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CTRI Number  CTRI/2025/10/096340 [Registered on: 22/10/2025] Trial Registered Prospectively
Last Modified On: 09/10/2025
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   Effects of 2 different pressure technique on muscle stiffness walking ability in people with stroke 
Scientific Title of Study   Effect of Circumferential Pressure using a sphygmomanometer vs. tendinous pressure on calf spasticity and gait in individuals with stroke: A Experimental study 
Trial Acronym  GAIT-PRESS 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Divya Kharwandikar 
Designation  postgraduate student (MPTh), Department of neurophysiotherapy) 
Affiliation  RJS College of Physiotherapy 
Address  RJS COLLEGE OF PHYSIOTHERAPY Kokamthan Tal- Kopargaon, Dist. Ahmednagar, Maharashtra

Ahmadnagar
MAHARASHTRA
423601
India 
Phone  9156432298  
Fax    
Email  kharwandikardivya1632@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr R S Gangatharan 
Designation  Principal RJS College of Physiotherapy 
Affiliation  RJS College of Physiotherapy 
Address  RJS COLLEGE OF PHYSIOTHERAPY Kokamthan Tal- Kopargaon, Dist. Ahmednagar, Maharashtra

Ahmadnagar
MAHARASHTRA
423601
India 
Phone  9840644110  
Fax    
Email  ganganeuro76@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr R S Gangatharan 
Designation  Principal RJS College of Physiotherapy 
Affiliation  RJS College of Physiotherapy 
Address  RJS COLLEGE OF PHYSIOTHERAPY Kokamthan Tal- Kopargaon, Dist. Ahmednagar, Maharashtra


MAHARASHTRA
423601
India 
Phone  9840644110  
Fax    
Email  ganganeuro76@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  Dr. Divya Kharwandikar 
Address  Rashtrasant Janardhan Swami College of Physiotherapy, Kokamthan Tal- Kopargaon, Dist. Ahmednagar, Maharashtra -423601. 
Type of Sponsor  Other [SELF] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Divya Kharwandikar  Neuro OPD of Rashtrasant Janardhan Swami College of Physiotherapy  Rashtrasant Janardhan Swami College of Physiotherapy, Kokamthan Tal- Kopargaon, Dist. Ahmednagar, Maharashtra -423601.
Ahmadnagar
MAHARASHTRA 		 9156432298

kharwandikardivya1632@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
RJS college of Physiotherapy ethics committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G811||Spastic hemiplegia,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  circumferential pressure application by using a sphygmomanometer and conventional physiotherapy   Patients will first be positioned supine for 10 minutes to facilitate relaxation, and blood pressure (BP) will be recorded. The procedure will be discontinued if diastolic BP falls below 50 mmHg. The intervention will be performed with the patient either in supine or sitting position, where a sphygmomanometer cuff will be applied around the calf (3 cm distal to the knee joint line or at the point of maximum muscle bulk) and inflated to 70–80 mmHg for 5 minutes, followed by 1 minute rest; this cycle will be repeated twice. Alongside, patients will undergo a conventional rehabilitation protocol including stretching and spasticity management (sustained calf stretching, slow stroking, and joint compression), PNF patterns for lower limbs, strengthening of antagonists (manual resistance, bridging, sit-to-stand, toe and heel raises), balance and stability training (wide base standing, tandem standing, perturbation, single-leg standing, balance board), and functional mobility training (forward and backward walking). 
Comparator Agent  tendinous pressure according roods inhibitory approach for achilles tendon   Tendinous pressure will be administered to the patient either in a supine or seated position. Firm pressure will be applied at the musculotendinous junction or across the Achilles tendon, which connects to the gastrocnemius and soleus muscles, on the affected side using the therapist’s thumb. The pressure will be sustained for 30 seconds and will be repeated for a total of four sets. 
 
Inclusion Criteria  
Age From  45.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1. Survivors diagnosed with stroke on computed tomography (CT) or magnetic
resonance imaging (MRI) with subacute and chronic onset of stroke (more
than 3 months)
2. Increased muscle tone of the affected lower limb gastro-soleus muscle
(Modified Ashworth scale grade from 1 to 3)
3. Brunnstorm stage of recovery 2 and 3
4. Voluntary control of affected lower limb and ankle (Voluntary control grade
from 2 to 4)
5. Unable to do dorsiflexion
6. Pressure sensation should be intact on the affected extremities
7. MMSE score in between 24 to 30
8. Patient should be Cooperative and motivated
9. Those who are willing to voluntarily participate in the study.
 
 
ExclusionCriteria 
Details  1. Contractures of affected calf muscle
2. Increased muscle tone of the affected lower limb gastro-soleus muscle
(modified ashworth scale grade 0 and 4)
3. Voluntary control grading stage 5 and 6
4. Any visual/ hearing problems
5. Cognitive impairment
6. Deformity of lower limb
7. Peripheral nerve injury
8. Peripheral vascular disease of the affected side
9. Any other neurological problem like head injury, cerebral palsy, multiple
sclerosis and spinal cord injury or uncontrolled cardiovascular or other
neurological condition were excluded.
10. The survivors who are not co-operative during the study 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1 Modified Ashworth Scale
(MAS)
2 Wisconsin Gait Scale (WGS)  		 At baseline and 6 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
NIL   
 
Target Sample Size   Total Sample Size="54"
Sample Size from India="54" 
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)   01/11/2025 
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 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   This study will evaluate the effect of circumferential pressure using a sphygmomanometer versus tendinous pressure on calf spasticity and gait in stroke survivors. A total of 54 participants aged 45 to 70 years with subacute or chronic stroke will be randomly assigned to 2 groups: circumferential pressure with conventional physiotherapy, tendinous pressure with conventional physiotherapy. Interventions will be given 5 days a week for 6 weeks. Spasticity will be assessed using the Modified Ashworth Scale, and gait will be measured by the Wisconsin Gait Scale. The study aims to determine effective low cost non invasive strategies to reduce calf spasticity and improve functional mobility in stroke patients. 
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