Role of Botulinum Toxin A in improving Gait and reduction of Spasticity in Stroke survivors: A Randomized Controlled Trial

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.