Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:37 PM
Ignite Modification Date:
2025-12-24 @ 5:37 PM
NCT ID:
NCT04932668
Eligibility Criteria:
Inclusion Criteria:
1. Post stroke (hemorrhagic or ischemic) with ankle plantarflexor (gastrocnemius and soleus) spasticity MAS 1+ to MAS 3,
2. Post stroke more than 6 months,
3. At least 18 years old,
4. Able to ambulate 10 meter either independently or aided (single point stick or quadripod)
5. Compliant to outpatient therapy.
6. Minimal cognitive (MMSE\> 24) and minimal sensory impairment,
7. Stable neurological and medical condition
Exclusion Criteria:
1. Introduction or changes in anti-spastic medication dose within 3 months or during study period,
2. Receiving intervention for spasticity (eg BoNT or serial casting) within 3 months or during research period,
3. New neurological condition/disease,
4. Presence of contraindications to NMES, which is: Pregnancy, Malignancy, Presence of electronic implant eg cardiac pacemaker, cardioverter defibrillator, Uncontrolled seizure/epilepsy, Infected tissues/ tuberculosis or osteomyelitis, Impaired lower limb circulation/ DVT/ thrombophlebitis, Recent fracture or osteoporosis, Actively bleeding tissue or person with untreated hemorrhagic disorder, Damaged or skin diseases at the affected lower limb
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04932668
Study Brief:
Protocol Section:
NCT04932668