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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50-75
SponsorFoundation University Islamabad

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Diabetes type 2 patients

50-75 years of age

Both Males and Female Gender

Duration of diabetes more than 5 years

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Otago and PNF exercise

    Procedure/Surgery

    Otago Exercise: This 6-week protocol focuses on strengthening and balance exercises. It starts with supported exercises and progresses to unsupported ones. Exercises include knee flexors, extensors, and hip abductors with ankle weights, ankle plantar and dorsiflexors, knee bends, backward stepping, walking and turning, sideways walking, tandem stance, and one-leg stance. Repetitions increase over time, from 10-20 reps with support to 30 reps without support. PNF Exercise The PNF protocol consists of 6 levels, progressing from simple to complex exercises. Level 1 involves D1/D2 patterns for ankle and hip with light resistance, while Level 2 focuses on seated D1/D2 patterns for the lower limb. Levels 3-6 introduce more dynamic exercises, including arm reaches while standing, PNF walking, dynamic step-ups, walking on unequal terrain, and obstacle navigation. The protocol emphasizes approximation, stabilization, resistance, and dynamic reversals to improve proprioception \& balance.

  • Otago Exercise

    Procedure/Surgery

    Knee Flexors, Knee Extensors, Hip-abductors- 10 reps of each Exercise with ankle weights to provide muscle resistance. For ankle planter flexors and dorsi flexors starting from 20 repetitions at week 1 with hold support and ending at 30 repetitions without any support on 6th week. For knee bends starting with 10 reps at week 1 and ending at 30 reps without support at 6th week. Backward stepping 10 times 2 steps backward at week 1 progressing to 10 times x 4 Steps x No Support at week 6 gradually. Walking and Turning Around- (make a figure of 8), twice, first with support and then without support. Sideways Walking- 10 steps, 4 times x first with support and then without support over the time of 6 weeks. Tandem Stance- 10 seconds first with support and then without support. Tandem Walk/ 20 reps first with support and then without support over the period of 6 weeks.

Treatment groups

30 Participants
are divided into 2 treatment groups
Group A: Otago with PNFExperimental treatment 1 intervention
Group B: Otago ExerciseActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Balance

Balance will be assessed using berg balance scale. total score is 58. low fall risk is 0-20, moderate risk 20-40, High risk 41-58

Time frame
6 weeks
2

Fear of fall

The Falls Efficacy Scale-International (FES-I) will be used to measures the level of concern about falling. The level of concern is measured on a four point Likert scale (1=not at all concerned to 4=very concerned).

Time frame
6 weeks
3

Balance

The functional reach test will be performed to analyze dynamic balance. The patients will be instructed to position themselves with their body perpendicular to the wall but not touching the wall, with shoulders flexed at 90°, elbows extended, and hands closed. The assessor will record the starting position at the 3rd metacarpal head on the yardstick and then instruct the patient to reach as far as they can without taking a step, and the distance will be measured between the initial measurements to the final measurement.

Time frame
6 weeks
4

Sensory function

The SEMMES WEINSTEIN MONOFILAMNET TESTING is considered a simple and inexpensive touch threshold test and is widely used by clinicians to evaluate sensory disturbances of neuropathic diseases. With the patient's eyes closed, monofilament is applied perpendicularly in a steady manner until the filament bends. Use a smooth motion to touch the skin with the filament, bend the filament for a full second, than lift from the skin. Patient raises hand to indicate that the monofilament touch sensation is perceived.

Time frame
6 weeks

Secondary outcomes

Other outcomes

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