| CTRI Number |
CTRI/2024/06/068813 [Registered on: 12/06/2024] Trial Registered Prospectively |
| Last Modified On: |
31/05/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effectiveness of backward walking on blood sugar levels,balance and quality of life |
|
Scientific Title of Study
|
Effect of backward walking on serum glucose levels, lumbar proprioception, balance and quality of life in Type 2 diabetes mellitus |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mrs. Hannah Rajsekhar Chandrasekhar Hannah Mohan |
| Designation |
Professor and Principal |
| Affiliation |
Apollo College of Physiotherapy |
| Address |
Apollo College of Physiotherapy, Apollo Health City Campus, A.I.M.S.R General Hospital, Jubilee Hills,
Hyderabad
3-6-309/64/B, Skylark apartments,Bassherbagh,Hyderabad
Pin code-500001
Hyderabad
TELANGANA
500033
India |
| Phone |
09866128232 |
| Fax |
|
| Email |
hanaraj2014@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Mrs. Hannah Rajsekhar Chandrasekhar Hannah Mohan |
| Designation |
Professor and Principal |
| Affiliation |
Apollo College of Physiotherapy |
| Address |
Apollo College of Physiotherapy,
Apollo Health City Campus,
AIMSR General Hospital,
Jubilee Hills,
Hyderabad
3-6-309/64/B, Skylark apartments, Basheerbagh, Hyderabad,Pin code-500001
Hyderabad
TELANGANA
500033
India |
| Phone |
09866128232 |
| Fax |
|
| Email |
hanaraj2014@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Mrs Hannah Rajsekhar Chandrasekhar Hannah Mohan |
| Designation |
Professor and Principal |
| Affiliation |
Apollo College of Physiotherapy |
| Address |
Apollo College of Physiotherapy,
Apollo Health City Campus,
AIMSR General Hospital,
Jubilee Hills,
Hyderabad
3-6-309/64/B, Skylark apartments, Basheerbagh, Hyderabad,Pin code-500001
Hyderabad
TELANGANA
500033
India |
| Phone |
09866128232 |
| Fax |
|
| Email |
hanaraj2014@gmail.com |
|
|
Source of Monetary or Material Support
|
| Apollo Institute of medical sciences and Research, Apollo College of Physiotherapy, Apollo Health City Campus, Jubilee Hills, Hyderabad, India.
Pin code-500033 |
|
|
Primary Sponsor
|
| Name |
Hannah RajsekharChandrasekhar Hannah Mohan |
| Address |
Apollo Institute of medical sciences and Research, Apollo College of Physiotherapy, Apollo Health City Campus, Jubilee Hills, Hyderabad, pin code-500033, India. |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Mrs Hannah Rajsekhar Chandrasekhar Hannah Mohan |
Apollo Institute of Medical Sciences and Research, Apollo Hospitals |
Department of Physiotherapy, Apollo College Of Physiotherapy, Apollo Health City Campus, Jubilee Hills, Hyderabad, India. Pin code-500033
Hyderabad
TELANGANA |
09866128232
hanaraj2014@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Apollo Institute of Medical Sciences and Research |
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, (2) ICD-10 Condition: E119||Type 2 diabetes mellitus without complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Backward walking+ Conventional therapy |
Backward Walking Training involves
In 50 m hallway, two sides runway tracts of 10 m in total length and 5 m in width in between the two tracts is marked by using reflector tape, then the patient in barefoot walks with normative gait in backward direction.
Conventional therapy involves Stretching exercises:Ham string, iliopsoas, Cat camel exercise, Strengthening exercises:Abdominal muscles and back extensors
Duration
1 year study.
Eight weeks protocol of backward walking training + Conventional therapy, 3 times per week,
In backward walking training-
1 min increment starting from 20 min,
longest training time was 40 min, and weekly training time was not more than 100 min.
|
| Comparator Agent |
Conventional therapy |
Duration-
Eight weeks protocol,3 times per week.
Stretching exercises:Ham string, iliopsoas
Cat camel exercise
Strengthening exercises:Abdominal muscles and back extensors
|
|
|
Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
1.Type 2 Diabetes Mellitus individuals with lumbar prorioception impairment.
2.Both gender
3.Age-45-55 years
|
|
| ExclusionCriteria |
| Details |
1.Severe traumatic illness in lower limbs.
2.Poor vision that affects walking.
3.Severe cardiopulmonary insufficiency.
4.Presence of other forms of neuropathies such as mononeuropathy.
5.Severe pain.
6.Psychiatric illness.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Serum glucose levels
2. Lumbar proprioception
3. Balance
4. Berg Balance scale
|
Baseline and after 8 weeks
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Quality of life |
Baseline and after 8 weeks |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
29/06/2024 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
The aim of the present study is to find out the efficacy of backward walking in regulating the serum glucose levels, improving the lumbar proprioception and improve balance and quality of life in individuals with Type 2 DM. The objectives are to investigate the effectiveness of backward walking on serum glucose levels, lumbar proprioception, balance and quality of life in individuals with Type 2 DM. 30 subjects between 45-55 age group, both male and female,will be assigned in each group ( 30 in conventional group and 30 in experimental group). Backward walking along with conventional treatment will be given to experimental group and conventional treatment will be given to control group for 8 week duration. The inclusion criteria are type 2 diabetes mellitus individuals and the exclusion criteria are severe traumatic illness in lower limbs, poor vision that affects walking, severe cardiopulmonary insufficiency, presence of other forms of neuropathies such as mononeuropathy, severe pain and muscle weakness and psychiatric illness. Outcomes of serum glucose levels, lumbar proprioception, balance and quality of life will be measured at baseline and at the end of 8 weeks of intervention.
|