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

U

University of Malaya

Status

Unknown

Conditions

Spasticity as Sequela of Stroke

Treatments

Other: Feasibility and Impact of Home-based Electrical Stimulation Program

Study type

Interventional

Funder types

Other

Identifiers

NCT04932668
2020427-8560

Details and patient eligibility

About

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.

Enrollment

20 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Trial design

Primary purpose

Other

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

20 participants in 1 patient group

Home-based Electrical Stimulation Program for lower limb spasticity
Experimental group
Description:
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.
Treatment:
Other: Feasibility and Impact of Home-based Electrical Stimulation Program

Trial documents
2

Trial contacts and locations

1

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Central trial contact

Tze Yang Chung

Data sourced from clinicaltrials.gov

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