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CTRI Number  CTRI/2025/07/089997 [Registered on: 02/07/2025] Trial Registered Prospectively
Last Modified On: 30/06/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Other (Specify) 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Effect of theraputty activities with mirror on hand functions of stroke patients  
Scientific Title of Study   Effectiveness of Mirror Therapy combined with Theraputty hand activities on hand functions in Stroke Survivors 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Kshitilipsha 
Designation  Pg Student 
Affiliation  Chettinad School of Occupational Therapy 
Address  Chettinad Academy of Research and Education, Chettinad Health City, Rajiv Gandhi Salai (OMR),Kelambakkam, Tamil Nadu 603103

Chennai
TAMIL NADU
603103
India 
Phone  8917287338  
Fax    
Email  kshitilipsha@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr. Pankaj Kumar 
Designation  Professor 
Affiliation  Chettinad School of Occupational Therapy 
Address  Chettinad Academy of Research and Education, Chettinad Health City, Rajiv Gandhi Salai (OMR),Kelambakkam, Tamil Nadu 603103

Chennai
TAMIL NADU
603103
India 
Phone  9910410156  
Fax    
Email  dean.csot@care.edu.in  
 
Details of Contact Person
Public Query
 
Name  Kshitilipsha 
Designation  Pg Student 
Affiliation  Chettinad School of Occupational Therapy 
Address  Chettinad Academy of Research and Education, Chettinad Health City, Rajiv Gandhi Salai (OMR),Kelambakkam, Tamil Nadu 603103

Chennai
TAMIL NADU
603103
India 
Phone  8917287338  
Fax    
Email  kshitilipsha@gmail.com  
 
Source of Monetary or Material Support  
Chettinad Hospital and Research Institution, Chettinad Health City, Rajiv Gandhi Salai (OMR),Kelambakkam, Tamil Nadu 603103 
 
Primary Sponsor  
Name  Kshitilipsha 
Address  Chettinad Hospital and Research Institution, Chettinad Health City, Rajiv Gandhi Salai (OMR),Kelambakkam, Tamil Nadu 603103 
Type of Sponsor  Other [self] 
 
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 Pankaj Kumar  Chettnad General Hospital  Chettinad Hospital and Research Institution, Chettinad Health City, Rajiv Gandhi Salai (OMR),Kelambakkam, Tamil Nadu 603103
Chennai
TAMIL NADU 
9910410156

dean.csot@care.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Human Ethics Committee for Student Research (CARE IHEC - I )  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: I639||Cerebral infarction, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Conventional occupational therapy  Conventional Occupational therapy like range of motion , fine motor coordination , gross motor coordination , sensory relearning , muscle strengthening.  
Intervention  Mirror Therapy combined with Theraputty hand activities  The study will begin with recruitments of participants from stroke care facilities or geriatric centers. After providing a detailed explanation of the study , informed consent will be obtained from the participants. Initial screening will then be conducted to determine eligibility (n is equal to x ). From this, 60 eligible particiants will be selected through convenient sampling. These participants will be randomly allocated into two groups : Group A and Group B. Group A will receive Mirror therapy and Thera-putty hand exercise intervention. Before the intervention, a baseline assessment using the Fugl-Meyer Assessment will be conducted. Following this, participants in Group A will undergo a four-week mirror therapy and Thera-putty hand exercise intervention. After the intervention period, a post intervention Fugl-Meyer Assessment will be performed. Group B will serve as the control group and continue with their regular therapy. Similar to Group A, a baseline Fugl-Meyer Assessment will be carried out before the intervention period. Participants will then continue their regular routine for the duration of the study, after which post intervention Fugl-Meyer Assessment will be conducted. Finally, data from both the groups will be analysed using SPSS statistical software to evaluate the outcomes of the intervention.  
 
Inclusion Criteria  
Age From  45.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. Post stroke patients with spasticity (MAS score 2).
2. Individuals suffered from stroke in the past one year.
 
 
ExclusionCriteria 
Details  1. Individuals who underwent any surgery.
2. Individuals with any other medical conditions.
3. Noncooperative individuals.
4. Individuals having any cognitive impairment
 
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
Fugl-Meyer Assessment  6 sessions per week for 4 weeks
Total no. of intervention session: 24
Duration of a therapy session: 30 minutes
 
 
Secondary Outcome  
Outcome  TimePoints 
NA  NA 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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)   01/09/2025 
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="2"
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  

Stroke is a major cause of long-term disability worldwide, often leading to significant movement impairments, especially in the upper limbs, with about 75% of survivors experiencing hand dysfunction that affects daily activities. The World Health Organization defines stroke as a sudden disruption in brain function due to impaired blood flow, and it remains more prevalent in urban than rural areas. Recovery of hand function is particularly slow because fine motor skills—essential for tasks like eating or dressing—are often impaired. Mirror Therapy (MT) and Theraputty hand exercises are two techniques used to improve hand function after stroke. MT uses visual feedback to stimulate brain areas controlling the affected limb, while Theraputty exercises physically strengthen and improve coordination in the hand. When used together, MT and Theraputty exercises can enhance motor recovery, increase patient motivation, and target both central and peripheral functions, potentially offering better outcomes than either approach alone. However, research on their combined effectiveness remains limited, highlighting the need for further study.


 
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