| CTRI Number |
CTRI/2024/01/062132 [Registered on: 31/01/2024] Trial Registered Prospectively |
| Last Modified On: |
17/03/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effectiveness of closed chain exercises on walking pattern in stroke patients |
|
Scientific Title of Study
|
Effectiveness of isokinetic exercises on gait parameters in hemiplegic patients with gait lab. A randomized controlled trial |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr. Sanjiv Kumar |
| Designation |
Professor |
| Affiliation |
KLE Institute of Physiotherapy |
| Address |
Dr. Sanjiv Kumar
KLE Institute of Physiotherapy
2nd floor
Nehru Nagar, near Dr. Prabhakar Kore KLE Hospital main gate
Belagavi
Belgaum
KARNATAKA
590010
India |
| Phone |
9448745648 |
| Fax |
|
| Email |
sanjiv3303@rediffmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Varsha Huddar |
| Designation |
Assistant Professor |
| Affiliation |
KLE Institute of Physiotherapy |
| Address |
Varsha Huddar
KLE Institute of Physiotherapy
2nd floor
Nehru Nagar near Dr. Prabhakar Kore KLE Hospital main gate
Belagavi
Belgaum
KARNATAKA
590010
India |
| Phone |
9880733370 |
| Fax |
|
| Email |
drvarshabadli@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Varsha Huddar |
| Designation |
Assistant Professor |
| Affiliation |
KLE Institute of Physiotherapy |
| Address |
Varsha Huddar
KLE Institute of Physiotherapy
2nd floor
Nehru Nagar near Dr. Prabhakar Kore KLE Hospital main gate
Belagavi
Belgaum
KARNATAKA
590010
India |
| Phone |
9880733370 |
| Fax |
|
| Email |
drvarshabadli@gmail.com |
|
|
Source of Monetary or Material Support
|
| KLE Academic Higher Education and Research University
JNMC Campus
Nehru Nagar
Belagavi
590010
|
|
|
Primary Sponsor
|
| Name |
KLE Academic Higher Education and Research University |
| Address |
KLE Academic Higher Education and Research University
Nehru Nagar
Belagavi |
| 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 |
| Varsha Huddar |
Dr. Prabakar Kores KLE Hospital and research center |
Advanced Physiotherapy center
Room no- 39
At basement
Belgaum
KARNATAKA |
9880733370
drvarshabadli@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| KLE Institute of Physiotherapy- Research and Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G819||Hemiplegia, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
closed chain exercises on land
|
conventional close kinetic chain exercises
full range of motion
spasticity management by positioning, prolonged icing, brushing, gentle stroking
mat activities
bridging exercises
stretching
strengthening exercises
weight bearing exercises
single one third knee bend ex
stationary bicycle
step up and down ex
dorsiflexion and pushing the wall
lunging
rolling towel with toes extension and inversion
all exercise will be repeated 10 times and tree times a week |
| Intervention |
closed kinetic chain exercises on isokinetic unit |
conventional close kinetic chain exercises
full range of motion
spasticity management by positioning, prolonged icing, brushing, gentle stroking
mat activities
bridging exercises
stretching
strengthening exercises
weight bearing exercises
closed kinetic chain exercise protocol at varied velocity
week 1 with 150/sec velocity
week 2 with 120/sec velocity
week 3 and 4 with 90/sec velocity
all exercise will be repeated 10 times and tree times a week |
|
|
Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Hemiparesis due to unilateral stroke
Stroke duration more than 5 months
Paresis of either right or left side
Functional ambulation classification level 2 and above
Ability to walk for a distance of at least 10 meters without any orthotics and walking device
Willing to participate in the study |
|
| ExclusionCriteria |
| Details |
unable to stand,
have central nervous system disorders ,
lower limb amputation, visual deficits,
orthopedic conditions such as CTEV, acute fractures, pregnancy and any cardiovascular problem |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Gait parameters
Spatial and temporal parameters of gait as analyzed by 3D gait analyzer lab |
At baseline and after 4 weeks of intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Quality of life SF-36 |
before the intervention
post 2 week of intervention |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
Final Enrollment numbers achieved (Total)= "17"
Final Enrollment numbers achieved (India)="17" |
|
Phase of Trial
|
Phase 1 |
|
Date of First Enrollment (India)
|
10/02/2024 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
Introduction: Sarah souza pontes et al conducted a systemic review
on effects of isokinetic muscle strengthening on muscle strength, mobility, and
gait in post-stroke patients which concluded that isokinetic muscle strengthening
seems to be a useful strategy for improving muscle strength, mobility, and gait
in post-stroke patients.
According to the literature variable treatments have
been used to improve the gait parameters and muscular strength which are
backward walking, treadmill walking, mirror box therapy,
open chain and closed chain kinematic exercises etc along with
different assessing instruments.
Need
for the study: The
combination of using isokinetic device and gait analyzer for assessment is the
new need to check for the effectiveness on gait parameters in hemiplegic
patients. Due to dearth in the adequate information of using an isokinetic
device and gait analyzer as an assessment and rehabilitative tool further
insight is needed. |