| CTRI Number |
CTRI/2025/02/080874 [Registered on: 19/02/2025] Trial Registered Prospectively |
| Last Modified On: |
15/02/2025 |
| 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
|
Measures to prevent falls in Stroke patients |
|
Scientific Title of Study
|
Effect of trunk rehabilitation exercises in preventing falls in stroke patients. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
CHELLAMMAL KRISHNAN |
| Designation |
HOD Physiotherapy Department |
| Affiliation |
Ananthapuri Hospitals and Research Institute |
| Address |
Physiotherapy Department, Room number 1013, NH Bypass 66, Airport Rd, near Courtyard Garden, Chackai
Thiruvananthapuram
KERALA
695024
India |
| Phone |
9895862841 |
| Fax |
|
| Email |
bynka5000@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr G K Mini |
| Designation |
Professor |
| Affiliation |
Ananthapuri Hospitals and Research Institute |
| Address |
Global Institute of Public Health, Room number 491, NH Bypass 66, Airport Rd, near Courtyard Garden, Chackai
Thiruvananthapuram
KERALA
695024
India |
| Phone |
09495376825 |
| Fax |
|
| Email |
gkmini.2014@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rajashekharan Nayar |
| Designation |
Principal |
| Affiliation |
Ananthapuri Hospitals and Research Institute |
| Address |
Global Institute of Public Health, Room number 4921, NH Bypass 66, Airport Rd, near Courtyard Garden, Chackai
Thiruvananthapuram
KERALA
695024
India |
| Phone |
09495376825 |
| Fax |
|
| Email |
krnayar@gmail.com |
|
|
Source of Monetary or Material Support
|
| Ananthapuri Hospitals and Research Institute, NH Bypass 66, Airport Rd, near Courtyard Garden, Chackai
Thiruvananthapuram
KERALA
695024
India |
|
|
Primary Sponsor
|
| Name |
CHELLAMMAL KRISHNAN |
| Address |
Ananthapuri Hospitals and Research Institute, Trivandrum 695024, Kerala |
| Type of Sponsor |
Other [Self] |
|
|
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 G K Mini |
Global Institute of Public Health, Ananthapuri Hospitals and Research Institute |
NH Bypass 66, Airport Rd, near Room number 491, Courtyard Garden, Chackai
Thiruvananthapuram
KERALA |
09895862841
bynka5000@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee of AHRI |
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 |
Conventional Therapy and Additional Trunk Rehabilitation Exercises |
Patients selected for study who fulfil the inclusion criteria will be explained the details of the intervention program, the daily session to be practised, the duration of intervention and the expectation from the patient during intervention sessions.
All patients are instructed to do 45 mins of conventional therapy exercises, 5 days a week for 4 weeks, 20 mins of trunk strengthening exercise with rest period of 20 mins between conventional and trunk rehabilitation exercises.
The exercises for the conventional therapy program include sit to stand, standing balance, walking, semi squats, stair climbing and strengthening program to upper and lower limbs.
The exercises for trunk rehabilitation programs involve forward flexion of the trunk, lower trunk rotation, upper trunk rotation in supine lying, forward reach in sitting, lower and upper trunk lateral flexion in sitting and semi squats.
|
| Comparator Agent |
Conventional Therapy Exercise Programme |
All patients are instructed to do 45 mins of conventional therapy exercises, 5 days a week for 4 weeks. The exercises in the conventional therapy program includes sit to Stand, standing balance, walking, semi Squats, stair climbing and strengthening program to upper and lower limbs.
No trunk rehabilitation specific exercises will be performed.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
First ever episode of stroke with one to three months of onset.
Who can follow and understand instructions
Who have sitting balance for atleaast two minutes
Modified Rankin scale of 3 and 4 |
|
| ExclusionCriteria |
| Details |
Patients with Bilateral stroke
Patients with Parkinsonism
Multiple Sclerosis
Head Injury
Dementia
Subjects with diplobia, subjects with BPPV
Subjects who received other treatments like ayurvedha, sidha
Patients with lower limb fractures |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in the incidence of falls or risk of falls is the primary outcome. Rate of falls or number of falls will be measured. |
one month, three month and six month timepoints |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Changes in balance, muscle strength, activities of daily living and quality of life will considered as secondary outcomes. |
Compared with the start of trial to six month, nine and twelve month date. |
| Balance or posture control measures like Berg Balance scale for functional balance |
Compared with the start of trial to six month, nine and twelve month date |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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 |
|
Date of First Enrollment (India)
|
17/03/2025 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Main aim of the study is to evaluate the effectiveness of trunk strengthening exercises in reducing the incidence of falls in stroke patients. Falls are a major concern for stroke patients and the episode of falls affect independence and rehabilitation of patients. Core strength and balance are critical for maintaining stability and thus preventing episode of falls. Trunk strengthening exercises along with conventional therapy exercises improve balance thus reducing the incidence of falls. Incidence of falls in both groups will be recorded and compared. All the participants will be assessed during baseline, 3, 6, 9 and 12 months Information about the incidence of falls recorded and secondary outcomes of balance, muscle strength will also be assessed. |