Home Based Electrical Stimulation on Post-stroke Lower Limb Tightness.
- Conditions
- Spasticity as Sequela of Stroke
- Interventions
- Other: Feasibility and Impact of Home-based Electrical Stimulation Program
- Registration Number
- NCT04932668
- Lead Sponsor
- University of Malaya
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 20
- Post stroke (hemorrhagic or ischemic) with ankle plantarflexor (gastrocnemius and soleus) spasticity MAS 1+ to MAS 3,
- Post stroke more than 6 months,
- At least 18 years old,
- Able to ambulate 10 meter either independently or aided (single point stick or quadripod)
- Compliant to outpatient therapy.
- Minimal cognitive (MMSE> 24) and minimal sensory impairment,
- Stable neurological and medical condition
- Introduction or changes in anti-spastic medication dose within 3 months or during study period,
- Receiving intervention for spasticity (eg BoNT or serial casting) within 3 months or during research period,
- New neurological condition/disease,
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Home-based Electrical Stimulation Program for lower limb spasticity Feasibility and Impact of Home-based Electrical Stimulation Program Single arm prospective intervention study to assess the feasibility and impact of a home-based program. 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.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Clinical measurement of spasticity 4 weeks (pre and post assessment) Modified Tardieu Scale (R1 and R2 angle of ankle dorsiflexion)
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
Trial Locations
- Locations (1)
University Malaya Medical Center
🇲🇾Kuala Lumpur, Malaysia