FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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.


 
Close