| 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
|
|
|
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 |
|
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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 |
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. |