| CTRI Number |
CTRI/2025/02/081153 [Registered on: 24/02/2025] Trial Registered Prospectively |
| Last Modified On: |
21/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
How Functional Electrical Stimulation with body Weight Supported Treadmill training and lower limb strengthening exercises will improve walking in Incomplete spinal cord injury |
|
Scientific Title of Study
|
Combined Use Of Functional Electrical Stimulation With Body Weight Supported Treadmill Training And Lower Limb Strength Training Exercise To Improve Gait Parameters In Individuals With Incomplete Spinal Cord Injury |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Reddycharla Reddamma |
| Designation |
Masters of physiotherapy |
| Affiliation |
R.L. Jalappa College of Physiotherapy, |
| Address |
R.L. Jalappa College of Physiotherapy, Sri Devaraj Urs Academy of Higher Education and Research, Kolar. Karanataka, 563101.
Kolar
KARNATAKA
563101
India |
| Phone |
9347726015 |
| Fax |
|
| Email |
reddycherlareddamma@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sarulatha H |
| Designation |
Professor and Guide |
| Affiliation |
R.L. Jalappa College of Physiotherapy, |
| Address |
R.L. Jalappa College of Physiotherapy, Sri Devaraj Urs Academy of Higher Education and Research, Kolar, Karanataka. 563101.
Kolar
KARNATAKA
563101
India |
| Phone |
9686235790 |
| Fax |
|
| Email |
charuparthe@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sarulatha H |
| Designation |
Professor and Guide |
| Affiliation |
R.L. Jalappa College of Physiotherapy, |
| Address |
R.L. Jalappa College of Physiotherapy, Sri Devaraj Urs Academy of Higher Education and Research, Kolar, Karanataka. 563101.
Kolar
KARNATAKA
563101
India |
| Phone |
9686235790 |
| Fax |
|
| Email |
charuparthe@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Devaraj Urs Academy of higher education and research, kolar, Karnataka, 563101 |
|
|
Primary Sponsor
|
| Name |
Sri Devaraj Urs Academy of Higher Education and Research , Kolar . |
| Address |
R.L. Jalappa College of Physiotherapy, Sri Devaraj Urs Academy of Higher Education and Research, Kolar, Karanataka,563101. |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Dr Sarulatha H |
R.L Jalappa Hospital and Research Center |
R.L. Jalappa college of Physiotherapy, Neurophysiotherapy Unit, room number 07,Sri Devaraj Urs Academy of Higher Education and Research , Kolar, Karnataka,563101 .
Kolar
KARNATAKA |
09686235790
charuparthe@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| R.L. Jalappa College of Physiotherapy, |
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 |
| Intervention |
Combined use of Functional Electrical stimulation with body weight supported treadmill training and lower limb strength training on gait parameters in individuals with incomplete spinal cord injury |
6 sessions per week
3 days-fes with BWSTT
3 days-strengthing exercise |
| Comparator Agent |
N/A |
N/A |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Spinal cord lesion - C2 - L1
ASLA Scale grade C and D
Atleast 3 months post spinal cord injury
Able to walk atleast 3 meters with assistance
Age group between 30 to 60 |
|
| ExclusionCriteria |
| Details |
Lower limb implants
Lower limb deformities
Diagnosed for cardio pulmonary disease on treatment in last 3 months |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
6 minute walk test
10 meter walk test
Hand held dynamometer |
baseline to 3 months after intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| N/A |
N/A |
|
|
Target Sample Size
|
Total Sample Size="26"
Sample Size from India="26"
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
|
N/A |
|
Date of First Enrollment (India)
|
07/03/2025 |
| 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
|
This study is a quasi- experimental , interventional study investigating the Combined use of Functional Electrical Stimulation with body supported treadmill training and lower limb strength training on gait parameters in individuals with incomplete spinal cord injury patients. The intervention period is 3 months in 26 patients from age 30 to 60 years old that will be conducted in physiotherapy out patient department of R.L Jalapa Hospital, Kolar , Karanataka, India. The primary outcome measures will be 6 minute walk test, 10 meter walk test and Hand held Dynamometer. |