| CTRI Number |
CTRI/2026/03/105666 [Registered on: 09/03/2026] Trial Registered Prospectively |
| Last Modified On: |
|
| 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
|
COMPARATIVE STUDY OF A.I. GENERATED PHYSIOTHERAPY PROTOCOLS & CONVENTIONAL PHYSIOTHERAPY PROTOCOLS FOR LOWER LIMB RECOVERY IN HEMIPARETIC PATIENTS. |
|
Scientific Title of Study
|
COMPARATIVE STUDY OF A.I. GENERATED PHYSIOTHERAPY PROTOCOLS & CONVENTIONAL PHYSIOTHERAPY PROTOCOLS FOR LOWER LIMB RECOVERY IN HEMIPARETIC PATIENTS. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shivam |
| Designation |
PG Student |
| Affiliation |
DAVIPTR |
| Address |
DAV Institute of Physiotherapy & Rehabilitation (DAVIPTR) is Mahatma Hans Raj Marg, Opposite Burlton Park, Jalandhar, Punjab - 144008.
Jalandhar
PUNJAB
144008
India |
| Phone |
8196875362 |
| Fax |
|
| Email |
ss2843391@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Shivam |
| Designation |
PG Student |
| Affiliation |
DAVIPTR |
| Address |
DAV Institute of Physiotherapy & Rehabilitation (DAVIPTR) is Mahatma Hans Raj Marg, Opposite Burlton Park, Jalandhar, Punjab - 144008.
PUNJAB
144008
India |
| Phone |
8196875362 |
| Fax |
|
| Email |
ss2843391@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Shivam |
| Designation |
PG Student |
| Affiliation |
DAVIPTR |
| Address |
DAV Institute of Physiotherapy & Rehabilitation (DAVIPTR) is Mahatma Hans Raj Marg, Opposite Burlton Park, Jalandhar, Punjab - 144008.
PUNJAB
144008
India |
| Phone |
8196875362 |
| Fax |
|
| Email |
ss2843391@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Other [] |
|
|
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 |
| Shivam |
DAV Institute of Physiotherapy And Rehabilitation |
DAV Institute of Physiotherapy & Rehabilitation (DAVIPTR) is Mahatma Hans Raj Marg, Opposite Burlton Park, Jalandhar, Punjab - 144008.
Jalandhar
PUNJAB |
8196875362
ss2843391@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G819||Hemiplegia, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
A.I. PHYSIOTHERAPY PROTOCOL |
Patients will receive an artificial intelligence generated individualized physiotherapy protocol for lower limb rehabilitation. The program will include task oriented training, strengthening exercises, balance training and gait training tailored according to patient assessment findings. Sessions will be conducted 5 days per week for 3 weeks. |
| Comparator Agent |
Conventional Physiotherapy Protocol |
Patients will receive conventional physiotherapy for lower limb rehabilitation including strengthening exercises, range of motion exercises, balance training and gait training as per standard clinical practice. Sessions will be conducted 5 days per week for 3 weeks. |
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
1.Age 35–55 years[31]
2.Patients diagnosed with first-ever unilateral hemiparesis
3.Able to follow simple commands (MINI MENTAL SCALE GREATER THAN EQUAL TO 24)
4.Able to stand with/without support
|
|
| ExclusionCriteria |
| Details |
1.Severe cognitive impairment (MINI MENTAL SCALE less than 24)
2.Unstable cardiovascular or respiratory conditions such as uncontrolled bronchial asthma, pulmonary hypertension, severe dyspnoea, congestive heart failure, cardiac pacemaker, unstable angina, etc.
3.Severe musculoskeletal conditions limiting ambulation such as recent fractures, severe osteoarthritis, post -surgical musculoskeletal condition, etc.
4.Recurrent stroke
5.Pre-existing diagnosed neurological disorders such as Parkinsons disease, Multiple Sclerosis, Spinal Cord Injury, etc.)
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare A.I. generated physiotherapy protocols & conventional physiotherapy protocols for lower limb recovery in hemiparetic patients. |
NIL |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To investigate the pre-treatment and post-treatment effect of conventional physiotherapy in lower limb functional motor recovery in hemiparetic patients.
2.To investigate the pre-treatment and post-treatment effect of AI generated physiotherapy protocol in lower limb functional motor recovery in hemiparetic patients.
3.To compare the outcomes (balance, ambulation, lower-limb motor function) of AI-generated physiotherapy protocols with conventional physiotherapy protocols on lower limb functional motor recovery in hemiparetic patients.
|
NIL |
|
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Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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)
|
01/05/2026 |
| 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="1"
Months="6"
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
|
The synopsis presents a study comparing AI-generated physiotherapy protocols with conventional physiotherapy protocols for improving lower-limb recovery in hemiparetic stroke patients. The study will include 20 participants randomly divided into two groups, each receiving treatment for 3 weeks (5 days per week). Outcomes such as balance, ambulation, and lower-limb motor function will be assessed using the Berg Balance Scale, 6-Minute Walk Test, and Fugl-Meyer Assessment (LE). The research aims to determine whether AI-generated rehabilitation protocols can provide better functional recovery than traditional physiotherapy approaches. |