| CTRI Number |
CTRI/2019/09/021190 [Registered on: 11/09/2019] Trial Registered Prospectively |
| Last Modified On: |
09/09/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Strength training of foot muscle for balance and quality of life in type II Diabetes population in the age group of 40-60 years |
|
Scientific Title of Study
|
Strength training of plantar flexor muscle for balance and quality of life in type II Diabetes population in the age group of 40-60 years |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vaishali Ingole |
| Designation |
Post Graduate Student |
| Affiliation |
All India institute of Physical Medicine and Rehabilitation |
| Address |
All India institute of Physical Medicine and Rehabilitation
Physiotherapy Department
K. Khadye marg Haji Ali Mahalaxmi Mumbai
Mumbai
MAHARASHTRA
400034
India |
| Phone |
8275197242 |
| Fax |
|
| Email |
vaishali.ingole55@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sandhya Wasnik |
| Designation |
Lecturer |
| Affiliation |
All India institute of Physical Medicine and Rehabilitation |
| Address |
All India institute of Physical Medicine and Rehabilitation
Physiotherapy Department
K. Khadye marg Haji Ali Mahalaxmi Mumbai
Mumbai
MAHARASHTRA
400034
India |
| Phone |
9619144265 |
| Fax |
|
| Email |
sandhyaw5@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sandhya Wasnik |
| Designation |
Lecturer |
| Affiliation |
All India institute of Physical Medicine and Rehabilitation |
| Address |
All India institute of Physical Medicine and Rehabilitation
Physiotherapy Department
K. Khadye marg Haji Ali Mahalaxmi Mumbai
Mumbai
MAHARASHTRA
400034
India |
| Phone |
9619144265 |
| Fax |
|
| Email |
sandhyaw5@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Physiotherapy,
All India institute of Physical Medicine and Rehabilitation K. Khadye marg Haji Ali Mahalaxmi, Mumbai 400034 |
|
|
Primary Sponsor
|
| Name |
Vaishali Ingole |
| Address |
All India institute of Physical Medicine and Rehabilitation
Physiotherapy Department
K. Khadye marg Haji Ali Mahalaxmi, Mumbai- 400034 |
| Type of Sponsor |
Other [Principal Investigator Initiated] |
|
|
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 |
| Sandhya Wasnik |
All India institute of Physical Medicine and Rehabilitation, Mumbai 400034 |
Department of Physiotherapy
Mumbai
MAHARASHTRA |
9619144265
sandhyaw5@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INDEPENDENT ETHICS COMMITTEE,AIIPMR |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E116||Type 2 diabetes mellitus with other specified complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Control group |
Aerobic exercise will be given weekly thrice for 4 weeks |
| Intervention |
Experimental group |
Plantar flexor muscle strengthening combined with aerobic exercise. Exercise will be given weekly thrice for 4 weeks |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Subject diagnosed with Type II Diabetes Mellitus.
Duration of Type II Diabetes Mellitus of >5years.
HbA1C< 8-9%with in 3 months.
Age group of 40-60 years.
BMI – 18 to 29.9
Michigan Neuropathy Screening Instrument score >8
|
|
| ExclusionCriteria |
| Details |
Osteo-articular deformities
Pain at hip- knee- ankle joints
History of any nerve injury neuropathy, or peripheral nerve injury
Acute neuritis with or without use of medication
History of diagnosed foot ulcers, 6 months before the study
Total or partial amputation of feet
Muscular disorders or rheumatoid arthritis
Subjects with visual and auditory impairment.
Walking with assistive devices
Varicose veins
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Plantar flexor strength: maximum voluntary contraction.
2.Quality of life: SF36 questionnaire will be used to assess Quality of life, it contains 36 items. It measures health on nine multi item dimension, based on functional, status, well-being and over all evaluation of health. The higher the score at SF36, the more positive a subject was about experienced quality of life.
3.Mini balance evaluation system test: It is a 14 item test with 0-2 score and total score is 28.
|
0-week
4-week |
|
|
Secondary Outcome
|
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
13/09/2019 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study is interventional study in which strength of plantar flexor muscle will be assessed in subjects with type II Diabetes Mellitus aged 40-60 years. Total 40 subjects will be recruited for this study. Control and interventional group will have 20 subjects each. Plantar flexor muscle strengthening adjunct to aerobic exercise will be given to experimental group and aerobic exercise will be given to control group for 4 weeks. Pre and post assessment of outcome measures will be done. Data will be statistically analysed. |