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

NCT04932668 | Unknown

• 1 other identifier: 2020427-8560
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Spasticity as Sequela of Stroke

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Clinical measurement of spasticity

  4 weeks (pre and post assessment)

• Clinical measurement of spasticity

  4 weeks (pre and post assessment)

• Ankle dorsiflexion muscle strength

  4 weeks (pre and post assessment)

• Functional Outcome

  4 weeks (pre and post assessment)

Study Arms (1)

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.

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

Interventions

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.

Also known as: Program

Home-based Electrical Stimulation Program for lower limb spasticity

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Malaya: lead

Study Sites (1)

University Malaya Medical Center

Kuala Lumpur, 59100, Malaysia

RECRUITING

Study Officials

• Raja Nabila BT Raja Mohamed Anuar

  University Malaya Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tze Yang Chung

CONTACT

+60192226593; chungty@ummc.edu.my

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor, Principal Investigator

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

Study Record Dates

• First Submitted: June 6, 2021
• First Posted: June 21, 2021
• Study Start: November 5, 2020
• Primary Completion: August 1, 2021
• Study Completion: February 1, 2022
• Last Updated: June 21, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

MY (1)