CTRI

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CTRI Number

CTRI/2025/07/092110 [Registered on: 31/07/2025] Trial Registered Prospectively

Last Modified On:

31/07/2025

Post Graduate Thesis

Yes

Type of Trial

Observational

Type of Study

Cross Sectional Study

Study Design

Single Arm Study

Public Title of Study

Exploring the relationship between fatigue, balance, and mobility in individuals with Parkinsons Disease.

Scientific Title of Study

Association of fatigue with postural stability and functional mobility in persons with Parkinson’s 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	Dr Palak Trivedi
Designation	Post Graduate Student
Affiliation	Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal
Address	Room No. 215, Department of Physiotherapy, Manipal College of Health Professions, Manipal Academy of Higher Education, Udupi Udupi KARNATAKA 576104 India
Phone	9029025575
Fax
Email	palak.mchpmpl2024@learner.manipal.edu

Details of Contact Person
Scientific Query

Name	Dr Manikandan Natarajan
Designation	Additional Professor and Head of Department ot Physiotherapy
Affiliation	Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal
Address	Room No. 215, Department of Physiotherapy, Manipal College of Health Professions, Manipal Academy of Higher Education, Udupi Udupi KARNATAKA 576104 India
Phone	9886898064
Fax
Email	mani.kandan@manipal.edu

Details of Contact Person
Public Query

Name	Dr John Solomon
Designation	Additional Professor, Department of Physiotherapy and Associate Dean, MCHP, MAHE, Manipal
Affiliation	Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal
Address	Room No. 215, Department of Physiotherapy, Manipal College of Health Professions, Manipal Academy of Higher Education, Udupi Udupi KARNATAKA 576104 India
Phone	9945670671
Fax
Email	john.solomon@manipal.edu

Source of Monetary or Material Support

Manipal College of Health Professions, Manipal Academy of Higher Education, Udupi, Karnataka - 576104

Primary Sponsor

Name	Manipal College of Health Professions
Address	Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal
Type of Sponsor	Other [Self]

Details of Secondary Sponsor

Name	Address
NIL	NIL

Countries of Recruitment

India

Sites of Study

No of Sites = 1
Name of Principal Investigator	Name of Site	Site Address	Phone/Fax/Email
Dr Palak Trivedi	Kasturba Hospital	Neurorehabilitation Unit, 3rd Floor, Kasturba Hospital, Manipal, Udupi, Karnataka - 576104 Udupi KARNATAKA	9029025575 palak.mchpmpl2024@learner.manipal.edu

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Patients	(1) ICD-10 Condition: G20\|\|Parkinsons disease,

Intervention / Comparator Agent

Type	Name	Details
Intervention	Nil	Nil
Intervention	Nil	Nil
Intervention	Nil	Nil

Inclusion Criteria

Age From	45.00 Year(s)
Age To	85.00 Year(s)
Gender	Both
Details	Patients diagnosed with Parkinson’s Disease Haemodynamically stable Able to read, write and have functional vision Patients who can stand independently for atleast 30 seconds and walk (with or without aid) for atleast 10 metres Patient is on stable anti-parkinsonian drug for atleast 1 month

ExclusionCriteria

Details

Hoehn and Yahr scale stage more than 4
Mini Cog score less than 3
Individuals with any recent lower limb injuries affecting balance or having other neurological disorders
Changes in Levodopa Equivalent Drug Dose (LEDD) less than 1 month ago

Method of Generating Random Sequence

Not Applicable

Method of Concealment

Not Applicable

Blinding/Masking

Not Applicable

Primary Outcome

Outcome	TimePoints
1. Fatigue measured using Parkinson’s Disease Fatigue Scale 16 2. Postural Control measured using Sway Velocity and Velocity Moment 3. Functional Mobility measured using Timed Up and Go Test	Baseline

Secondary Outcome

Outcome	TimePoints
Balance Confidence measured using Falls Efficacy Scale	Baseline
Quality of Life measured using PDQ-8 scale	Baseline
Community mobility measured using mobility disability scale	Baseline

Target Sample Size

Total Sample Size="88"
Sample Size from India="88"
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)

11/08/2025

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="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

This cross-sectional observation study aims to associate fatigue using PFS-16 scale, with postural stability measured using BTrackS system and functional mobility using timed up and go test in persons with Parkinson’s Disease. The study will also explore the relationship of fatigue with clinical impairments, quality of life, community mobility. A total number of eighty eight participants will be recruited for the study. The study will be conducted in the Neurorehabilitation Unit of Kasturba Hospital, Manipal, over a period of twelve months. Ethical approval has been obtained and CTRI registration is being completed.