Additional Effects of Proprioceptive Neuromuscular Facilitation With Otago Exercises on Fall Risk in Diabetes Mellitus Patients

Foundation University Islamabad

Status: Enrolling

Conditions: Proprioceptive Neuromuscular Facilitation; Diabetes (DM); Fall Risk; Postural Balance; Sensory Function; Fear of Falling; Diabetic Neuropathy Peripheral

Treatments: Procedure: Otago Exercise; Procedure: Otago and PNF exercise

Study type: Interventional

Funder types: Other

Identifiers

NCT07122726

FUI/CTR/2024/83

Details and patient eligibility

About

Diabetes Mellitus is considered as one of the most prevalent issues among global population and 50% of all the diabetic patients particularly diabetes type II develop peripheral neuropathy. Diabetic Peripheral Neuropathy (DPN) affects feet and legs first, followed by the hands and arms.

This study will involve two groups, one performing the Otago Exercise Program, and the other performing a combined PNF and Otago exercise protocol. This study aims to assess the additional effects of Proprioceptive Neuromuscular Facilitation with Otago Exercise Program on Risk of fall which will be assessed by assessing balance, Fear of Fall and Sensory Function.

Key outcome measures, including the Berg Balance Scale, Fall Efficacy Scale, Functional Reach test and Semmes Weinstein Monofilament Test will be used in evaluating the effectiveness of the exercise interventions. The participants would be screened through Michigan Neuropathy Screening Instrument and Berg Balance scale for inclusion criteria, and outcome measures will be assessed by using Berg Balance Scale, Fall efficacy scale, Functional Reach Test and Semmes Weinstein Monofilament testing method on the day of starting the intervention and on the last day of intervention. Intervention will be given for a total of 40-50 minutes per session, 3 sessions/week for consecutive 6 weeks And than the data will be recorded at the end of 6 weeks again.

Full description

The occurrence of diabetes mellitus (DM) is continually rising and has become one of the most evidently emerging chronic disease globally. One of the major consequence of Diabetes Mellitus is Diabetic Peripheral Neuropathy (DPN) which is associated with symptoms like pain, tingling, numbness, paresthesia, balance problems and falls etc. The overall pooled prevalence of diabetic peripheral neuropathy in Pakistan was estimated to be 43.16%. Diabetic Peripheral Neuropathy (DPN) causes weakness, numbness and pain in the hands and feet. Sensory disturbance leads to loss of vibration, pressure, temperature and pain. In addition people with DPN experience muscle weakness, loss of ankle reflexes, drop balance, loss of coordination etc.

Proprioceptive Neuromuscular Facilitation (PNF) is a system that uses diagonal and spiral movements, and different techniques like Reversal of Antagonists, Dynamic Reversals, and Rhythmic Initiation intended at facilitating, strengthening, gaining control of movement. The Otago Exercise Program was originally designed to prevent falls by improving balance. It involves leg muscle strengthening, walking and balance retraining exercises designed specifically to prevent falls and improve balance.

This study offers a novel approach by comparing the effects of the Otago Exercise Program with a combined PNF and Otago exercise protocol, targeting multiple domains crucial for functional improvement in DPN patients. This study is a randomized control trial and will be conducted for a duration of year, and Non-probability Convenient Sampling technique will be used for the study. The exercises will be performed for 6 weeks and thrice a week for 40-50 minutes on sample of 30 selected through G Power.

Enrollment: 30 estimated patients

Sex: All

Ages: 50 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diabetes type 2 patients
• 50-75 years of age
• Both Males and Female Gender
• Duration of diabetes more than 5 years
• Participants positive for Michigan Neuropathy Screening Instrument
• Patients having berg balance scale score >20

Exclusion criteria

• Surgical procedure involving knee, ankle, or hip joints.
• Foot Ulcers and Deformities.
• Diagnosis of neurological diseases (CVA, MS, Parkinson disease etc.) besides DPN.
• Absence of Visual Impairment and Hearing loss Patients having comprehension difficulties
• Physical disability that prevents from performing the exercises

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

30 participants in 2 patient groups

Otago with PNF

Experimental group

Description:

Otago exercise plan is comprised set of 14 exercises including strengthening and balance exercises. The strengthening exercises include strengthening of Knee Flexors, Knee Extensors, Hip-abductors Ankle dorsiflexors and ankle planter flexors and the balance exercises include following activities: Knee Bends Backward Walking, Walking and Turning Around, Sideways Walking, Tandem Stance, Tandem Walk, One Leg stance, Heel Walking, Toe Walking, Heel toe walk backwards, Sit to stand, Stair Walking The PNF pattern includes includes incorporating diagonal patterns, reversal of agonists, and combination of isotonic to enhance neuromuscular control. These techniques will be applied progressively based on patient response and capability. The gradually increasing resistance throughout the range of motion will be applied. The exercise intervention consists of 6 levels. These exercises will be performed for a duration 6 weeks and will be performed thrice for a period of 40/50 minutes.

Treatment:

Procedure: Otago and PNF exercise

Otago Exercise

Active Comparator group

Description:

Otago exercise plan is comprised set of 14 exercises including strengthening and balance exercises. The strengthening exercises include strengthening of Knee Flexors, Knee Extensors, Hip-abductors Ankle dorsiflexors and ankle planter flexors and the balance exercises include following activities: Knee Bends Backward Walking, Walking and Turning Around, Sideways Walking, Tandem Stance, Tandem Walk, One Leg stance, Heel Walking, Toe Walking, Heel toe walk backwards, Sit to stand, Stair Walking These exercises will be performed for a duration 6 weeks and will be performed thrice for a period of 40/50 minutes.

Treatment:

Procedure: Otago Exercise