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CTRI Number  CTRI/2018/05/013580 [Registered on: 01/05/2018] Trial Registered Prospectively
Last Modified On: 09/12/2019
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Hand Function in Stroke Patients 
Scientific Title of Study   Relationship Between Wrist Flexor Spasticity and Hand Function in Patients with Stroke 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Sukanya Dandekar 
Designation  1st MPT Neurosciences 
Affiliation  D.V.V.P.Fs College of Physiotherapy 
Address  Department of Neurosciences, D V.V.p.Fs College of Physiotherapy
Department of Neurosciences, D V.V.p.Fs College of Physiotherapy
Ahmadnagar
MAHARASHTRA
41411
India 
Phone  8329911203  
Fax    
Email  sukanya.dandekar@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Suvarna Ganvir 
Designation  HOD and Professor 
Affiliation  D.V.V.P.Fs College of Physiotherapy 
Address  Department of Neurosciences, DVVPFs College of Physiotherapy
Opp.Govt.Milk Dairy,M.I.D.C, Ahmednagar
Ahmadnagar
MAHARASHTRA
41411
India 
Phone  9372910683  
Fax    
Email  suvarna.ganvir@gmail.com  
 
Details of Contact Person
Public Query
 
Name  DrSuvarna Ganvir 
Designation  HOD and Professor 
Affiliation  D.V.V.P.Fs College of Physiotherapy 
Address  Department of Neurosciences, D V.V.p.Fs College of Physiotherapy
Department of Neurosciences, D V.V.p.Fs College of Physiotherapy
Ahmadnagar
MAHARASHTRA
41411
India 
Phone  9372910683  
Fax    
Email  suvarna.ganvir@gmail.com  
 
Source of Monetary or Material Support  
D.V.V.P.Fs College of Physiotherapy, opp Govt Milk Dairy, MIDC Ahmednagar 
 
Primary Sponsor  
Name  DV V P Fs College of Physiotherapy 
Address  college of physiotherapy, opp govt. milk dairy, M.I.D.C, Ahmednagar, 414111 
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 
Sukanya Dandekar  D.V.V.P.Fs College of Physiotherapy  Department of Neurosciences, Opp.Govt.Milk Dairy, M.I.D.C, Ahmednagar
Pune
MAHARASHTRA 
8329911203

sukanya.dandekar@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Stroke patients,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Single stroke duration 3 wks to 6 months
 
 
ExclusionCriteria 
Details   
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
Action Research Arm Test  8-10 minutes 
 
Secondary Outcome  
Outcome  TimePoints 
Modified Tardieu Scale  5-6 minutes 
 
Target Sample Size   Total Sample Size="39"
Sample Size from India="39" 
Final Enrollment numbers achieved (Total)= "39"
Final Enrollment numbers achieved (India)="39" 
Phase of Trial   N/A 
Date of First Enrollment (India)
Modification(s)  
01/06/2018 
Date of Study Completion (India) 02/07/2019 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   None yet 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary
Modification(s)  

The study was conducted to identify the relationship between wrist flexor spasticity and hand function in patients with stroke. The wrist flexor spasticity was assessed by Modified Tardieu Scale which is a valid and reliable tool. The hand function was assessed by Action Research Arm Test which also a valid and reliable test . The scores of both were analysed and correlated by Pearson Correlation Co-efficient .The results of this study stated that there is a weak positive correlation between wrist flexor spasticity and hand function. There is a weak negative correlation between elbow flexor spasticity and hand function.

 The results of the study are similar to the few studies conducted before and support the finding that spasticity does not influence the function of the hand. Few similar studies hypothesize that the spasticity manifests more when the limb is at rest. When the activity starts the strength predominantly comes into picture. This may be of one the reasons why weak correlation between these two variables is seen. The presence of spasticity in one position may not predict spasticity in other position. The grip and finger strength is also required to perform the function of hand. The strength maybe reduced because of the paresis and also the shortening of flexors. Thus, the muscles are unable to produce the required strength for the task.

Thus, the study concludes that spasticity does not affect hand function in stroke patients.Considering the limitations in this study, future studies can be conducted where the strength of upper extremity muscles can also be measured. More factors which influence the hand function can be assessed. The study population was sub-acute stroke. Further studies can be conducted considering chronic stroke population. 

 
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