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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Home-based Electrical Stimulation Program for lower limb spasticity | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Feasibility and Impact of Home-based Electrical Stimulation Program | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Retention Rate | The proportion of patients who completed the program. Patient completed divided with patient recruited, expressed in percentage (%). | 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). | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical measurement of spasticity | Ankle dorsiflexor (gastroc) Modified Ashworth Scale (MAS) as measured in MAS grade 1, 1+, 2, 3, 4 | 4 weeks (pre and post assessment) |
| Clinical measurement of spasticity |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tze Yang Chung | Contact | +60192226593 | chungty@ummc.edu.my |
| Name | Affiliation | Role |
|---|---|---|
| Raja Nabila BT Raja Mohamed Anuar | University Malaya Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Malaya Medical Center | Recruiting | Kuala Lumpur | 59100 | Malaysia |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 1, 2020 | Dec 13, 2020 | Prot_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Apr 1, 2020 | Jun 12, 2021 | ICF_001.pdf |
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To evaluate the feasibility and acceptability of a home-based NMES program on lower limb spasticity in patient with post-stroke
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Modified Tardieu Scale (R1 and R2 angle of ankle dorsiflexion)
| 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) | 4 weeks (pre and post assessment) |
| Functional Outcome | 10 meter walking test | 4 weeks (pre and post assessment) |