| CTRI Number |
CTRI/2020/06/026091 [Registered on: 24/06/2020] Trial Registered Prospectively |
| Last Modified On: |
23/06/2020 |
| 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 Infrared and Tai Chi Exercise to improve Balance in Elderly patients |
|
Scientific Title of Study
|
Does Combination of Monochromatic Infrared Energy and Tai Chi Exercise improve Balance in Elderly with lower-extremity disease? Double-blinded randomized controlled study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Gopal Nambi |
| Designation |
Associate Professor |
| Affiliation |
Prince Sattam Bin Abdulaziz University |
| Address |
Department of Physical Therapy and Health Rehabilitation,
College of Applied medical sciences,
Prince Sattam Bin Abdulaziz University,
Al- Kharj, Saudi Arabia.
11942
Other |
| Phone |
|
| Fax |
|
| Email |
physio_gopal@rediffmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Gopal Nambi |
| Designation |
Associate Professor |
| Affiliation |
Prince Sattam Bin Abdulaziz University |
| Address |
Department of Physical Therapy and Health Rehabilitation,
College of Applied medical sciences,
Prince Sattam Bin Abdulaziz University,
Al- Kharj, Saudi Arabia.
11942
Other |
| Phone |
|
| Fax |
|
| Email |
physio_gopal@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Gopal Nambi |
| Designation |
Associate Professor |
| Affiliation |
Prince Sattam Bin Abdulaziz University |
| Address |
Department of Physical Therapy and Health Rehabilitation,
College of Applied medical sciences,
Prince Sattam Bin Abdulaziz University,
Al- Kharj, Saudi Arabia.
11942
Other |
| Phone |
|
| Fax |
|
| Email |
physio_gopal@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| Prince Sattam Bin Abdulaziz University, Al- Kharj, Saudi Arabia. |
|
|
Primary Sponsor
|
| Name |
Prince Sattam Bin Abdulaziz University Al Kharj Saudi Arabia |
| Address |
Department of Physical Therapy and Health Rehabilitation,
College of Applied medical sciences,
Prince Sattam Bin Abdulaziz University,
Al- Kharj, Saudi Arabia.
|
| Type of Sponsor |
Government funding agency |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
Saudi Arabia |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Gopal Nambi |
Prince Sattam Bin Abdul Aziz University |
Department of Physical Therapy and Health Rehabilitation,
College of Applied medical sciences,
Prince Sattam Bin Abdulaziz University,
Al- Kharj, Saudi Arabia.
|
00966501878382
physio_gopal@rediffmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Department Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M00-M99||Diseases of the musculoskeletal system and connective tissue, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Monochromatic infrared energy (MIRE) with Tai Chi exercise |
The device passes monochromatic infrared energy at a frequency of 292 Hz and wavelengths of 890 nm and intensity of 21.67 mW/cm2. It consists of 8 flexible pads, each with 60 Gallium, Aluminum, Arsenide diodes. The patients were asked to take a comfortable position in long sitting on the bed and MIRE will be applied.It was given 4 days in a week for 4 weeks.
The Tai Chi classes were taught by experienced Tai Chi instructors who followed the classical Yang style (24 forms), which emphasizes multidirectional weight shifting, awareness of body alignment, and multi-segmental (arms, legs, and trunk) movement coordination. 15 repetiotions of 3 sets will be given 4 days in aweek for 4 weeks. |
| Comparator Agent |
Tai chai exercise |
The Tai Chi classes were taught by experienced Tai Chi instructors who followed the classical Yang style (24 forms), which emphasizes multidirectional weight shifting, awareness of body alignment, and multi-segmental (arms, legs, and trunk) movement coordination. 15 repetiotions of 3 sets will be given 4 days in aweek for 4 weeks. |
|
|
Inclusion Criteria
|
| Age From |
70.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
Not participating in the moderate or vigorous activity; moving independently; being free of chronic medical problems that would limit participation in low-to-moderate intensity exercise; no medical problem hider the session and had no cognitive impairments. |
|
| ExclusionCriteria |
| Details |
Subjects who have a history of severe motor deficits and balance performance deficits, stroke, Parkinson’s disease, vestibular diseases, and severe arstions arthritis in lower-extremities |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Anthropometrics
2. Ankle/brachial index (ABI)
3. Berg balance scale (BBS)
|
Baseline
after 3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Tinetti clinical scale (TCS)
2. Timed up and go (TUG) |
Baseline
after 3 months |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="0"
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
Date Missing |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
26/06/2020 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Applicable |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
It is proved that
Monochromatic infrared energy (MIRE) is significantly effective to improve foot
sensation in old people which in turn helps them to improve their balance. It is a treatment with infrared energy
delivered with Aluminum, Arsenide, and Gallium diodes kept inside flexible
pads. Its wavelength is eight hundred
ninety nanometers. The warm light from this helps to improve blood supply to
the area. When the blood supply increases, it gives oxygen which is essential
for tissues and removes metabolic waste materials which act as pain
stimulators. So pain will be reduced automatically. Hemoglobin in the capillary
blood absorbs these waves and releases nitric oxide and fastens capillary
circulation. It also increases the speed of conduction of sensory nerves and
improves wound healing. The purpose of the study was to
evaluate the effect of MIRE along with tai chi exercise in improving balance
and reducing fall risk in the elderly with LEDs.
|