| CTRI Number |
CTRI/2025/03/081878 [Registered on: 07/03/2025] Trial Registered Prospectively |
| Last Modified On: |
07/03/2025 |
| 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
|
Using compression therapy along with Traditional Balance Exercises to improve balance in stroke patient |
|
Scientific Title of Study
|
Effect of Intermittent Vacuum Therapy (IVT) as an Adjuvant Therapy To Conventional Balance Protocol in Chronic Stroke Patient |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Khushboo Agrawal |
| Designation |
MPT Student |
| Affiliation |
Sunandan Divatia School Of Science |
| Address |
Department of Physiotherapy ground floor Nanavati Mac super speciality Hospital SV Road Vile Parle west
Mumbai
MAHARASHTRA
400056
India |
| Phone |
9422184455 |
| Fax |
|
| Email |
khushbooagrawal4455@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sabah Thaver |
| Designation |
Assistant professor- physiotherapy |
| Affiliation |
Sunandan Divatia School Of Science |
| Address |
Sunandan Divatia school of science department of physiotherapy 7th floor Mithibai College Building Bhaktivedanta Road Vile Parle west
Mumbai
MAHARASHTRA
400056
India |
| Phone |
9820691076 |
| Fax |
|
| Email |
Sabah.thaver@nmims.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sabah Thaver |
| Designation |
Assistant professor- physiotherapy |
| Affiliation |
Sunandan Divatia School Of Science |
| Address |
Sunandan Divatia school of science department of physiotherapy 7th floor Mithibai College Building Bhaktivedanta Road Vile Parle west
Mumbai
MAHARASHTRA
400056
India |
| Phone |
9820691076 |
| Fax |
|
| Email |
Sabah.thaver@nmims.edu |
|
|
Source of Monetary or Material Support
|
| Department of Physiotherapy, Ground Floor, Nanavati Max Super Speciality Hospital, SV Road, Vileparle West, Mumbai 400067 |
|
|
Primary Sponsor
|
| Name |
NONE |
| Address |
NA |
| Type of Sponsor |
Other [NIL] |
|
|
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 |
| Dr Ali Irani |
Nanavati Max Super Speciality Hospital |
Department of Physiotherapy
Ground Floor
SV Road
Vile Parle West
Mumbai
Maharashtra
Mumbai
MAHARASHTRA |
02261347560
physiodept.nanavati@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Nanavati Max Super Speciality Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G939||Disorder of brain, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
FAME(Fitness and Mobility Exercise Program) |
It is a 4 week intervention with total 12 sessions - 3 sessions per week (alternate days) |
| Intervention |
IVT(Intermittent Vacuum Therapy) |
It is a 4 week intervention with total 12 sessions - 3 sessions per week (alternate days) |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
Patient with chronic stroke
with a chief complains of balance issues
Can walk at least for 10 meters
MMSE more than 24
|
|
| ExclusionCriteria |
| Details |
Any recent injuries and fractures,
Neurological disease such as seizure
disorder, head injury, or peripheral neuropathy
Musculoskeletal conditions preventing
participation in rehabilitation program
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Berg Balance Scale |
Baseline and post 4 weeks of intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Time Up and Go |
Baseline and post 4 weeks of intervention |
| Four Square Step Test |
Baseline and post 4 weeks of intervention |
|
|
Target Sample Size
|
Total Sample Size="54"
Sample Size from India="54"
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)
|
25/03/2025 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
TITLE: Effect of intermittent vacuum therapy(IVT) as an adjuvant therapy to conventional balance protocol in chronic stroke patients
INTRODUCTION: Stroke is a sudden loss of brain function due to interrupted blood flow, either by blockage or bleeding Balance impairment and falls are common post-stroke issues. Rehabilitation includes physiotherapy and emerging treatments like Intermittent Vacuum Therapy IVT enhances blood circulation in the lower body using alternating pressure potentially improving recovery and balance in stroke patients by increasing oxygenation and vascular function in the lower extremities.
RATIONALE: Impaired balance is a common issue in stroke patients, leading to a high risk of falls, injuries, and prolonged hospital stays. Conventional rehabilitation, including physiotherapy and balance training, is the primary approach for improving balance. However, Intermittent Vacuum Therapy (IVT) is emerging as a promising adjunct therapy. IVT, based on NASA’s Lower Body Negative Pressure Device (LBNPD), enhances blood circulation and lymphatic function by intermittently applying negative pressure to the lower body. This therapy promotes blood redistribution to the lower extremities, improving vascular function, oxygenation, and muscle perfusion. Studies suggest that IVT, combined with conventional rehabilitation, enhances balance and functional ambulation in chronic stroke patients. By improving circulation and postural control, IVT may accelerate recovery and reduce fall risks, ultimately enhancing quality of life.
AIMS: To access the effect of intermittent vacuum therapy as adjuvant to conventional balance protocol in chronic stroke patience
OBJECTIVES: To assess the effect of conventional balance protocol in chronic stroke patients
To assess the effect of IVT as an adjuvant to conventional balance protocol in chronic stroke patients
To compare both the groups
OUTCOME MEASURES: 1 Four Square Step test To assess dynamic stability and coordination 2 Time up and GO to assess lower extremity function, mobility, and fall risk 3 Berg Balance scale To assess balance
PROTOCOL: The intervention was developed using FAMEs (fitness and mobility exercise program) protocol is a structured rehabilitation program designed for/patient to improve mobility, strength, balance, and cardiovascular fitness it includes five phases which include 1 warmup 2 stretching 3 functional strengthening 4 balance 5 agility and fitness Fame is typically delivered in group settings and tailored to individual capabilities, promoting independency and reducing fall risk studies show it enhances walking ability, muscle, strength, and overall quality of life in stroke survivors, making it an effective long-term rehab rehabilitation approach Frequency thrice a week for four week intensity duration, 45 minutes, type balance training it include WEEK 1 2 Sets*5 Reps WEEK 2: 3sets*5Reps WEEK 3: 4 sets*5Reps WEEK 4: 3Sets*10Reps |