| CTRI Number |
CTRI/2026/02/103970 [Registered on: 16/02/2026] Trial Registered Prospectively |
| Last Modified On: |
15/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
improving walking and daily function in stroke patients through foot dexterity training |
|
Scientific Title of Study
|
Effects of lower limb dexterity training on gait and functional performance in stroke population |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Jasti Krishna Pramada |
| Designation |
Post Graduate |
| Affiliation |
|
| Address |
Ramaiah College of Physiotherapy, MS Ramaiah nagar, MSRIT Post, Bangalore
Bangalore
KARNATAKA
560054
India |
| Phone |
9381967387 |
| Fax |
|
| Email |
pramadajasti@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ramesh Debur |
| Designation |
Professor |
| Affiliation |
Ramaiah College of Physiotherapy |
| Address |
Ramaiah College of Physiotherapy, MS Ramaiah nagar, MSRIT Post, Bangalore
Bangalore
KARNATAKA
560054
India |
| Phone |
9845544848 |
| Fax |
|
| Email |
rameshdebur.rcp@msruas.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Ramesh Debur |
| Designation |
Professor |
| Affiliation |
Ramaiah College of Physiotherapy |
| Address |
Ramaiah College of Physiotherapy, MS Ramaiah nagar, MSRIT Post, Bangalore
Bangalore
KARNATAKA
560054
India |
| Phone |
9845544848 |
| Fax |
|
| Email |
rameshdebur.rcp@msruas.ac.in |
|
|
Source of Monetary or Material Support
|
| Ramaiah College of Physiotherapy, MSR Nagar, MSRIT Post, Bangalore, Karnataka, India, 560054 |
|
|
Primary Sponsor
|
| Name |
Ramaiah College of Physiotherapy |
| Address |
Ramaiah College of Physiotherapy, MS Ramaiah nagar, MSRIT Post, Bangalore, Karnataka, India, 560054 |
| Type of Sponsor |
Other [college] |
|
|
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 |
| Jasti Krishna Pramada |
Ramaiah memorial hopsital |
Department of rehabilitation, Ramaiah memorial hospital, MS Ramaiah nagar, MSRIT post, Bangalore
Bangalore
KARNATAKA |
9381967387
pramadajasti@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ramaiah Medical College Ethics Committee |
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 |
Lower Limb Dexterity Training |
Lower limb dexterity training is given as an intervention to stroke patients to see the improvements in gait and functional performance. it will be given as a 3 day intervention for 20 minutes per session. |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Individuals clinically diagnosed with hemiparetic stroke of late sub acute to chronic stages
Participants who can walk independently
Fugl meyer lower limb score less than 21
Participants who can understand commands |
|
| ExclusionCriteria |
| Details |
Orthopedic and other neurological conditions interfering with gait
Unstable medical conditions |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Gait parameters and TUG score |
day 1 and day 3 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="17"
Sample Size from India="17"
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)
|
26/02/2026 |
| 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="0"
Months="5"
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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [pramadajasti@gmail.com].
- For how long will this data be available start date provided 02-01-2027 and end date provided 15-10-2027?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - nil
|
|
Brief Summary
|
This study is a single arm study aims to evaluate the effects of lower limb dexterity training on gait and functional performance in stroke patients. Impaired foot and ankle control after stroke can reduce mobility and balance. Participants will undergo three sessions of structured dexterity exercises using the DEXI-Fast device. Gait parameters will be measured with the GAITRite system, and functional performance will be assessed using the Timed Up and Go (TUG) test. Pre- and post-training outcomes will be compared to determine improvements. The study seeks to identify whether enhancing lower limb dexterity can improve gait and functional independence after stroke. |