| CTRI Number |
CTRI/2018/05/013580 [Registered on: 01/05/2018] Trial Registered Prospectively |
| Last Modified On: |
09/12/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Hand Function in Stroke Patients |
|
Scientific Title of Study
|
Relationship Between Wrist Flexor Spasticity and Hand Function in Patients with Stroke |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sukanya Dandekar |
| Designation |
1st MPT Neurosciences |
| Affiliation |
D.V.V.P.Fs College of Physiotherapy |
| Address |
Department of Neurosciences, D V.V.p.Fs College of Physiotherapy Department of Neurosciences, D V.V.p.Fs College of Physiotherapy Ahmadnagar MAHARASHTRA 41411 India |
| Phone |
8329911203 |
| Fax |
|
| Email |
sukanya.dandekar@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Suvarna Ganvir |
| Designation |
HOD and Professor |
| Affiliation |
D.V.V.P.Fs College of Physiotherapy |
| Address |
Department of Neurosciences, DVVPFs College of Physiotherapy Opp.Govt.Milk Dairy,M.I.D.C, Ahmednagar Ahmadnagar MAHARASHTRA 41411 India |
| Phone |
9372910683 |
| Fax |
|
| Email |
suvarna.ganvir@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
DrSuvarna Ganvir |
| Designation |
HOD and Professor |
| Affiliation |
D.V.V.P.Fs College of Physiotherapy |
| Address |
Department of Neurosciences, D V.V.p.Fs College of Physiotherapy Department of Neurosciences, D V.V.p.Fs College of Physiotherapy Ahmadnagar MAHARASHTRA 41411 India |
| Phone |
9372910683 |
| Fax |
|
| Email |
suvarna.ganvir@gmail.com |
|
|
Source of Monetary or Material Support
|
| D.V.V.P.Fs College of Physiotherapy, opp Govt Milk Dairy, MIDC Ahmednagar |
|
|
Primary Sponsor
|
| Name |
DV V P Fs College of Physiotherapy |
| Address |
college of physiotherapy, opp govt. milk dairy, M.I.D.C, Ahmednagar, 414111 |
| Type of Sponsor |
Private medical college |
|
|
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 |
| Sukanya Dandekar |
D.V.V.P.Fs College of Physiotherapy |
Department of Neurosciences, Opp.Govt.Milk Dairy, M.I.D.C, Ahmednagar Pune MAHARASHTRA |
8329911203
sukanya.dandekar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Stroke patients, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Single stroke duration 3 wks to 6 months
|
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| Action Research Arm Test |
8-10 minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Modified Tardieu Scale |
5-6 minutes |
|
|
Target Sample Size
|
Total Sample Size="39" Sample Size from India="39"
Final Enrollment numbers achieved (Total)= "39"
Final Enrollment numbers achieved (India)="39" |
|
Phase of Trial
|
N/A |
Date of First Enrollment (India)
Modification(s)
|
01/06/2018 |
| Date of Study Completion (India) |
02/07/2019 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1" Months="0" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
The
study was conducted to identify the relationship between wrist flexor spasticity and hand
function in patients with stroke. The wrist flexor spasticity was assessed
by Modified Tardieu Scale which is a valid and reliable tool. The hand function
was assessed by Action Research Arm Test which also a valid and reliable
test . The scores of both were analysed and correlated by Pearson
Correlation Co-efficient .The
results of this study stated that there is a weak positive correlation between
wrist flexor spasticity and hand function. There is a weak negative correlation
between elbow flexor spasticity and hand function.
The results of the study are similar to
the few studies conducted before and support the finding that spasticity does
not influence the function of the hand. Few similar studies hypothesize that
the spasticity manifests more when the limb is at rest. When the activity
starts the strength predominantly comes into picture. This may be of one the
reasons why weak correlation between these two variables is seen. The presence
of spasticity in one position may not predict spasticity in other position. The
grip and finger strength is also required to perform the function of hand. The
strength maybe reduced because of the paresis and also the shortening of
flexors. Thus, the muscles are unable to produce the required strength for the
task.
Thus, the study concludes that spasticity does
not affect hand function in stroke patients.Considering the limitations in this
study, future studies can be conducted where the strength of upper extremity
muscles can also be measured. More factors which influence the hand function can
be assessed. The study population was sub-acute stroke. Further studies can be
conducted considering chronic stroke population. |