FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2020/03/024277 [Registered on: 26/03/2020] Trial Registered Prospectively
Last Modified On: 05/12/2021
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Effect of foot muscle exercises on toe grip, balance and muscle activation in diabetes mellitus. 
Scientific Title of Study   Effect of foot exercises on hallux grip force, postural stability and muscle activity in patients with Diabetes Mellitus: A Randomized Controlled Trial 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Jaspreet Kaur 
Designation  Assistant Professor 
Affiliation  Guru Jambheshwar University of Science and Technology Hisar 
Address  Department of Physiotherapy Guru Jambheshwar University of Science and Technology Hisar

Hisar
HARYANA
125001
India 
Phone  9466092657  
Fax    
Email  jaspreet248103@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Jaspreet Kaur 
Designation  Assistant Professor 
Affiliation  Guru Jambheshwar University of Science and Technology Hisar 
Address  Department of Physiotherapy Guru Jambheshwar University of Science and Technology Hisar

Hisar
HARYANA
125001
India 
Phone  9466092657  
Fax    
Email  jaspreet248103@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Jaspreet Kaur 
Designation  Assistant Professor 
Affiliation  Guru Jambheshwar University of Science and Technology Hisar 
Address  Department of Physiotherapy Guru Jambheshwar University of Science andTechnology Hisar

Hisar
HARYANA
125001
India 
Phone  9466092657  
Fax    
Email  jaspreet248103@gmail.com  
 
Source of Monetary or Material Support  
Department of Physiotherapy, Guru Jambheshwar University of Science and Technology, Hisar, Haryana 
 
Primary Sponsor  
Name  Department of Physiotherapy 
Address  Guru Jambheshwar University of Science & Technologgy Hisar 
Type of Sponsor  Government funding agency 
 
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 
Neerja Thukral  Guru Jambheshwar University of Science and Technology Hisar  Room No. 4, Department of Physiotherapy Guru Jambheshwar University of Science and Technology Hisar
Hisar
HARYANA 
9671114674

neerja.thukral@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethical committee of Department of Physiotherapy of Guru Jambheshwar University of Science and Technology Hisar  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E08-E13||Diabetes mellitus,  
 
Intervention / Comparator Agent
Modification(s)  
Type  Name  Details 
Intervention  Group A  Subjects of Group A will be given warming up as well as whole foot exercises for 12 weeks, twice weekly.  
Intervention  Group B  Subjects of Group B will be given warming up as well as intrinsic foot muscle exercises for 12 weeks twice weekly. 
Comparator Agent  Group C (Control Group)  Warming up exercises including ankle toe movements, calf stretching. 
 
Inclusion Criteria  
Age From  35.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1.Patients with diagnosed Diabetes Mellitus
2. both genders
3. history of diabetes mellitus for more than or equal to 2 years. 
 
ExclusionCriteria 
Details  1. Patients with other neurological or musculoskeletal disorders
2. Non-diabetic neuropathy
3. Uncontrolled hypertension
4. Visual impairments
5. Vestibular dysfunction
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Not Applicable 
Blinding/Masking   Participant Blinded 
Primary Outcome
Modification(s)  
Outcome  TimePoints 
1.Hallus Grip Force
2. Postural Stability
3. Muscle Activity 
After 12 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Nil  nil 
 
Target Sample Size   Total Sample Size="75"
Sample Size from India="75" 
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   N/A 
Date of First Enrollment (India)   30/03/2020 
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="1"
Months="6"
Days="20" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   Nil 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

Diabetes mellitus is the most common, non-communicable, heterogeneous metabolic disorder which is characterized by hyperglycemia and has attained epidemic proportions worldwide. Long standing Diabetes mellitus leads to various musculoskeletal and systemic complications which most commonly include peripheral neuropathy and foot conditions leading to loss of protective sensation, limited joint movement, atrophy of intrinsic muscles of foot, decreased strength of lower limbs due to affliction of both large and small diameter afferent as well as efferent axons causing impaired balance and postural stability. It has been reported in various studies that diabetes mellitus patients have impaired foot-ankle muscle strength as assessed via hallux grip force, hallux plantar strength and manual muscle testing. Patients with decreased hallux grip force are shown to have diminished foot-ankle muscle strength and associated impairment in balance and postural stability. Also, alterations in muscle activity have been found in patients with diabetes.

            Previous studies have incorporated the effect of various exercise trainings on foot function, daily activity and biomechanics of foot in patients with diabetes mellitus and neuropathy, none of the studies have focused on the effect of foot muscle exercises on grip force, foot muscle activity and postural stability. Also, mostly exercise programs usually neglect foot muscles-extrinsic as well as intrinsic, though they play a major role in maintaining balance and postural stability. Therefore, the primary objective of this study will focus on to find the effect of various  foot muscle exercises on hallux grip force, postural stability and foot muscle activation pattern in patients with diabetes mellitus 
Close