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Not yet recruiting NCT07575113

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

No phase Interventional Diabetic Peripheral Neuropathy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Otago Program, BEAT it Program.
Who it may be relevant to
Registry conditions: Diabetic Peripheral Neuropathy. Basic parameters: 45 years — 65 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Pakistan
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

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

Interventions

  • 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)
  • 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

Primary outcome measures

  • 4 Stage Balance Test [Time frame: 8th week]
  • Mini BESTest [Time frame: 8th week]
  • Functional Reach Test [Time frame: 8th week]
  • Functional Gait Assessment [Time frame: 8th week]
  • Norfolk Quality of Life-Diabetic Neuropathy (QOL-DN) questionnaire [Time frame: 8th week]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Pakistan · 1 center
  • THQ hospital — Lahore

Identifiers

NCT: NCT07575113 · REC/RCR &AHS/24/0296

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗