| CTRI Number |
CTRI/2021/06/034188 [Registered on: 11/06/2021] Trial Registered Prospectively |
| Last Modified On: |
10/06/2021 |
| 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
|
Effectiveness of Upper Limb Exercises in Patients with Type 2 Diabetes Mellitus |
|
Scientific Title of Study
|
Effectiveness of Upper Limb Training Protocols on Neuromuscular Parameters and Functional Disability in Patients with Type 2 Diabetes Mellitus |
| 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 |
Associate Professor |
| Affiliation |
Guru Jabheswar University of Science and Technology Hisar |
| Address |
Department of Physiotherapy Guru Jabheswar University of Science
and Technology
Hisar
HARYANA
125001
India
Hisar
HARYANA
125001
India |
| Phone |
8708565384 |
| Fax |
|
| Email |
jaspreet248103@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jaspreet Kaur |
| Designation |
Associate Professor |
| Affiliation |
Guru Jabheswar University of Science and Technology Hisar |
| Address |
Department of Physiotherapy Guru Jabheswar University of Science
and Technology
Hisar
HARYANA
125001
India
Hisar
HARYANA
125001
India |
| Phone |
8708565384 |
| Fax |
|
| Email |
jaspreet248103@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jaspreet Kaur |
| Designation |
Associate Professor |
| Affiliation |
Guru Jabheswar University of Science and Technology Hisar |
| Address |
Department of Physiotherapy Guru Jabheswar University of Science
and Technology
Hisar
HARYANA
125001
India
Hisar
HARYANA
125001
India |
| Phone |
8708565384 |
| Fax |
|
| Email |
jaspreet248103@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Physiotherapy, Guru Jambheshwar University
of Science and Technology Hisar |
|
|
Primary Sponsor
|
| Name |
Guru Jambheshwar University of Science and Technology Hisar |
| Address |
Department of Physiotherapy Guru Jabheshwar University of Science and Technology Hisar |
| Type of Sponsor |
Other [University] |
|
|
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 |
| Mamta Boora |
Room No 1, OPD Deparment of Physiotherapy |
Room No 1, OPD, Deparment of Physiotherapy,Guru Jambheswar
University of Science
and Technology
Hisar
HARYANA |
8683810061
mamtaboora50@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Comittee,GJUS&T Hisar |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E118||Type 2 diabetes mellitus with unspecified complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Control |
The participants will do only Warm up exercises. |
| Intervention |
Sensorimotor intervention |
Subjects in this group will receive Sensorimotor intervention thrice weekly for six weeks. |
| Intervention |
Strength training |
The participants will be asked to do Upper limb Strength training exercises thrice weekly for six weeks. |
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients with Type 2 diabetes mellitus
2. Duration of diabetes more than 5 years
3. Age group: 35-65 years
4. Both male and females
|
|
| ExclusionCriteria |
| Details |
1. Patients with any neurological or
musculoskeletal disorders that may
interfere with collection of data.
2. Patients with other type of neuropathy.
3. Trauma in the course of nerve in upper
limb
4. Uncontrolled hypertension
5. Visual impairments
6. Vestibular dysfunction
7. Severe anxiety, depression and mental
retardation
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Strength
Muscle activation
Nerve conduction velocity
Shoulder pain and Functional disability
|
Baseline , 6th and 10th week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Manual dexterity |
Baseline , 6th and 10th week |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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)
|
16/06/2021 |
| 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="2"
Days="10" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Not yet published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Diabetes Mellitus is one of the most prevalent metabolic health disease characterized by chronic and persistent hyperglycemia which affects approximately 425 million adults worldwide and its incidence is rising at very high pace in low and middle income countries .Currently, it has become an important health condition and increasing prevalence globally, particularly in Asia.Upper limb is one of the important target for musculoskeletal complications in patients with T2DM and these musculoskeletal complications also contribute to loss in quality of life in these patients .Hand complications in patients with T2DM may affect activities of daily living and lead to disabilities in self-care activities, reduced interpersonal interactions, loss of independence overall reduced quality of life. Therefore, the present study intends to find out the effect of strength training and sensorimotor training on various parameters in patients with T2DM. Aim of the study To determine the effect of strength training and sensorimotor training on strength , muscular activation , nerve conduction velocity , and functional disability of upper limb in patients with Type 2 Diabetes mellitus Need of the study Diabetes Mellitus is one of the largest global public health emergencies of 21st century and India being the diabetes capital as per WHO. Diabetic foot has always been a point of worry for treatment by physicians but complications like shoulder disability and diabetic hand syndrome has not have gained enough recognition . The functioning of hands and the patient’s ability to self-care affects coping with the disease, performing everyday activities, preparing and eating meals, administering insulin injections, measuring blood glucose levels, as well as overall quality of life . Procedure: All participants will be allocated into three groups through computer generated random number tables. Participants will divided into three groups . Group A will be asked to perform Upper limb Strengthening exercises , Group B will receive Sensorimotor intervention ,and GroupC will be Control group and do only warm up exercises. Pre and Post intervention data will include analysis of Strength by hand held dynamometer , muscle activation by EMG, nerve conduction by NCV and functional disability by SPADI Questionnaire of all three groups . |