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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-05

Study Completion Date

2022-02-28

Brief Summary

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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.

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Detailed Description

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Conditions

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Spasticity as Sequela of Stroke

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

To evaluate the feasibility and acceptability of a home-based NMES program on lower limb spasticity in patient with post-stroke

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Home-based Electrical Stimulation Program for lower limb spasticity

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.

Group Type EXPERIMENTAL

Feasibility and Impact of Home-based Electrical Stimulation Program

Intervention Type OTHER

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.

Interventions

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Feasibility 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.

Intervention Type OTHER

Other Intervention Names

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Program

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No