| CTRI Number |
CTRI/2024/04/066057 [Registered on: 22/04/2024] Trial Registered Prospectively |
| Last Modified On: |
29/04/2024 |
| Post Graduate Thesis |
Yes |
| 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 physiotherapy interventions in roundback patients on involuntary nervous system and midback angle |
|
Scientific Title of Study
|
Effect of posture correction in hyperkyphotic patients on autonomic nervous system: A Randomized Controlled Trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
yogita |
| Designation |
MPT student |
| Affiliation |
Guru Jambheshwar University of Science and Technology |
| Address |
Department Of Physiotherapy, Room no- 07, Guru Jambheshwar University Of Science and Technology, Hisar, Haryana, 125001, India
Hisar
HARYANA
125001
India |
| Phone |
7988669068 |
| Fax |
|
| Email |
yogitalega@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Manoj Malik |
| Designation |
assistant professor |
| Affiliation |
Department of Physiotherapy, Guru Jambheshwar University of Science and Technology |
| Address |
Department of Physiotherapy, Room no - 07, Guru Jambheshwar University of Science and Technology, Hisar, Haryana
Hisar
HARYANA
125001
India |
| Phone |
9896221262 |
| Fax |
|
| Email |
manojmalikpt@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sonu Punia |
| Designation |
assistant professor |
| Affiliation |
Department of Physiotherapy,Guru Jambheshwar University of Science and Technology |
| Address |
Department of Physiotherapy, Room no- 07, Guru Jambheshwar University of Science and Technology, Hisar, 125001, Haryana, India
Hisar
HARYANA
125001
India |
| Phone |
9466373990 |
| Fax |
|
| Email |
sonu.punianeuropt@gmail.com |
|
|
Source of Monetary or Material Support
|
| Guru Jambheshwar University of Science and Technology, 125001 Hisar, Haryana, India |
|
|
Primary Sponsor
|
| Name |
Yogita |
| Address |
Department of Physiotherapy, Room no-07, Guru Jambheshwar University of Science and Technology, Hisar, 125001, Haryana, India |
| Type of Sponsor |
Other [self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Manoj Malik |
Guru Jambheshwar University of Science and Technology |
Room no-7, OPD, DEPARTMENT OF PHYSIOTHERAPY, GURU JAMBHESHWAR UNIVERSITY OF SCIENCE AND TECHNOLOGY, HISAR
Hisar
HARYANA |
9896221262
manojmalikpt@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M400||Postural kyphosis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
corner stretches
sub- occipital stretches
upper trapezius stretches
neck flexor strengthening
I, T,Y and W strengthening
kyphosis correction exercise 1
kyphosis correction exercise 2
TENS |
subjects of this group will undergo stretching, strengthening and corrective exercise along with TENS thrice a week for 3 weeks |
| Comparator Agent |
corner stretches
sub- occipital stretches
upper trapezius stretches
neck flexors strengthening
I, T, Y and W strengthening
kyphosis correction exercise 1
kyphosis correction exercise 2
TENS
manipulation |
subjects of this group will undergo these exercise thrice a week for 3 weeks and manipulation for 3 weeks with progression from once a week to thrice a week |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
thoracic hyperkyphosis angle above 45 degrees
restricted spinal range of motion
Numerical pain rating scale rating above 3 |
|
| ExclusionCriteria |
| Details |
Recent or past history of Prolapsed disc, spinal injury
Recent vertebral fracture
Upper or lower motor neuron disease
Physically disabled person
Diabetic patients
Ankylosing spondylitis
Uncooperative patients
Patient with communication disorder |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Numerical pain rating scale
Skin sympathetic response
Heart rate variability
|
outcome measures will be measured at the baseline and then post intervention after 3 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| thoracic kyphosis angle |
at the baseline and post intervention after 3 weeks |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
30/04/2024 |
| 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="0"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Hyperkyphosis is a postural deformity in which kyphosis angle increases above 40 degrees, it may affects 32% of adults and 60% of elderly population. It may leads to visible hump on back, spinal deformity, rounded shoulder, fatigue, mild back pain , balance impairments, respiratory compromise etc. Autonomic nervous system regulates involuntary physiological process including heart rate, blood pressure, respiration, digestion etc, recent studies shows relation between posture and autonomic nervous system . ANS is intimately responsive to change in the afferent articular input due to joint dysfunction. There is still limited evidence showing relation between hyperkyphosis and autonomic nervous system. so this study aims to find the effect of posture correction in hyperkyphotic patients on autonomic nervous system. |