| CTRI Number |
CTRI/2019/04/018667 [Registered on: 18/04/2019] Trial Registered Prospectively |
| Last Modified On: |
27/11/2019 |
| 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
|
Role of Targeted and assisted physiotherapy in post-stroke rehabilitation. |
|
Scientific Title of Study
|
Role of Targeted Corrected Assisted Synchronized and Periodic therapy in post stroke rehabilitation |
| Trial Acronym |
T-CASP |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sunil Pradhan |
| Designation |
Head of The Department of Neurology.SGPGI |
| Affiliation |
SGPGI |
| Address |
C Block
Neurology Deepartment
SGPGI
Lucknow
Lucknow
UTTAR PRADESH
226014
India |
| Phone |
9728089029 |
| Fax |
|
| Email |
drspradhan@rediffmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sunil Pradhan |
| Designation |
Head of The Department of Neurology.SGPGI |
| Affiliation |
SGPGI |
| Address |
C Block
Neurology Deepartment
SGPGI
Lucknow
Lucknow
UTTAR PRADESH
226014
India |
| Phone |
9728089029 |
| Fax |
|
| Email |
drspradhan@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sunil Pradhan |
| Designation |
Head of The Department of Neurology.SGPGI |
| Affiliation |
SGPGI |
| Address |
C Block
Neurology Deepartment
SGPGI
Lucknow
Lucknow
UTTAR PRADESH
226014
India |
| Phone |
9728089029 |
| Fax |
|
| Email |
drspradhan@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| Sanjay Gandhi Postgraduate Institute of Medical Sciences,LUcknow, Uttar Pradesh,226014 |
|
|
Primary Sponsor
|
| Name |
Sunil Pradhan |
| Address |
C block
Neurology Department
SGPGI
Lucknow |
| 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 |
| Anirudh Rao Deshmukh |
SGPGI |
Room Number 1, C block, Neurology Department
Lucknow
UTTAR PRADESH |
09728089029
anirudhrao1983@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee,SGPGI |
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 |
| Comparator Agent |
Conventional Physiotherapy |
Conventional physiotherapy involving passive stretching of muscles and joints two times daily will be cried out by a physiotherapist. |
| Intervention |
Targeted Corrected assisted synchronized and periodic therapy |
Patients and their relatives will be trained in T-CASP on first visit. The therapy will be administered by patients relative at home every 2 and half hours. The exercise should be done at least six times in a day lasting for a minimum of 30 min. Patient will be assessed for improvement in Cognition and motor parameters at 3 months and 6 months. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
6 weeks after stroke
Spasticity> Grade 1
Power <8/10
mRS>2-<5 |
|
| ExclusionCriteria |
| Details |
Joint Contractures.
Post Stroke Movement Disorders.
Severe osteoporosis |
|
|
Method of Generating Random Sequence
|
Stratified randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in Spasticity, Power and Cognitive Function |
0,3 months and 6 months. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Depression Scores |
6 months |
|
|
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)
|
30/04/2019 |
| 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="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
Publication Details
Modification(s)
|
Role of home based Targeted-CASP therapy in Post stroke rehabilitation. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
Post-stroke spasticity and cognitive dysfunction often predisposes stroke survivors to a highly compromised lifestyle that adversely affects functional, emotional, and social dimensions.. The potential role of various forms of physical and cognitive therapy techniques have been clearly highlighted in the available literature on stroke survivors. However, the currently available exercise techniques have demonstrated varying degrees of beneficial effects in different aspects of motor, psychological, and functional outcomes among stroke survivors. We introduce a new rehabilitation technique called Targeted Corrected-Assisted-Synchronized –Periodic therapy. In the present paper, we intend to evaluate its role in different aspects of stroke outcome in comparison to conventional forms of physiotherapy. |