Home Based Electrical Stimulation on Post-stroke Lower Limb Tightness.

University of Malaya20 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Spasticity as Sequela of Stroke

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Retention Rate

The proportion of patients who completed the program. Patient completed divided with patient recruited, expressed in percentage (%).

Time frame: 4 weeks

Acceptability

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).

Time frame: 4 weeks

Secondary Outcomes

Clinical measurement of spasticity

Ankle dorsiflexor (gastroc) Modified Ashworth Scale (MAS) as measured in MAS grade 1, 1+, 2, 3, 4

Time frame: 4 weeks (pre and post assessment)

Clinical measurement of spasticity

Modified Tardieu Scale (R1 and R2 angle of ankle dorsiflexion)

Time frame: 4 weeks (pre and post assessment)

Ankle dorsiflexion muscle strength

Manual Muscle Testing as measured in 0-5 (with 0 no movement and 5 is the strongest)

Time frame: 4 weeks (pre and post assessment)

Functional Outcome

10 meter walking test

Time frame: 4 weeks (pre and post assessment)

Home Based Electrical Stimulation on Post-stroke Lower Limb Tightness.

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts