Status:
COMPLETED
Effect of Exercise on Gait and Balance in Peripheral Neuropathy
Lead Sponsor:
US Department of Veterans Affairs
Conditions:
Diabetic Neuropathies
Peripheral Nerve Diseases
Eligibility:
All Genders
Phase:
NA
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 p...
Detailed Description
Since the 1970's, 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 l...
Eligibility Criteria
Inclusion
- Corrected vision not worse than 20/50 to have visual acuity to read and follow instructions.
- Ability to ambulate household distances with or without an assistive device. This reflects a minimum functional status for ambulation as primary mode of mobility.
- Symptoms and Signs consistent with LLPN as determined by the Michigan Diabetic Neuropathy Scale (Score greater than 6, presence of mild PN). The Michigan Diabetic Neuropathy Score quantifies sensory impairment, muscle strength, and reflexes, using vibration, filament, pin prick, and physical touch. Scale ranges from 0-46, with higher score indicating great severity of PN. The score is used to stratify severity of PN, and takes approximately 10-15 minutes to complete. Testing aspects elicit sensation from small and moderate nerve fibers, and is more sensitive to mild to moderate sensory neuropathy. This test was selected rather than the gold standard EMG in order to screen for study subjects, is less invasive, and reduces the burden of subject screening for inclusion into this study.
Exclusion
- Cognitive impairment with MMSE score less than 24, level 24 and below scores indicated cognitive impairments, limiting ability to remember instructions.
- Metastatic cancer, limits ability to complete the intensity and duration of the study.
- Central neurological dysfunction e.g. diagnosis of hemiparesis, cerebellar dysfunction, Parkinson's disease as determined by medical record review. These neurological impairments impair gait and balance, and would jeopardize safety if randomized to an intervention group.
- Lower extremity amputation, a physical disability that results in altered postural balance.
- Lower extremity abnormality other than peripheral neuropathy, such as foot drop, as participation in class would compromise patient safety.
- Mobility limitations due to altered lower extremity skin integrity/ulcer, where pain would limit gait and weight-bearing would be contraindicated such as stasis and foot ulcers or claudication.
- Medically unstable upon exam, i.e. poorly controlled blood pressure and blood sugar, coronary artery disease, where group participation would compromise medical status.
Key Trial Info
Start Date :
January 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2012
Estimated Enrollment :
101 Patients enrolled
Trial Details
Trial ID
NCT00270842
Start Date
January 1 2006
End Date
September 1 2012
Last Update
April 8 2015
Active Locations (1)
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1
James A. Haley Veterans Hospital
Tampa, Florida, United States, 33637-1022