Clinical trial NCT04932668: Home Based Electrical Stimulation on Post-stroke Lower Limb Tightness.
Official title: The Feasibility and Impact of A Home-Based NMES Program on Post-Stroke Lower Limb Spasticity
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Spasticity as Sequela of Stroke
Lead sponsor: University of Malaya
Sponsor class: OTHER
First posted: 2021-06-21
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: To evaluate the feasibility and acceptability of a home-based NMES program on lower limb spasticity in patient with post-stroke
Primary purpose: OTHER

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.


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

Primary outcomes:
measure: Retention Rate
timeFrame: 4 weeks
measure: Acceptability
timeFrame: 4 weeks
Secondary outcomes:
measure: Clinical measurement of spasticity
timeFrame: 4 weeks (pre and post assessment)
measure: Clinical measurement of spasticity
timeFrame: 4 weeks (pre and post assessment)
measure: Ankle dorsiflexion muscle strength
timeFrame: 4 weeks (pre and post assessment)
measure: Functional Outcome
timeFrame: 4 weeks (pre and post assessment)
Other outcomes:
Locations:
city: Kuala Lumpur
country: Malaysia
facility: University Malaya Medical Center
Study officials:
affiliation: University Malaya Medical Center
name: Raja Nabila BT Raja Mohamed Anuar
role: PRINCIPAL_INVESTIGATOR
References: