CTRI Number |
CTRI/2025/03/082837 [Registered on: 19/03/2025] Trial Registered Prospectively |
Last Modified On: |
19/03/2025 |
Post Graduate Thesis |
Yes |
Type of Trial |
Observational |
Type of Study
|
Cross Sectional Study |
Study Design |
Other |
Public Title of Study
|
how people with Parkinson’s disease can sense the position and movement of their legs (proprioception) and how this affects their ability to move and perform daily activities. |
Scientific Title of Study
|
An Analysis Of Single And Multijoint Proprioception Of Lower Limb And Functional Mobility Among Patients 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 |
Sravani P N |
Designation |
MPT Neurosciences |
Affiliation |
Sri Ramachandra Institute of Higher Education and Research |
Address |
Sri Ramachandra Institute of Higher Education and Research Faculty of Physiotherapy Room 2.2No 1 Ramachandra Nagar
Chennai,TAMIL NADU 600116 India
Chennai TAMIL NADU 600116 India |
Phone |
8056242474 |
Fax |
|
Email |
sravanipn2001@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Radhika C M |
Designation |
MPT NEUROSCIENCES |
Affiliation |
Sri Ramachandra Institute of Higher Education and Research |
Address |
Sri Ramachandra Institute of Higher Education and Research
Faculty of Physiotherapy 2nd Floor No 1 Ramachandra Nagar
Chennai Tamilnadu 600116 India
Chennai TAMIL NADU 600116 India |
Phone |
9841376961 |
Fax |
|
Email |
radhikacm@sriramachandra.edu.in |
|
Details of Contact Person Public Query
|
Name |
Radhika C M |
Designation |
MPT NEUROSCIENCES |
Affiliation |
Sri Ramachandra Institute of Higher Education and Research |
Address |
Sri Ramachandra Institute of Higher Education and Research Faculty of Physiotherapy 2nd Floor No 1 Ramachandra Nagar
Chennai Tamilnadu 600116 India
Chennai TAMIL NADU 600116 India |
Phone |
9841376961 |
Fax |
|
Email |
radhikacm@sriramachandra.edu.in |
|
Source of Monetary or Material Support
|
Department of Neurology G Block Sri Ramachandra Institute of Higher Education and Research. No 1 Ramachandra Nagar Sri Ramachandra Nagar Chennai Tamilnadu India |
|
Primary Sponsor
|
Name |
Sravani P N |
Address |
Sri Ramachandra Institute of Higher Education and Research .No 1 Ramachandra Nagar Sri Ramachandra Nagar Chennai Tamilnadu India |
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 |
Radhika C M |
Department of Neurology Sri Ramachandra Institute of Higher Education and Research |
Sri Ramachandra Institute of Higher Education and Research,
Faculty of Physiotherapy No 1 Ramachandra Nagar
Chennai TAMIL NADU 600116 India Chennai TAMIL NADU |
9841376961
radhikacm@sriramachandra.edu.in |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Sri Ramachandra Ethics Committee For Students Projects |
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 |
Nil |
Nil |
Comparator Agent |
Nil |
Nil |
|
Inclusion Criteria
|
Age From |
40.00 Year(s) |
Age To |
70.00 Year(s) |
Gender |
Both |
Details |
Patient diagnosed with Parkinsons disease
Adults with mild to moderate parkinsons disease
If they able to walk independently with or without aid |
|
ExclusionCriteria |
Details |
1.Individuals with cognitive impairment will be excluded from the study since they have difficulty understanding the instructions given.
2.Patients with early-onset PD and late stages of PD
3.A history of other neurological disease(s), or a history of severe ankle injury
|
|
Method of Generating Random Sequence
|
Other |
Method of Concealment
|
Other |
Blinding/Masking
|
Not Applicable |
Primary Outcome
|
Outcome |
TimePoints |
1.JOINT REPOSITION TEST FOR HIP AND KNEE JOINT
2.TARGET POINT
|
One Time (1 day) |
|
Secondary Outcome
|
Outcome |
TimePoints |
TIMED UP AND GO TEST
|
One Time (1 day) |
|
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
|
N/A |
Date of First Enrollment (India)
|
30/03/2025 |
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="0" 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
|
Parkinson’s is the second most common neurodegenerative disease. Parkinson’s disease is generally characterized by rigidity,
tremor, bradykinesia, stooped posture, freezing of gait. Recent reports confirm
the presence of proprioception deficit in patients with Parkinson’s
disease. Increased neuronal responses
and noise within the basal ganglia lead to reduced joint specificity in
proprioceptive integration, impairing accurate movement and coordination. This disruption impairs the brain’s capacity to accurately
integrate sensory signals, causing diminished awareness of limb and trunk
positions, particularly affecting kinesthesia (the sense of movement). As the
disease progresses, these proprioceptive disturbances worsen, contributing to
increasingly impaired movement coordination, greater challenges in motor
control . Most
of the studies are done proprioception in a single joint rather than using the
multi-joint. where, Single-joint proprioception tests assess sensory feedback
from specific joints but may not capture the broader impact on overall limb
function. Whole-limb assessments offer a more comprehensive evaluation by
considering how proprioceptive deficits affect the coordination and execution
of movements involving multiple joints and muscles. This approach provides a
better understanding of how proprioceptive impairments influence functional
activities. Therefore, we could like to test single joint and multi-joint
proprioception of lower limb in patients with Parkinson’s disease and to assess
the presence of variation and its impact on functional mobility like gait
patients with Parkinson’s. |