| CTRI Number |
CTRI/2026/02/103815 [Registered on: 13/02/2026] Trial Registered Prospectively |
| Last Modified On: |
25/06/2026 |
| 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
|
Improving Walking Ability in Stroke Patients: Which is Better – Eccentric (Lowering) or Concentric (Lifting) Leg Exercises |
|
Scientific Title of Study
|
Effect of eccentric versus concentric strengthening on functional mobility in subacute stroke 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 |
Farseen Mohammed P |
| Designation |
Post Graduate Student (MPT – Neurosciences) |
| Affiliation |
Yenepoya Deemed to be University |
| Address |
Department of Physiotherapy,
Yenepoya Physiotherapy College,
6th Floor, Ayush Campus,
Naringana, Deralakatte,
Mangaluru
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9895861495 |
| Fax |
|
| Email |
farseenmohammedp@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Lourdhuraj I |
| Designation |
Principal |
| Affiliation |
Yenepoya Deemed to be University |
| Address |
Department of Physiotherapy,
Yenepoya Physiotherapy College,
6th Floor, Ayush Campus,
Naringana, Deralakatte,
Mangaluru
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9940529169 |
| Fax |
|
| Email |
lourdhuraj@yenepoya.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Prof Lourdhuraj I |
| Designation |
Principal |
| Affiliation |
Yenepoya Deemed to be University |
| Address |
Department of Physiotherapy,
Yenepoya Physiotherapy College,
6th Floor, Ayush Campus,
Naringana, Deralakatte,
Mangaluru
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9940529169 |
| Fax |
|
| Email |
lourdhuraj@yenepoya.edu.in |
|
|
Source of Monetary or Material Support
|
| Yenepoya Deemed to be University,
Yenepoya (Ayush) Campus, Naringana, Deralakatte,
Mangaluru – 575018,
Karnataka, India |
|
|
Primary Sponsor
|
| Name |
Farseen Mohammed P |
| Address |
Yenepoya Physiotherapy College, University Road, Deralakatte, Mangaluru, 575018, Karnataka, India |
| Type of Sponsor |
Other [(Self)] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Prof Lourdhuraj I |
Yenepoya Physiotherapy College, University Road, Deralakatte, Mangaluru, 575018, Karnataka, India |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Subhash Rai K N |
Yenepoya Ayurveda Medical College and Hospital |
Department of Physiotherapy,
Yenepoya (AYUSH) Campus,
Naringana, Deralakatte,
4th Floor,
Mangaluru – 575018,
Dakshina Kannada District,
Karnataka, India
Dakshina Kannada
KARNATAKA |
9620310633
drsubhashrai489@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Yenepoya Ethics Committee-3 (YEC-3) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I679||Cerebrovascular disease, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Concentric Strengthening |
The strengthening program targets major lower limb muscles using concentric resistance exercises with weight cuffs. For the quadriceps (knee extensors), the patient performs seated knee extensions (10 reps × 3 sets) with a weight cuff at the ankle, progressing every two weeks by increasing resistance or switching to a standing position. Hamstring curls are done in prone lying with the cuff over the ankle, curling the leg against resistance (10 reps × 3 sets). Progression includes increasing the load or performing seated hamstring curls, starting with body weight and adding resistance as tolerated. Ankle dorsiflexion and plantarflexion exercises involve moving the ankle with resistance in the concentric phase, performed for 3 sets of 10 reps, beginning with 0.5–1 kg and increasing as tolerated before adding reps. For gluteal muscles (hip extensors), bridging exercises are done in supine with a thigh weight cuff (10 reps × 3 sets), progressing every two weeks with increased resistance or advancing to single-leg bridging based on control. Lastly, gluteus medius (hip abductor) strengthening includes sidelying straight leg raises with weight cuffs on the thigh or ankle (10 reps × 3 sets), progressing by adding weight biweekly or transitioning to standing. Each exercise is performed for around 5 minutes per muscle group. |
| Intervention |
Eccentric Strengthening |
The strengthening program focuses on key lower limb muscles using weight cuffs and progressive resistance. For quadriceps, seated knee extensions are performed (10 reps × 3 sets), progressing every 2 weeks by increasing resistance or shifting to standing. Hamstring curls are done in prone lying with weight cuffs (10 reps × 3 sets), with progression via seat adjustments or increased weight. Ankle dorsiflexion/plantarflexion exercises use light resistance (0.5–1 kg) in the eccentric phase, gradually increasing weight as tolerated. Gluteal (hip extensor) strengthening involves bridging with weight cuffs (10 reps × 3 sets), advancing to single-leg bridging and higher resistance biweekly. Gluteus medius (hip abductor) is trained through side-lying leg raises, with resistance increased every two weeks or progressed to standing as control improves. Each session lasts around 5 minutes per muscle group. |
|
Inclusion Criteria
Modification(s)
|
| Age From |
40.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
First ever haemorrhagic stroke confirmed by CT or MRI neuroimaging
Stroke in the subacute phase from one month to six months after onset
Demonstrable lower limb functional impairment including impaired gait, balance or mobility
Modified Rankin Scale score of 2 to 3
Modified Ashworth Scale score of 2 or less in the lower limb
Brunnstrom Stages of Recovery 3 to 5 for the lower limb
Montreal Cognitive Assessment score greater than 24 using validated Kannada and Malayalam versions as appropriate |
|
| ExclusionCriteria |
| Details |
Other neurological disorders including Parkinson disease, multiple sclerosis and peripheral neuropathy
Orthopaedic or musculoskeletal conditions limiting participation in the intervention
Severe or uncontrolled systemic illness including cardiac disease, uncontrolled hypertension or recent myocardial infarction within the previous three months
Severe cognitive dysfunction with Montreal Cognitive Assessment score less than 24 or severe aphasia precluding comprehension of instructions
Bilateral stroke involvement
Concurrent enrolment in another structured lower limb rehabilitation programme |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Timed Up and Go (TUG) Test
|
Baseline (Pre-intervention), End of 4 weeks (Post-intervention)
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 2-Minute Walk Test (2MWT) |
Baseline (Pre-intervention), End of 4 weeks (Post-intervention)
|
|
|
Target Sample Size
|
Total Sample Size="34"
Sample Size from India="34"
Final Enrollment numbers achieved (Total)= "34"
Final Enrollment numbers achieved (India)="34" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
23/02/2026 |
| Date of Study Completion (India) |
30/05/2026 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
30/05/2026 |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| 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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
- 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 - Any purpose.
- By what mechanism will data be made available?
Response (Others) -
- For how long will this data be available start date provided 02-01-1970 and end date provided 02-01-1970?
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
Modification(s)
|
This study compared the effects of eccentric and concentric strengthening exercises on functional mobility in individuals with subacute haemorrhagic stroke. A total of 34 participants were randomly allocated into two groups. Group A received eccentric strengthening along with general neurophysiotherapy, while Group B received concentric strengthening along with general neurophysiotherapy. Functional mobility was assessed using the Timed Up and Go Test and the 2 Minute Walk Test before and after a 4 week intervention period. Both groups demonstrated improvement in functional mobility following the intervention. However, participants who received eccentric strengthening showed greater improvement in mobility outcomes compared with those who received concentric strengthening. The findings suggest that eccentric strengthening combined with general neurophysiotherapy may be more effective in improving functional mobility in individuals with subacute haemorrhagic stroke. |