Additional Effects of Proprioceptive Neuromuscular Facilitation With Otago Exercises on Fall Risk in Diabetes Mellitus Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Balance
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Otago with PNF
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.
干预措施: Otago and PNF exercise (Procedure)
Otago Exercise
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.
干预措施: Otago Exercise (Procedure)
结局指标
主要结局
Balance
时间窗: 6 weeks
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
Fear of fall
时间窗: 6 weeks
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).
Sensory function
时间窗: 6 weeks
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.
Balance
时间窗: 6 weeks
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.
Fear of fall
时间窗: 6 weeks
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).
Sensory function
时间窗: 6 weeks
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.
次要结局
未报告次要终点