| CTRI Number |
CTRI/2022/11/047124 [Registered on: 09/11/2022] Trial Registered Prospectively |
| Last Modified On: |
07/11/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Perturbation-Based Balance Training for stroke patient |
|
Scientific Title of Study
|
Effects of Perturbation-Based Balance Training along with usual therapy for improving lower limb functional activity for people who experienced a stroke |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Nazmun Nahar Munna |
| Designation |
M.Sc in Physiotherapy Fellow |
| Affiliation |
Bangladesh Health Professions Institute |
| Address |
BHPI, CRP-Savar, Dhaka, Bangladesh
1343
Other |
| Phone |
|
| Fax |
|
| Email |
nazmunmunna@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ehsanur Rahman |
| Designation |
Associate Professor |
| Affiliation |
Bangladesh Health Professions Institute |
| Address |
Department of Physiotherapy, BHPI, CRP, savar, Dhaka
1343
Other |
| Phone |
|
| Fax |
|
| Email |
ehsanurrahman.bhpi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Ehsanur Rahman |
| Designation |
Associate Professor |
| Affiliation |
Bangladesh Health Professions Institute (BHPI) |
| Address |
Department of Physiotherapy, BHPI, CRP, savar, Dhaka
1343
Other |
| Phone |
|
| Fax |
|
| Email |
ehsanurrahman.bhpi@gmail.com |
|
|
Source of Monetary or Material Support
|
| Centre for the Rehabilitation of the Paralysed (CRP) |
|
|
Primary Sponsor
|
| Name |
Nazmun Nahar Munna |
| Address |
CRP-Savar, Dhaka, Bangladesh. |
| Type of Sponsor |
Other [Self-funded] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
Bangladesh |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Nazmun Nahar Munna |
Outdoor Neurology and Stroke rehabilitation unit |
Department of Physiotherapy,
Centre for the Rehabilitation of the Paralysed (CRP), Savar, Dhaka, Bangladesh-1343.
|
8801919318726
nazmunmunna@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| BHPI Ethics Committee |
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 |
Perturbation based balance training (PBBT) therapy |
PBBT therapy will be administered for 30 minutes in addition to 15 minutes of standard therapy consisting one session, once a day for 5 days in a week continue until four weeks of therapy. |
| Comparator Agent |
Standard Usual therapy |
1. Slow stretching for spastic tone and quick stretching for flaccid tone in lower limb.
2. Transitional movement practice like bed mobility, wheelchair transferring.
3. Lying to sitting practice.
4. Static and dynamic sitting balance practice like reaching practice, retrieving object from floor.
5. Selective movement and coordination practice like Frankle exercise.
6. Rood approach for sensory stimulation.
Every treatment will be administered 10 rep x 1 set for 45 minutes of each session, once a day for 5 days a week will continue until four weeks.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Diagnosis of a ï¬rst- ever unilateral stroke conï¬rmed by CT or MRI scanning of Head
2. Well general condition with stabilized vital signs and normal consciousness
3. Brunnstrom recovery stage one to four for the affected upper limb
4. 2 months to 4 months after stroke onset
5. Attend voluntarily for this study with a signed informed consent.
|
|
| ExclusionCriteria |
| Details |
1. Reversible stroke.
2. Hemorrhagic stroke
3. Severe visceral organ (e.g., heart, lung, liver, and kidney) dysfunction
4. Severe cognitive dysfunction
5. History of mental disease and cannot cooperate in rehabilitation treatment
6. Deaf and mutes both are excluded
7. Unable to receive treatment in designated hospital at speciï¬c time or unable to be followed up regularly
8. Implanted with cardiac pacemaker with upper limb dysfunction due to other causes
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To elucidate the effects of Perturbation-Based Balance Training (PBBT) for improving lower limb functional activity for patient with stroke in Subacute Persons with Stroke |
After 4 weeks of intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To delineate the demographic physical status of the people with stroke. |
Baseline and after 4 weeks of intervention |
| To inspect the effectiveness of PBBT on sub-acute stroke patients during rehabilitation compared to conventional physiotherapy. |
Baseline and after 4 weeks of intervention |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="0"
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)
|
Date Missing |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
20/11/2022 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="1"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Applicable |
|
Publication Details
|
Not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Perturbation-based balance training (PBT) is a sort
of exercise in which participants frequently lose their equilibrium in order to
learn and improve balance reaction control. It differs
from other balancing training programs in that it focuses on improving reactive
balance control in order to avoid a fall after a balance failure in real life.
PBT has been proven in studies to increase voluntary movement speed and
control, improve fast balancing reflexes, and reduce the occurrence of falls. As in Bangladesh, CRP has the facility to
rehabilitate the people living with Stroke for a prolonged period, there is
scope to introduce perturbation-based balance training in individualized structures
for People with Stroke. The scope of practicing PBBT is fitted with the
cultural context and organizational policy of CRP. The study results may help
guide the physiotherapist and will give valuable information about stroke
survivors’ functional and disability status, which will be beneficial for both
stroke survivors and for developing the platform of the physiotherapy
profession. The study is intended to elicit the
effectiveness of PBBT on lower limb functional recovery in patients with sub-acute
stroke. |