| CTRI Number |
CTRI/2017/11/010351 [Registered on: 02/11/2017] Trial Registered Prospectively |
| Last Modified On: |
23/10/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
TENS On Balance And Postural Sway In Geriatric Population |
|
Scientific Title of Study
|
Effect Of Transcutaneous Electrical Nerve Stimulation On Balance And Postural Sway In Geriatric Population |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ayyappan Jayavel |
| Designation |
Assistant Professor |
| Affiliation |
SRM College of Physiotherapy, SRM university |
| Address |
Room No: 01
Department of Physiotherapy
SRM University
Kattankulathur
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
9994948597 |
| Fax |
|
| Email |
ayyappanpt@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Charitha Matta |
| Designation |
PG Student |
| Affiliation |
SRM College of Physiotherapy, SRM university |
| Address |
Room No: 01
Department of Physiotherapy
SRM University
Kattankulathur
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
|
| Fax |
|
| Email |
charithamatta@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Charitha Matta |
| Designation |
PG Student |
| Affiliation |
SRM College of Physiotherapy, SRM university |
| Address |
Room No: 01
Department of Physiotherapy
SRM University
Kattankulathur
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
|
| Fax |
|
| Email |
charithamatta@gmail.com |
|
|
Source of Monetary or Material Support
|
| Ayyappan Jayavel
Department of Physiotherapy
SRM University
Kattankulathur |
|
|
Primary Sponsor
|
| Name |
Ayyappan |
| Address |
SRM College of Physiotherapy
SRM University
Kattankuathur |
| Type of Sponsor |
Other [SELF] |
|
|
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 |
| Ayyappan Jayavel |
Post Graduate Research Lab |
Room No: 01
Department of Physiotherapy
SRM University
Kattankulathur
Kancheepuram
TAMIL NADU |
9994948597
ayyappanpt@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committe |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy Geriatric population |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
N/A |
N/A |
| Intervention |
TENS |
Transcutaneus Electrical Nerve Stimulation is a highly accessible and easily applied modality shown to provide effective somatosensory input modulating central neural activity.
The stimulation (pulse width of 200micro seconds, frequency of 100 Hz, duration of 20 minutes) was delivered by a dual-channel commercial TENS unit in prone lying.
Pre TENS balance and postural sway measures and Post TENS balance and postural sway measures will be taken immediately after application of TENS, then on the 5th minute, 10th minute, 20th minute and 30th minute.
|
|
|
Inclusion Criteria
|
| Age From |
60.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Healthy Geriatric opulation |
|
| ExclusionCriteria |
| Details |
1.Neurological and cardiovascular diseases.
2.Vestibular diseases.
3.Stroke, parkinson’s and alzheimer’s disease.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Balance Test android application
|
Day 3 end of the expriment
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| N/A |
N/A |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "12"
Final Enrollment numbers achieved (India)="12" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
30/11/2017 |
| Date of Study Completion (India) |
31/01/2018 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Postural control is performed by combining sensory information from visual, vestibular and somatosensory systems in the CNS. Augmentation of somatosensory input during stance is often needed, such as when stance is challenged by external interferences or when the sensory systems that sub serve postural control are affected by pathology.TENS is a highly accessible and easily applied modality shown to provide effective somatosensory input modulating central neural activity, its effect on postural stability has rarely been the focus of research attention. Cutaneous stimulation of the lower limbs may help to improve the balance of older people.The aim of the current study is to gain further insight into the effects of sensory TENS on stance stability in older age individuals by applying threshold sensory stimulation on the medio-lateral Gastrocnemius muscles. |