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

Spasticity as Sequela of Stroke Clinical Trial

Official title:

The Feasibility and Impact of A Home-Based NMES Program on Post-Stroke Lower Limb Spasticity

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04932668
• Other study ID #: 2020427-8560
• Status: Recruiting
• Phase: N/A
• Start date: November 5, 2020
• Est. completion date: February 2022

Study information

• Verified date: June 2021
• Source: University of Malaya
• Contact: Tze Yang Chung
• Phone: +60192226593
• Email: chungty[@]ummc.edu.my
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: February 2022
• Est. primary completion date: August 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Muscle Spasticity
• Spasticity as Sequela of Stroke
• Stroke

Intervention

Other:
• 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.

Locations

Country	Name	City	State
Malaysia	University Malaya Medical Center	Kuala Lumpur

Sponsors (1)

Lead Sponsor	Collaborator
University of Malaya

Country where clinical trial is conducted

Malaysia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Retention Rate	The proportion of patients who completed the program. Patient completed divided with patient recruited, expressed in percentage (%).	4 weeks
Primary	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
Secondary	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)
Secondary	Clinical measurement of spasticity	Modified Tardieu Scale (R1 and R2 angle of ankle dorsiflexion)	4 weeks (pre and post assessment)
Secondary	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)
Secondary	Functional Outcome	10 meter walking test	4 weeks (pre and post assessment)