Effectiveness of Proprioceptive Neuromuscular Facilitation Stretching versus Pedocycle on HbA1c level and quality of life among Diabetic Neuropathy—A Pilot Study
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- 1. Michigan Neuropathy Screening Instrument (MNSI) scoring.
研究概览
简要总结
STUDY DESIGN: Pilot Study
STUDY AREA: Tarawati Charitable Foundation Mandawali East Delhi
STUDY POPULATION: Diabetic neuropathy with specific age range (45 to 65 years and include both male and female)
SAMPLING TECHNIQUE: Random Sampling
**SAMPLING SIZE:**36 [10 in each group + 2 subjects added extra in each group]
SELECTION CRITERIA OF PATIENTS:
INCLUSION CRITERIA
-
Subject age under 45 to 65 years.
-
Subject having an HbA1c level equal to or more than 6.5 percent.
-
Subject having a history of diabetes for more than 7 years.
-
At least 2 symptoms of diabetic neuropathies on the MNSI questionnaire subject included in the study.
-
Score greater than 1 point on a 10-point scale for physical assessment according to the MNSI instrument.
Exclusion
-
Avoid those subjects who go to the gym or yoga classes.
-
Last 6 months recent surgery.
-
Suffer from any severe condition like cancer or TB.
-
Last 6 months any upper or lower limb fracture.
-
Subject who has a foot ulcer or deformity.
STEP 1:
A total no. [N] = 36 subjects will be enrolled in the study according to inclusion and exclusion criteria, 10 in each group, and 2 will be added extra in each group. If the subject leaves in the middle, then 2 subjects are included extra in each group. Prolonged diabetes for more than 7 years. The Michigan Neuropathy Screening Instrument (MNSI) is a tool used to check the questionnaire and physical examination. On this basis, select the diabetic neuropathy patient. Consent must be taken prior to making them part of the study.
STEP 2:
Participants dividing into 3 groups. Group A (1 intervention: PNF stretching upper limb and lower limb), Group B (2 interventions: pedocycle), and Group C (3 control: no intervention will be given to this group) of 12 subjects in each group. The intervention will be explained in the participant consent form.
STEP 3:• Pre- assessment
1. HbA1c test: measures average reading.
-
MDQOL-17 Questionnaire = Quality of life
-
MNSI scoring
STEP 4:
[Group A] PNF stretching to upper and lower limbs follows D1, D2, D3, and D4 patterns.
-
3 days a week for 6 weeks.
-
Each pattern of stretch is held in position for 30 secs.
-
Between each repetition, provide 15 seconds of relaxation.
-
Between each pattern, provide 30 seconds of relaxation.
5.4 repetitions of each pattern.
- Every 2 weeks add 4 repetitions.
[Group B] Pedocycling
-
Warm up and cool down.
-
5 min of pedocycling.
-
During pedocycling, 60 percent of maximum heart rate should be maintained.
-
3 sessions a week for 6 weeks.
-
Every 2 weeks, add in 5 minutes of pedocycling.
[Group C] Control Group
-
We are not providing any physiotherapy intervention.
-
We only need to check the outcomes at the beginning (baseline).
-
And again, check the outcomes at the end (post-assessment) in a normal way.
STEP 5: After 6 weeks outcome measure
1. HbA1c test: measures average reading.
-
MDQOL-17 Questionnaire = Quality of life
-
MNSI scoring
研究设计
- 研究类型
- Interventional
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 40.00 Year(s) 至 65.00 Year(s)(—)
- 性别
- All
入选标准
- •Subject age under 45 to 65 years.
- •Subject having an HbA1c level equal to or more than 6.5 percent.
- •Subject having a history of diabetes for more than 7 years.
- •At least 2 symptoms of diabetic neuropathies on the MNSI questionnaire.
- •Score greater than 1 point on a 10-point scale for physical assessment according to the MNSI instrument.
排除标准
- •Avoid those subject who going to gym or yoga classes
- •Last 6 month recent surgery.
- •Suffer from any severe condition like cancer or TB.
- •Last 6 months any upper or lower limb fracture.
- •Subject who has a foot ulcer or deformity.
结局指标
主要结局
1. Michigan Neuropathy Screening Instrument (MNSI) scoring.
时间窗: 1. The Michigan Neuropathy Screening Instrument (MNSI) is a tool that is used to check the symptoms of diabetic neuropathies pre-protocol, then 6 weeks later, check the scoring again. | 2. Average blood sugar level check through the HbA1c test, which is a laboratory test. | 2. Initially, the HbA1c level pre-protocol, and then after the 6-week protocol, check HbA1c level again.
2.HbA1c level check by laboratory test.
时间窗: 1. The Michigan Neuropathy Screening Instrument (MNSI) is a tool that is used to check the symptoms of diabetic neuropathies pre-protocol, then 6 weeks later, check the scoring again. | 2. Average blood sugar level check through the HbA1c test, which is a laboratory test. | 2. Initially, the HbA1c level pre-protocol, and then after the 6-week protocol, check HbA1c level again.
次要结局
- 1. Michigan Neuropathy Screening Instrument (MNSI) scoring.(2. Modified Diabetes Quality of Life (MDQoL)-17 questionnaire.)
研究者
Aarti
Galgotias University
