| CTRI Number |
CTRI/2022/05/042526 [Registered on: 12/05/2022] Trial Registered Prospectively |
| Last Modified On: |
10/05/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Other |
|
Public Title of Study
|
Effectiveness of Transcranial Direct Current Stimulation and Sensorimotor Training in Stroke Patients |
|
Scientific Title of Study
|
Efficacy of Transcranial Direct Current Stimulation and Sensorimotor Training on Balance and Gait in Stroke Patients: A Randomized Controlled Trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Manoj Malik |
| Designation |
Assistant Professor |
| Affiliation |
Department of Physiotherapy Guru Jambheshwar University of Science and Technology Hisar Haryana |
| Address |
Department of Physiotherapy Guru Jambheshwar University of Science and Technology Hisar Haryana
Hisar
HARYANA
125001
India |
| Phone |
9896221262 |
| Fax |
|
| Email |
malik_manoj@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Manoj Malik |
| Designation |
Assistant Professor |
| Affiliation |
Department of Physiotherapy Guru Jambheshwar University of Science and Technology Hisar Haryana |
| Address |
Department of Physiotherapy Guru Jambheshwar University of Science and Technology Hisar Haryana
Hisar
HARYANA
125001
India |
| Phone |
9896221262 |
| Fax |
|
| Email |
malik_manoj@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Manoj Malik |
| Designation |
Assistant Professor |
| Affiliation |
Department of Physiotherapy Guru Jambheshwar University of Science and Technology Hisar Haryana |
| Address |
Department of Physiotherapy Guru Jambheshwar University of Science and Technology Hisar Haryana
Hisar
HARYANA
125001
India |
| Phone |
9896221262 |
| Fax |
|
| Email |
malik_manoj@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Ritu Tomer(MPT), Research Scholar,Department of Physiotherapy Guru Jambheshwar University of Science and Technology Hisar |
|
|
Primary Sponsor
|
| Name |
Guru Jambheshwar University of Science and Technology Hisar |
| Address |
Department of Physiotherapy Guru Jambheshwar University of Science and Technology Hisar |
| Type of Sponsor |
Other [University] |
|
|
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 |
| Ritu Tomer |
Guru Jamheshwar University of Science and Technology |
Room no. 5, Department of Physiotherapy
Hisar
HARYANA |
7206287155
tomerritu66@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Comittee GJUS & T |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G819||Hemiplegia, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Control |
Group C will be given conventional exercises |
| Intervention |
Sensorimotor Training and Sham Transcranial Direct Current Stimulation |
Group B will be given Sensorimotor Training and sham Transcranial direct current stimulation for 4 times a week for 4 weeks and conventional exercises. |
| Intervention |
Transcranial Direct Current Stimulation and Sensorimotor Training |
Group A will be given TDCS andSensorimotor Training 4 times per week for 4 weeks and conventional exercises |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients with chronic stroke (>6 months, both ischaemic & haemorrhagic) with FMA-LE more than 20.
Patient able to walk independently or with assistance.
No Relapse between 3-6 months.
Normal or corrected vision.
No cerebellar lesion. |
|
| ExclusionCriteria |
| Details |
Psychiatric disorders.
Patient with history of brain injury, cranial bone anomalies, cranial bone fractures and surgeries.
History of epileptic seizures.
Uncooperative patients.
Metal implant in the stimulation area.
Vestibular disorders.
Skin allergy.
Cognitive impairment.
Congenital/acquired deformity
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Berg Balance Scale
Time Up and Go Test
Dynamic gait Index
Electromyography(EMG) |
Baseline
After 4 weeks
After 1 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="75"
Sample Size from India="75"
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)
|
16/05/2022 |
| 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="6"
Days="15" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Stroke is the second major cause of death and the third most frequent cause of impairments worldwide. The global burden of stroke is approximated to be more than 80 million stroke patients reported in 2016. The number of stroke cases is increasing in India, due to demographic transition. The prevalence rate of stroke ranges from 84–262/100,000 in rural and 334–424/100,000 in cities of India. Based on recent data approximately 119-145/100,000 cases of stroke are noted. It leads to motor and sensory impairment including muscle weakness, spasticity, incoordination, proprioception which leads to residual deficits, imbalance and gait abnormalities.Noninvasive neuromodulatory techniques are hypothesised to change synaptic effectiveness in glutamatergic and GABAergic circuits, which are important for motor learning. Among the NIBS techniques, Transcranial direct current stimulation is extensively used alone or in combination with other therapies in past decade to improve motor functions, balance and gait in stroke patients and has shown significant results in improving post stroke residual impairments.
tDCS has been proved to be promising approach in treating imbalance and gait abnormalities. Sensorimotor training (SMT) is thought to influence the control of equilibrium and posture by active & passive facilitation of afferents. SMT affects the higher centers of subcortical structures through spinothalamic, vestibulospinal, and vestibulocerebellar pathways that influence the coordinated posture and equilibrium. So, the combination of the tDCS with sensorimotor training may prove to be beneficial in improving balance and gait in stroke patients. But so far, the combined effect of tDCS and sensorimotor training has not been investigated. Therefore, the main aim of this study is to evaluate the effect of tDCS with sensorimotor training on the balance and gait in stroke patients. |