Spasticity as Sequela of Stroke
Conditions
Brief summary
Spasticity is a common complication post stroke. Post-stroke spasticity along with weakness and lack of coordination result in gait abnormalities and functional limitations. Recent treatment option include neuromuscular electric stimulation (NMES), a form of therapy that applies electrical currents to produce contraction of innervated muscle by depolarizing local motor nerves. Currently, there are wide varieties of NMES devices available commercially for consumer. The main purpose of this study is to evaluate the feasibility and acceptability of a home-based NMES program on lower limb spasticity in patient with post-stroke more than 6 months and to assess the impact of the program. This is single arm prospective intervention study. Patient will apply home-based NMES on their leg for 20 minutes, 5 days a week for 4 weeks. At the end of the study, an outcome measures will be assessed and patient will be required to answer a questionnaires on their experience.
Interventions
OTHERFeasibility and Impact of Home-based Electrical Stimulation Program
Home-based NMES program on spastic leg. The NMES pre-programmed dosage (locked): NMES waveform is biphasic PC, Frequency 50Hz, pulse width 400µs, ON:OFF 10s:20s and current amplitude: individual maximum tolerated to achieve ankle dorsiflexion.
Sponsors
University of Malaya
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Intervention model description
To evaluate the feasibility and acceptability of a home-based NMES program on lower limb spasticity in patient with post-stroke
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Retention Rate | 4 weeks | The proportion of patients who completed the program. Patient completed divided with patient recruited, expressed in percentage (%). |
| Acceptability | 4 weeks | Acceptability as evaluated at the end of the intervention by brief structured questionnaire developed for this study using 5 point Likert scale with 1 (strongly agree) and 5 (strongly agree). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical measurement of spasticity | 4 weeks (pre and post assessment) | Ankle dorsiflexor (gastroc) Modified Ashworth Scale (MAS) as measured in MAS grade 1, 1+, 2, 3, 4 |
| Ankle dorsiflexion muscle strength | 4 weeks (pre and post assessment) | Manual Muscle Testing as measured in 0-5 (with 0 no movement and 5 is the strongest) |
| Functional Outcome | 4 weeks (pre and post assessment) | 10 meter walking test |
Countries
Malaysia
Contacts
Primary ContactTze Yang Chung
Outcome results
None listed