| CTRI Number |
CTRI/2025/09/094027 [Registered on: 01/09/2025] Trial Registered Prospectively |
| Last Modified On: |
23/10/2025 |
| 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
|
To find the effect of multimodal physical rehabilitation to improve pain and quality of life in Parkinsons Disease |
|
Scientific Title of Study
|
Effect of multimodal physical rehabilitation on pain and quality of life in Parkinsons Disease patients with neck and back pain A randomized controlled trial |
| Trial Acronym |
NILL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| PHD 221515L |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Remya N. |
| Designation |
Professor and HOD |
| Affiliation |
Dept of Physiotherapy,Little Flower Institute of Medical Sciences and Research, Angamaly, Ernakulam, Kerala. Affiliated to Kerala University of Health Sciences,Thrissur,Kerala |
| Address |
Little Flower Institute of Medical Sciences and Research,
7th Floor,
St Alphonsa Block,
Little Flower Hospital and Research Centre,
Angamaly
Ernakulam,
Kerala.
Ernakulam
KERALA
683572
India |
| Phone |
9567148491 |
| Fax |
91 484 2452646 |
| Email |
remyaneelambaran10@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Remya N. |
| Designation |
Professor and HOD |
| Affiliation |
Little Flower Institute of Medical Sciences and Research, Angamaly, Ernakulam, Kerala. Affiliated to Kerala University of Health Sciences,Thrissur,Kerala |
| Address |
Dept of Physiotherapy,
Little Flower Institute of Medical Sciences and Research,
7th Floor,
St Alphonsa Block,
Little Flower Hospital and Research Centre,
Angamaly
Ernakulam,
Kerala.
Ernakulam
KERALA
683572
India |
| Phone |
9567148491 |
| Fax |
91 484 2452646 |
| Email |
remyaneelambaran10@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Remya N. |
| Designation |
Professor and HOD |
| Affiliation |
Dept of PhysiotherapyLittle Flower Institute of Medical Sciences and Research, Angamaly, Ernakulam, Kerala. Affiliated to Kerala University of Health Sciences,Thrissur,Kerala |
| Address |
Dept of Physiotherapy,
Little Flower Institute of Medical Sciences and Research,
7th Floor,
St Alphonsa Block,
Little Flower Hospital and Research Centre,
Angamaly
Ernakulam,
Kerala.
S
Ernakulam
KERALA
683572
India |
| Phone |
9567148491 |
| Fax |
91 484 2452646 |
| Email |
remyaneelambaran10@gmail.com |
|
|
Source of Monetary or Material Support
|
| Little Flower Institute of Medical Sciences and Research and Little Flower Hospital and Research Centre ,
7th Floor,
St Alphonsa Block,
Little Flower Hospital and Research Centre,
Angamaly-683572
Ernakulam,
Kerala.
|
|
|
Primary Sponsor
|
| Name |
Little Flower Hospital and Research CentreAngamalyErnakulmKerala |
| Address |
Dept of Physiotherapy,
Little Flower Institute of Medical Sciences and Research,
7th Floor,
St Alphonsa Block,
Little Flower Hospital and Research Centre,
Angamaly-683572
Ernakulam,
Kerala.
|
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| DrRemya N |
Little Flower Hospital and Research Centre, |
Dept of Physiotherapy,
Little Flower Institute of Medical Sciences and Research,
7th Floor,
St Alphonsa Block,
Little Flower Hospital and Research Centre,
Angamaly-683572
Ernakulam,
Kerala.
Ernakulam
KERALA |
09567148491
remyaneelambaran10@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Little Flower Hospital and Research Centre Institutional Ethical Committee |
Not Applicable |
|
|
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 |
MULTIMODAL REHABILITATION |
Posture correction Exercises, Exercise for spinal proprioception,
Transverse abdominis activation,core muscle activation,spinal flexibility exercise.
Exercise Protocol
Duration: 4 weeks
Frequency: 4 days per week
Number of sessions: single session per day
Intensity: Progressive increase each week
Total Time: 60 minutes exercise session. Before the exercise session, a 10-minute warm-up will be followed by relaxation training. At the end of the session, a 10-minute cool-down will be included.
Rest: Rest for 2 minutes after every 10 minutes of exercise, or adjust the rest time according to the patient’s tolerance.
|
| Comparator Agent |
Standard treatment |
After the initial assessment, the patient will be instructed to do a set of standard exercises. Patients will be asked to perform the exercise daily at home and booklets will be provided for the same. Patients Will be asked to come for review once in a week. Post test assessment will be taken on the last day after the treatment.
Duration: 4 weeks
Frequency: 4 days per week
Number of sessions: single session per day
Intensity: Progressive increase each week
Total Time: 30 minutes exercise session. Before the exercise session, a 10-minute warm-up will be followed by relaxation training. At the end of the session, a 10-minute cool-down will be included.
Rest: Rest for 2 minutes after every 10 minutes of exercise, or adjust the rest time according to the patient’s tolerance.
|
|
|
Inclusion Criteria
|
| Age From |
50.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Diagnosed cases of Parkinson’s Disease with pain in the neck and back region (McGill Pain Questionnaire)
Age 50 to 65 years
Subjects with Parkinson’s Disease in the stage of 1 to 3 as per the Modified Hoehn and Yahr scale
Subjects with Parkinson’s Disease in the category of score 7-13 in the Short Falls Efficacy Scale International (FES I)
|
|
| ExclusionCriteria |
| Details |
Subjects not will to give informed consent for study.
Subjects with Becks Depression Inventory score 11 and above
Subjects with the Montreal Cognitive Assessment (MoCA) score less than 10
Any cardiovascular disease that interrupts exercises
All other secondary Parkinson’s Disease and Parkinsonism plus syndrome
Inflammatory infective demyelinating disorders of CNS
Vestibular dysfunction
Recent fractures or surgeries of upper limb, shoulder girdle, ribs and spine
Psychiatric and non cooperative patients
Intervertebral disc prolapses and other diseases of spine
Spinal and upper limb deformities
Fixed kyphosis
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
•After including the subjects with pain into the study, to differentiate whether the pain is related to Parkinsons disease or not, the PD Pain Classification Scale (PDPCS) will be utilized. Additionally, the Kings PD Questionnaire will be employed to categorize the pain into various domains.
1.McGill Pain Questionnaire for pain
2.Visual Analogue Scale for pain
3.The Parkinson Disease Questionnaire 39 for Quality of Life
|
Pre- test score will be assessed on the first day before the treatment. On completion of the treatment of four weeks, post interventional assessment will do and the scores obtained will documented for analysis.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Kinovea software for posture
•2.Mcgill’s Torso Muscular Endurance Test Battery for core muscle endurance
3.Transverse Abdominus Activation using Pressure Biofeedback
4.Fingertips to floor (FTF) test for assessing spine flexibility |
Pre- test score will be assessed on the first day before the treatment. On completion of the treatment of four weeks, post interventional assessment will do & the scores obtained will documented for analysis.
|
|
|
Target Sample Size
|
Total Sample Size="92"
Sample Size from India="92"
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)
|
01/10/2025 |
| 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="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
Response - Analytic Code
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [remyaneelambaran10@gmail.com].
- For how long will this data be available start date provided 01-10-2025 and end date provided 01-10-2026?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
The study is being conducted as part of a PhD program under the Kerala University of Health Sciences, Kerala
All preliminary requirements for PhD data collection have been fulfilled, including approvals from the Institutional Scientific Committee, Institutional Ethics Committee, Doctoral Committee, and theProtocol presentation committee of Kerala University of Health Sciences.
The initial research proposal, which included all components to be measured, was submitted. Following the protocol presentation before the Kerala University of Health Sciences, it was recommended to designate two measures as primary outcome measures and the remaining as secondary outcome measures. Accordingly, two ethical clearance certificates have been obtained from the institute, one before the study title has been modified and another after modification,in alignment with the university’s recommendations and ethical standards.
There is no change in content or protocol after the title change, the content remains absolutely the same.
|