Effect of Exercise on Gait and Balance in Peripheral Neuropathy
1 other identifier
interventional
101
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2006
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 23, 2005
CompletedFirst Posted
Study publicly available on registry
December 28, 2005
CompletedStudy Start
First participant enrolled
January 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2012
CompletedResults Posted
Study results publicly available
April 8, 2015
CompletedApril 8, 2015
April 1, 2015
3 years
December 23, 2005
October 14, 2014
April 7, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Gait and Balance Measures
The Berg Balance Scale is a commonly used clinical, performance-based measure designed to evaluate performance during various balance activities in community dwelling and institutionalized older adults. The scale consists of 14 common daily balance tasks. Administration requires only minimal basic equipment and takes approximately 15 minutes. All 14 sub-tests are scored on a 5-point ordinal scale based on the subject's ability to perform the requested task safely and in a timely manner. Sub-test scores are summed to achieve a total score ranging from 0 to 56 with higher scores indicating better performance.
10 weeks
Secondary Outcomes (1)
Fall Self Efficacy
10 weeks
Study Arms (3)
Education Control Group
PLACEBO COMPARATOREducation group that is the control group for the study. Is a 10 week course with diverse health education topics.
Functional Balance Training
EXPERIMENTALExercise group that participated in functional balance training
Tai chi
EXPERIMENTALExercise Group that participated in tai chi training classes
Interventions
This intervention is a 10 week Tai Chi group exercise class designed specifically for persons with Peripheral Neuropathy, having difficulty feeling their feet.
This intervention is a 10 week Functional Balance group exercise class designed specifically for persons with Peripheral Neuropathy, having difficulty feeling their feet.
This control group participated in 10 weeks of general health education classes.
Eligibility Criteria
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.
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
James A. Haley Veterans Hospital
Tampa, Florida, 33637-1022, United States
Related Publications (1)
Quigley PA, Bulat T, Schulz B, Friedman Y, Hart-Hughes S, Richardson JK, Barnett S. Exercise interventions, gait, and balance in older subjects with distal symmetric polyneuropathy: a three-group randomized clinical trial. Am J Phys Med Rehabil. 2014 Jan;93(1):1-12; quiz 13-6. doi: 10.1097/PHM.0000000000000052.
PMID: 24355993RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Due to the large number of drop outs following the 10 week data point, maintenance of gait and balance changes is uncertain.
Results Point of Contact
- Title
- Dr. Patricia A. Quigley
- Organization
- James A. Haley VA
Study Officials
- PRINCIPAL INVESTIGATOR
Patricia A Quigley, PhD MPH
James A. Haley Veterans Hospital
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- FED
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 23, 2005
First Posted
December 28, 2005
Study Start
January 1, 2006
Primary Completion
January 1, 2009
Study Completion
September 1, 2012
Last Updated
April 8, 2015
Results First Posted
April 8, 2015
Record last verified: 2015-04