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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  
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 
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  
Status 
Not Applicable 
 
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

 
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