Comparison of Otago and Beat it Program on Balance, Gait and QOL in Diabetic Neuropathy

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age45-65
SponsorRiphah International University

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Otago Program

    Other intervention

    The 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 intervention

    Strengthening 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

32 Participants
are divided into 2 treatment groups
Group A: Otago programActive comparator 1 intervention
Group B: BEAT it programExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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%)

Time frame
8th week
2

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.

Time frame
8th week
3

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%

Time frame
8th week
4

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)

Time frame
8th week

Secondary outcomes

Other outcomes

Sponsors and contacts

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