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CTRI Number  CTRI/2025/10/095601 [Registered on: 06/10/2025] Trial Registered Prospectively
Last Modified On: 04/10/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A study to compare stretchnig exercises and pedocycle exercise on blood sugar level (HbA1c level) and quality of life in people with diabetic nerve problem 
Scientific Title of Study   Effectiveness of Proprioceptive Neuromuscular Facilitation Stretching versus Pedocycle on HbA1c level and quality of life among Diabetic Neuropathy—A Pilot Study 
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Aarti 
Designation  Student 
Affiliation  Galgotias University  
Address  84/502 5th floor Siddarth Gali Mandawali Fazalpur New Delhi -110092

East
DELHI
110092
India 
Phone  9717299632  
Fax    
Email  nathaarti4@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Nidhi Singh 
Designation  Professor 
Affiliation  Galgotias University 
Address  Galgotias University Plot No. 2 Sector 17-A Yamuna Expressway Gautam Buddh Nagar Greater Noida Uttar Pradesh 201308

Gautam Buddha Nagar
UTTAR PRADESH
201308
India 
Phone  7042627025  
Fax    
Email  nidhi.file.assign@gmail.com  
 
Details of Contact Person
Public Query  
Name  Nidhi Singh 
Designation  Professor 
Affiliation  Galgotias University 
Address  Galgotias University Plot No. 2 Sector 17-A Yamuna Expressway Gautam Buddh Nagar Greater Noida Uttar Pradesh 201308

Gautam Buddha Nagar
UTTAR PRADESH
201308
India 
Phone  7042627025  
Fax    
Email  nidhi.file.assign@gmail.com  
 
Source of Monetary or Material Support  
None 
 
Primary Sponsor  
Name  Aarti 
Address  Galgotias University Plot No. 2 Sector 17-A Yamuna Expressway Gautam Buddh Nagar Greater Noida Uttar Pradesh 201308 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Mamta Pandey PT  Taravati Ram Gopal Mehra Foundation Charitable Medical Center  Plot no. 8 I.P. Extension Pataprganj Near Navniti Apartments Delhi - 110092
East
DELHI 		 9582149900

tanushreepandey0@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Departmental Research Committee, Department of Physiotherapy , School of allied health Sciences,Galgotias Unversity  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G63||Polyneuropathy in diseases classified elsewhere,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Group C  [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.  
Intervention  Pedocycle  [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.  
Intervention  Proprioceptive Neuromuscular Facilitation (PNF) stretching   [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. 6. Every 2 weeks add 4 repetitions.  
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  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.
5. Score greater than 1 point on a 10-point scale for physical assessment according to the MNSI instrument.


 
 
ExclusionCriteria 
Details  1. Avoid those subject who going to gym or yoga classes
2. Last 6 month 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.
 
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
1. Michigan Neuropathy Screening Instrument (MNSI) scoring.
2.HbA1c level check by laboratory test. 		 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. 
 
Secondary Outcome  
Outcome  TimePoints 
1. Michigan Neuropathy Screening Instrument (MNSI) scoring.
2. Modified Diabetes Quality of Life (MDQoL)-17 questionnaire.
 		 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. MDQoL-17 is used to check quality of life among diabetic subjects. Initially check the quality of life pre-protocol and then check after 6 weeks. 
 
Target Sample Size   Total Sample Size="36"
Sample Size from India="36" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 1 
Date of First Enrollment (India)   22/10/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="1"
Days="15" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

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.

2. MDQOL-17 Questionnaire = Quality of life

3. 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.

 6. 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.

2. MDQOL-17 Questionnaire = Quality of life

3. MNSI scoring  

 

 

 

 
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