| CTRI Number |
CTRI/2023/07/055866 [Registered on: 31/07/2023] Trial Registered Prospectively |
| Last Modified On: |
24/01/2025 |
| 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
|
Effect of body exercise and patient preferred sitting tasks training to improve
daily activities among early stroke patients |
|
Scientific Title of Study
|
Effect of truncal exercise and patient preferred sitting tasks training on functional ability in sub-acute stroke |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Swathi V |
| Designation |
PG Student |
| Affiliation |
KMCH college of physiotherapy |
| Address |
KMCH College of physiotherapy
Coimbatore 641048
Tamilnadu
Coimbatore
TAMIL NADU
641048
India |
| Phone |
9597304793 |
| Fax |
|
| Email |
swathisri2241999@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
A Brammatha |
| Designation |
Professor |
| Affiliation |
KMCH college of physiotherapy |
| Address |
KMCH College of physiotherapy
Coimbatore 641048
Tamilnadu
Coimbatore
TAMIL NADU
641048
India |
| Phone |
9751509033 |
| Fax |
|
| Email |
brammathapt@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Swathi V |
| Designation |
PG Student |
| Affiliation |
KMCH college of physiotherapy |
| Address |
KMCH College of physiotherapy
Coimbatore 641048
Tamilnadu
Coimbatore
TAMIL NADU
641048
India |
| Phone |
9597304793 |
| Fax |
|
| Email |
swathisri2241999@gmail.com |
|
|
Source of Monetary or Material Support
|
| KMCH Institute of health sciences |
|
|
Primary Sponsor
|
| Name |
KMCH Institute of health sciences |
| Address |
KMCH Institute of health sciences and research
Coimbatore - 641014 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Swathi V |
Kovai Medical Center Hospital |
Kovai Medical Center Hospital, physical medicine and rehabilitation,
99, Avinashi,
Coimbatore 641 014, Tamilnadu, India.
Coimbatore
TAMIL NADU |
9597304793
swathisri2241999@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| KMCH Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I678||Other specified cerebrovascular diseases, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
control group |
30 subjects are randomly allocated for control group who will receives conventional physiotherapy alone |
| Intervention |
Truncal exercise and patient preferred sitting task training |
30 subjects are randomly allocated for interventional group who will receive both truncal exercise and patient preferred sitting task training.
1) Truncal exercises - 45minutes/session /twice a day
5days /week
for 3 weeks
2) Patient preferred sitting tasks training -
30 minutes/session/twice a day
5 days /week
for 3 weeks |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Female |
| Details |
1)Patients diagnosed with infarct or hemorrhage of right or left hemisphere which is investigated by CT/MRI scan
2)Patients with loss of sitting balance and trunk control with TIS Score of 3 with medically stable.
3) Post stroke from day 3
4) Healthy caregivers with the age of 20 – 60 years old.
|
|
| ExclusionCriteria |
| Details |
1) Subjects with non – stroke related sensory or motor impairments which affecting their motor performance.
2) Any perceptual dysfunctions such as Unilateral neglect and disorders of spatial perception.
3) Modified rankin scale score >4 |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Trunk balance and control |
Baseline
3 weeks
8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
sitting balance
Caregiver Burden
Lower limb strength |
Baseline
3week
8week |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
10/08/2023 |
| Date of Study Completion (India) |
29/12/2023 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
29/12/2023 |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Stroke is the second leading cause of disability and death. Research suggests that incidence of stroke in India ranges between 105 and 152/1,00,000 people per year. Most patients with acute and sub – acute stroke have a poor sitting balance. Thus, the prevalence of sitting balance impairments among post – stroke with values ranging from 16.7% to as high as 83%.However, the trunk training exercise is given early after stroke is most important training that specifically targets trunk muscles and trunk functions at post – stroke. The intervention most often focus on the time therapy (min/hours).Repeated practice of a challenging movement by patient preferred sitting task can produce physiological changes in motor neurons. PROCEDURE 60 In- patients of Kovai Medical Center and Hospital undergoing treatment for rehabilitation will be selected in the study. Patients will be recruited on their first referral of physiotherapy from day 3 considered as medically stable by their consulting physicians. This study will select in – patients referred to Department of Physical Medicine and Rehabilitation, Kovai Medical Center and Hospital. Patients who fulfill inclusion criteria and provide informed consent will be selected for the study. Patient vitals are to be screened and observed before, during and end of the treatment session.
Group A – experimental group receives truncal exercise with patient preferred sitting task training. Group B – control group receives the conventional therapy alone. Pre – test and post – test measures are using trunk impairment scale (TIS), function in sitting test (FIST) and Zarit Burden Interview (ZBI) , 5 times Sit to stand at test.
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