| CTRI Number |
CTRI/2018/01/011577 [Registered on: 29/01/2018] Trial Registered Retrospectively |
| Last Modified On: |
24/01/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Trunk muscle activity in stroke survivors |
|
Scientific Title of Study
|
Correlation of muscle activity during trunk training activities with trunk performance in stroke survivors |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Arunima Biswas |
| Designation |
MPT in Neurosciences |
| Affiliation |
School of Allied Health Sciences, Manipal University |
| Address |
Department of physiotherapy,
School of Allied Health Sciences, Manipal University, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9987194977 |
| Fax |
|
| Email |
arunimabiswas07@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Manikandan N |
| Designation |
Associate Professor |
| Affiliation |
School of Allied Health Sciences |
| Address |
Department of Physiotherapy,
School of Allied Health Sciences, Manipal University, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9886898064 |
| Fax |
|
| Email |
mani.kandan@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Manikandan N |
| Designation |
Associate Professor |
| Affiliation |
School of Allied Health Sciences |
| Address |
Department of Physiotherapy,
School of Allied Health Sciences, Manipal University, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9886898064 |
| Fax |
|
| Email |
mani.kandan@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Room number 6,first floor,department of Physiotherapy, SOAHS, Mahe, manipal |
|
|
Primary Sponsor
|
| Name |
Manipal Univeristy |
| Address |
Department of Physiotherapy, SOAHS, Manipal University, Manipal |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Arunima Biswas |
Kasturba Hospital |
room number 6, artificial limb center, department of physiotherapy,soahs,mahe,manipal
Udupi
KARNATAKA |
9987194977
arunimabisws07@gmail.com |
|
|
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 |
Stroke survivors, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
1)Individuals with either ischaemic or haemorrhagic stroke.
2)Onset duration less than 6 months of stroke.
3)Either gender
4)Ability to sit independently for at least 30 seconds
5)Ability to do sit to stand transition with or without supervision
6)Mini Mental State Examination score of ≥24
|
|
| ExclusionCriteria |
| Details |
1)Any pre-existing musculoskeletal conditions that limit the transition movements
2)Bilateral stroke
3)Medically unstable patients
4)Severe spasticity
5)Obese individuals
6)Previous history of lumbar spine or hip surgery
7)Uncooperative patients |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Trunk Impairment Scale
RMS amplitude in mV using surface EMG electrodes |
at baseline day 1 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| not secondary outcome |
not secondary outcome |
|
|
Target Sample Size
|
Total Sample Size="28"
Sample Size from India="28"
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)
|
01/08/2017 |
| 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)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
28 stroke survivors will be recruited for the study. Ethical
clearance was obtained from the Institutional Ethics Committee (IEC), Kasturba hospital, Manipal, prior to
onset of study. The subjects will be screened based on the inclusion criteria.
Selected subjects will be explained about the study and a written informed
consent will be obtained for their participation. Their demographic
characteristics will be recorded followed by a detailed assessment. Trunk
performance will be assessed using the Trunk Impairment Scale and trunk muscle
activity will be recorded using surface EMG electrodes during performance of
trunk training activities: pelvic bridging and sit-to-stand transition. A rest
period of 10 minutes will be provided between each activity. Care will be taken
with respect to privacy of female subjects and the safety of the subjects
during the testing to which end the therapist will be by the side of the
subject at all times. Familiarization of the activities will be done prior to
the evaluation and the order of activity will be randomly chosen using lottery
method for each subject. The data obtained will be statistically analyzed |