Effects of BRACE (Balance, Resistance, Aerobic and Cognitive Exercise) Protocol for Balance Training in Patients With Diabetic Peripheral Neuropathy.
Trial Snapshot
- Phase
- Not Applicable
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Berg Balance Scale
Study Overview
Brief Summary
The purpose of the study is to determine the effects of the BRACE( Balance, Resistance, Aerobic and Cognitive Exercise) protocol for balance training in patients with Diabetic Peripheral Neuropathy. A Randomized Control Trial is being conducted at Railways General Hospital, Rawalpindi. The sample size was calculated through the open epi tool. A total of 60 patients are divided into two groups, 30 participants in the experimental group and 30 participants in the control group. The study duration will be six months. The sampling technique applied was simple random sampling for recruitment and group randomization using the sealed envelope method. Patients with the age of 40-65 years having type II diabetes for more than 5 years are included in the study. Tools used in the study are Berg balance scale, timed up and go test, functional reach test, Montreal Cognitive Assessment scale (MOCA), and force plate. Data will be analyzed through Statistical Package for the Social Sciences (SPSS), version 21.
Detailed Description
American Diabetic Association (ADA) defined Diabetes mellitus as a group of metabolic diseases characterized by hyperglycemia resulting from defects in insulin secretion, insulin action, or both. The chronic hyperglycemia of diabetes is associated with dysfunction of various organs, especially the eyes, kidneys, nerves, heart, and blood vessels.
Most common among the neuropathies are chronic sensorimotor distal symmetric polyneuropathy (DPN) and autonomic neuropathies. According to ADA(American Diabetes Association), DPN(Diabetic Peripheral Neuropathy) is "the presence of symptoms and/or signs of peripheral nerve dysfunction in people with diabetes after exclusion of other causes. It is estimated that 60% to 70% of individuals with diabetes have mild to severe forms of nervous system damage.
DPN(Diabetic Peripheral Neuropathy) causes decreased sensation, proprioception, reflexes, and strength in the lower extremities, leading to balance dysfunction. Physical therapy interventions utilized to reduce the balance dysfunction can range from restoration of the health of the neurons to sensory integration to compensatory strategies. Various treatment protocols include improving circulation, the guided practice of integrating internal and external sensory input, education on sensation loss and fall risk, instruction on home modifications, and introduction of assistive devices to minimize balance dysfunction.
A systematic and evidence-based search of relevant literature was performed by utilizing PubMed and Google Scholar as search engines.
Search term for the initial literature review was Diabetes mellitus, the prevalence of DPN(diabetic peripheral neuropathy), causes of peripheral neuropathies and loss of balance, the pathophysiology of diabetes-related peripheral neuropathy, treatment options for balance training, strengthening lower extremities, aerobics, cognitive approach. The search was limited to papers in English preferably published since 2000 with full text available. Different studies were available regarding balance exercises and their effects but limited data was available regarding BRACE ( Balance, Resistance, Anaerobic, and Cognitive Exercise) protocol as a whole in recent years.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Masking Description
Outcomes assessor and participants.
Eligibility Criteria
- Ages
- 40 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients with type-2 Diabetes
- •Diabetes of more than 5 years of the duration
Exclusion Criteria
- •Patients have vertebrobasilar insufficiency (tested by VBI tests)
- •Atlanto-axial instability (tested by sharp purser test)
- •Osteoporosis
- •Rheumatoid arthritis
- •Neuropathies
- •Recent surgeries
Arms & Interventions
Balance Training Home plan
The Control group is undergoing balance training only, 3 days a week, and will be for 8 weeks. Balance training includes 10minutes of warm-up and 30 minutes of balance exercises. A force plate will be used to measure the postural sways. Measurements will be taken at a base-line, after the first session, at mid-level (4th week) and at the end (8th week).
These exercises include Static Balance exercises(1-2weeks): Romberg with eyes open & close, Tandem standing with eyes open & close with alternate feet, Single leg stance.
Static/ Dynamic/ Anticipatory Postural Control (3-4weeks): Sit to Stand, FRT( forward reach test) that is forward, sideways, cross reach, and timed up and go test.
Static/ Dynamic/ Anticipatory? Reactive Postural Control (5-6weeks): Perturbations:
Controlled by the therapist in sitting & standing, Throwing a ball, kicking a ball.
(7-8weeks): Combination of All
Intervention: RACE Protocol: Balance training along with resistance, aerobic and cognitive exercises. (Other)
BRACE Protocol: Balance training along with resistance, aerobic and cognitive excercises
BRACE protocol for balance training 3 days a week for 8 consecutive weeks on alternate days.
These exercises include Static Balance exercises(1-2weeks) plus Chair rise 30 sec without using hands, 6-minute walk, count reverse from 50, push the wall, and reverse count from 20.
Static, dynamic, anticipatory postural control (3-4weeks) plus Stair climbing without using rails, marching in space, remember 5 words, name 5 animals, repeat 5 words, spell the word like APPLE, spell backward again.
Static, dynamic, anticipatory postural control (5-6weeks) plus Squatting, cycling, count even numbers from 1-50.
calculation: Addition, subtraction, multiplication, division. (7-8weeks): Combination of all.
Intervention: RACE Protocol: Balance training along with resistance, aerobic and cognitive exercises. (Other)
Outcomes
Primary Outcomes
Berg Balance Scale
Time Frame: Up to 8 weeks
To objectively determine a patient's ability (or inability) to safely balance during a series of pre-determined tasks. It is a 14 item list with each item consisting of a five-point ordinal scale ranging from 0 to 4, with 0 indicating the lowest level of function with a total of 56 scores. This scale is interpreted as 0-20 on the BBS represents balance impairment; 21-40 on the BBS represents acceptable balance; 41-56 on the BBS represents a good balance. Measurements will be taken at a base-line, after the first session, at mid-level (4th week) and at the end (8th week).
Secondary Outcomes
- MoCA(Up to 8 weeks)
- Postural sway(Up to 8 weeks)
- Gait and Posture assessment by application(Up to 8 weeks)
- Michigan Neuropathy Screening Instrument(Up to 8 weeks)
- TUG test(Up to 8 weeks)
- FRT test(Up to 8 weeks)