| CTRI Number |
CTRI/2021/04/033033 [Registered on: 22/04/2021] Trial Registered Prospectively |
| Last Modified On: |
22/04/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A clinical trial to study the Effect of Mirror Therapy for improvement of upper extremity motor function in stroke patient admitted in KIMS, PBMH Hospital, Bhubaneswar, Odisha. |
|
Scientific Title of Study
|
Efficacy of Mirror Therapy to improve Motor function of upper extremity in Stroke patient admitted at Tertiary Care Hospital, Bhubaneswar.(A Randomized Pilot Study). |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Anita Panigrahi |
| Designation |
M.sc Nursing 2nd year student |
| Affiliation |
Kalinga Institute of Nursing Sciences |
| Address |
Kalinga Institute of nursing sciences (KINS), Campus-5
KIIT square, Patia
Bhubaneswar, Odisha
Khordha
ORISSA
751024
India |
| Phone |
8249284694 |
| Fax |
|
| Email |
anitapanigrahikins@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Anita Panigrahi |
| Designation |
M.sc Nursing 2nd year student |
| Affiliation |
Kalinga Institute of Nursing Sciences |
| Address |
Kalinga Institute of nursing sciences (KINS), Campus-5
KIIT square, Patia
Bhubaneswar, Odisha
Khordha
ORISSA
751024
India |
| Phone |
8249284694 |
| Fax |
|
| Email |
anitapanigrahikins@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Anita Panigrahi |
| Designation |
M.sc Nursing 2nd year student |
| Affiliation |
Kalinga Institute of Nursing Sciences |
| Address |
Kalinga Institute of nursing sciences (KINS), Campus-5
KIIT square, Patia
Bhubaneswar, Odisha
Khordha
ORISSA
751024
India |
| Phone |
8249284694 |
| Fax |
|
| Email |
anitapanigrahikins@gmail.com |
|
|
Source of Monetary or Material Support
|
| Anita panigrahi
Pradyumna Bal Memorial Hospital, kalinga institute of medical sciences, Bhubaneswar
|
|
|
Primary Sponsor
|
| Name |
Anita Panigrahi |
| Address |
Kalinga Institute medical sciences, campus-5
Patia, Bhubaneswar, Odisha
751024 |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DR N K DAS |
Kalinga Institute of medical sciences, Pradyumna Bal Memorial Hospital , Bhubaneswar |
Neuro medicine and Neuro Surgery Department
Khordha
ORISSA |
7327096159
narendrakumar.Das@kims.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G811||Spastic hemiplegia, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
control group |
In control group for assess and evaluate the motor function without giving intervention. Here only routine care will be provided |
| Intervention |
Mirror Therapy |
mirror therapy refers to using mirror to create the reflective illusion, while doing movements in the unaffected limb of stroke patients for a period of five times in a week with the duration of 20-30 minutes totally for Four weeks. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients with the age group 20 -60 years.
Patients with upper extremity hemiplegia with stroke.
Patients who are willing to participate in the study.
Patient with GCS (12-15)
Patients who are able to understand and obeys commands.
Patient who knows english or odia language.
|
|
| ExclusionCriteria |
| Details |
Patients who are very sick and unable to co-operate.
Patients who underwent any surgery within last 2 months.
Patients with sensory perceptual alterations.
Terminally ill patients
|
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| TO evaluate the efficacy of mirror therapy on upper extremity of motor function of stroke patients. |
7 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To assess the pre and post test level of upper extremity motor function in stroke patients.
|
7 months |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
01/05/2021 |
| 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="0"
Months="7"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
not applicable |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
· This study will address the improvement of motor function in upper extremity after administration of mirror therapy among stroke patients, as measured by Fugl-Meyer motor function assessment tool. study mirror therapy refers to using mirror to create the reflective illusion, while doing movements in the unaffected limb of stroke patients for a period of five times in a week with the duration of 20-30 minutes totally for four weeks Lack of movement especially if the dominant arm is affected, can be frightening and frustrating for the patient, since the hand performs so many functions than the leg. Mirror therapy is simple, inexpensive and has no side effect. So it can use for stroke patients those who having difficulty to perform other type of exercise. In this study quantitative research approach randomized controlled trial design used. |