| CTRI Number |
CTRI/2024/07/070496 [Registered on: 11/07/2024] Trial Registered Prospectively |
| Last Modified On: |
10/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Neuro-rehabilitation for improving Hand function in patients with Stroke |
|
Scientific Title of Study
|
Development and Testing of Neuro-Rehabilitation Strategies for improving Hand Functions beyond Brunnstrom Stage II 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 |
Prachi Tiwari |
| Designation |
PhD Scholar |
| Affiliation |
Lovely Professional University |
| Address |
Department of Physiotherapy, School of Physiotherapy and Paramedical Sciences, Faculty of Applied Medical Sciences, Lovely Professional University,Phagwara, Punjab
Kapurthala
PUNJAB
144411
India |
| Phone |
9811644726 |
| Fax |
|
| Email |
prachitiwari005@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Suresh Mani |
| Designation |
Professor |
| Affiliation |
Lovely Professional University |
| Address |
Department of Physiotherapy, School of Physiotherapy and Paramedical Sciences, Faculty of Applied Medical Sciences, Lovely Professional University,Phagwara, Punjab
Kapurthala
PUNJAB
144411
India |
| Phone |
9878331006 |
| Fax |
|
| Email |
suresh.22315@lpu.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Prachi Tiwari |
| Designation |
PhD Scholar |
| Affiliation |
Lovely Professional University |
| Address |
Department of Physiotherapy, School of Physiotherapy and Paramedical Sciences, Faculty of Applied Medical Sciences, Lovely Professional University,Phagwara, Punjab
PUNJAB
144411
India |
| Phone |
9811644726 |
| Fax |
|
| Email |
prachitiwari005@gmail.com |
|
|
Source of Monetary or Material Support
|
| Jamia Hamdard,Hamdard Nagar, New Delhi-110062, India |
|
|
Primary Sponsor
|
| Name |
Nil |
| Address |
Nil |
| Type of Sponsor |
Other [Nil] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sunil Kohli |
Jamia Hamdard |
Department of Physiotherapy, Rehabilitation Center, Room No.-05, Hamdard Nagar, New Delhi-110062
South
DELHI |
9873351206
sunil.kohli@gmail.com |
| Prachi Tiwari |
Jamia Hamdard |
Department of Physiotherapy,Rehabilitation Center, Room No.-05, Hamdard Nagar, New Delhi-110062
South
DELHI |
9811644726
prachitiwari005@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Jamia Hamdard Institutional Ethical Committee |
Approved |
| Lovely Professional University |
No Objection Certificate |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G460||Middle cerebral artery syndrome, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional Physiotherapy |
range of motion, stretching and strengthening exercises of Hand.
The duration of the study will be 12 weeks as most of the improvement in hand function occurs in between 8 weeks to 32 weeks. The dosage will be 45 mins, 5 days per week, at 50-80 % of maximum Heart Rate. This 45 mins session will include 5-10 min of warm-up and cool-down. |
| Intervention |
Neurorehabilitation Strategies |
1. Electrosomatosensory Stimulation of Median,Ulnar and Radial nerve
2. Mirror Therapy
3. MRP
4. NDT
5. Trunk Stability Exercises
6. Constrained Induced Movement Therapy
The duration of the study will be 12 weeks as most of the improvement in hand function occurs in between 8 weeks to 32 weeks.The dosage will be 45 mins, 5 days per week, at 50-80 % of maximum Heart Rate. This 45 mins session will include 5-10 min of warm-up and cool-down. |
|
|
Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients with acute episode of stroke
2. Patient with Middle Cerebral Artery (MCA) involvement
3. Patients having haemorrhagic or non-haemorrhagic stroke
4. Patients who were in stage III in Brunnstrom hand recovery scale.
5. Mini mental State Examination Scale (MMSE) Score equal to or greater than 24
6. Patients who are able to understand and obeys command
|
|
| ExclusionCriteria |
| Details |
1. Patients having a history of prior stroke involving other hemisphere
2. Patients having poor cognitive function and aphasia
3. Patients having visual ,hearing deficit and perceptual deficit
4. Patients having emotional changes such as emotional lability, indifference, euphoria, anosoagnosia
5. Patients having secondary deformation due to musculoskeletal disease in hand
6. Patient having musculoskeletal disorder affecting shoulder.
7. Pain with VAS score greater than 4
8. Patients having uncontrolled diabetes and hypertension.
9. Patient having any other neurological disorder except stroke Demyelinating and Degenerative diseases of brain such as myelopathy ,myopathy, traumatic head injury, intracranial tumour
10. Arthritis
11. Acute Respiratory Distress Syndrome
12. Patient with Myocardial Infaction ,stable angina
13. Patient having pacemaker or any other metal implant in body
14. Pregnancy
15. Uncontrolled epilepsy
16. Poor skin condition or those allergic to wipes of adhesive tape
|
|
|
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 |
| Spasticity,Cognitive status,Grip strength,Pinch strength,Hand function,Co-activation, muscle activation,Disability,Fine motor skills,Finger dexterity |
Outcome measures will be evaluated at baseline, 6th and at the end of 12th week of intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Stroke Motor Recovery Scale,Disability,Recovery of Motor Impairment,Disability,Lifestyle after stroke |
Outcome measures will be evaluated at baseline, 6th and at the end of 12th week of intervention |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
22/07/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
22/07/2024 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="15" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Not published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Stroke patients who met the inclusion and exclusion criteria will be selected for the study and will then be asked to sign a consent form. After signing the informed consent, stroke patients will be assigned to experimental and control group. Baseline measurement including Mini mental state examination (MMSE), demographic data etc. will be done to allow for more in-depth description of the participant’s impairment. The experimental group will receive the developed intervention and control group will receive conventional physiotherapy. All outcome measures will be recorded at the baseline assessment, and after every two week of intervention and at the end on completion of intervention. Randomization will be performed using computer generated randomization table with a 1:1 ratio by a statistician not involved in the study. Subjects will be blinded to the groups will be allocated to Neuro-rehabilitation strategies group (Experimental Group) and conventional intervention group (Control Group). Group allocations will be assigned through sealed opaque envelopes. The envelopes will be kept in a closet by independent researcher who are not involved in the study. Experimental group will receive developed neurorehabilitation strategies and conventional physiotherapy that will be given to control group includes range of motion, stretching and strengthening exercises of upper limb. The duration of the study will be 12 weeks as most of the improvement in hand function occurs in between 8 weeks to 32 week. The dosage will be 45 mins, 5 days per week, at 50-80 % of maximum Heart Rate. This 45 mins session will include 5-10 min of warm-up and cool-down.
Outcome measures will be evaluated at baseline, 6th and at the end of 12th week of intervention |