| CTRI Number |
CTRI/2024/07/071705 [Registered on: 31/07/2024] Trial Registered Prospectively |
| Last Modified On: |
30/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect of Mirror box therapy along with whole body vibration machine in stroke patients. |
|
Scientific Title of Study
|
Combined effect of mirror therapy along with whole body vibration on upper limb functions in stroke patients. A randomized controlled trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr. Sanjiv Kumar |
| Designation |
Principal, Professor, Department of Neuro physiotherapy |
| Affiliation |
KAHER Institute of Physiotherapy |
| Address |
KAHER Institute Of Physiotherapy , Nehru Nagar JNMC Campus, Belagavi - Karnataka - 590010
Belgaum
KARNATAKA
590010
India |
| Phone |
9448745648 |
| Fax |
|
| Email |
sanjiv3303@rediffmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Sanjiv Kumar |
| Designation |
Principal, Professor, Department of Neuro physiotherapy |
| Affiliation |
KAHER Institute of Physiotherapy |
| Address |
KAHER Institute Of Physiotherapy , Nehru Nagar JNMC Campus, Belagavi - Karnataka - 590010
Belgaum
KARNATAKA
590010
India |
| Phone |
09448745648 |
| Fax |
|
| Email |
sanjiv3303@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
SUPRIYO SARKAR |
| Designation |
Department Of NeuroPhysiotherapy |
| Affiliation |
KAHER Institute of Physiotherapy |
| Address |
KAHER Institute Of Physiotherapy , Nehru Nagar JNMC Campus, Belagavi - Karnataka - 590010
Belgaum
KARNATAKA
590010
India |
| Phone |
08340793061 |
| Fax |
|
| Email |
supriyo2015sarkar@gmail.com |
|
|
Source of Monetary or Material Support
|
| KAHER Institute Of Physiotherapy - Karnataka - 590010 |
|
|
Primary Sponsor
|
| Name |
KAHER Institute Of Physiotherapy |
| Address |
KAHER Institute Of Physiotherapy , Nehru Nagar JNMC Campus , Belagavi - Karnataka - 590010 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| KAHER Institute of Physiotherapy |
KAHER Institute Of Physiotherapy , Nehru Nagar JNMC Campus , Belagavi - Karnataka - 590010 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Supriyo Sarkar |
KLES Dr. Prabhakar Kore Hospital and Medical Research Centre |
KAHER Institute Of Physiotherapy , Nehru Nagar JNMC Campus , Belagavi - Karnataka - 590010
Belgaum
KARNATAKA |
08340793061
supriyo2015sarkar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| KAHER Institue of Physiotherapy |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I639||Cerebral infarction, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
MIRROR THERAPY |
Mirror therapy has shown promise in improving motor function and reducing pain after stroke. MT is an easy-to-apply low-cost technique that can improve an individuals UL function with minimal therapist intervention and can be integrated to the home environment. Mirror Therapy will be given for 15 minutes with breaks in between. |
| Comparator Agent |
WHOLE BODY VIBRATION |
Whole-body vibration training has been suggested to enhance muscle strength and motor function. It has been found that task-oriented training after WBV effectively improved motor function and increased grip strength in patients with subacute stroke. Whole Body Vibrator will be given for 15 minutes with breaks in between. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Diagnosed cases of stroke from 18-65 years of age, having MMSE score above 25.
Upper Limb Impairements as per the Sollerman Hand Function Test scale (SHFT) score between (1-2).
Willing to participate in this study.
|
|
| ExclusionCriteria |
| Details |
Patients having Cardiovascular or Pulmonary conditions that may restrict the assessment.
Medically unstable patients.
Ataxic Patients.
Orthopaedic conditions such as Fractures.
Epileptic Patients.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Whole-body vibration training has been suggested to enhance muscle strength and motor function. It has been found that task-oriented training after WBV effectively improved motor function and increased grip strength in patients with subacute stroke. Limited studies have investigated the combined effect of mirror therapy and whole-body vibration training on upper limb function in stroke patients.
|
Whole Body Vibrator will be given for 15 minutes, 3 times a week for 4 weeks. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate the Combined Effect of Mirror Therapy with Whole Body Vibrator on Upper Limb Functions using Jebsen - Taylor Hand Function Test and Tardeiu Scale and Functional Independence Measure scale. |
1 Year |
|
|
Target Sample Size
|
Total Sample Size="34"
Sample Size from India="34"
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)
|
25/08/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
25/08/2024 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Stroke often leads to upper limb motor impairments, such as muscle weakness, loss of dexterous movement. Motor impairments are associated with an increased risk for stroke-related pain, stiffness and contractures in Upper Limb. Motor impairments occur in approximately 80% of all cases and are associated with permanent disability and dependence in at least 30%. This negatively affects patients’ activities of daily living and quality of life. Mirror therapy has shown promise in improving motor function and reducing pain after stroke. MT is an easy-to-apply low-cost technique that can improve an individual’s UL function with minimal therapist intervention and can be integrated to the home environment. Whole-body vibration training has been suggested to enhance muscle strength and motor function. It has been found that task-oriented training after WBV effectively improved motor function and increased grip strength in patients with subacute stroke. Inspite of these therapies, residual paralysis in upper limb functions have been evident. Studies have suggested that combination of therapies could give better outcome. Limited studies have investigated the combined effect of mirror therapy and whole-body vibration training on upper limb function in stroke patients. Hence, this study was undertaken to evaluate the combined effect of mirror therapy and whole body vibrator on hand functions in stroke patients. |