| CTRI Number |
CTRI/2017/05/008668 [Registered on: 25/05/2017] Trial Registered Retrospectively |
| Last Modified On: |
12/09/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Medical Device
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Lakwa ke baad patients ke balance & chal (gait) par exercise ke sath sath dawa (fluoxetine) awam device (tDCS) ka prabhav |
|
Scientific Title of Study
|
Effect of Dual-Task Exercise in Conjunction with Fluoxetine &
Transcranial Direct Current Stimulation (tDCS) on Postural Stability and Gait in Stroke
Patients. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr M V Padma Srivastava MD DM FAMS FNASc |
| Designation |
Professor, Head Unit- II |
| Affiliation |
AIIMS, New Delhi |
| Address |
Dept. of Neurology, All India Institute of Medical Sciences (AIIMS), New Delhi
Room No-708, 7th Floor, C.N. Centre, AIIMS, New Delhi
New Delhi
DELHI
110029
India |
| Phone |
26594794 |
| Fax |
|
| Email |
vasanthapadma123@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr M V Padma Srivastava MD DM FAMS FNASc |
| Designation |
Professor, Head Unit- II |
| Affiliation |
AIIMS, New Delhi |
| Address |
Dept. of Neurology, All India Institute of Medical Sciences (AIIMS), New Delhi
Room No-708, 7th Floor, C.N. Centre, AIIMS, New Delhi
New Delhi
DELHI
110029
India |
| Phone |
26594794 |
| Fax |
|
| Email |
vasanthapadma123@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
B Roy |
| Designation |
Scientist-B |
| Affiliation |
Dept. of Neurology, AIIMS, New Delhi |
| Address |
Room No 708, 7th Floor, Department of Neurology, C. N Center, AIIMS, Ansari Nagar,
New Delhi
DELHI
110029
India |
| Phone |
9013279182 |
| Fax |
|
| Email |
dr.baijnath.roy@gmail.com |
|
|
Source of Monetary or Material Support
|
| Indian Council of Medical Research, Delhi & All India Institute of Medical Sciences, Delhi |
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences |
| Address |
Asnsari, Nagar, New Delhi-29 |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Indian Council of Medical Research |
Ansari Nagar East, New Delhi, Delhi-110029 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Prof M V Padma Srivastava |
All India Institute of Medical Sciences |
Room No 708, 7th Floor, Department of Neurology, C.N Center, Ansari Nagar
New Delhi
DELHI |
26594794
vasanthapadma123@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee, AIIMS, New Delhi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Stroke, Post stroke Impairment of Postural Satbility & Gait, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Group A: tDCS, Fluoxetine, DTT |
Subjects in this arm will undergo 6 times a week for 2 weeks (12sessions) of bihemispheric active
transcranial direct current stimulation (tDCS) with each session lasting 20 minutes. This will be
followed by 2 extra sessions every other week of active tDCS with session lasting 20 minutes.
Additionally, subjects will also be taking 20mg of fluoxetine by mouth and DTT daily for 6 weeks.
Fluoxetine will be given two hours before the tDCS and DTT. Dual Task Gait Training (DTT) will
begin within 1 hour after each bihemispheric tDCS session and will last for 45 minutes. All subjects
will also be trained to do Dual Task Gait Training at home for 45 minutea and up to 6 weeks. |
| Intervention |
Group B: Sham tDCS, Fluoxetine, DTT |
Subjects in this arm will undergo 6 times a week for 2 weeks (12sessions) of bihemispheric sham
transcranial direct current stimulation (sham tDCS) with each session lasting 20 minutes. This will
be followed by 2 extra sessions every other week of sham tDCS with session lasting 20 minutes.
Additionally, subjects will also be taking 20 mg of fluoxetine by mouth and DTT daily for 6 weeks.
Fluoxetine will be given two hours before the tDCS and DTT. Dual Task Gait Training (DTT) will
begin within 1 hour after each sham tDCS session and will last for 45 minutes. All subjects will also
be trained to do Dual Task Gait Training at home for 45 minutes and up to 6 weeks. |
| Intervention |
Group C: tDCS, placebo of Fluoxetine, DTT |
Subjects in this arm will undergo 6 times a week for 2 weeks (12sessions) of bihemispheric active
transcranial direct current stimulation (tDCS) with each session lasting 20 minutes. This will be
followed by 2 extra sessions every other week of active tDCS with session lasting 20 minutes.
Additionally, subjects will also be taking placebo of fluoxetine by mouth and DTT daily for 6 weeks.
Fluoxetine will be given two hours before the tDCS and DTT. Placebo fluoxetine tablet will be
identical in form, clour, and odor and packaging.
Dual Task Gait Training (DTT) will begin within 1 hour after each bihemispheric active tDCS
session and will last for 45 minutes. All subjects will also be trained to do Dual Task Gait Training
at home for 45 minutes and up to 6 weeks. |
| Comparator Agent |
Group D: Sham tDCS, placebo of Fluoxetine, DTT |
Subjects in this arm will undergo 6 times a week for 2 weeks (12sessions) of bihemispheric sham
transcranial direct current stimulation (sham tDCS) with each session lasting 20 minutes. This will
be followed by 2 extra sessions every other week of sham tDCS with session lasting 20 minutes.
Additionally, subjects will also be taking placebo of fluoxetine by mouth and DTT daily for 6 weeks.
Fluoxetine will be given two hours before the tDCS and DTT. Placebo fluoxetine tablet will be
identical in form, clour, and odor and packaging.
Dual Task Gait Training (DTT) will begin within 1 hour after each bihemispheric sham tDCS
session and will last for 45 minutes. All subjects will also be trained to do Dual Task Gait Training
at home for 45 minutes and up to 6 weeks. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
1. First-time ischemic or hemorrhagic stroke as diagnosed by CT/MRI
2. Ischemic or hemorrhagic stroke between 1 to 6 months from the index event that has caused hemiparesis, as examined and/or confirmed by medical records.
3. Able to stand with support
4. Both gender; age ≥ 18 years and ≤ 75 years
5. Conscious and comprehensible
6. Subjects need to be able to provide informed consent. |
|
| ExclusionCriteria |
| Details |
1. Stroke patients < 18 years and > 75 years
2. Patient with any disability other than stroke that would preclude gait training,
3. Taking antidepressant drugs two weeks before inclusion
4. Patients taking any other selective serotonin reuptake inhibitors (SSRI) at the time of enrollment or two weeks before inclusion.
Patients taking any other medication likely to have adverse interaction with SSRIs
Flaccid hemiplegia
8. Taking neuroleptic drugs or benzodiazepines 2 weeks before inclusion
9. Other major diseases with life expectancy ≤ 3 months.
10. Any uncontrolled health condition for which exercise is contraindicated,
11. Any neurologic or orthopedic diseases that might interfere with the study,
12. Metallic implant within the brain
13. Epilepsy
14. Cardiac pace maker
15. Cognitive impairments
16. Pregnancy
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Gait Analysis variables and FMA-LE |
At Baseline, After 6 Weeks, and After 12 Weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.NIHSS
2.Modified Rankin scale (mRS)
3. Modified Ashworth Scale (MAS)
4. Berg Balance Scale (BBS)
5. Time Up and Go Test (TUG)
6. Functional Reach Test (FRT)
7. Modified Barthel Index (mBI)
|
At baseline, After 6 Weeks, And After 12 Weeks |
|
|
Target Sample Size
|
Total Sample Size="240"
Sample Size from India="240"
Final Enrollment numbers achieved (Total)= "224"
Final Enrollment numbers achieved (India)="224" |
|
Phase of Trial
|
Phase 1 |
|
Date of First Enrollment (India)
|
01/01/2017 |
| Date of Study Completion (India) |
10/03/2020 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="3"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Abstract published in the journal of Neurorehabilitation adn Neural Repair 2018 and also in the Journal of IBRO report 2019. Final result of the study is under process of publication. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
Stroke is the leading
cause of mortality and disability worldwide. Restoration of walking ability and
gait rehabilitation are therefore highly relevant for people who are unable to
walk independently after stroke.
Aims & Objectives: To determine the effectiveness of dual-task
exercise in conjunction with fluoxetine & transcranial direct current
stimulation (tDCS) on postural stability and gait in stroke patients.
Material & Methods: 224 Patients with first ever stroke were Randomized
& Allocated to one of four treatment groups. 12 sessions of bihemispheric tDCS
(2mA) with each session lasting for 20 minutes followed by 2 extra sessions
every other week. 20 mg of Fluoxetine/placebo along with DTT were given for 6 weeks.
The gait and clinical variables were used as outcome measures at the time point
baseline, 1FU (after 6 weeks) & 2 FU (after 12 weeks).
Result: The
statistical analysis was carried out on average of the three consecutive gait
trials from the Group-A, Group- B, Group-C, and Group-D. A Friedman Test was
used to analyze differences within groups at three different time points for
gait and clinical variables. A Krushkal Wallis Test was used to measure mean
rank differences between gait and clinical variables of four groups at three
different time points.
There was no statistically
significant difference between the groups at the time point baseline in the all
gait and clinical variables. There were statistically significant
difference between the groups at the
time point 1 FU in the gait variables such as Cadence, Gait Time, Gait
Distance, Gait Velocity, Step Time, Step Length, Stride Time, Stride Length, Stance
Phase Time and double support time respectively (p = 0.001, p = 0.001, p = 0.001,
p = 0.001, p = 0.002, p = 0.001, p = 0.001, p = 0.001 p = 0.002, and p = 0.005 respectively)
and FMA scores (p = 0.001) . There were statistically significant differences
between the groups at the time point 2 FU in the gait variables such as
Cadence, Gait Time, Gait Distance, Gait Velocity, Step Time, Step Length,
Stride Time, Stride Length, Stance Phase Time, and Double Support Phase Time
respectively (p = 0.002, p = 0.001, p = 0.001, p = 0.001, p = 0.004, p = 0.001, p = 0.001, p = 0.001, p = 0.007, and
p = 0.001 respectively ) and FMA scores ((p = 0.001). No statistically
significant difference between the group in respect to Step width and Swing
Phase Time.
Conclusion:
It was found that the combination therapy with Dual Task Training (DTT), Fluoxetine and transcranial
direct current stimulation (tDCS) is more efficacious than individual therapy
with Fluoxetine or tDCS or sham and Placebo alone.
Key Words:
Stroke Rehabilitation,
Fluoxetine, Transcranial Direct Current Stimulation, Dual Task Exercise, Motor
Recovery, Cortical Excitability, Gait
|