Ignite Creation Date:
2024-05-05 @ 4:35 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00270842
Status:
COMPLETED
Last Update Posted:
2015-04-08
First Post:
2005-12-23
Brief Title:
Effect of Exercise on Gait and Balance in Peripheral Neuropathy
Sponsor:
US Department of Veterans Affairs
Organization:
VA Office of Research and Development
Study Overview
Official Title:
Effect of Exercise on Gait and Balance in Peripheral Neuropathy
Status:
COMPLETED
Status Verified Date:
2015-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to find out if participation in one of the study groups functional balance training Tai Chi or education results in better outcomes overall The outcomes that we are primarily interested in are related to walking ability and balance
Detailed Description:
Since the 1970s researchers and epidemiologists have documented that patient falls are a high-risk high volume high cost adverse events contributing to morbidity mortality decreased quality of life and premature nursing home placement Despite thousands of research studies published on patient falls few studies have focused on the effectiveness of interventions and fall rates and associated injuries among the elderly continue to rise Impaired gait and balance referred to as impaired stability is one of the most significant causes and consequences of falls Persons with peripheral neuropathy represent one of the largest patient populations with impaired stability Lower limb peripheral neuropathy LLPN includes sensory and motor impairments that result in impaired gait and balance jeopardizing safe mobility Emerging evidence suggests that exercise programs can be effective in improving gait and balance in general fall risk populations as well as reducing falls and fall-related injuries Exercise interventions have been designed to reduce fall risk and promote successful aging These interventions come in many forms but the most common interventions are exercise training and Tai Chi offered individually and in small group formats Further research is needed to gain insight into the underlying mechanisms of different type of exercises and their impact on stability in veterans with LLPN Research is needed to determine the type or combination of types of exercise to produce a more normal andor stable gait in this high-risk patient population Researchers are beginning to document that exercise interventions positively influence a persons fall self efficacy ie self confidence for avoiding a fall an important factor in understanding and examining a persons behaviors related to fall risks The emphasis on functionally based interventions has led to inappropriate broad groupings of older persons with mobility disorders A weakness of previous studies was that they aggregated heterogeneous patient populations resulting in neurological and musculoskeletal diagnostic heterogeneity and the confounding of results Focusing on a homogeneous patient population is necessary to distinguish unique sensory gait and balance deficits that contribute to impaired stability and mobility risk as well as to better understand unique responses to treatment that are clouded when diverse patients are aggregated We will target veterans with LLPN--one of the largest groups of patients referred to our Falls Clinic and an understudied population with respect to safe patient mobility This will allow us to design targeted interventions likely to be more effective than those tested on heterogeneous elderly populations where visual and vestibular input to compensate for impaired proprioception were not taken into account
The goal of this study is to improve successful adaptation to aging and quality of life in veterans with lower limb peripheral neuropathy LLPN Functional Balance Training and Tai Chi the two exercise interventions tested in this study have been documented to improve gait and balance and decrease falls and associated fall-related injuries in the general elderly population We are interested in whether one or both of these exercise interventions successful in general elderly populations would be effective in a special subpopulation of elderly namely persons with LLPN
The purpose of this study is to compare the effectiveness of these two exercise interventions and an education control group Effectiveness will be assessed by studying the impact of interventions on 1 composite measures of stability gait and balance 2 fall self-efficacy and 3 patient acceptance Given the well-documented links between falls and fall-related injuries ultimate outcomes our study will focus on stability intermediate outcome Because falls and fall-related injuries are relatively rare events examining stability as an outcome will allow us to have sufficient power to test our hypotheses with a relatively small sample size thereby decreasing the cost and duration of the study without sacrificing the rigor of the research design
The goal of this study is to improve successful adaptation to aging and quality of life in veterans with lower limb peripheral neuropathy LLPN Functional Balance Training and Tai Chi the two exercise interventions tested in this study have been documented to improve gait and balance and decrease falls and associated fall-related injuries in the general elderly population We are interested in whether one or both of these exercise interventions successful in general elderly populations would be effective in a special subpopulation of elderly namely persons with LLPN
The purpose of this study is to compare the effectiveness of these two exercise interventions and an education control group Effectiveness will be assessed by studying the impact of interventions on 1 composite measures of stability gait and balance 2 fall self-efficacy and 3 patient acceptance Given the well-documented links between falls and fall-related injuries ultimate outcomes our study will focus on stability intermediate outcome Because falls and fall-related injuries are relatively rare events examining stability as an outcome will allow us to have sufficient power to test our hypotheses with a relatively small sample size thereby decreasing the cost and duration of the study without sacrificing the rigor of the research design
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None