| CTRI Number |
CTRI/2024/06/069275 [Registered on: 20/06/2024] Trial Registered Prospectively |
| Last Modified On: |
19/06/2024 |
| 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 Head up Cervical Orthosis and Exercises on Functional outcome in Subjects with Parkinsons Disease. |
|
Scientific Title of Study
|
Modified Head up Cervical Orthosis with Novel Structured Exercise on Functional outcome and Quality of Life in Subjects with Parkinsons Disease |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
CHANDRIKA PC |
| Designation |
Professor |
| Affiliation |
Padmashree Institute of Physiotherapy |
| Address |
No.149 Padmashree Campus
Padmashree Institute Of Physiotherapy
III Floor
Neuro Department
Sulikere (Post)
Kommaghatta
BANGALORE - 560060
Chandrika PC
# 23, Sai Nilaya, Jawaharlal street
Sheshadripuram
Bangalore - 560020
Bangalore
KARNATAKA
560060
India |
| Phone |
7022027784 |
| Fax |
|
| Email |
chandrikapc21@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Chandrika PC |
| Designation |
Professor |
| Affiliation |
Padmashree Institute of Physiotherapy |
| Address |
No.149 Padmashree Campus
Padmashree Institute Of Physiotherapy
III Floor
Neuro Department
Sulikere (Post)
Kommaghatta
BANGALORE - 560060
BANGALORE - 560060
Chandrika PC
#23, Sai Nilaya, Jawaharlalstreet
Sheshadripuram
Bangalore - 560020
Bangalore
KARNATAKA
560060
India |
| Phone |
7022027784 |
| Fax |
|
| Email |
chandrikapc21@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
CHANDRIKA PC |
| Designation |
Professor |
| Affiliation |
Padmashree Institute of Physiotherapy |
| Address |
Padmashree Campus
Padmashree Institute Of Physiotherapy
III Floor
Neuro Department
No.149 Padmashree Campus
Sulikere (Post)
Kommaghatta
BANGALORE - 560060
Chandrika PC
#23, Sai Nilaya, Jawaharlalstreet
Sheshadripuram
Bangalore - 560020
Bangalore
KARNATAKA
560060
India |
| Phone |
7022027784 |
| Fax |
|
| Email |
chandrikapc21@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr. Prashanth LK
Parkinsons Disease and Movement Disorder Clinic
No.15, First Floor, Royal Plaza, Dr. Rajkumar road, avbove ICICI Bank, Opposite to Theresa Hospital
Rajajingar
Bangalore - 560010 |
|
|
Primary Sponsor
|
| Name |
Chandrika PC |
| Address |
Professor
No.149 Padmashree Campus
Padmashree Institute Of Physiotherapy
III Floor
Neuro Department
Sulikere (Post)
Kommaghatta
BANGALORE - 560060 |
| 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 |
| CHANDRIKA PC |
PADMASHREE INSTITUTE OF PHYSIOTHERAPY |
PADMASHREE INSTITUTE OF PHYSIOTHERAPY
NO. 149 PADMASHREE CAMPUS
SULIKERE (POST)
KOMMAGHATTA
Bangalore
KARNATAKA |
7022027784
chandrikapc21@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| PADMASHREE INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G20||Parkinsons disease, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
modified head up collar and structured exercises |
Objective of the study 1.Effect of Modified Head up Cervical orthosis with novel structured exercise on Posture, Balance, Cognition, Fear of fall and QOL in subjects with Parkinson’s disease. 2.Impact of postural alignment on non- motor symptoms in Parkinson’s disease. 3. Effect of Modified Head up Cervical orthosis with novel structured exercise on non- motor symptoms in subjects with Parkinson’s disease. Screening will be done on the basis of inclusion and exclusion criteria for both the groups. Eligible subjects will be allotted into group A and B by simple random sampling. Demographic data of the participants will be documented after the signing of the consent form. The demographic data such as age (years), height (m), weight (kg), body mass index (BMI) (kg/m2), and blood pressure (BP) (mmHg) will be noted. Group A (Experimental group): The Experimental group will be provided with Modified Head up Cervical Orthosis with Novel structured exercise. Group B (Control group): The Control group will undergo conventional exercises. Procedure of intervention for Group A (Experimental group): Modified Head up Cervical orthosis with Novel structured exercise 33, 47, 48 Exercises will be given 30 minutes after taking anti PD medications. Modified head up collar will be adjusted |
|
|
Inclusion Criteria
|
| Age From |
60.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1.Age 60 – 80
2.Gender: Both male and female
3.Ability to walk for at least 15 meters independently without a walking aid,
4. Ability to follow simple orders and commands
5.Modified Hoehn and yahr stages – 1, 1.5, 2, 2.5 and 3 |
|
| ExclusionCriteria |
| Details |
1.Subjects with hypersensitive skin
2.Subjects underwent any surgeries in 6 months duration
3.Subjects with other neurological conditions
4.Subjects taking antipsychotic drugs
5.Subjects with any musculoskeletal deformities or injuries
6.Participants with visual and hearing impairments
7.Subjects who are not willing to participate |
|
|
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 |
Craniovertebral Angle
Non motor symptoms
|
12 weeks pre and post |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Non motor symptoms
Balance
Falls |
12 weeks pre and post |
|
|
Target Sample Size
|
Total Sample Size="64"
Sample Size from India="64"
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 1 |
|
Date of First Enrollment (India)
|
01/07/2024 |
| 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="1"
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
|
From the current search, it is seen that using cervical orthoses in post postural impairment have been disagreed by the subjects as it restricts the ADL and causes discomfort and on the other side performing long duration exercises may not fully involve the subjects mentally and physically due to lack of attention, drowsiness, fatigue, incontinence and low outcome expectation on motor and non - motor symptoms. Hence, this study aims to know use of head up collar as a preventive measure and implementing the novel structured exercise protocol may help the subjects to overcome the non-motor symptoms by considering the subjective barriers as mentioned above in delaying the progression of non-motor and motor symptoms. From 2015 to 2021, a literature search was conducted using Google Scholar, PubMed, and Science Direct. Postural impairment, posture in the elderly, posture correction, orthoses, spinal abnormalities, and orthoses in Parkinson’s disease were used to search the database. This search revealed that there is a lack of studies on the effects of spinal orthoses on postural deficits and the use of spinal orthoses in the early stages of Parkinson’s disease. As a result, it’s important to know if wearing a spinal brace early on can help prevent postural instability and thereby improve cognition and QOL.
|