The Effect of Foot Orthoses on the Balance of Elderly Women With Osteoporosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 94
- 试验地点
- 1
- 主要终点
- Berg Balance Scale (BBS)
研究概览
简要总结
The objective of this study was to determine if foot orthoses are effective in improving balance, pain and disability in elderly women with osteoporosis.
详细描述
Aging has been associated with balance impairment. The use of foot orthoses has been shown to be a feasible strategy for improving postural control.The objective of this study was to determine if foot orthoses (with metatarsal pad and medial arch support) are effective as an adjuvant treatment to improve balance, foot pain and disability in elderly women with osteoporosis. Another purpose was to verify if social demographic and clinical factors such as age, race, education, marital status, age of menopause, use of drugs related to balance dysfunction, visual or hearing complaints, body mass index, previous fractures and number of falls may influence the results.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of osteoporosis
排除标准
- •reduced tactile and thermal foot sensibility
- •compromised skin integrity of the lower limbs
- •autoimmune rheumatic diseases
- •vestibular symptoms
- •central nervous system pathologies
- •peripheral neuropathy
- •use of insoles in the last month
- •lower limb prostheses
- •previous history of foot surgery
- •amputation of the lower limbs
- •inability to attend the necessary reevaluations and/or to follow instructions and procedures of the research protocol
研究组 & 干预措施
Foot orthosis
Forty-seven women in treatment in the outpatient clinic of the Rheumatology Division of State University of Campinas(UNICAMP) who met the inclusion criteria for this study (being female with osteoporosis and aged 60 or above) were assigned, at random, to wear ethyl-vinyl-acetate insoles with medial arch supports and metatarsal pads over a four-week period. Balance, using the Berg Balance Scale (BBS) and the Timed Up and Go (TUG) indexes; pain, using a numeric pain scale (NPS); and disability of the feet, using the Manchester Foot Pain and Disability Index (MFPDI), were assessed at baseline and after four weeks.
干预措施: Foot orthosis (Orthotics Unit of the Clinical Hospital of UNICAMP) (Device)
Control Group
Forty-seven elderly women with osteoporosis (in treatment in the outpatient clinic of the Rheumatology Division of State University of Campinas- UNICAMP) were assigned, at random, to enter the control group with no foot intervention. Balance, using the Berg Balance Scale (BBS) and the Timed Up and Go (TUG) indexes; pain, using a numeric pain scale (NPS); and disability of the feet, using the Manchester Foot Pain and Disability Index (MFPDI), were assessed at baseline and after four weeks.
结局指标
主要结局
Berg Balance Scale (BBS)
时间窗: 4 weeks
The BBS is a balance assessment test that rates the ability of a subject to maintain balance while performing each of 14 movements required in everyday activities (transferring, standing unsupported, rising from a sitting to a standing position, tandem standing, turning 360° and single-leg standing). Scoring is based on an ordinal 5-point scale from 0 to 4. Total scores ranges from 0 to 56. The smaller value, the worse balance: from 0-20: a whell chair is needed: 20-41: needing walk assistence; 41-56 - independent walking.
Timed up and Go Test (TUG)
时间窗: 4 weeks
The TUG test is used to assess the dynamic balance of an individual. It measures the amount of time (recorded in seconds) it takes for the individual to rise from a standard arm chair, walk a distance of 3 meters and return to the initial position resting against the back of the chair.
次要结局
- Numeric Pain Scale(4 weeks)
- Manchester Foot and Pain Disability Index(MFPDI)(4 weeks)
研究者
Ibsen Coimbra
Director of Medical Department of The Faculty of Medical Sciences, State University of Campinas (Unicamp), Brazil
University of Campinas, Brazil