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临床试验/CTRI/2025/10/095601
CTRI/2025/10/095601尚未招募1 期

Effectiveness of Proprioceptive Neuromuscular Facilitation Stretching versus Pedocycle on HbA1c level and quality of life among Diabetic Neuropathy—A Pilot Study

Aarti1 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2025年10月22日最近更新:

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

  1. Subject age under 45 to 65 years.

  2. Subject having an HbA1c level equal to or more than 6.5 percent.

  3. Subject having a history of diabetes for more than 7 years.

  4. At least 2 symptoms of diabetic neuropathies on the MNSI questionnaire subject included in the study.

  5. Score greater than 1 point on a 10-point scale for physical assessment according to the MNSI instrument.

Exclusion

  1. Avoid those subjects who go to the gym or yoga classes.

  2. Last 6 months recent surgery.

  3. Suffer from any severe condition like cancer or TB.

  4. Last 6 months any upper or lower limb fracture.

  5. 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.

  1. MDQOL-17 Questionnaire = Quality of life

  2. MNSI scoring

STEP 4:

[Group A] PNF stretching to upper and lower limbs follows D1, D2, D3, and D4 patterns.

  1. 3 days a week for 6 weeks.

  2. Each pattern of stretch is held in position for 30 secs.

  3. Between each repetition, provide 15 seconds of relaxation.

  4. Between each pattern, provide 30 seconds of relaxation.

5.4 repetitions of each pattern.

  1. Every 2 weeks add 4 repetitions.

[Group B] Pedocycling

  1. Warm up and cool down.

  2. 5 min of pedocycling.

  3. During pedocycling, 60 percent of maximum heart rate should be maintained.

  4. 3 sessions a week for 6 weeks.

  5. Every 2 weeks, add in 5 minutes of pedocycling.

[Group C] Control Group

  1. We are not providing any physiotherapy intervention.

  2. We only need to check the outcomes at the beginning (baseline).

  3. 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.

  1. MDQOL-17 Questionnaire = Quality of life

  2. 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

发起方
Aarti
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Aarti

Galgotias University

研究点 (1)

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