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CTRI Number  CTRI/2026/02/103817 [Registered on: 13/02/2026] Trial Registered Prospectively
Last Modified On: 12/02/2026
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   Effect of calf muscle therapy and functional training on gait in people with stroke 
Scientific Title of Study   Effect of Gastrocnemius Spasticity Reduction and Strenthening plus Task Oriented Training on Gait Functions of Stroke Survivors 
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 Sandeep Singh 
Designation  Head of Department and Assistant Professor 
Affiliation  Punjabi University Patiala 
Address  Physiotherapy Department Punjabi University Patiala Punjab 147002 India

Patiala
PUNJAB
147002
India 
Phone  9417802490  
Fax    
Email  Sandeep.physiotherapy@pup.ac.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Sandeep Singh 
Designation  Head of Department and Assistant Professor 
Affiliation  Punjabi University Patiala 
Address  Physiotherapy Department Punjabi University Patiala Punjab 147002 India


PUNJAB
147002
India 
Phone  9417802490  
Fax    
Email  Sandeep.physiotherapy@pup.ac.in  
 
Details of Contact Person
Public Query  
Name  Mehak Sharma 
Designation  Post Graduate Student 
Affiliation  Punjabi University Patiala 
Address  Physiotherapy Department Punjabi University Patiala Punjab 147002 India

Patiala
PUNJAB
147002
India 
Phone  7011315603  
Fax    
Email  mehaksharma804@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  Mehak Sharma 
Address  Physiotherapy Department Punjabi University Patiala Punjab 147002 India 
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 Sandeep Singh  Bhai Ghaniya Health Centre  Physiotherapy Department Neurological OPD-2 Punjabi University Patiala
Patiala
PUNJAB 		 9417802490

Sandeep.physiotherapy@pup.ac.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G969||Disorder of central nervous system, unspecified, (2) ICD-10 Condition: G968||Other specified disorders of central nervous system,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Ultrasound plus Task Oriented Training  Ultrasound: frequency of 1MHz with an intensity 2W/cm2,10 minutes treatment time and will be conducted 3 days a week for a total duration of 4 weeks Task Oriented Training: Alternating ascending and descending a ramp and a flight of stairs with atleast 3 steps Heel lifting Waling comfortably for 5 meter Stepping forward , backward and sideways on wooden block Walking on varying surfaces and over obstacles set at irregular intervals Standing up from chair, walking 3 meters, turning around, walking back and sitting down on the chair will be conducted 3 days per week for 4 weeks and each exercises lasted for 5 to 7 minutes. 
Intervention  Ultrasound plus Task Oriented Training plus Strength Training  Ultrasound: frequency of 1MHz with an intensity 2W/cm2,10 minutes treatment time and will be conducted 3 days a week for a total duration of 4 weeks Task Oriented Training: Alternating ascending and descending a ramp and a flight of stairs with atleast 3 steps Heel lifting Waling comfortably for 5 meter Stepping forward , backward and sideways on wooden block Walking on varying surfaces and over obstacles set at irregular intervals Standing up from chair, walking 3 meters, turning around, walking back and sitting down on the chair will be conducted 3 days per week for 4 weeks and each exercises lasted for 5 to 7 minutes. Strength Training:(a) training of concentric and eccentric muscle activity during sit-stand and stand to sit without using upper limb muscle( 5 sets, 10 reps),progression continued until the participant was able to complete 10 repetitions from a starting point of 120 degree hip flexion (b) Training concentric and eccentric muscle activity during ascending and descending stairs or step, the initial height of the step was determined by assessing the participant ability to place the paretic foot on and off step approx 5 times, the exercise was progressed through placing alternate feet on and off step, the same process is used for descending a step, progression continued untill participant could complete 5 sets for 10 reps 
 
Inclusion Criteria  
Age From  45.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  Individuals who had sustained stroke for more than 6 months
Stroke survivors with intact cognitive ability as exhibited by their ability to comprehend
The ability to walk independently or with assitive device for minimum of 15 meter
Independent walking having functional ambulatory score more than 3
MAS score of grades plus 1 and 2 
 
ExclusionCriteria 
Details  Presence of any contractures or deformity at hip knee and ankle
Ankle impairment
History of epilepsy
Neurodegenerative disease
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Other 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Modified Ashworth Scale
Fugl-Meyer assessment of lower extremity
Berg Balance Scale
Modified Emory Functional Ambulation Profile  		 At the baseline and end of 4th week 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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="0"
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   Stroke survivors often experience motor impairment that significantly affect gait and mobility. One of the most common complication of gastrocnemius spasticity which leads to abnormal muscle tone resulting reduced in stride length and instability. The study investigate the combined effect of gastrocnemius spasticity reduction and muscle strengthening plus task oriented training on gait functions of stroke survivors. Spasticity reduction includes ultrasound  as it based on neural and non - neural effect, strengthening exercises improve the force generating capacity of the gastrocnemius muscle to enhance propulsion during gait and task oriented training focus on repetitive, goal directed functional task like stair climbing, walking, standing which help retrain the brain. Overall combining spasticity reduction and muscle strengthening with task oriented training is a promising strategy for enhancing gait functions and spasticity. 
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