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CTRI Number  CTRI/2024/07/070767 [Registered on: 18/07/2024] Trial Registered Prospectively
Last Modified On: 18/07/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Single Arm Study 
Public Title of Study   A pre-post experimental study examined the effects of unsupervised at-home exercises on pain, balance, lower limb strength, and functional activity in patients with diabetes polyneuropathy. 
Scientific Title of Study   Effect of unsupervised home exercises on pain, balance, lower limb strength, and functional activity in patients with diabetes polyneuropathy: a pre-post experimental 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  Riddhi Vinay Godhe 
Designation  Post-graduate 
Affiliation  Nitte Institute of physiotherapy NITTE(Deemed to be university) 
Address  Department of physiotherapy,room no 20,second based division,Nitte Institute of physiotherapy NITTE(Deemed to be university)Derlakatte,Mangalore,Karnataka,India Dakshina Kannada KARNATAKA India

Dakshina Kannada
KARNATAKA
575018
India 
Phone  8459269868  
Fax    
Email  godhe.riddhi@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Purusotham Chippala 
Designation  Professor 
Affiliation  Nitte Institute of physiotherapy NITTE(Deemed to be university) 
Address  Department Of Physiotherapy, Room No-20, Second Base Division, Nitte Institute of Physiotherapy,NITTE (Deemed to be University), Deralakatte, Mangaluru, Karnataka, India Dakshina Kannada KARNATAKA

Dakshina Kannada
KARNATAKA
575018
India 
Phone  9916460185  
Fax    
Email  chippala_puru@nitte.edu.in  
 
Details of Contact Person
Public Query  
Name  Dr Purusotham Chippala 
Designation  Professor 
Affiliation  Nitte Institute of physiotherapy NITTE(Deemed to be university) 
Address  Department Of Physiotherapy, Room No-20, Second Base Division, Nitte Institute of Physiotherapy,NITTE (Deemed to be University), Deralakatte, Mangaluru, Karnataka, India Dakshina Kannada KARNATAKA

Dakshina Kannada
KARNATAKA
575018
India 
Phone  9916460185  
Fax    
Email  chippala_puru@nitte.edu.in  
 
Source of Monetary or Material Support  
Nitte Institue Of Physiotherapy, NITTE(Deemed to be university)Department of physiotherapy, room no 20, second based division Deralkatte, Mangaluru, Karnataka India 
 
Primary Sponsor  
Name  Nitte Institute of Physiotherapy NITTEDeemed to be university 
Address  Nitte Institue Of Physiotherapy, NITTE(Deemed to be university)Department of physiotherapy, room no 20, second based division Deralkatte, Mangaluru, Karnataka India Nithyananda Nagar,Deralakatte Mangaluru Dakshina Kannada Karnataka India  
Type of Sponsor  Other [Nitte Institue Of Physiotherapy] 
 
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 Purusotham Chippala  Justice K.S Hegde Charitable Hospital  Department No. 10, Department of General Medicine, medical science complex, Deralakatte, Mangaluru, India570518
Dakshina Kannada
KARNATAKA 		 9916460185

chippala_puru@nitte.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee of Nitte Institute of Physiotherapy  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  nil  nil 
Intervention  unsupervised home exercises  Duration of 1 hour. Implemented 3 days per week for 8 weeks. 1.Range of motion exercises for lower limb 2.Muscle strengthening exercises for lower limb 3.Exercises for improving static balance 4.Exercises for improving dynamic balance 5.Endurance exercises FIIT principle: 1) Range of motion exercises and muscle strengthening: 10 repetitions per set, with 3 sets per session. 1 session per day. The intensity determined by individuals 10 Repetition Maximum (10RM). 2) Static and Dynamic Balance: Three sets of 20 second hold of static balance exercises, with intensity determined using the Berg Balance Scale. 2 laps of 30m of each of dynamic exercises.  
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  1.Documented diagnosis of acute and subacute diabetic polyneuropathy.
2.Participants with the age range of 40-75 years.
3.Intact sensation in both upper and lower limb
4.Patients with medium to low fall risk
5.Numerical Pain Rating Scale (NPRS) with range of (3 - 6) during work or
at rest 
 
ExclusionCriteria 
Details  1.Individuals with significant cognitive impairment.
2.Non documented diagnosis of diabetic polyneuropathy.
3.Impaired sensation in both upper and lower limb.
4.Individuals with foot ulcers.
5.Individuals who have undergone amputation.
6.Participants with uncontrolled medical conditions. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1.Douleur neuropathique en 4 questions (dn4)
2.Berg balance scale
 		 At baseline and
after 8 weeks of treatment. 
 
Secondary Outcome  
Outcome  TimePoints 
1. Hand Held dynamometer
2. Barthel Index 		 At baseline 
 
Target Sample Size   Total Sample Size="38"
Sample Size from India="38" 
Final Enrollment numbers achieved (Total)= "38"
Final Enrollment numbers achieved (India)="38" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   29/07/2024 
Date of Study Completion (India) 28/02/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
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  

20% to 80% of people with type 2 diabetes mellitus (T2DM) experience diabetic polyneuropathy (DPN), a frequent consequence. Patients with DPN are more likely to experience refractory neuropathic pain, limb weakness in both the upper and lower extremities, unstable walking, diminished physical functioning, and a tendency to develop foot ulcers.

Individuals with diabetes polyneuropathy having restricted mobility may find it difficult to attend physiotherapy clinics due to transportation, cost, time and absenteeism at work. However, these difficulties may be met at home with planned, unsupervised exercise programs.

Gaining insight into how home exercises affect people with diabetic polyneuropathy might provide important information on how well, realistically, and consistently patients can complete their activities.

Evaluating the impact of unsupervised home exercises in persons with diabetic polyneuropathy is crucial, considering the costs associated with physiotherapy clinic visits, transportation, and equipment needs.

 
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