| CTRI Number |
CTRI/2024/10/075752 [Registered on: 23/10/2024] Trial Registered Prospectively |
| Last Modified On: |
19/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
"Effectiveness of G-Gaiter Robotic-Assisted Gait Training in Improving Gait Function in Post-Stroke Patients: An Interventional Study" |
|
Scientific Title of Study
|
Robotic assisted gait training with G-Gaiter in post stroke patients- An Interventional Study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Alka Ragh V |
| Designation |
Post graduate resident |
| Affiliation |
Yenepoya Physiotherapy College |
| Address |
Yenepoya physiotherapy college. Naringana, 6th floor, Deralakatte
Mangalore, Karnataka
India
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9400461446 |
| Fax |
|
| Email |
3007alkaragh@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Mariyamath Arifa |
| Designation |
Assistant professor |
| Affiliation |
Yenepoya Physiotherapy College |
| Address |
Yenepoya Physiotherapy College,
Naringana, 6th floor, Deralakatte,
Mangalore , Karnataka
India
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
8123111672 |
| Fax |
|
| Email |
arifamariyam.am@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Mariyamath Arifa |
| Designation |
Assistant professor |
| Affiliation |
Yenepoya Physiotherapy College |
| Address |
Yenepoya Physiotherapy College.
Naringana, 6th floor, Deralakatte, Dakshina kannada,
Mangalore
India
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
8123111672 |
| Fax |
|
| Email |
arifamariyam.am@gmail.com |
|
|
Source of Monetary or Material Support
|
| Yenepoya Physiotherapy College, Yenepoya deemed to be university, Deralakatte,Mangalore,Dakshina Kannada, PIN code:575018 |
|
|
Primary Sponsor
|
| Name |
Alka Ragh V |
| Address |
Yenepoya physiotherapy college. Naringana, Deralakatte, Mangalore- 575018
Karnataka |
| Type of Sponsor |
Other [Self ] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Subhalakshmi |
Thanal Brain& Spine Medcity |
3rd floor,physiotherapy department,kanjirode, Kannur-670592
Kannur
KERALA |
8606950002
brainspine@thanal.org.in |
| Mariyamath Arifa |
Yenepoya Ayurveda medical college and hospital |
4th floor, physiotherapy OPD,Ayush campus,Naringana, Mangalore -575018
Dakshina Kannada
KARNATAKA |
8123111672
arifamariyam.am@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Thanal Brain and Spine Medcity Ethics Commitee |
No Objection Certificate |
| Yenepoya ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G968||Other specified disorders of central nervous system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional gait training |
Walking on parallel bar in a straight line, and sideways
Total duration-2 session/day
Total session- 5days/ week for 4 week |
| Intervention |
Robotic gait training |
G-gaiter gait training
Total duration-2 session/day
Total session- 5days/ week for 4 week |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Independent outdoor walking before the episode of stroke.
Ability to follow one-step command.
Ability to tolerate passive standing for atleast 15 minutes.
Acute stroke (no longer than 6 weeks).
Brunnstrom stage 1. |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Modified Functional Ambulation Category.
Modified river mead mobility index |
Walking ability and Mobility |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Berg balance scale |
Dynamic balance |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="40" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
05/11/2024 |
| Date of Study Completion (India) |
10/05/2025 |
| 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)
|
Not Yet Recruiting |
| 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
|
Robotic gait training has been found to be an effective treatment approach that helps boost patient confidence during gait training. This study investigates the effectiveness of using a robotic G-Gaiter for gait training in post-stroke patients. The findings will compare the G-Gaiter with conventional gait training methods, highlighting its positive effects. This research will provide short-term benefits for patient recovery and inform therapists about its advantages |