| CTRI Number |
CTRI/2024/02/062808 [Registered on: 19/02/2024] Trial Registered Prospectively |
| Last Modified On: |
24/07/2024 |
| 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 sustaining paretic lower limb on an unstable surface provoke muscle contraction in lower extremity in patients with hemiplegia |
|
Scientific Title of Study
|
Effect of sustaining paretic lower limb on an unstable surface to provoke muscle contraction in lower extremity in patients with hemiplegia. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
J mishal devadhanam |
| Designation |
MPT Neurosciences |
| Affiliation |
Sri Ramachandra Institute of Higher Education and Research |
| Address |
Department of Physiotherapy
1- Sri ramachandra nagar, porur, Chennai 116
Chennai TAMIL NADU 600116 India |
| Phone |
9445639204 |
| Fax |
|
| Email |
j.mishal08@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr R Sivakumar |
| Designation |
MPT Neurosciences, PhD, FAIMER |
| Affiliation |
Sri Ramachandra Institute of Higher Education and Research |
| Address |
Department of Physiotherapy
1- Sri ramachandra nagar, porur , chennai 116
Chennai TAMIL NADU 600116 India |
| Phone |
9840068412 |
| Fax |
|
| Email |
rsivkumar@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
J mishal devadhanam |
| Designation |
MPT Neurosciences |
| Affiliation |
Sri Ramachandra Institute of Higher Education and Research |
| Address |
Department of Physiotherapy
1- Sri ramachandra nagar, porur, chennai 116
Chennai TAMIL NADU 600116 India |
| Phone |
9445639204 |
| Fax |
|
| Email |
j.mishal08@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Ramachandra Institute of Higher Education and Research
Address: 1- Sri ramachandra nagar, porur, chennai 116 |
|
|
Primary Sponsor
|
| Name |
Mishal Devadhanam J |
| Address |
1- sri ramachandra nagar porur chennai 600116 |
| 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 |
| Mishal Devadhanam J |
Sri Ramachandra Medical Centre and Hospital., Chennai 600116. |
Neurology and Neurosurgery wards
1- sri ramachandra nagar porur chennai 600116 Chennai TAMIL NADU |
9445639204
j.mishal08@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sri Ramachandra Institute of higher education and research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G00-G99||Diseases of the nervous system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional therapy |
1.AROM exs 10 reps
2.Pelvic Bridging 10 reps
3.Hip flexion and extension exs 10 reps
4.Weight bearing to lower limbs 10reps
5.Quadriceps end range flexion exs 10 reps
6.Facilitating Dorsiflexion by taping the muscles 10 reps
7.Facilitating Quadriceps by taping the muscle group 10reps |
| Intervention |
Placing the paretic lower limb on unstable surface |
Placing the paretic lower limb on unstable surface for 10 sec for 10 rep/session for 2 weeks |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
85.00 Year(s) |
| Gender |
Both |
| Details |
1. First-time stroke patients who are able to understand the commands to perform the activities for the study
2. Diagnosed ischemic stroke within 5 days of stroke
3. Chedoke-McMaster Stroke Assessment: Motor recovery stage 2 or less than in lower extremity
4. Ability to maintain unsupported sitting in bed or on a chair
|
|
| ExclusionCriteria |
| Details |
1. Patients who do not comprehend to commands.
2. Patients with any other neurological or orthopaedic impairments that would limit the ability to undertake the activity.
3. History of any lower limb injury that can affect the outcome of the study.
4. Patients with profound proprioception deficit in the paretic lower extremity.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| If the study is successful, then this could be simple training with minimal equipment and minimal manual assistance and easy self- exercise for the patient, as well as functional training as well. |
2weeks
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Change in EMG (i.e) increase in amplitude of the EMG |
2weeks |
|
|
Target Sample Size
|
Total Sample Size="56" Sample Size from India="56"
Final Enrollment numbers achieved (Total)= "56"
Final Enrollment numbers achieved (India)="56" |
|
Phase of Trial
|
Phase 1/ Phase 2 |
|
Date of First Enrollment (India)
|
20/02/2024 |
| Date of Study Completion (India) |
22/06/2024 |
| Date of First Enrollment (Global) |
20/02/2024 |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0" Months="6" 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
Modification(s)
|
Subjects
with First-time ischemic stroke who can follow the commands to perform the
activities for the study, having motor recovery of Brunnstrom stage 2 and below
in lower extremity and having the ability to maintain unsupported sitting in
bed were included in the study. Subjects with any other neurological or
orthopedic impairments that would limit the ability to undertake the activity,
presence of profound spasticity and having history of lower limb injury that
can affect the outcome of the study were not included in the study. Subjects
with profound proprioception deficit in the paretic lower extremity were also
excluded.
Sample
size was calculated with a sample of 10 stroke survivors, meeting the inclusion
criteria. They were given training in supine similar to the study protocol, to
stimulate muscle contraction in gluteus medius. Pre and post intervention surface
electromyographic measurement was taken as per the standard protocol. The
difference was considered for sample size calculation, with alpha error 0.05,
effect size 0.9. The calculated number was 28 subjects in each group.
Subjects
meeting these inclusion criteria were included in the study after obtaining a
written informed consent from willing participants. Surface electromyography (SEMG) recording were taken
from paretic Gluteus medius, Tensor fascialata and Quadriceps femoris muscles
for all the participants on the day of inclusion into the study. Baseline SEMG for
tensor fascialata and Gluteus medius muscles was recorded with participants in
supine lying and for Quadricep femoris muscle, the participants were positioned
in high sitting. Electrode position for EMG was standardised based on Surface
Electromyography for the Non-Invasive Assessment of Muscles (SENIAM) guidelines www.seniam.org .As per the guidelines, for Tensor
fascialata, the active electrode was placed on lateral aspects of thigh, the
reference electrode was placed on Anterior superior iliac spine and the ground
electrode was placed on the lateral condyle of the femur and the participants
were instructed to attempt to abduct their paretic limb. For Gluteus medius, the
active electrode was placed on posterolateral aspect of the muscle belly, the
reference electrode was placed on the posterior superior iliac spine, the
ground electrode was placed on lateral condyle of femur and the participants
were instructed to attempt to abduct their paretic limb. For Quadricep femoris, the active electrode
was placed at the muscle belly, the reference electrode was placed 5cm below
the anterior superior iliac spine and ground electrode was placed above the
patella and participants were instructed to attempt to extend their paretic
limb. SEMG was recorded using Neuro trac software 4.0 from VM (Verity Medical
Ltd, United Kingdom) using silver chloride adhesive electrodes.
Participants
were randomly allocated by block randomization of four into two groups. The control group had the routine care and the experimental group were
given the routine care along with training to hold their paretic lower limb on
unstable surfaces in supine lying and high sitting. In routine care participants in both the group
received 45 minutes of physiotherapy including facilitatory techniques for
upper extremity, lower extremity and trunk and functional training.
In addition, the participants in experimental group were instructed to
stabilize/hold their paretic limb on a ball, while ensuring the ball remained
in place. The interventions were given for 10session
over 10 days.
Post-intervention
the SEMG recordings from Gluteus
medius, tensor fascialata and quadriceps femoris muscles were taken 6 hours
after the completion of 10 sessions of therapy, in the similar procedure as
base line recording.
Data analysis:
The average SEMG values of each
muscle is taken for data analysis. The maximum value among the three trials was
considered for testing. The within group and between the group data was tested
using paired and un-paired “t†test, with significance level at p≤0.05. |