| CTRI Number |
CTRI/2018/12/016685 [Registered on: 14/12/2018] Trial Registered Prospectively |
| Last Modified On: |
13/12/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Effect of strength training of uninvolved leg on balance and walking among stroke subjects-A Non Randomized Trial |
|
Scientific Title of Study
|
Effect of structured strength training of unaffected lower limb on balance and gait among stroke subjects-A Non Randomized Trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Neha kumari |
| Designation |
Post Graduate student |
| Affiliation |
Manipal Academy of Higher Education |
| Address |
Department of Physiotherapy, Kasturba Medical College Center of Basic Sciences,
Bejai, Mangalore.
Dakshina Kannada
KARNATAKA
575004
India |
| Phone |
9972304205 |
| Fax |
|
| Email |
neha.lpps@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Akshata Nayak |
| Designation |
Assistant Professor-Selection Grade |
| Affiliation |
Manipal Academy of Higher Education |
| Address |
Department of Physiotherapy, Kasturba Medical College Center of Basic Sciences,
Bejai, Mangalore.
Dakshina Kannada
KARNATAKA
575004
India |
| Phone |
9986054034 |
| Fax |
|
| Email |
akshat_nd@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Neha kumari |
| Designation |
Post Graduae Student |
| Affiliation |
Manipal Academy of Higher Education |
| Address |
Department of Physiotherapy, Kasturba Medical College Center of Basic Sciences,
Bejai, Mangalore.
Dakshina Kannada
KARNATAKA
575004
India |
| Phone |
9972304205 |
| Fax |
|
| Email |
neha.lpps@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Manipal Academy of Higher Education |
| Manipal Academy of Higher Education, Madhav Nagar, Manipal, Udupi district, Karnataka - 576104 |
|
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Primary Sponsor
|
| Name |
Manipal Academy of Higher Education |
| Address |
Madhav Nagar,
Manipal |
| Type of Sponsor |
Private medical college |
|
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Details of Secondary Sponsor
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Neha kumari |
KMC, Mangalore |
Department of Physiotherapy,5th floor KMC hospital, Ambedkar circle, Mangalore
Dakshina Kannada
KARNATAKA |
9972304205
neha.lpps@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I693||Sequelae of cerebral infarction, (2) ICD-10 Condition: I69||Sequelae of cerebrovascular disease, (3) ICD-10 Condition: I691||Sequelae of nontraumatic intracerebral hemorrhage, (4) ICD-10 Condition: I690||Sequelae of nontraumatic subarachnoid hemorrhage, (5) ICD-10 Condition: I692||Sequelae of other nontraumatic intracranial hemorrhage, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional Stroke Rehabilitation |
Routinely prescribed exercises for Stroke 45-60 minutes per day for 12 sessions. |
| Intervention |
Structured Strength Training for unaffected lower limb |
Structured Strength Training for unaffected lower limb (15 minutes) along with routinely prescribed exercises for stroke for 45-60 minutes once daily, for 12 sessions. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
85.00 Year(s) |
| Gender |
Both |
| Details |
Clinically stable, single episode of diagnosed case of stroke referred by the Neurologist and Physician.
Ability to understand and follow instructions with MMSE score more than or equal to 23.
Ability to walk 5 metes with or without assistive device.
|
|
| ExclusionCriteria |
| Details |
Stroke Subjects having concurrent neurological disorders like Alzheimer’s, Parkinson etc.
An unstable hypertension or cardiovascular condition, as determined by a physician which may affect the performance.
Any musculoskeletal disorder which may affect the performance.
Infra-tentorial stroke.
Pusher’s syndrome or other perceptual deficits.
Severe visual field deficits |
|
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Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Balance
Observational Gait Analysis |
Pre-intervention
post intervention (2 weeks) |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
| Lower Limb Muscle Strength |
Pre-intervention
Post intervention (2 weeks) |
|
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Target Sample Size
|
Total Sample Size="28"
Sample Size from India="28"
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 1 |
|
Date of First Enrollment (India)
|
16/12/2018 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
|
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Diagnosed stroke subjects, referred by Neurologists to the Department of Physiotherapy will be approached . Informed consent will be taken from willing subjects. The purpose of the study will be explained.Subjects will be screened based on inclusion and exclusion criteria. Demographic and baseline data will be collected through hand held dynamometer, Brunel Balance Scale. Wisconsin Gait Scale and Videography. A camera mounted on tripod stand with spirit level will be kept at 4 meters perpendicular distance from the midpoint of walkway with the height of the camera corresponding to the level of knee joint. Duct tapes will be used to mark the specified distance. Reflective markers will be applied on greater trochanter, lateral condyle of femur, medial malleolus of fibula and head of fifth metatarsal. The subject will be made to ambulate 5 meter distances with or without support according to the subject’s ability and the video will be recorded by GoPro Hero camera. Video analysis of each will be done using Kinovea video analysis software by freezing each stance phase of gait cycle and following things will be measured: 1. Degree of flexion of the hip. 2. Degree of hyperextension of knee . 3. Degree of ankle dorsiflexion. 4. Total time taken to complete the distance. the subjects will be allocated in two groups. A structured strength training of the unaffected lower limb with conventional rehabilitation will given to one group and other group will be receiving conventional rehabilitation. 12 sessions post intervention outcome measurements will be collected.
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