Post-Stroke Spasticity, Spastic Equinovarus Foot
Conditions
Keywords
Botulinum Toxin A, Extracorporeal Shock Wave Therapy, Equinovarus Foot, Spasticity, ESWT, Stroke
Brief summary
Spastic equinovarus foot is the most common lower limb motor impairment after stroke and has a significant impact on gait, mobility, and quality of life. Botulinum toxin type A (BoNT-A) is considered the first-line treatment for focal post-stroke spasticity. Extracorporeal shock wave therapy (ESWT) has shown promising results as an adjunctive treatment; however, the optimal timing for its administration in combination with BoNT-A remains unknown. This prospective, randomized, evaluator-blinded clinical trial aims to determine whether focal ESWT administered before or after BoNT-A injection is more effective than BoNT-A alone in patients with chronic post-stroke spastic equinovarus foot. Sixty-nine participants will be randomly allocated to one of three treatment groups: (1) BoNT-A alone; (2) one session of focal ESWT immediately before BoNT-A injection; or (3) one session of focal ESWT two weeks after BoNT-A injection. The primary outcome is spasticity measured with the Modified Ashworth Scale (MAS). Secondary outcomes include the Modified Tardieu Scale, passive ankle range of motion, muscle strength (MRC), 10-Meter Walk Test (10MWT), Functional Ambulation Classification (FAC), pain (VAS), Patient-Specific Assessment Scale (PSAS), muscle echogenicity using the Heckmatt scale, and muscle stiffness assessed by real-time elastography. Assessments will be performed at baseline and during follow-up through week 54.
Detailed description
Stroke is one of the leading causes of long-term disability worldwide. Lower limb spasticity develops in a substantial proportion of stroke survivors, with the spastic equinovarus foot representing the most common gait pattern impairment. This condition negatively affects walking ability, balance, activities of daily living, and quality of life. Botulinum toxin type A (BoNT-A) is considered the standard treatment for focal post-stroke spasticity. Nevertheless, its clinical effect is temporary and additional therapeutic strategies are needed to optimize and prolong treatment benefits. Extracorporeal shock wave therapy (ESWT) is a non-invasive intervention that has demonstrated beneficial effects on muscle tone, muscle stiffness, pain, and functional recovery. Experimental and clinical evidence suggests that ESWT may enhance the effects of BoNT-A, although the optimal timing of ESWT administration has not yet been established. This study is a prospective, randomized, single-blind, three-arm clinical trial conducted at the Department of Physical and Rehabilitation Medicine of Hospital Clínico San Carlos (Madrid, Spain). Participants with chronic post-stroke spastic equinovarus foot who meet the eligibility criteria will be randomly assigned to one of three treatment groups: Group A: BoNT-A injection alone. Group B: One session of focal ESWT immediately before BoNT-A injection. Group C: BoNT-A injection followed by one session of focal ESWT two weeks later. PROYECTO TESIS.docx The primary outcome is lower limb spasticity measured using the Modified Ashworth Scale (MAS). Secondary outcomes include the Modified Tardieu Scale, passive ankle dorsiflexion range of motion, muscle strength measured by the Medical Research Council (MRC) scale, gait performance assessed by the 10-Meter Walk Test (10MWT) and Functional Ambulation Classification (FAC), pain assessed by the Visual Analogue Scale (VAS), patient-reported function using the Patient-Specific Assessment Scale (PSAS), muscle echogenicity using the Heckmatt scale, and muscle stiffness evaluated by real-time elastography. PROYECTO TESIS.docx Clinical and ultrasound evaluations will be performed at baseline and at 4, 12, 24, 28, 42, and 54 weeks after treatment. The findings are expected to clarify whether the timing of focal ESWT administration influences the effectiveness of BoNT-A in the treatment of post-stroke spastic equinovarus foot and may contribute to optimizing rehabilitation protocols.
Interventions
DRUGBotulinum toxin type A
Botulinum toxin type A (Botox®, onabotulinumtoxinA) injected under ultrasound guidance into the spastic lower-limb muscles according to each participant's clinical presentation and the study protocol. Injection sites and doses are individualized based on the pattern and severity of spasticity.
DEVICEFocal Extracorporeal Shock Wave Therapy (ESWT)
One session of focal extracorporeal shock wave therapy (ESWT) applied to the spastic calf muscles according to the study protocol using standardized treatment parameters.
Sponsors
María Belén Martínez Luna
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
The outcome assessor will be blinded to treatment allocation throughout the study. Participants will be instructed not to disclose their assigned intervention during follow-up assessments. The healthcare provider administering the interventions and the participants will not be blinded.
Intervention model description
Participants will be randomly assigned in a 1:1:1 ratio to one of three parallel groups: (1) botulinum toxin type A (BoNT-A) alone; (2) focal extracorporeal shock wave therapy (ESWT) immediately before BoNT-A injection; or (3) focal ESWT administered two weeks after BoNT-A injection. Participants will remain in their assigned group throughout the study.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adults aged 18 to 87 years. * Clinical diagnosis of chronic stroke. * Presence of unilateral spastic equinovarus foot. * Lower-limb spasticity requiring treatment with botulinum toxin type A. * Ability to understand the study procedures and provide written informed consent.
Exclusion criteria
* Botulinum toxin type A injection in the affected lower limb within the previous 12 weeks. * Previous extracorporeal shock wave therapy in the affected lower limb within the previous 12 weeks. * Fixed ankle contracture preventing passive correction. * Other neurological or musculoskeletal disorders affecting gait assessment. * Pregnancy or breastfeeding. * Contraindications to botulinum toxin type A or extracorporeal shock wave therapy. * Severe cognitive impairment preventing participation or informed consent. * Participation in another interventional clinical trial.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in spasticity assessed by the Modified Ashworth Scale (MAS) | Baseline, 4, 12, 24, 28, 42 and 54 weeks. | Change in lower-limb spasticity measured using the Modified Ashworth Scale (MAS) after treatment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Modified Tardieu Scale | Baseline, 4, 12, 24, 28, 42 and 54 weeks | Change in lower-limb spasticity assessed using the Modified Tardieu Scale, including the quality of muscle reaction and the angle of muscle reaction at different stretching velocities. |
| Change in passive ankle dorsiflexion range of motion | Baseline, 4, 12, 24, 28, 42 and 54 weeks | Passive ankle dorsiflexion range of motion will be measured in degrees using a goniometer, with the knee flexed and extended. Higher values indicate greater ankle dorsiflexion. |
| Change in lower-limb muscle strength assessed by the Medical Research Council Scale | Baseline, 4, 12, 24, 28, 42 and 54 weeks | Muscle strength will be assessed using the Medical Research Council Scale, ranging from 0 to 5, where 0 indicates no visible muscle contraction and 5 indicates normal muscle strength. |
| Change in gait speed assessed by the 10-Meter Walk Test | Baseline, 4, 12, 24, 28, 42 and 54 weeks | Gait speed will be assessed using the 10-Meter Walk Test and expressed in meters per second. Higher gait speed indicates better walking performance. |
| Change in muscle echogenicity assessed by the Heckmatt Scale | Baseline, 4, 12, 24, 28, 42 and 54 weeks | Muscle echogenicity will be assessed by ultrasound using the Heckmatt Scale, ranging from grade I to grade IV. Higher grades indicate increased muscle echogenicity and greater structural muscle alteration. |
| Change in pain intensity assessed by the Visual Analogue Scale | Baseline, 4, 12, 24, 28, 42 and 54 weeks | Pain intensity associated with spasticity will be assessed using a Visual Analogue Scale ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. |
| Change in patient-reported function assessed by the Patient-Specific Assessment Scale | Baseline, 4, 12, 24, 28, 42 and 54 weeks | Patient-reported difficulty with activities affected by spastic equinovarus foot will be assessed using the Patient-Specific Assessment Scale. The evaluated activities include maintaining balance, walking quickly, climbing stairs, descending stairs, and putting on shoes. |
Countries
Spain
Contacts
PRINCIPAL_INVESTIGATORBelén Martínez Luna, MD
Hospital Clinico San carlos
Outcome results
None listed