| CTRI Number |
CTRI/2025/05/087588 [Registered on: 26/05/2025] Trial Registered Prospectively |
| Last Modified On: |
23/05/2025 |
| 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
|
Boosting Leg Recovery After Stroke: A Study on Watching and Imagining Movements |
|
Scientific Title of Study
|
Combined Effect of Action Observation and Motor Imagery on Motor Function of Lower Limb Among Patients with Acute Stroke: 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 |
Dr Shreya Franklin |
| Designation |
postgraduate |
| Affiliation |
NITTE Institute of Physiotherapy |
| Address |
Department of Physiotherapy,room no 20,second based division,
Nitte Institute of physiotherapy NITTE (Deemed to be university)
Derlakatte, Mangaluru
KARNATAKA
575018
India
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9833390313 |
| Fax |
|
| Email |
shreyafranklin@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Krishna Prasad K M |
| Designation |
Assistant Professor |
| Affiliation |
NITTE Institute of Physiotherapy |
| Address |
Department of Physiotherapy,room no 20,second based division,
Nitte Institute of physiotherapy NITTE (Deemed to be university)
Derlakatte, Mangaluru
KARNATAKA
575018
India
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
8301061501 |
| Fax |
|
| Email |
krinshnapr@nitte.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Krishna Prasad K M |
| Designation |
Assistant Professor |
| Affiliation |
NITTE Institute of Physiotherapy |
| Address |
Department of Physiotherapy,room no 20,second based division,
Nitte Institute of physiotherapy NITTE (Deemed to be university)
Derlakatte, Mangaluru
KARNATAKA
575018
India
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
8301061501 |
| Fax |
|
| Email |
krinshnapr@nitte.edu.in |
|
|
Source of Monetary or Material Support
|
| Department of Physiotherapy,room no 20,second based division,
Nitte Institute of physiotherapy NITTE (Deemed to be university)
Derlakatte, Mangaluru
KARNATAKA
575018
India |
|
|
Primary Sponsor
|
| Name |
Nitte Institute of Physiotherapy |
| Address |
Department of Physiotherapy, Room number 20, second base division, NITTE Institute of Physiotherapy, NITTE (Deemed to be University),Deralakatte. Mangaluru-575018, Karnataka, India |
| Type of Sponsor |
Other [NITTE Institute of Physiotherapy NITTE (Deemed to be University)] |
|
|
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 Shreya Franklin |
Justice K S Hegde Charitable Hospital |
Department number 10
Department of General
Medicine,medical
science complex,
Deralakatte, Mangaluru 575018
Dakshina Kannada
Karnataka
India
Dakshina Kannada
KARNATAKA |
9833390313
shreyafranklin@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee of NITTE Institute of Physiotherapy |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G811||Spastic hemiplegia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Action observation and motor imagery |
Intervention Name: Action Observation and Motor Imagery (AO+MI) Training
Description:
Participants in this group will receive AO+MI training for 3 weeks, 5 days/week, 45 minutes per session.
Each session includes:
Action Observation (AO) – 15 minutes: Participants will watch 30-second videos demonstrating specific lower limb movements.
Motor Imagery (MI) – 15 minutes: Participants will receive verbal cues to mentally rehearse the observed movements without physical execution.
Rest Interval: 1–2 minutes between tasks.
Repetitions: Each movement imagined 3 times.
Week-wise Details:
Week 1:
AO: Watching videos of (i) straight leg raises in supine, (ii) ankle dorsiflexion/plantar flexion, (iii) knee flexion in supine.
MI: Imagining (i) leg lifts in supine, (ii) ankle movements, (iii) knee flexion in supine.
Week 2:
AO: Watching (i) hip lifts in supine, (ii) leg abduction/adduction, (iii) knee extension in sitting.
MI: Imagining (i) hip lifts, (ii) leg lateral movements, (iii) knee extension in sitting.
Week 3:
AO: Watching (i) knee lifts in sitting, (ii) weight shifting while seated.
MI: Imagining (i) knee lifts, (ii) weight shifting in sitting. |
| Comparator Agent |
conventional physical therapy |
Intervention Name: Conventional Physical Therapy
Type: Physiotherapy
Description:
Participants will undergo conventional physical therapy for 3 weeks, 5 days per week, 45 minutes per session, with 1–2-minute rest breaks between sets.
Week-wise Details:
Week 1–2: Early Mobilization and Bed Exercises
Goals: Prevent complications (e.g., contractures, pressure sores), enhance circulation, and promote muscle activation.
ROM Exercises (10 reps each): Ankle pumps, knee bends, hip flexion/extension
Stretching: Calf, hamstrings, adductors
Muscle Activation:
Isometric contractions of the quadriceps and gluteals (hold 5–10 seconds)
Assisted bridging (5–7 reps)
Mobility Training:
Rolling side to side
Sit-to-supine and supine-to-sit transitions
Week 3: Progressive Mobility and Weight Bearing
Sitting Activities:
Weight shifts (side-to-side, forward-backward; 5–10 reps)
Seated marching (5–10 reps)
Lower Limb Movements:
Assisted knee extension (5–10 reps)
Heel slides (10 reps)
Bridging progression: partial/full bridging (10 reps)
Standing:
Early static standing and weight bearing (1–2 mins, progressing to 5 mins if safe)
|
|
|
Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Patients with MRI or CT-confirmed acute Anterior Cerebral Artery (ACA) stroke
Stroke onset between 7 to 30 days prior to enrollment
Presence of lower limb hemiplegia
Age between 45 and 80 years
Both male and female participants
Glasgow Coma Scale (GCS) score of 10 or more out of 15
Montreal Cognitive Assessment (MoCA) score of 18 or higher, indicating stable cognition
Brunnstrom Recovery Stage (BRS) between stage 3 and stage 5
|
|
| ExclusionCriteria |
| Details |
MCA, PCA stroke
Co-existing LL musculoskeletal disorders
Other neurological or psychiatric disorders
severe sensory deficits
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Fugl-Meyer Assessment of Lower Extremity |
Fugl-Meyer Assessment – Lower Extremity (FMAL-LE), a reliable performance-based scale to assess sensorimotor impairment post-stroke. Scored 0–2 per item, max score 34. Assessed pre- and post-intervention (at 3 weeks) to evaluate motor recovery. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Montreal Cognitive Assessment-MoCA |
MoCA will be used pre intervention as a screening tool to assess cognition & orientation, essential for AOT & MI. It evaluates multiple cognitive domains with high sensitivity, specificity ensuring participants can follow instructions & differentiate imagined versus real actions |
|
|
Target Sample Size
|
Total Sample Size="52"
Sample Size from India="52"
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)
|
01/07/2025 |
| 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 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
|
Stroke is a major contributor to adult disability worldwide, often resulting in significant lower limb motor deficits that limit mobility, balance, and independence. While conventional physiotherapy remains the cornerstone of stroke rehabilitation, innovative neurorehabilitation techniques are gaining attention for their ability to promote brain plasticity. Action Observation (AO) and Motor Imagery (MI), two non-invasive, cognitive-based strategies, have independently shown potential to enhance motor recovery. However, limited evidence exists on the combined application of AO and MI in stroke rehabilitation, especially for the lower limbs. This randomized controlled trial investigates the synergistic effect of AO and MI, integrated with standard physiotherapy, on improving lower limb motor function in patients with acute stroke. The study aims to offer a novel, effective, and accessible intervention to accelerate functional recovery and restore independence in stroke survivors |