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CTRI Number  CTRI/2024/10/075686 [Registered on: 23/10/2024] Trial Registered Prospectively
Last Modified On: 28/10/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Study to see how Botulinum Toxin A can help stroke patients improve their way of walking and reduce tightness of muscles 
Scientific Title of Study   Role of Botulinum Toxin A in improving Gait and reduction of Spasticity in Stroke survivors: 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 Ivanah Pauline Nongrum 
Designation  Junior Resident 
Affiliation  All India Institute of Medical Sciences, Raebareli 
Address  Department of Physical Medicine and Rehabilitation, All India Institute of Medical Sciences, Raebareli, Dalmau Rd, Munshiganj, Madhupuri, Uttar Pradesh 229405

Rae Bareli
UTTAR PRADESH
229405
India 
Phone  9113620812  
Fax    
Email  ivanah.nongrum@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Satyasheel Singh Asthana 
Designation  Assistant Professor 
Affiliation  All India Institute of Medical Sciences, Raebareli 
Address  Room 28, Department of Physical Medicine and Rehabilitation, All India Institute of Medical Sciences, Raebareli, Dalmau Rd, Munshiganj, Madhupuri, Uttar Pradesh 229405

Rae Bareli
UTTAR PRADESH
229405
India 
Phone  9169385726  
Fax    
Email  satyapmr2015@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Satyasheel Singh Asthana 
Designation  Assistant Professor 
Affiliation  All India Institute of Medical Sciences, Raebareli 
Address  Room 28, Department of Physical Medicine and Rehabilitation, All India Institute of Medical Sciences, Raebareli, Dalmau Rd, Munshiganj, Madhupuri, Uttar Pradesh 229405

Rae Bareli
UTTAR PRADESH
229405
India 
Phone  9169385726  
Fax    
Email  satyapmr2015@gmail.com  
 
Source of Monetary or Material Support  
All India Institute of Medical Sciences, Raebareli, Dalmau Rd, Munshiganj, Madhupuri, Uttar Pradesh 229405, India 
 
Primary Sponsor  
Name  All India Institute of Medical Sciences, Raebareli, Uttar Pradesh 
Address  All India Institute of Medical Sciences, Raebareli, Dalmau Rd, Munshiganj, Madhupuri, Uttar Pradesh 229405 
Type of Sponsor  Government medical college 
 
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 Ivanah Pauline Nongrum  All India Institute of Medical Sciences, Raebareli  Room 22/28, Ground floor, Department of Physical Medicine and Rehabilitation, All India Institute of Medical Sciences, Raebareli, Dalmau Rd, Munshiganj, Madhupuri, Uttar Pradesh 229405
Rae Bareli
UTTAR PRADESH 
9113620812

ivanah.nongrum@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee (IEC), AIIMS Raebareli, Uttar Pradesh, India  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  Group A Standard Neurorehabilitation along with administration of Injection Botulinum Toxin A in selected spastic muscles  Participants in Group A Patients with hemiplegia following stroke that has resulted in lower limb spasticity of grade 2 or 3 according to Modified Ashworth Scale will undergo complete clinical examination. This will be followed by administration of an individualized Standard Neurorehabilitation care program along with administration of Injection Botulinum Toxin A in selected spastic muscles of the lower limb as per surface landmark technique. Dose of Injection Botulinum Toxin A will be calculated according to the number and size of involved muscles and degree of spasticity and will be diluted with 0.9% preservative free Normal Saline to achieve a concentration of 5 units/0.1ml.  
Comparator Agent  Group B Standard Neurorehabilitation protocol  Participants in Group B Patients with hemiplegia following stroke that has resulted in lower limb spasticity of grade 2 or 3 according to Modified Ashworth Scale will undergo complete clinical examination. This will be followed by administration of an individualized Standard Neurorehabilitation protocol which will be comprised of various therapeutic exercises and Orthotic devices tailored to their specific needs and condition. This will include patient and caregiver education about prognosis, postural care, balance and coordination training, stretching exercises of spastic muscles, strengthening exercises, activities of daily living care, endurance training exercises, gait retraining by using parallel bars and progressing from level ground to walking on inclined surfaces. Standardization of therapeutic exercises with regard to frequency: Two sessions daily for 5 days in a week in the Department of PMR, AIIMS, Raebareli. Participants will also be taught a home-based neurorehabilitation protocol. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  -Patients with hemiplegia following stroke that has resulted in lower limb spasticity.
-Age of the patient between 18 to 80 years.
-Spasticity of Grade 2 or Grade 3 according to Modified Ashworth Scale.
-No prior Botulinum toxin A injections in the past.
-Patient must give consent to take part in the study.
-Patient must be under a government funded scheme- such as Ayushman Bharat, CM Fund. 
 
ExclusionCriteria 
Details  -Significant cognitive impairment.
-Significant issues of lower limb including recent fractures/ fixed contractures/ Deep vein thrombosis.
-Significant illness- Malignancy.
-Pregnancy and lactation.
-Uncontrolled Diabetes Mellitus.
-Under treatment for any Psychiatric issues (failure to comply and follow up).
-Patient not willing to participate. 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
-Walking velocity and Cadence using 10-meter walk test.
-Spasticity according to Modified Ashworth Scale (MAS).
 
-Baseline
-1 month
-3 months
-6 months 
 
Secondary Outcome  
Outcome  TimePoints 
-Timed Up and Go (TUG) test.
-Functional independence Measure (FIM).
 
-Baseline
-1 month
-3 months
-6 months 
 
Target Sample Size   Total Sample Size="16"
Sample Size from India="16" 
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)   14/11/2024 
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="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Open to Recruitment 
Recruitment Status of Trial (India)  Open to Recruitment 
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 commonly present with spastic hemiplegia. Spasticity can interfere with rehabilitation causing pain and joint contractures on account of shortening of muscle or ligaments, thereby limiting recovery of the individual’s ability to carry out routine day to day activities. Spasticity in patients may present with gait dysfunction, fine motor dysfunction, spontaneous muscle contractions. Spasticity can be managed by a step ladder pattern involving removal of noxious stimuli triggering spasticity, proper positioning, stretching and casting, physical modalities, electrical stimulation, orthoses, pharmacological treatment including oral and transdermal medication, intrathecal therapies, chemical denervation with Botulinum toxin A or phenol, surgical interventions. In stroke patients, Botulinum toxin changes the cortical excitability of unaffected hemisphere. This indicates that maladaptive cortical reorganization may also contribute to spasticity and may improve with peripheral botulinum toxin injection. There are a number of studies evaluating the effect of administering Injection Botulinum Toxin A in spastic upper limb muscles but there are limited studies on the effect of this intervention on gait and spasticity of lower limbs. Previous Randomized controlled trial studies have shown an increase in walking velocity with improved gait in the group receiving the Botulinum Toxin A (BoNT-A) Injection. 

Aim: To evaluate the effect of using Botulinum toxin A injection on walking velocity and changes in gait of spastic hemiplegic patients of Cerebrovascular accidents.

Objectives: 

Primary objectives: 1) To assess change in walking velocity and Cadence after administering botulinum toxin A injection in spastic hemiplegic patients of Cerebrovascular accidents using 10-meter walk test. 2) To assess change in Spasticity grade as per Modified Ashworth Scale (MAS).

Secondary objectives: 1) Evaluation of mobility, balance, walking ability using Timed Up and Go (TUG) test. 2) Evaluation of change in functional status (Functional independence Measure). 

Patients will be randomized into two groups by envelope method. There will be no blinding. Group A will include patients receiving Injection Botulinum Toxin A along with standard neurorehabilitation program. Group B will include patients treated with standard rehabilitation Neurorehabilitation program.

Randomization: The patients will be randomized to the two groups by envelope method. There will be no blinding in the study.

Participants will undergo assessments at baseline, at 1 month, 3 months and 6 months after receiving the intervention. Outcome variables such as Walking velocity and Cadence using 10-meter walk test, Spasticity according to Modified Ashworth Scale, Timed Up and Go (TUG) test time and Functional independence Measure (FIM) score will be documented and updated at the above timelines.

Null Hypothesis: No change in spasticity after Injection Botulinum Toxin A at 1 month, 3 months and 6months.

Alternate Hypothesis: There is a reduction in spasticity enabling improvement in walking ability after Injection Botulinum Toxin A.

 

 
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