Enhance Balance and Mobility in People With Type 2 Diabetic Peripheral Neuropathy



Status:Completed
Conditions:Diabetic Neuropathy, Neurology
Therapuetic Areas:Endocrinology, Neurology
Healthy:No
Age Range:55 - 80
Updated:1/28/2018
Start Date:May 2016
End Date:December 2017

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High Intensity Muscle Power and Balance Perturbation Training to Enhance Balance and Mobility in People With Type 2 Diabetic Peripheral Neuropathy

Type 2 diabetes results in a host of neuromuscular, muscular, and autonomic system
impairments that accelerate age-associated limitations in functional independence and the
risk of falls. Diabetic peripheral neuropathy (DPN) contributes to functional declines in
balance and mobility because of limitations metabolic abnormalities. The constellation of
impairments accompanying type 2 diabetes diminishes muscle function and performance including
strength and power. Loss of strength at higher speeds of movement (deficit in power) occurs
in neural activation of muscles, changes in muscle properties, and through in older
individuals with DPN compared to older controls. Consequently, this deficit in speed
dependent muscle power production leads to limitations in rapidly responding to sudden loss
of balance stability to prevent falling. The goal of this pilot research program is to
determine the feasibility and effectiveness of a mechanism-based therapeutic intervention fro
improving balance and mobility functions and preventing falls in older adults with DPN. The
investigators pan to use the results from this pilot study to design and implement a larger
randomized control trial.

The long-term goal of this research is to establish the effectiveness of a mechanism-based
therapeutic intervention for improving balance and mobility functions and preventing falls in
older adults with type 2 diabetic peripheral neuropathy (DPN).

Specific Aim 1 will determine if combined high intensity isolated leg muscle power exercise
with balance perturbation training (ActiveStep) and aerobic exercise achieves greater
improvements in balance stabilization (protective stepping behavior and kinematics) and
mobility function (gait parameters and timed functional measures) than a lifestyle based
intervention that primarily focuses on aerobic exercise through underlying mechanisms of
improved neuromuscular activation (rate and magnitude) and sensorimotor control, improved
muscle quality, and increased blood flow to enhance neuromuscular and sensorimotor
performance in people with DPN.

Specific Aim #2: To determine if a neuromotor balance training program combined with muscle
power exercise training and aerobic exercise, leading to improved neuromuscular and
sensorimotor mechanisms, is more effective in improving clinical tests of balance and
mobility functions in those with DPN compared with a traditional exercise intervention.

Inclusion Criteria:

- HbA1C of 5.7% to 9.0% or a fasting blood glucose of greater than or equal to 100

- Participants that are diabetic should be stable on medications for at least 3 months
prior to entering the study

- Neuropathy is most likely caused by impaired glucose regulation determined by medical
or family history

- Autonomic neuropathy as defined by Toronto Neuropathy Expert Group 2010/2011 consensus
criteria

- Medically stable at time of enrollment as determined by screening process

Exclusion Criteria:

- Neuropathy due to factors other than impaired glucose regulation determined by
screening process

- Other severe medical illness or condition that would preclude safe participation in
the study as determined by the study team

- Severe Autonomic Neuropathy that would limit study participation

- Musculoskeletal limitations that would preclude participation in balance assessment of
protective stepping
We found this trial at
2
sites
Baltimore, Maryland 21201
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Baltimore, Maryland 21201
Principal Investigator: Mark W. Rogers, PT, PhD
Phone: 410-706-0841
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