| CTRI Number |
CTRI/2024/10/075765 [Registered on: 23/10/2024] Trial Registered Prospectively |
| Last Modified On: |
08/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Other |
|
Public Title of Study
|
Impact of Square Stepping Exercise on balance and risk of fall in individuals with Diabetic Neuropathy. |
|
Scientific Title of Study
|
Effect of Square Stepping Exercise on balance and risk of fall in subjects with Diabetic Neuropathy. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Trishna Deka |
| Designation |
PG Student |
| Affiliation |
Padmashree Institute of Physiotherapy |
| Address |
MPT Student (MPT in Neurological Sciences), Padmashree Institute of Physiotherapy. 149, Padmashree Campus, Kommaghatta Village, Sulikere (Post.), Kengeri Bangalore KARNATAKA 560060 India |
| Phone |
9864741511 |
| Fax |
|
| Email |
trishnadeka21july@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Sudheera Kunduru |
| Designation |
Professor |
| Affiliation |
Padmashree Institute of Physiotherapy |
| Address |
HoD, Department of Physiotherapy, Padmashree Institute of Physiotherapy 149, Padmashree Campus, Kommaghatta Village, Sulikere (Post.), Kengeri, Bangalore KARNATAKA 560060 India |
| Phone |
9845061340 |
| Fax |
|
| Email |
sudheera.physio@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Sudheera Kunduru |
| Designation |
Professor |
| Affiliation |
Padmashree Institute of Physiotherapy |
| Address |
HoD, Department of Physiotherapy, Padmashree Institute of Physiotherapy. 149, Padmashree Campus, Kommaghatta Village, Sulikere (Post.), Kengeri, Bangalore KARNATAKA 560060 India |
| Phone |
9845061340 |
| Fax |
|
| Email |
sudheera.physio@gmail.com |
|
|
Source of Monetary or Material Support
|
| Padmashree Institute of Physiotherapy, 149, Padmashree Campus, Kommaghatta, Kengeri, Bangalore, Karnataka, India, 560060 |
|
|
Primary Sponsor
|
| Name |
Trishna Deka |
| Address |
Padmashree Institute of Physiotherapy, 149, Padmashree Campus, Kommaghatta Village, Sulikere (Post.), Kengeri, Bangalore, Karnataka 560060 |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 3 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Sudheera Kunduru |
ESIC Hospital |
Rajajinagar, Bangalore Bangalore KARNATAKA |
9845061340
sudheera.physio@gmail.com |
| Sudheera Kunduru |
Padmashree Diagnostics |
Vijaynagar, Bangalore Bangalore KARNATAKA |
9845061340
sudheera.physio@gmail.com |
| Sudheera Kunduru |
Padmashree Physiotherapy Clinic and Rehab Centre |
Nagarbhavi, Bangalore Bangalore KARNATAKA |
9845061340
sudheera.physio@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Padmashree Institutional Ethics Committee, Padmashree Campus Kengeri |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E114||Type 2 diabetes mellitus with neurological complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional Therapy |
Participants will be asked to perform active range of motion (AROM) exercise for both the lower limbs (including hip, knee and ankle joints), gait training and spot marching on a stable surface. Intervention will be given for 50 minutes with 10 minutes of warm-up and cool-down period, 3 times a week for 8 weeks. |
| Intervention |
Square Stepping Exercise |
The exercises will be performed by the subjects on a thin mat. The mat will be divided into 40 small squares, each measuring 25 cm square, with total area of 250 cm into 100 cm. There are 200 movement patterns in the SSE, divided into three levels of difficulty: beginner, intermediate, and advanced. The intermediate and advanced levels each have three levels, while the beginners level has two levels in turn. It will begin with walking-like movement patterns and progress to increasingly complex patterns that require for lateral, diagonal, and backward movements in addition to forward movement. It will be advised to the participants to avoid stepping on the dividing lines of the squares. Intervention will be given for 50 minutes with 10 minutes of warm-up and cool-down period, 3 times a week for 8 weeks. |
|
|
Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Type 2 Diabetes Mellitus subjects (duration more than 5 years).
2. Michigan Neuropathy Screening Instrument, Physical Assessment Score more than 2 out of 10.
3. Subjects with Fear of Fall (FES-I Score more than 20).
4. Ability to walk independently without an assistive device. |
|
| ExclusionCriteria |
| Details |
1. Subjects having diabetic foot ulcers, partial or total foot amputation.
2. Subjects with any other neurological or musculoskeletal impairments.
3. Subjects with major vascular complications (venous/arterial ulcers).
4. Subjects with severe retinopathy or severe nephropathy.
5. Subjects with severe psychiatric illness.
6. Subjects with severe hearing and visual deficits.
7. Non-cooperative subjects.
8. Existence of any other factors that interfere with balance except Diabetic Neuropathy. |
|
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Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Berg Balance Scale |
Maximum Score 56 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Timed Up and Go (TUG) Test |
Normal is 10 seconds or less |
|
|
Target Sample Size
|
Total Sample Size="62" Sample Size from India="62"
Final Enrollment numbers achieved (Total)= "62"
Final Enrollment numbers achieved (India)="62" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/11/2024 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
15/05/2025 |
|
Estimated Duration of Trial
|
Years="0" Months="6" 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
|
Diabetic Neuropathy (DN) is one of the commonest causes of peripheral neuropathy and is defined as signs and symptoms of peripheral nerve dysfunction in a patient with diabetes mellitus in whom other causes of peripheral nerve dysfunction have been excluded. When compared to people with T1DM, the incidence is greater in T2DM. Individuals with diabetes are susceptible to developing neuropathy at any point, with an increased risk correlating with advancing age and a duration of diabetes exceeding five years. Diabetic neuropathy is a major cause of falls in elderly patients and people with peripheral neuropathy caused by diabetes often experience balance disorders. Patients with this condition experience more postural sway, particularly when their eyes are closed. Exercise has been shown to enhance various metabolic factors that can influence nerve health and micro-vascular function, potentially providing indirect protection against peripheral nerve damage. Patients with diabetic neuropathy benefit from exercise therapy, including balance exercises, since it increases oxygen pressure in the skin, lower limbs, and chest, hence improving skin blood flow. Alterations in shear stress and pressure on the plantar surfaces during standing tasks can activate mechanoreceptors, transmitting signals to higher nervous centres and thereby, enhancing balance in patients with diabetic neuropathy. Research suggests that Square Stepping Exercise is an apparently most effective alternative to walking for improvement of balance. Its effectiveness has been shown to be beneficial for subjects with stroke, Parkinson’s Disease, Multiple Sclerosis and elderly population. But there is a dearth of literature concerning Diabetic Neuropathy. Hence, the present study is developed with the aim to investigate the effect of SSE on balance and risk of falls in subjects with Diabetic Neuropathy. This study will include 62 participants, who will be divided equally into two groups: Group A & Group B. Participants in Group A will receive Square Stepping Exercise and Group B will receive Conventional Therapy. Both groups will receive intervention for 50 minutes with 10 minutes of warm-up and cool-down period, 3 times a week for 8 weeks. Data will be collected from both the groups pre and post intervention by using Berg Balance Scale and Timed Up and Go test. Statistical analysis will be done by Statistician to compare the results. |