| 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
|
|
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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 |
|
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Regulatory Clearance Status from DCGI
|
|
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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.
|
|
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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
|
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Method of Generating Random Sequence
|
|
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Method of Concealment
|
|
|
Blinding/Masking
|
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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
|
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Secondary Outcome
|
|
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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. |