| CTRI Number |
CTRI/2026/02/104643 [Registered on: 24/02/2026] Trial Registered Prospectively |
| Last Modified On: |
24/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Efficacy of a Personalized Physiotherapy Protocol Stratified by Apraxia Subtype and Lesion Location Versus Standard Care in Management of Post-Stroke Limb Apraxia |
|
Scientific Title of Study
|
Evaluation of Comparative Efficacy of a Personalized Physiotherapy Protocol Stratified by Apraxia Subtype and Lesion Location Versus Standard Care in Management of Post-Stroke Limb Apraxia: A Randomized Controlled Trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Anshu Tikariha |
| Designation |
Assistant Professor |
| Affiliation |
|
| Address |
Department of Neurophysiotherapy, Ravi Nair Physiotherapy College, Datta Meghe Institute of Higher Education and Research, Sawangi (Meghe), Wardha, Maharashtra
Wardha
MAHARASHTRA
442001
India |
| Phone |
9479262305 |
| Fax |
|
| Email |
tikarihaanshu@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Anshu Tikariha |
| Designation |
Assistant Professor |
| Affiliation |
|
| Address |
Department of Neurophysiotherapy, Ravi Nair Physiotherapy College, Datta Meghe Institute of Higher Education and Research, Sawangi (Meghe), Wardha, Maharashtra
Wardha
MAHARASHTRA
442001
India |
| Phone |
9479262305 |
| Fax |
|
| Email |
tikarihaanshu@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Anshu Tikariha |
| Designation |
Assistant Professor |
| Affiliation |
|
| Address |
Department of Neurophysiotherapy, Ravi Nair Physiotherapy College, Datta Meghe Institute of Higher Education and Research, Sawangi (Meghe), Wardha, Maharashtra
Wardha
MAHARASHTRA
442001
India |
| Phone |
9479262305 |
| Fax |
|
| Email |
tikarihaanshu@gmail.com |
|
|
Source of Monetary or Material Support
|
| Acharya Vinoba Bhave Rural Hospital, Sawangi (Meghe), Wardha, Maharashtra |
| Datta Meghe Institute of Higher Education and Research, Sawangi (Meghe), Wardha, Maharashtra |
|
|
Primary Sponsor
|
| Name |
Anshu Tikariha |
| Address |
Ravi Nair Physiotherapy College, Datta Meghe Institute of Higher Education and Research, Sawangi (Meghe), Wardha, Maharashtra |
| 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 |
| Dr Anshu Tikariha PT |
Centre for Neurosciences, Acharya Vinoba Bhave Rural Hospital |
Sawangi (Meghe), Wardha, Maharashtra
Wardha
MAHARASHTRA |
9479262305
tikarihaanshu@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITEE |
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 |
| Intervention |
Personalized physiotherapy protocol |
Personalized physiotherapy protocol stratified by apraxia subtype (ideomotor and ideational) and lesion location (frontal and parietal) |
| Comparator Agent |
Standard physiotherapy care |
Participants will receive conventional physiotherapy for 6 weeks, five days per week, with each session lasting 45–60 minutes. The intervention includes strategy and gesture training (three sessions per week, 30 minutes each; two restorative gesture training sessions and one strategy training session) along with hemiplegia-oriented physiotherapy. |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. First ever stroke with left-sided unilateral vascular lesion, confirmed via neuroimaging within 3 to 6 months of stroke. 2. Right handed individuals, as determined by Briggs and Nebes Laterality Inventory, to control for hemispheric dominance in praxis processing. 3. Cognitive function within normal range, indicated by a Mini-Mental State Examination (MMSE) score more than 23 4. Presence of limb apraxia, confirmed by Van Heugten Apraxia Test with a score less than 86. For IA, the De Renzi Test for IA score is between 0 to 14 and for IMA, the De Renzi Test for IMA score is between 0 to 72. 5. Score between 0 and 3 on the Modified Rankin Scale (mRS) that is mild to moderately severe post-stroke disability 6. Spasticity graded less than 2 according to the Modified Ashworth Scale and Brunnstrom stage 4 and above. 7. Age between 40 and 65 years. |
|
| ExclusionCriteria |
| Details |
1. Presence of neurodegenerative disorders like Parkinsons disease, dementia, Alzheimers and severe cognitive impairment. 2.Severe aphasia using Aphasia Severity Rating, ASR, more than or equal to 2. 3.Previous history of other neurological disorders, a known intellectual or learning disorder 4. Severe comorbid medical conditions or debilitating chronic disease like chronic liver disease or chronic kidney disease, limiting participation in rehabilitation |
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Functional independence (Barthel Index score, Functional Independence Measure), Motor planning accuracy
|
3 weeks and 6 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Quality of Life (Stroke Impact scale-16) |
3 weeks and 6 weeks |
|
|
Target Sample Size
|
Total Sample Size="96"
Sample Size from India="96"
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)
|
16/03/2026 |
| 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="4"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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 randomized, double-blind, parallel-group trial compares a personalized physiotherapy protocol stratified by apraxia subtype and lesion location with standard physiotherapy care in patients with post-stroke limb apraxia. Ninety-six participants will be randomized (1:1) to receive either personalized or conventional rehabilitation, five sessions per week for six weeks. Primary outcomes include functional independence (Barthel Index, FIM) and motor planning accuracy assessed using kinematic parameters, while quality of life (SIS16) is a secondary outcome. The study hypothesizes that stratified, lesion-informed physiotherapy will produce superior clinical improvement compared to standard care. |