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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Spasticity as Sequela of Stroke
• Intervention / Treatment: Other: Feasibility and Impact of Home-based Electrical Stimulation Program

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Tze Yang Chung; Phone Number: +60192226593; Email: chungty@ummc.edu.my

Study Locations

• Malaysia
  • Kuala Lumpur, Malaysia, 59100
    • Recruiting
    • University Malaya Medical Center
    • Contact: Tze Yang Chung; Phone Number: +60192226593; Email: chungty@ummc.edu.my

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 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.

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.; Other Names: Program

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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)

Collaborators and Investigators

• Sponsor: University of Malaya
• Investigators: Principal Investigator: Raja Nabila BT Raja Mohamed Anuar, University Malaya Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): November 5, 2020
• Primary Completion (Anticipated): August 1, 2021
• Study Completion (Anticipated): February 1, 2022

Study Registration Dates

• First Submitted: June 6, 2021
• First Submitted That Met QC Criteria: June 12, 2021
• First Posted (Actual): June 21, 2021

Study Record Updates

• Last Update Posted (Actual): June 21, 2021
• Last Update Submitted That Met QC Criteria: June 12, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Musculoskeletal Diseases; Muscular Diseases; Neuromuscular Manifestations; Muscle Hypertonia; Stroke; Muscle Spasticity
• Other Study ID Numbers: 2020427-8560

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No