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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Diabetic Peripheral Neuropathy
• Intervention / Treatment: Other: Otago Program; Other: BEAT it Program

Detailed Description

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

• Study Type: Interventional
• Enrollment (Estimated): 32
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Muneeb khan, PhD; Phone Number: +92336799611; Email: muneeb.khan@riphah.edu.pk

Study Locations

• Pakistan
  • Punjab Province
    • Lahore, Punjab Province, Pakistan, 54500
      • THQ hospital
      • Contact: Javeria Ghazal, MS; Phone Number: +923335154664; Email: javeria.ghazal@riphah.edu.pk
      • Principal Investigator: Sania Hassan, MS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Otago program; Participants performed a combination of warm-up, strengthening, balance, and aerobic exercises at home.	Other: Otago Program; 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)
Experimental: BEAT it program; 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; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.; 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%)	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

Collaborators and Investigators

• Sponsor: Riphah International University
• Investigators: Principal Investigator: Javeria Ghazal, MS, Riphah International University

Study record dates

Study Major Dates

• Study Start (Estimated): May 15, 2026
• Primary Completion (Estimated): August 30, 2026
• Study Completion (Estimated): September 15, 2026

Study Registration Dates

• First Submitted: February 23, 2026
• First Submitted That Met QC Criteria: May 4, 2026
• First Posted (Actual): May 8, 2026

Study Record Updates

• Last Update Posted (Actual): May 8, 2026
• Last Update Submitted That Met QC Criteria: May 4, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Balance; Gait; Quality of life; Diabetic Peripheral Neuropathy
• Other Study ID Numbers: REC/RCR &AHS/24/0296

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No