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

NCT07575113 | Not Yet Recruiting

• 1 other identifier: REC/RCR &AHS/24/0296
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Diabetic Peripheral Neuropathy

Keywords

Balance; Gait; Quality of life; Diabetic Peripheral Neuropathy

Outcome Measures

Primary Outcomes (5)

• 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%)

  8th week

• 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.

  8th week

• 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%

  8th week

• 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)

  8th week

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

  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

  8th week

Study Arms (2)

Otago program

ACTIVE COMPARATOR

Participants performed a combination of warm-up, strengthening, balance, and aerobic exercises at home.

Other: Otago Program

BEAT it program

EXPERIMENTAL

Participants performed moderate-intensity aerobic, resistance, balance, and flexibility exercises, along with education on diabetes self-management. The exercises were designed to be completed at home using minimal equipment or household items

Other: BEAT it Program

Interventions

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)

Otago program

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

BEAT it program

Eligibility Criteria

• Age: 45 Years - 65 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

THQ hospital

Lahore, Punjab Province, 54500, Pakistan

Location

Study Officials

• Javeria Ghazal, MS

  Riphah International University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Muneeb khan, PhD

CONTACT

+92336799611; muneeb.khan@riphah.edu.pk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 23, 2026
• First Posted: May 8, 2026
• Study Start (Estimated): May 15, 2026
• Primary Completion (Estimated): August 30, 2026
• Study Completion (Estimated): September 15, 2026
• Last Updated: May 8, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)