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NCT Number: NCT07575113

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

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.

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Key information

Conditions

Diabetic Peripheral Neuropathy

Age range

45 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

THQ hospital

Lahore, Punjab Province, 54500, Pakistan

Location contact

Javeria Ghazal, MS

CONTACT

[email protected]

+923335154664

Sania Hassan, MS

PRINCIPAL_INVESTIGATOR

About this study

Limited studies have been conducted to assess gait and quality of life. Most of the studies related to the Otago exercise program conducted in the geriatric population, stroke, Parkinson's, alcoholic neuropathy, chronic inflammatory polyneuropathy, and so on, a few studies conducted on diabetes, however up to the researcher's knowledge its effect on diabetic neuropathy has not been found. Similarly, studies related to the BEAT IT Program conducted in cancer patients and diabetes populations. Hence there is a need for comparative study on Otago exercise program and BEAT IT program to assess balance, gait and quality of life in patients with diabetic peripheral neuropathy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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
  • History of surgical procedure at the knee, ankle, or hip or indication of surgery throughout the intervention period malignancy, other neurological or orthopedic impairments (such as stroke, poliomyelitis, rheumatoid arthritis, prosthesis, or severe osteoarthritis), major vascular complications (venous or arterial ulcers), severe retinopathy, or severe nephropathy that causes edema or needs hemodialysis

Treatment and study plan

Otago Program

Other

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

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

Primary outcomes

  1. 4 Stage Balance Test

    Time frame: 8th week

    The Four Stage Balance Test is a validated measure recommended to evaluate static balance. Four standing positions get progressively harder to maintain.

    • Stand with your feet side-by-side
    • Place the instep of one foot so it is touching the big toe of the other foot.
    • Tandem stance Place one foot in front of the other, heel touching toes
    • Stand on one foot. Reliability 0.66, Sensitivity (60%-67%), Specificity (71%-76%)

  2. Mini BESTest

    Time frame: 8th week

    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.

  3. Functional Reach Test

    Time frame: 8th week

    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%

  4. Functional Gait Assessment

    Time frame: 8th week

    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)

  5. Norfolk Quality of Life-Diabetic Neuropathy (QOL-DN) questionnaire

    Time frame: 8th week

    The Norfolk Quality-of Life Diabetic Neuropathy tool (QOL-DN) has been found to be reliable across many different populations. This comprehensive tool has demonstrated sensitivity to both small and large fiber impairment while also detecting improvements in neuropathy. Intra class Reliability >0.9; Internal Consistency >0.6

Study contacts

Contact information is provided by the study sponsor or research team.

Muneeb khan, PhD

CONTACT

[email protected]

+92336799611

Sponsors and collaborators

Lead sponsor

Riphah International University

Other

Registry information

Official study title

Comparative Effects of Otago Exercise Program and Beat it Program on Balance, Gait and Quality of Life in Patients With Diabetic Peripheral Neuropathy

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
May 8, 2026
Registry last updated
May 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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