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

Primary Purpose

Spasticity as Sequela of Stroke

Status
Unknown status
Phase
Not Applicable
Locations
Malaysia
Study Type
Interventional
Intervention
Feasibility and Impact of Home-based Electrical Stimulation Program
Sponsored by
University of Malaya
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Spasticity as Sequela of Stroke

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Malaya Medical CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Home-based Electrical Stimulation Program for lower limb spasticity

Arm Description

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.

Outcomes

Primary Outcome Measures

Retention Rate
The proportion of patients who completed the program. Patient completed divided with patient recruited, expressed in percentage (%).
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).

Secondary Outcome Measures

Clinical measurement of spasticity
Ankle dorsiflexor (gastroc) Modified Ashworth Scale (MAS) as measured in MAS grade 1, 1+, 2, 3, 4
Clinical measurement of spasticity
Modified Tardieu Scale (R1 and R2 angle of ankle dorsiflexion)
Ankle dorsiflexion muscle strength
Manual Muscle Testing as measured in 0-5 (with 0 no movement and 5 is the strongest)
Functional Outcome
10 meter walking test

Full Information

First Posted
June 6, 2021
Last Updated
June 12, 2021
Sponsor
University of Malaya
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1. Study Identification

Unique Protocol Identification Number
NCT04932668
Brief Title
Home Based Electrical Stimulation on Post-stroke Lower Limb Tightness.
Official Title
The Feasibility and Impact of A Home-Based NMES Program on Post-Stroke Lower Limb Spasticity
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Unknown status
Study Start Date
November 5, 2020 (Actual)
Primary Completion Date
August 2021 (Anticipated)
Study Completion Date
February 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Malaya

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spasticity as Sequela of Stroke

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
To evaluate the feasibility and acceptability of a home-based NMES program on lower limb spasticity in patient with post-stroke
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Home-based Electrical Stimulation Program for lower limb spasticity
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Feasibility and Impact of Home-based Electrical Stimulation Program
Other Intervention Name(s)
Program
Intervention Description
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.
Primary Outcome Measure Information:
Title
Retention Rate
Description
The proportion of patients who completed the program. Patient completed divided with patient recruited, expressed in percentage (%).
Time Frame
4 weeks
Title
Acceptability
Description
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).
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Clinical measurement of spasticity
Description
Ankle dorsiflexor (gastroc) Modified Ashworth Scale (MAS) as measured in MAS grade 1, 1+, 2, 3, 4
Time Frame
4 weeks (pre and post assessment)
Title
Clinical measurement of spasticity
Description
Modified Tardieu Scale (R1 and R2 angle of ankle dorsiflexion)
Time Frame
4 weeks (pre and post assessment)
Title
Ankle dorsiflexion muscle strength
Description
Manual Muscle Testing as measured in 0-5 (with 0 no movement and 5 is the strongest)
Time Frame
4 weeks (pre and post assessment)
Title
Functional Outcome
Description
10 meter walking test
Time Frame
4 weeks (pre and post assessment)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tze Yang Chung
Phone
+60192226593
Email
chungty@ummc.edu.my
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Raja Nabila BT Raja Mohamed Anuar
Organizational Affiliation
University Malaya Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Malaya Medical Center
City
Kuala Lumpur
ZIP/Postal Code
59100
Country
Malaysia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tze Yang Chung
Phone
+60192226593
Email
chungty@ummc.edu.my

12. IPD Sharing Statement

Plan to Share IPD
No

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

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