FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/09/073845 [Registered on: 12/09/2024] Trial Registered Prospectively
Last Modified On: 11/09/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Single Arm Study 
Public Title of Study   effectiveness of novel physiotherapy intervention to improve upper limb function in patients with chronic stroke.  
Scientific Title of Study   Effectiveness of Combined Motor cognitive dual task training and mirror therapy on upper limb function, ADLs, Quality of life in patients with chronic stroke  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Amil Agarwal 
Designation  Student  
Affiliation  SCHOOL OF HEALTH SCIENCES/ CHHATRAPATI SHAHUJI MAHARAJ UNIVERSITY KANPUR  
Address  School of Health Sciences, Department of Physiotherapy SHS 106 CSJMU Kanpur

Kanpur Nagar
UTTAR PRADESH
208024
India 
Phone  8707601324  
Fax    
Email  CSJMA1800131156@csjmu.ac.in  
 
Details of Contact Person
Scientific Query
 
Name  Dr Digvijay Sharma  
Designation  Director  
Affiliation  SCHOOL OF HEALTH SCIENCES/CHHATRAPATI SHAHUJI MAHARAJ UNIVERSITY  
Address  School of Health Sciences Department of Physiotherapy SHS 106 CSJMU Kanpur

Kanpur Nagar
UTTAR PRADESH
208024
India 
Phone  9839217108  
Fax    
Email  digvijaysharma@csjmu.ac.in  
 
Details of Contact Person
Public Query
 
Name  Dr Digvijay Sharma  
Designation  Director  
Affiliation  SCHOOL OF HEALTH SCIENCES/CHHATRAPATI SHAHUJI MAHARAJ UNIVERSITY  
Address  School of Health Sciences Department of Physiotherapy SHS106 CSJMU Kanpur

Kanpur Nagar
UTTAR PRADESH
208024
India 
Phone  9839217108  
Fax    
Email  digvijaysharma@csjmu.ac.in  
 
Source of Monetary or Material Support  
School of Health Sciences, Department of Physiotherapy SHS 106 CSJMU Kanpur Kanpur Nagar UTTAR PRADESH 208024 India  
 
Primary Sponsor  
Name  School of Health Sciences  
Address  School of Health Sciences, chhatrapati Shahuji Maharaj University kanpur UP India 208012 
Type of Sponsor  Research institution 
 
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 Digvijay Sharma   SCHOOL OF HEALTH SCIENCES PHYSIOTHERAPY OPD  School of Health Sciences Department of Physiotherapy Physiotherapy OPD SHS 106 CSJMU Kalyanpur
Kanpur Nagar
UTTAR PRADESH 
9839217108

digvijaysharma@csjmu.ac.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Human Ethical Committee, CSJMU kanpur   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G811||Spastic hemiplegia,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Motor-Cognitive Dual Task Training and Mirror Therapy   in motor cognitive dual task training, patient will be asked to stack cones on top of each other, open bottles and buttonning shirt while repeating certain phrases, answering yes or no question and counting backward and forward. for mirror therapy, patient will be asked to place less affected hand infront of the mirror and affected hand behind the mirror and ask the patient to perform movement of hand, wrist, forearm, elbow.It will be performed for 2 weeks, 6 days a week for 40 minutes.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  unilateral stroke greater than 6 months
Ischemic infarct or hemorrhagic stroke
Brunnstrom stage 1 to 4
MMSE score greater than 24
 
 
ExclusionCriteria 
Details  any major musculoskeletal comorbidity,
Epilepsy or Any time of Seizures
Visuo- Spatial neglect
aphasia 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Fugl Meyer Assessment for upper extremity
Modified Barthel Index
Stroke Specific Quality of Life 
2 WEEKS 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="17"
Sample Size from India="17" 
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)   26/09/2024 
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 Yet Recruiting 
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  

Introduction- Stroke is a neurologic disease which occurs due to reduced blood supply to the brain. Stroke is the leading cause of mortality and morbidity throughout the world. More than 65% of patients, 40% will never recover their upper extremity function. First few months after stroke is considered golden period due to heightened neuroplasticity. But even after this period neural plasticity can be stimulated through the use of dual task training and mirror therapy. Chronic stroke is defined as stroke which occurred 6 months ago. Objective of this study will be to identify the effect of dual task training and mirror therapy on upper limb function, activities of daily living and quality of life in patients with chronic stroke. Hypothesis of our study is that combined dual task training and mirror therapy will be produced significant result on upper limb function, ADL’s and Quality of life in patients with chronic stroke.

Methods- Sample size of this study was calculated using G power Software. 17 participants will be enrolled this study according to the selection criteria. Upper limb function, activities of daily living and quality of life will be assessed at baseline and after 2 weeks of intervention using Fugl Meyer Upper extremity scale, Modified Barthel index and stroke specific quality of life index. Intervention will be provided 6 days/week for 60 minutes. 20 minutes for dual task training, 20 minutes for mirror therapy and 20 minutes for conventional physiotherapy which will include neurodevelopmental therapy, stretching and strengthening exercises. Data will be normalized and presented in the form of descriptive statistics. Data will be analyzed using SPSS software and parametric test will be applied. P value less than 0.005 will be considered statistically significant. Then the results will be published.

Discussion- The results of this study will be provided significant insights into neurorehabilitation of stroke patients in chronic phase.

 
Close