Effect of Exercise on Gait and Balance in Peripheral Neuropathy

Completed · Not applicable

Conditions studied: Diabetic Neuropathies, Peripheral Nerve Diseases, Peripheral Nervous System Diseases

In brief

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.

Key facts

Study ID

NCT00270842

Run by

US Department of Veterans Affairs

People needed

101

Starts

2006-01-01

Expected to finish

2012-09-01

Last updated by the study team

2015-04-08

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• James A. Haley Veterans Hospital — Tampa, Florida, United States

Full record on ClinicalTrials.gov

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