CTRI Number |
CTRI/2019/12/022415 [Registered on: 18/12/2019] Trial Registered Prospectively |
Last Modified On: |
15/08/2020 |
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
|
Efficacy of Proprioceptive Neuromuscular Facilitation (Physiotherapy Technique) on Forward Head Posture in Patient of Parkinsons Disease. |
Scientific Title of Study
|
Efficacy of Proprioceptive Neuromuscular Facilitation on Posture in Parkinson Disease: A Randomised Controlled Trial. |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
Nil |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Dr Manoj Malik |
Designation |
Assistant Professor |
Affiliation |
Guru Jambeshwar University Science and technology |
Address |
Department of physiotherapy Guru Jambeshwer University Science And Technology Hisar Haryana Guru Jambeshwer University Science And Technology Hisar Haryana Hisar HARYANA 125001 India |
Phone |
9896221262 |
Fax |
|
Email |
malik_manoj@yahoo.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Sonu Punia |
Designation |
Assistant Professor |
Affiliation |
Guru Jumbeshwer University Science And Technology Hisar Haryana |
Address |
Department of physiotherapy Guru Jambeshwer University Science And Technology Hisar Haryana Guru Jambeshwer University Science And Technology Hisar Haryana Hisar HARYANA 125001 India |
Phone |
9466373990 |
Fax |
|
Email |
sonu.punianeuropt@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Dr Sonu Punia |
Designation |
Assistant Professor |
Affiliation |
Guru Jumbeshwer University Science And Technology Hisar Haryana |
Address |
Department of physiotherapy Guru Jambeshwer University Science And Technology Hisar Haryana Guru Jambeshwer University Science And Technology Hisar Haryana Hisar HARYANA 125001 India |
Phone |
9466373990 |
Fax |
|
Email |
sonu.punianeuropt@gmail.com |
|
Source of Monetary or Material Support
|
Ms Kritika PG Student Department of Physiotherpay Guru Jumbeshwer University Science And Technology Hisar Haryana |
|
Primary Sponsor
|
Name |
Department of Physiotherapy |
Address |
Guru Jambeshwer University Science And Technology Hisar Haryana |
Type of Sponsor |
Other [] |
|
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 |
Ms Kritika |
Department of Physiotherapy |
OPD Room no.4 and division of Physiotherapy
Guru Jambeshwer University Science And Technology Hisar HARYANA |
8053166205
kritikabodwal95@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
IEC |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: G219||Secondary parkinsonism, unspecified, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Intervention |
PNF Technique in Upper Limb will be given |
The intervention will be given thrice in a week for 2 weeks. |
Comparator Agent |
Resisted Exercises of Upper Limb to correct forward head posture |
The intervention will be given thrice in a week for 2 weeks |
|
Inclusion Criteria
|
Age From |
40.00 Year(s) |
Age To |
75.00 Year(s) |
Gender |
Both |
Details |
Patient suffering from Parkinson disease with forward head posture |
|
ExclusionCriteria |
Details |
Patients with
Metabolic disorders
Heart disease
Congenital anomaly of cervical spine
Uncooperative patient
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
Method of Concealment
|
Not Applicable |
Blinding/Masking
|
Participant Blinded |
Primary Outcome
|
Outcome |
TimePoints |
Craniovertebral angle |
1 Month |
|
Secondary Outcome
|
Outcome |
TimePoints |
not available |
not available |
|
Target Sample Size
|
Total Sample Size="20" Sample Size from India="20"
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)
|
20/12/2019 |
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="6" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
Recruitment Status of Trial (India) |
Open to Recruitment |
Publication Details
|
Nil |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
|
Parkinson’s
disease is second most common neurodegenerative disease. Parkinson’s disease or
Paralysis was first described as “the shaking palsy†by James Parkinson in
1817. It is chronic, progressive degenerative disorder of nervous system
characterised by cardinal features of rigidity, akinesia, bradykinesia, tremors
and postural instability.About 5 million people are affected worldwide.
Prevalence rises from 1% with those with 60years age to 4% in population over
80 years.
The
disease is slightly more frequent in men than women. The prevalence of the
disease is generally accepted to range from 100 to 200 per 100,000 people and
the annual incidence is thought to be 15 per 100,000.
Parkinson
disease is a disorder of the dopamine producing neuron of the substantianigra
in the basal ganglia. The substantianigra is subcortical grey matter that
contain pigmented neurons. The severity of loss of dopamine correlated well
with the amount of movement slowness or bredykinesia exhibited by the patients.
Loss of dopamine neurons and the production of lewy bodies within the pigmented
substantianigra neurons are hallmarks of idiopathic Parkinson disease.
Four
motor symptoms are considered cardinal in PD: tremor, rigidity, slowness of
movement, and postural instability. The range of other motor symptoms include
posture and gait disturbances such as a forward-flexed posture with a typical
festinating gait.1 Forward head posture (FHP) is the anterior
positioning of the cervical spine. It is the most common deviation from the
normal curvature of the cervical spine. It involves an excessive anterior
position of the head in relation to the theoretical plumb line perpendicular to
the body centre of gravity. In forward head posture there is extension of upper
cervical spine, flattening and flexion of lower cervical spine with an increase
in lordsis and rounding of the upper back and elevation and protraction of the
shoulders.4Physiotherapy treatment i.e. PNF and resisted exercise is
better to improve range of motion and forward head posture in Parkinson’s
patients.
Need of the study:
Parkinson’s
disease affects 1–2 per 1000 of the population at any time. PD prevalence is
increasing with age and PD affects 1% of the population above 60 years. The
posture in Parkinson’s disease deteriorate. Forward head and stooped posture is
very common in these patients. Pharmacological treatment doesn’t curepostural
instability. Hence physiotherapy correction i.e. strengthening exercises and
PNF techniques are very effective in treatment of forward head posture. |