About this trial
this study aims to compare the effects of Otago exercise program and BEAT IT program on balance, gait and quality of life in patients with diabetic peripheral neuropathy.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
physician-diagnosed type 2 diabetes, with peripheral neuropathy (defined by Michigan Neuropathy Screening Instrument questionnaire score of 5 or greater) the ability to walk independently for 20 m (97).
Having score between 46 to 52 (out of a total of 56 points) on the BBS
Disqualifiers
fracture of the lower limb within the 6 months before the study
diabetic ulcer, infection or partial amputation in feet
disease or functional impairment of auditory, vestibular system
Dementia or inability to give consistent information
Trial design
Parallel
Treatments tested in this trial
Otago Program
Other interventionThe program included: 5 Strengthening exercises and 12 balance exercises. 30-40 min, 4x/week for 8 weeks. Balance Exercises: Knee bends Backwards walking Walking and turning around Sideways walking Tandem stance (heel toe stance) Tandem walk (heel toe walk) One leg stance Heel walking Toe walk Heel toe walking backwards Sit to stand Stair walking Strength exercises: Knee extensor Knee flexor Hip adductor Ankle planter flexors (calf raises) Ankle dorsiflexors (toe raises)
BEAT it Program
Other interventionStrengthening exercises Toe spreading Ankle pump Mini wall squats Slow march in standing Knee with pillow press up Bridging Step up and down on stair 1st step Toe curls Stretching Hamstring stretch Dorsiflexors and planter flexors stretch Quads stretch Biceps stretch Triceps stretch Balance exercises Leg front and back swinging Weight shifting front and back Leg sideways Sideway alternate step Tandem stand Alternate heel toe raises Sessions were performed; * for 45 to 60 minutes/ day. * 4 times per week for 8 weeks
Treatment groups
Trial outcomes
Primary outcomes
4 Stage Balance Test
The Four Stage Balance Test is a validated measure recommended to evaluate static balance. Four standing positions get progressively harder to maintain. 1. Stand with your feet side-by-side 2. Place the instep of one foot so it is touching the big toe of the other foot. 3. Tandem stance Place one foot in front of the other, heel touching toes 4. Stand on one foot. Reliability 0.66, Sensitivity (60%-67%), Specificity (71%-76%)
Mini BESTest
This test measures dynamic balance, functional mobility, and gait. The Mini-BESTest, the shortened form of BESTest, contains only 14 different tasks and involves four sub-sections: anticipatory postural adjustments, postural response to external perturbations, sensory orientation, and stability in gait. Two items of Mini-BESTest are assessed bilaterally, but only the lower score was added to the maximum score of 28 points, which results from grading based on a 3-point ordinal scale ranging from 0 (severe balance impairment) to 2 (no balance impairment) (108). Reliability 0.98; Validity 0.65.
Functional Reach Test
FRT is used to evaluate anticipatory balance which correlates with fall risks. This test measures the margin of stability along with the ability to measure balance during a functional task. Reliability 0.89; Sensitivity 76%; Specificity 34%
Functional Gait Assessment
The FGA has been validated for the assessment of balance in people with vestibular dysfunction, community-dwelling older adults, patients with stroke, and patients with Parkinson disease. The FGA has good reliability (interrater reliability: intraclass correlation coefficient \[ICC\]=.74; interrater reliability: ICC=.86 to .93) and internal consistency (Cronbach alpha=.79)
Sponsors and contacts
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