| CTRI Number |
CTRI/2023/09/057907 [Registered on: 21/09/2023] Trial Registered Prospectively |
| Last Modified On: |
20/09/2023 |
| 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
|
Task Oriented circuit training for the patient of stroke
|
|
Scientific Title of Study
|
A study of Task Oriented circuit training for the patient of ischemic stroke with neurological deficit
|
| Trial Acronym |
Nill |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Farjana Sharmin |
| Designation |
Consultant |
| Affiliation |
Centre for the Rehabilitation of the Paralysed (CRP), Dhaka, Bangladesh |
| Address |
Room-03,Deperatment of Physiotherapy,Centre for the Rehabilitation of the Paralysed (CRP), Dhaka, Bangladesh.
1343
Other |
| Phone |
01614118881 |
| Fax |
|
| Email |
rumanaphysio@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Farjana Sharmin |
| Designation |
Consultant |
| Affiliation |
Centre for the Rehabilitation of the Paralysed (CRP), Dhaka, Bangladesh |
| Address |
Room-03,Deperatment of Physiotherapy,Centre for the Rehabilitation of the Paralysed (CRP), Dhaka, Bangladesh.
1343
Other |
| Phone |
01614118881 |
| Fax |
|
| Email |
rumanaphysio@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Farjana Sharmin |
| Designation |
Consultant |
| Affiliation |
Centre for the Rehabilitation of the Paralysed (CRP), Dhaka, Bangladesh |
| Address |
Room-03,Deperatment of Physiotherapy,Centre for the Rehabilitation of the Paralysed (CRP), Dhaka, Bangladesh.
1343
Other |
| Phone |
01614118881 |
| Fax |
|
| Email |
rumanaphysio@gmail.com |
|
|
Source of Monetary or Material Support
|
| Centre for the Rehabilitation of the Paralysed (CRP), Dhaka, Bangladesh. |
|
|
Primary Sponsor
|
| Name |
Nill |
| Address |
Nill |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| Mohammad Anwar Hossain |
Centre for the Rehabilitation of the Paralysed(CRP) |
Room no-01, Centre for the Rehabilitation of the Paralysed - CRP, Dhaka, Bangladesh
|
01753559949
anwar.hossain@crp-bangladesh.org |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| CRP 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 |
| Comparator Agent |
conventional physiotherapy |
Allow 2 minutes workstations and 5 minutes for one workstation total 23 minutes and 1
minutes rest period each workstation to avoid fatigue |
| Intervention |
Task oriented circuit training |
Allow 2 minutes for nine workstations and 5 minutes for one workstation total 23 minutes and 1
minutes rest period each workstation to avoid fatigue |
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
1. Ischemic stroke patient with neurological deficit and with the confirmed diagnosis by the neurologist (Harris, Eng, Miller and Dawson, 2009).
2. Age of patient ranging from 35 to 75 years (Bosch et al., 2014)
3. At least one and half months of post stroke ((Blennerhassett and Dite, 2004).
4. Ability to walk 10 m independently or using an aid or orthotic with or without supervision or aid (Kim et al., 2012).
5. Functional ambulation category ( FAC) Score of at least grade three (Frimpong et al., 2016).
6. Impaired motor function of arm which was due to one or more of the following: weakness, sensory loss, ataxia, visuospatial impairment (Han et al., 2012).
7. Impaired arm motor function but able to perform reach to grasp movement (Michaelsen, Dannenbaum and Levin, 2006).
8. Able to tolerate the duration of interventions and evaluation (Han et al., 2012).
9. First or second stroke resulting in right or left sided hemiparesis ((Mudge, Barber and Stott, 2009).
10. Both male and female will be included (Moon, Park, Kim and Na, 2018)
11. Patient has the ability to provide informed consent ((Blennerhassett and Dite, 2004).
|
|
| ExclusionCriteria |
| Details |
1. Patient suffering from unstable cardiac condition, uncontrolled hypertension or congestive heart failure ((Mudge, Barber and Stott, 2009).
2. Participants were excluded if they had progressive neurologic disease and other significant health problems that adversely affected walking ability (Mudge, Barber and Stott, 2009).
3. Participant with aphasia, cardiac arrhythmias and any such conditions for which exercise are contraindicated (Frimpong et al., 2016).
4. Perceptual, apraxic or major cognitive deficits (Michaelsen, Dannenbaum and Levin, 2006).
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Goniometer will be used for Range of Motion measurement; Tone will be measured by Modified Ashworth Scale; Functional Independence by the Barthel Index; Ten meter walk test for speed of gait; Speed of performing a dynamic single limb stance task will measure by Step test; functional ambulation category will be used to measure Functional ambulation ability |
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NILL |
Nill |
|
|
Target Sample Size
|
Total Sample Size="200"
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)
|
00/00/0000 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
30/09/2023 |
| 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 Applicable |
|
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
|
To conduct the study the investigator will collect
data through using different types of data collection tools. Goniometer will be used for Range of Motion
measurement; Tone will be
measured by Modified Ashworth Scale; Functional Independence by the Barthel Index; Ten meter
walk test for speed of gait; Speed
of performing a dynamic single limb stance task will measure by Step test;
functional ambulation category will be used to measure Functional
ambulation ability and structural
questionnaire will be used for socio-demographical and life style indicators. |