| 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
|
|
|
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
|
|
|
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. |