg/m², female = 56%) in 5 groups were recruited: mid-age adults with diabetes undergoing HD (Mid-age HD+, n = 38) and without HD (Mid-age HD-, n = 40); older adults with diabetes undergoing HD (Older HD+, n = 36) and without HD (Older HD-, n = 37); and non-diabetic older adults (Older DM-, n = 45). Gait parameters (stride velocity, stride length, gait cycle time, and double support) and balance parameters (ankle, hip, and center of mass sways) were quantified using validated wearable platforms. Groups with diabetes had overall poorer gait and balance compared to the non-diabetic group (p < 0.050). Among people with diabetes, HD+ had significantly worsened gait and balance when comparing to HD- (Cohen's effect size d = 0.63⁻2.32, p < 0.050). Between-group difference was more pronounced among older adults with the largest effect size observed for stride length (d = 2.32, p < 0.001). Results suggested that deterioration in normalized gait speed among HD+ was negatively correlated with age (r = -0.404, p < 0.001), while this correlation was diminished among HD-. Interestingly, results also suggested that poor gait among Older HD- is related to poor ankle stability, while no correlation was observed between poor ankle stability and poor gait among Older HD+. Using objective assessments, results confirmed that the presence of diabetes can deteriorate gait and balance, and this deterioration can be magnified by HD process. Among HD- people with diabetes, poor ankle stability described poor gait. However, among people with diabetes undergoing HD, age was a dominate factor describing poor gait irrespective of static balance. Results also suggested feasibility of using wearable platforms to quantify motor performance during routine dialysis clinic visit. These objective assessments may assist in identifying early deterioration in motor function, which in turn may promote timely intervention.

Project description:BackgroundTo study the effect of hip fracture type on physical performance, functional ability and change in mobility four to six months after the injury.MethodsA total of 1331 patients out of consecutive 2052 patients aged ≥ 65 years who underwent hip fracture surgery were included in the study. Patient information was collected on admission, during hospitalization, by phone interview and at the geriatric outpatient clinic 4 to 6 months after the fracture. Of the 1331 eligible patients, Grip strength, Timed Up and Go -test (TUG), Elderly Mobility Scale (EMS), mobility change compared to pre-fracture mobility level, Basic Activities of Daily Living (BADL) and Instrumental Activities of Daily Living (IADL) were used to determine physical performance and functional ability. Logistic regression was used for the analyses which was adjusted for gender, age, American Society of Anesthesiologists score, diagnosis of cognitive disorder, pre-fracture living arrangements, mobility and need of mobility aid.ResultsPatients with pertrochanteric hip fracture had an EMS lower than 14 (Odds Ratio (OR) 1.38, 95% confidence intervals (CI) 1.00-1.90), TUG time ≥ 20 s (OR 1.69, 95% CI 1.22-2.33) and they had declined in mobility (OR 1.58, 95% CI 1.20-2.09) compared to femoral neck fracture patients 4 to 6 months post-hip fracture in multivariable-adjusted logistic regression analyses. Grip strength and functional ability (IADL, BADL) 4 to 6 months after hip fracture did not differ between fracture types. There were no statistically significant differences in physical performance in patients with a subtrochanteric fracture compared to patients with a femoral neck fracture.ConclusionsPertrochanteric hip fracture independently associated with poorer physical performance 4 to 6 months post hip fracture compared to other hip fracture types. Pertrochanteric hip fracture patients should be given special attention in terms of regaining their previous level of mobility.

Project description:Overground robotic-assisted gait training (O-RAGT) has been shown to improve clinical functional outcomes in people living with stroke. The purpose of this study was to identify whether a home-based O-RAGT program, in combination with usual care physiotherapy, would demonstrate improvements in vascular health in individuals with chronic stroke, and, whether any changes in vascular outcomes would be sustained 3 months after completing the program. Thirty-four participants with chronic stroke (between 3 months and 5 years post-stroke) were randomized to either a 10-week O-RAGT program in combination with usual care physiotherapy, or to a usual care physiotherapy only control group. Participants' (n = 31) pulse wave analysis (PWA), and regional [carotid-femoral pulse wave analysis (cfPWV)] and local (carotid) measures of arterial stiffness were assessed at baseline, post-intervention, and 3-month post-intervention. Analysis of covariance demonstrated a significant reduction (improvement) in cfPWV between BL and PI for O-RAGT (8.81 ± 2.51 vs. 7.92 ± 2.17 m/s, respectively), whilst the control group remained unchanged (9.87 ± 2.46 vs. 9.84 ± 1.76 m/s, respectively; p < 0.05; ηp2 = 0.14). The improvement in cfPWV was maintained 3 months after completing the O-RAGT program. There were no significant Condition by Time interactions for all PWA and carotid arterial stiffness measures (p > 0.05). A significant increase in physical activity, as determined by the time spent stepping, was observed for O-RAGT between baseline and post-intervention assessments (3.2 ± 3.0-5.2 ± 3.3%, respectively) but not for CON (p < 0.05). The improvement in cfPWV, in combination with an increase in physical activity whilst wearing the O-RAGT and concomitant reduction in sedentary behavior, are important positive findings when considering the application of this technology for "at home" rehabilitation therapy for stroke survivors. Further research is needed to determine whether implementing "at home" O-RAGT programs should be a part of the stroke treatment pathway.Clinical trial registrationhttps://clinicaltrials.gov, identifier NCT03104127.

Project description:The aim of this trial was to evaluate the clinical effectiveness and cost-effectiveness of a home-based exercise program delivered four months following hip-fracture surgery. In the two-armed randomized, single blinded clinical trial we included persons who lived in the catchment area, were 70 years or older, and community-dwelling at time of the fracture. We excluded persons who were unable to walk ten meters prior to the fracture, and those who were bedridden or had medical contraindications for exercise at baseline (ie. four months after the fracture). All participants underwent routine treatment and rehabilitation. The intervention group received additional 20 sessions (10 weeks) structured, home exercise targeting gait and balance, delivered by physiotherapists in primary health care. Gait speed was the primary outcome. Secondary outcomes included physical activity, gait characteristics, cognitive function, activities of daily living, health-related quality of life, and health care costs extracted from hospital and municipality records. In total, 223 participants were included. Four months post surgery 143 were randomized for the exercise trial (70% women, mean age 83.4 (SD 6.1) years, mean gait speed 0.6 (SD 0.2) m/sec). Estimated between group difference in gait speed was 0.09 m/sec (95% CI: 0.04 to 0.14, p<0.001) at posttest and 0.07 m/sec (95% CI: 0.02 to 0.12, p = 0.009) 12 months post surgery. The mean between-group QALY difference was -0.009 (95% CI: -0.061 to 0.038). The mean between-group total cost difference was +242.9 EUR (95% CI: -8397 to 8584). Our findings suggest that gait recovery after hip fracture can be improved by introducing a home-based balance and gait exercise program four months post surgery, without increasing total health care costs. Future research should focus on how to implement gait and balance exercise in comprehensive interventions that increase adherence among the most vulnerable persons and have an effect on daily life activities and patient-centred outcomes. Trial registration: ClinicalTrials.gov NCT01379456.

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Randomised controlled trial assessing the effect of a technology-assisted gait and balance training on mobility in older people after hip fracture: study protocol.

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Randomised controlled trial assessing the effect of a technology-assisted gait and balance training on mobility in older people after hip fracture: study protocol.

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