| CTRI Number |
CTRI/2024/05/067499 [Registered on: 16/05/2024] Trial Registered Prospectively |
| Last Modified On: |
10/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Other |
|
Public Title of Study
|
Effect of treadmill training on activation of tibialis anterior muscle in stroke individuals |
|
Scientific Title of Study
|
Effect of normal versus inclined treadmill training on activation of tibialis anterior muscle in stroke individuals |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Charchika Mohanty |
| Designation |
Post Graduate Student |
| Affiliation |
Dr.D.Y.PATIL COLLEGE OF PHYSIOTHERAPY |
| Address |
Dr.D.Y.Patil College of Physiotherapy, Department of neurosciences , third floor Sant Tukaram Nagar, Pimpri Colony, Pimpri , Pune Maharashtra
Pune
MAHARASHTRA
411018
India |
| Phone |
8895592781 |
| Fax |
|
| Email |
charchika1834@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sanjivani Kamble |
| Designation |
Associate Professor |
| Affiliation |
Dr.D.Y.PATIL COLLEGE OF PHYSIOTHERAPY |
| Address |
Department of Neurosciences, 3rd floor Dr.D.Y.Patil College of PhysiotherapySant Tukaram Nagar, Pimpri Colony, Pimpri-chinchiwad, Pune Maharashtra
Pune
MAHARASHTRA
411018
India |
| Phone |
9860117191 |
| Fax |
|
| Email |
sanjivani.dhote@dpu.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sanjivani Kamble |
| Designation |
Associate Professor |
| Affiliation |
Dr.D.Y.Patil College of Physiotherapy |
| Address |
Dr.D.Y.Patil College of Physiotherapy,Neuroscience department 3rd floor, Sant Tukaram Nagar, Pimpri Colony, Pimpri-chinchiwad, Pune Maharashtra
Pune
MAHARASHTRA
411018
India |
| Phone |
9860117191 |
| Fax |
|
| Email |
sanjivani.dhote@dpu.edu.in |
|
|
Source of Monetary or Material Support
|
| Dr.D.Y.Patil College of Physiotherapy, Neurosciences |
|
|
Primary Sponsor
|
| Name |
Charchika Mohanty |
| Address |
Dr.D.Y.Patil College of Physiotherapy,Sant Tukaram nagar, Pimpri- Chinchwad, Maharashtra 411018 |
| 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 |
| DrSanjivani Kamble |
Dr.D.Y.Patil College of Physiotherapy ,Pune |
Department of Neurosciences, 3rd floor Dr.D.Y.Patil College of PhysiotherapySant Tukaram Nagar, Pimpri Colony, Pimpri-chinchiwad, Pune Maharashtra
Pune
MAHARASHTRA |
9860117191
sanjivani.dhote@dpu.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee of Dr. D. Y. Patil college of physiotherapy,pune |
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 |
CONTROL GROUP |
Surface EMG will be recorded on tibialis anterior muscle on pre-intervention 1st week.
Treatment will be given Group A
consecutively for 4 days per week for 4 weeks on normal treadmill.
The belt speed will be increased slowly until a comfortable walking speed was reached as determined by the subject.
Surface EMG will be recorded on tibialis anterior muscle on post-intervention by 4th week.
|
| Intervention |
EXPERIMENTAL GROUP |
Surface EMG will be recorded on tibialis anterior muscle on pre-intervention 1st week.
Treatment will be given Group B
consecutively for 4 days per week for 4 weeks on inclined treadmill.
The belt speed will be increased slowly until a comfortable walking speed was reached as determined by the subject.
Surface EMG will be recorded on tibialis anterior muscle on post-intervention by 4th week.
|
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1)Individuals diagnosed with stroke more than 6 months.
2)Individuals with Spasticity of Tibialis Anterior muscle range from (grade 1,1+) according to modified Ashworth scale.
3)Individuals with Functional ambulatory categories score level (4,5).
4)Vitals should be the normal limit.
|
|
| ExclusionCriteria |
| Details |
1) Individuals with Atrial fibrillation
2) Individuals with uncontrolled BP
3) Individuals with active cancer
4) Individuals with lower extremity contractures,
5) Individuals with rheumatoid arthritis.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| surface electromyography |
pre value 0th week
post value 4th week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| N/A |
N/A |
|
|
Target Sample Size
|
Total Sample Size="32"
Sample Size from India="32"
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 2 |
|
Date of First Enrollment (India)
|
20/06/2024 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
Stroke often weakens muscle, leading to gait impairments and difficulty walking. The impact of tibialis anterior activation can help develop more effective rehabilitation strategies to improve gait function, foot drop, dorsiflexion of the foot and walking ability. The treadmill training increase gait speed and walking endurance balance and restoration of gait in stroke individuals.
This study is conducted to determine the locomotor training for maximizing tibialis anterior muscle activation by using surface electromyography on the paretic side on 32 stroke individuals could lead to the development of more effective rehabilitation strategies for improving gait patterns and quality of life in stroke population.
|