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
|
|
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
|
|
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 |