| CTRI Number |
CTRI/2016/04/006795 [Registered on: 05/04/2016] Trial Registered Retrospectively |
| Last Modified On: |
04/04/2016 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Benefits and harms of very early and frequent mobilisation started with in 48 hours following acute stroke. |
|
Scientific Title of Study
|
Very Early Mobilisation Following Acute Stroke: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 |
Purusotham Chipplaa |
| Designation |
Assistant Professor |
| Affiliation |
Nitte Institute of Physiotherapy |
| Address |
Nitte Institute of Physiotherapy,
Medical Sciences Complex,Deralakatte,Mangalore,DK,Karnataka,India
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
919916460185 |
| Fax |
|
| Email |
chippala_puru@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Purusotham Chipplaa |
| Designation |
Assistant Professor |
| Affiliation |
Nitte Institute of Physiotherapy |
| Address |
Nitte Institute of Physiotherapy,
Medical Sciences Complex,Deralakatte,Mangalore,DK,Karnataka,India
KARNATAKA
575018
India |
| Phone |
919916460185 |
| Fax |
|
| Email |
chippala_puru@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Purusotham Chipplaa |
| Designation |
Assistant Professor |
| Affiliation |
Nitte Institute of Physiotherapy |
| Address |
Nitte Institute of Physiotherapy,
Medical Sciences Complex,Deralakatte,Mangalore,DK,Karnataka,India
KARNATAKA
575018
India |
| Phone |
919916460185 |
| Fax |
|
| Email |
chippala_puru@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Nitte UniversityNitte Institute of Physiotherapy |
| Address |
Nitte Institute of physiotherapy,Medical Sciences Complex,Deralakatte,Mangalore-575018,Karnataka,India. |
| Type of Sponsor |
Private medical college |
|
|
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 |
| Purusotham Chippala |
Nitte University-Nitte Institute of physiotherapy,Department of Neurological physiotherapy |
Justice K.S Hegde Charitable Hospital,Department of physiotherapy, Room number:20, Deralakatte,Mangalore-575018
Dakshina Kannada
KARNATAKA |
9916460185
chippala_puru@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Central Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Acute Stroke or Cerebro vascular Accident, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Standard care group |
Standard care group includes-Passive and active (if possible) mobilisation, Correct positioning in bed, mobilisation in bed, sitting balance activities, facilitation of limb and trunk control activities, education of patient and care giver.Total duration of treatment will be given for standard care is seven days or until discharge, which ever is sooner.
|
| Intervention |
Very early mobilisation including early and frequent out of bed activities and Standard care |
Very early mobilisation including early and frequent out of bed activities such as sitting out of bed,sit to stand transfer, standing with and with out support, walking with and with out support and standard care. Total duration of treatment will be given for seven days or until discharge,which ever is sooner. |
|
|
Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
Patient’s age above 18 years,
Acute stroke patients admitted within 24 hours of symptom onset to the stroke unit,
Able to react to verbal commands,
Both sex (Male and Female),
Systolic Blood Pressure between 120 and 180 mm Hg,
Oxygen saturation > 92% (with or without supplementation),
Heart rate between 40 and 100 beats per minute,
Temperature < 38.5â—‹C,
Patients were recruited after attaining physician permission and if mobilisation within 24 hours of stroke is permitted.
|
|
| ExclusionCriteria |
| Details |
Deterioration within ï¬rst hour of admission to hospital,
Patients with pre morbid modified Rankin Scale (mRS) Score >3,
Concurrent progressive neurological disorder
Unstable coronary condition (e.g. acute myocardial infarction) or other medical condition that would impose hazard to the patient,
Or if their physiological variables (blood pressure, oxygen, heart rate, temperature) fall outside set safety limits,
Severe heart failure,
Lower limb fracture preventing mobilisation,
Terminal cancer patients.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Complications at 3 months,
Functional status (Barthel Index score),
Functional disability (The modified Rankin Scale (mRS)) |
On Admission
At discharge
At three months follow up |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Health related quality of life(SF-36),
Psychological well being (HOSPITAL ANXIETY AND DEPRESSION RATING SCALE) |
On Admission
At discharge
At three months follow up |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
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
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
19/03/2012 |
| 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="3"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
Publication Details
|
1. Chippala P, Sharma R. Effect of very early mobilisation on functional status in patients with acute stroke: A single-blind, randomized controlled trail. Clin Rehabil. 2015 Jul 21. pii: 0269215515596054. [Epub ahead of print].
2.Purusotham Chippala, Raghava Sharma.Effects of Very Early Mobilisation on Disability and Adverse Events in the First 3 Months Post Stroke: A Single-Blind, Randomized Controlled Trial.
International Journal of Health Sciences and Research (IJHSR), 2015; 5(10):166-174. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Aims and Objectives of the Study: (1) To determine the effect of very early mobilisation on activities of daily living following acute stroke. (2) To determine the potential adverse events after very early mobilisation following acute stroke. (3) To determine the effect of very early mobilisation on quality of life following acute stroke. (4) To determine the effect of very early mobilisation on psychological well being following acute stroke. (5) To determine the effect of very early mobilisation on the level of disability following acute stroke.
Need for the Study: There is paucity of data regarding the effect of very early mobilisation on functional status following acute stroke. Stroke patients are at very high risk of developing complications, with an estimated 85% experiencing hospital related health problems. There is considerable evidence that early mobilisation is feasible and safe. There is no evidence to suggest that the practice should be discontinued in countries where very early mobilisation is a well established intervention but at the same time there is scarcity of evidences to suggest that the practice should be adopted more broadly.
|