| CTRI Number |
CTRI/2021/10/037226 [Registered on: 11/10/2021] Trial Registered Prospectively |
| Last Modified On: |
03/10/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Lower Limb Coordination And Walking Speed In Parkinson Patients |
|
Scientific Title of Study
|
Correlation Between Lower Limb Coordination And Walking Speed And Distance In Parkinson’s Disease |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ajjewadiermath Vaishnavi Jaydev |
| Designation |
MPT |
| Affiliation |
Father Muller Medical College |
| Address |
Father Muller College of Allied Health Sciences, Physiotherapy Department, Kankanady, Mangalore
Dakshina Kannada KARNATAKA 575002 India |
| Phone |
8310107131 |
| Fax |
|
| Email |
vaishnavia32@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Sydney Roshan Rebello |
| Designation |
Professor |
| Affiliation |
Father Muller Medical College |
| Address |
Father Muller College of Allied Health Sciences, Physiotherapy Department, Kankanady, Mangalore
Dakshina Kannada KARNATAKA 575002 India |
| Phone |
9343569219 |
| Fax |
|
| Email |
sydnypt@fathermuller.in |
|
Details of Contact Person Public Query
|
| Name |
Ajjewadiermath Vaishnavi Jaydev |
| Designation |
MPT |
| Affiliation |
Father Muller Medical College |
| Address |
Father Muller College of Allied Health Sciences, Physiotherapy Department, Kankanady, Mangalore
Dakshina Kannada KARNATAKA 575002 India |
| Phone |
8310107131 |
| Fax |
|
| Email |
vaishnavi32@gmail.com |
|
|
Source of Monetary or Material Support
|
| Father Muller College of Allied Health Sciences, Kankanady, Mangalore, Dakshin Kanada, Karnataka, 575002 |
|
|
Primary Sponsor
|
| Name |
Father Muller Medical College |
| Address |
Father Muller College of Allied Health Sciences, Kankanady, Mangalore, Dakshin Kanada, Karnataka, 575002 |
| Type of Sponsor |
Private medical college |
|
|
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 |
| Ajjewadiermath Vaishnavi Jaydev |
Father Muller Medical College |
Department Of Physiotherapy Dakshina Kannada KARNATAKA |
8310107131
vaishnavia32@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Father Mullers Institutional Ethics Committee(FMIEC) |
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 |
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
50.00 Year(s) |
| Age To |
85.00 Year(s) |
| Gender |
Both |
| Details |
Patient with Parkinsons
Modified Hoen & Yahr stage 1to 3
The ability to move independently
Full awareness of the patient
The absence of any diseases that directly endanger the life and health of the patient
|
|
| ExclusionCriteria |
| Details |
Any lower limb surgeries in past 1 year
Peripheral neuropathy
Vertigo
Unstable angina in previous 1 month
Myocardial infarction in previous 1 month
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Lower Extremity Motor Coordination Test (LEMOCOT)
10m Walk Test
6min Walk Test |
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Montreal Cognitive Assessment (MoCA)
Falls efficacy scale
MDS- UPDRS |
Baseline |
|
|
Target Sample Size
|
Total Sample Size="56" Sample Size from India="56"
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)
|
21/10/2021 |
| 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
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Parkinson’s
disease is defined as a progressive neurological condition. These results due
to dopamine deficiency as basal ganglia dysfunction occurs. The dysfunction of
basal ganglia directly interferes with voluntary movements, sequential
processes and complex motor skills are difficult to perform. Therefore, it is
common for gait deformities to occur. Coordination requires a complex
interaction between biomechanics and neurophysiological factors.
Parkinson’s
disease is caused by the degeneration of substantia nigra which leads to
dysfunction of basal ganglia. The cardinal features of Parkinson’s disease are
characterised by motor symptoms such as bradykinesia, rigidity, tremors and
akinesia. There are various levels at which the effects of
Parkinson disease can be described. Within the brain, the major pathological
change is progressive degeneration of neurons in pars compacta of substantia
nigra which is one of the nuclei that constitutes the basal ganglia. These
neurons usually transmit dopamine to the striatum, which is another basal
ganglia nucleus. But their degeneration leads to dysfunction of these neuronal
circuits which include the basal ganglia and thee motor cortical areas.
Abnormalities of movements such as movement slowness, difficulty with gait and
balance are also the primary manifestation of Parkinson’s disease. Anomaly of
muscle activity and the neuronal activity correlate with the motor symptoms. In
other terms motor symptoms can also be described in context of motor control
that explains how movement variables, such as limbs position and speed, are
coordinated and controlled. To understand motor symptoms as motor control
abnormalities defines how the disease disrupts normal control processes. For
e.g., in Parkinson disease the slowness of movement, would be explained as
disruption of a control processes that determine the normal movement speed.
Gait
hypokinesia is one of the major symptoms of Parkinson disease that can be seen
from the early stages of the disease. Even if the patients have not begun with
anti-parkinsonian medicine course yet, may tend to have a slower gait speed as
compared to healthy individuals. Most patients with Hoehn and Yahr scale stage
of 2-3 require assistance for walking. Recently gait has been accepted as an executive
function rather than just a simple motor function that can be affected by
cognitive impairments. It is stated the gait speed is negatively correlated. Gait speed is also correlated with cognitive state and the deceleration of gait
speed can even occur before a cognitive disorder starts.
As
gait disorders in Parkinson’s disease are hallmark of the condition they have
led to loss of independence and an increased risk of falls. The
essential component of daily activities is walking which is a dynamic, rhythmic
and complex task. This involves the central nervous system (CNS) to adopt high
levels of information processing and control strategies to accurately
coordinate gait cycles.
No
study has been conducted to evaluate the relationship between lower limb
coordination with walking speed and distance in people with Parkinson’s
disease. Hence the purpose of this study is to evaluate the relationship
between coordination of lower limbs with walking speed and distance.
RESEARCH
QUESTION
Is
there a correlation between lower limb coordination and walking speed and
distance in people with Parkinson’s disease?
HYPOTHESIS
(H1): There is a correlation between lower limb coordination
and walking speed and distance in people with Parkinson’s disease.
NULL
HYPOTHESIS (H0):
There
is no correlation between lower limb coordination and walking speed and
distance in people with Parkinson’s disease |