| CTRI Number |
CTRI/2025/04/085463 [Registered on: 23/04/2025] Trial Registered Prospectively |
| Last Modified On: |
17/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect of cawthorne-cooksey exercises on balance and gait among patients with stroke-an experimental study |
|
Scientific Title of Study
|
Effect of cawthorne-cooksey exercises on balance and gait among individuals with hemiparesis |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vaghela Smrutiben Prafullbhai |
| Designation |
Pursuing Masters in Physiotherapy |
| Affiliation |
Ahmedabad Institute of Medical Sciences |
| Address |
Room no.1 Division Exercise therapy Department Physiotherapy
Near Lions Karnavati Eye Hospital,Lapkaman,Gota-Vadsar,Ahmedabad,Gujarat,India
Ahmadabad
GUJARAT
380060
India |
| Phone |
7485943830 |
| Fax |
|
| Email |
zeelvaghela11@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Aalopi Dave |
| Designation |
Assistant Professor |
| Affiliation |
Ahmedabad Institute of Medical Sciences |
| Address |
Room no.1 Division Exercise therapy Department Physiotherapy
Near Lions Karnavati Eye Hospital,Lapkaman,Gota-Vadsar,Ahmedabad,Gujarat,India
Ahmadabad
GUJARAT
380060
India |
| Phone |
8487042076 |
| Fax |
|
| Email |
ozaaalopi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Aalopi Dave |
| Designation |
Assistant Professor |
| Affiliation |
Ahmedabad Institute of Medical Sciences |
| Address |
Room no.1 Division Exercise therapy Department Physiotherapy
Near Lions Karnavati Eye Hospital,Lapkaman,Gota-Vadsar,Ahmedabad,Gujarat,India
Ahmadabad
GUJARAT
380060
India |
| Phone |
8487042076 |
| Fax |
|
| Email |
ozaaalopi@gmail.com |
|
|
Source of Monetary or Material Support
|
| Ahmedabad Institute of Medical Sciences,Near Lions Karnavati Eye Hospital,Lapkaman,Gota-Vadsar,Ahmedabad,Gujarat,India |
|
|
Primary Sponsor
|
| Name |
Ahmedabad Institute of Medical Sciences |
| Address |
Room no.1 Division Exercise therapy Department Physiotherapy
Near Lions Karnavati Eye Hospital,Lapkaman,Gota-Vadsar,Ahmedabad,Gujarat,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 |
| DrAALOPI DAVE |
Ahmedabad Institute of Medical Sciences |
Room no.1 Division Exercise therapy Department Physiotherapy Ahmedabad Institute of Medical Sciences Near Lions Karnavati Eye Hospital.Lapkaman,Gota-Vadsar,Ahmedabad-380060,Gujarat.
Ahmadabad
GUJARAT |
8487042076
ozaaalopi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Research And Ethics Commitee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G468||Other vascular syndromes of brainin cerebrovascular diseases, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Cawthorne-Cooksey Exercises |
5 days/3 weeks |
| Comparator Agent |
Conventional Group |
5 days/3weeks |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Subject who willingly participate in this study
Individuals with hemiparesis
Age is 40 to 65 years
Both Genders
MMSE score is 24 or more than 24
BBS score is 41 out of 56
MMAS score is 2 or below 2.
VCG score 4 or more than 4.
|
|
| ExclusionCriteria |
| Details |
Dislocation of lower limb
Recent fractures
Any audio and visual deficit
Patient with any psychological disorder
Cardiovascular condition
Patients with any cognitive impairments
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Timed up and go test |
at baseline and at 3 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Functional Gait Analysis |
at baseline and at 3 weeks |
|
|
Target Sample Size
|
Total Sample Size="36"
Sample Size from India="36"
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)
|
01/05/2025 |
| 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="0"
Months="6"
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
|
BACKGROUNDStroke is the sudden loss of neurological function
caused by an interruption of blood flow to the brain. Maintaining balance
requires an interaction between sensory (visual, vestibular, somatosensory) and
motor systems within the central nervous system. Hemiparesis occurs in stroke
inpatients and is a common disability that could restrict joint movement and
reduce the ability of muscle contraction. In addition, motor disability can
cause imbalance of the left and right sides of the body, reduce balance ability
and gait endurance, and induce a fear of falling when performing physical
activity. The Cawthorne-Cooksey exercise includes movements of the head, task
requiring coordination of eyes with the head, total body movements, and balance
tasks.
NEED OF THE STUDYBalance can be severely affected in individuals with Hemiparesis. As affection in balance is essential component, it is necessary to focus on its rehabilitation. There is also presence of slow gait cycle and speed, which decreases the walking ability and reduces the endurance level, overall leading to difficulty in activities of daily living of hemiparetic individuals. Several researches had been done on Cawthorne-Cooksey exercises which showed improvement in balance and gait in Multiple Sclerosis, Cerebral Palsy and Geriatric populations, meanwhile there are few studies on Hemiparetic individuals. Therefore, the need arises to find out the effect of Cawthorne-Cooksey exercises on balance and gait in individuals with Hemiparesis. AIMAim of the study is to find out the effect of Cawthorne-Cooksey exercises on balance and gait among individuals with Hemiparesis. OBJECTIVE· To evaluate the effect of Cawthorne-Cooksey exercises on balance in individuals with hemiparesis by Timed Up and Go Test. · To evaluate the effect of Cawthorne-Cooksey exercises on gait in individuals with hemiparesis by Functional gait assessment. · To evaluate the effect of conventional exercise on balance in individuals with hemiparesis by Timed Up and Go Test. · To evaluate the effect of conventional exercise on gait in individuals with hemiparesis by Functional Gait Assessment. · To compare the effect of Cawthorne-Cooksey exercises and Conventional exercise on balance in individuals with hemiparesis by Timed Up and Go Test. · To compare the effect of Cawthorne-Cooksey exercises and Conventional exercise on gait in individuals with hemiparesis by Functional gait assessment. PROCEDUREAfter being approved by the ethical Commitee, according to inclusion and exclusion criteria 36 subjects will be divided into groups. Informed consent will be taken. In both groups, pre and post data will be measured. Group A: Experimental Group (Cawthorne-Cooksey Exercise) Group B: Control Group (Conventional Exercise)
Group A: Experimental Group (Cawthorne-Cooksey Exercise) CONSIST OF: Eye Movements: · Looking up and looking down. · Looking alternately left and right. Head Movements: · Bending alternatively forward and backward (eyes opened and eye closed). · Turning alternatively to the left then right (eyes opened and closed). Arm And Body Movements: · Shrugging and rotating shoulder. · Bending forward and picking up objects from the floor. · Turning head and trunk alternatively to the left and then right. Standing Position: · Eye movements (as described above). · Head movements (as described above). · Arm and body movements (as described above). · Switching from sitting to standing. Walking Position: · Walking up and down a flight of stairs. · Walking in a circle with head turned left and right. The sessions were 5 times a week for 3 weeks (total 15 sessions). each session of 45-60 minutes. In first day of training participants were demonstrated and participants were instructed to perform the procedure. Each exercise was repeated 10 times. Group B: Control Group (Conventional Exercise) CONSIST OF: In this group conventional exercise was given. Participants were asked to perform 7 conventional exercises which include, 1.forward walking 2.backward walking 3.tandem standing 4.tandem walking 5.Side walking 6.Stair climbing 7.Stair descending The sessions were 5 times a week for 3 weeks (15 sessions). On the first day of training participants were demonstrated with a verbal explanation and participants were instructed to perform the procedure. On the second day participants were instructed to perform the procedure. Each step pattern was repeated 10 times.
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