Spasticity as Sequela of StrokeNCT04932668
Home Based Electrical Stimulation on Post-stroke Lower Limb Tightness.
A study testing Feasibility and Impact of Home-based Electrical Stimulation Program in people with Spasticity as Sequela of Stroke, run by University of Malaya at 1 site in Malaysia.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spasticity as Sequela of Stroke
- What is being tested?
- Feasibility and Impact of Home-based Electrical Stimulation Program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteMalaysia
- Study dates
- 5 Nov 2020to Feb 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Malaysia1 site, 1 recruiting
- Recruiting
University Malaya Medical Center
Kuala Lumpur, 59100
Tze Yang Chung, +60192226593, chungty@ummc.edu.my
About this study
Official title: 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.
- Conditions
- Spasticity as Sequela of Stroke
- Being tested
- Feasibility and Impact of Home-based Electrical Stimulation Program
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Feasibility and Impact of Home-based Electrical Stimulation ProgramOther
Also called 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Feasibility and Impact of Home-based Electrical Stimulation Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Retention Rate
The proportion of patients who completed the program. Patient completed divided with patient recruited, expressed in percentage (%).
Measured: 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).
Measured: 4 weeks
Secondary outcomes (4)
Clinical measurement of spasticity
Ankle dorsiflexor (gastroc) Modified Ashworth Scale (MAS) as measured in MAS grade 1, 1+, 2, 3, 4
Measured: 4 weeks (pre and post assessment)
Clinical measurement of spasticity
Modified Tardieu Scale (R1 and R2 angle of ankle dorsiflexion)
Measured: 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)
Measured: 4 weeks (pre and post assessment)
Functional Outcome
10 meter walking test
Measured: 4 weeks (pre and post assessment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2021
- Study start5 Nov 2020
- Primary completionAug 2021 (estimated)
- Study completionFeb 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spasticity as Sequela of StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Malaya
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Raja Nabila binti Raja Mohamed Anuar, University of Malaya
- Investigators
- Raja Nabila BT Raja Mohamed Anuar, Principal investigator, University Malaya Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04932668
- Sponsor's protocol ID
- 2020427-8560
- Status last verified
- Jun 2021
- First submitted
- 6 Jun 2021
- Last updated
- 21 Jun 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Feasibility and Impact of A Home-Based NMES Program on Post-Stroke Lower Limb Spasticity
- ClinicalTrials.gov ID
- NCT04932668
- Acronym / sponsor ID
- 2020427-8560
- Conditions
- Spasticity as Sequela of Stroke
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of MalayaUniversity, hospital or other
- Study start
- 5 Nov 2020 (actual)
- Primary completion
- Aug 2021 (estimated)
- Study completion
- Feb 2022 (estimated)
- First posted
- 21 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- To evaluate the feasibility and acceptability of a home-based NMES program on lower limb spasticity in patient with post-stroke
| Arm | Type | Receives |
|---|---|---|
| Home-based Electrical Stimulation Program for lower limb spasticity | Experimental | Other: Feasibility and Impact of Home-based Electrical Stimulation ProgramSingle 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Feasibility and Impact of Home-based Electrical Stimulation ProgramAlso: ProgramHome-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 | Home-based Electrical Stimulation Program for lower limb spasticity |
Primary outcome
Retention Rate
Time frame: 4 weeks
The proportion of patients who completed the program. Patient completed divided with patient recruited, expressed in percentage (%).
Acceptability
Time frame: 4 weeks
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 secondary outcomes
Clinical measurement of spasticity
Time frame: 4 weeks (pre and post assessment)
Clinical measurement of spasticity
Time frame: 4 weeks (pre and post assessment)
Ankle dorsiflexion muscle strength
Time frame: 4 weeks (pre and post assessment)
Functional Outcome
Time frame: 4 weeks (pre and post assessment)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2021.
- Individual participant dataSharing planned: No
Related trials for Spasticity as Sequela of Stroke
Active, not recruitingObservational study
A Study to Estimate How Often Post-stroke Spasticity Occurs and to Provide a Standard Guideline on the Best Way to Monitor Its Development
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Cryoneurolysis for Spasticity Treatment: Long-term Clinical Outcomes and Mechanisms in the Central Nervous System
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Phenol and Botulinum Toxin vs Botulinum Toxin Alone for Post-Stroke Upper-Limb Spasticity
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Raja Nabila BT Raja Mohamed Anuar principal investigator
University Malaya Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Feasibility and Impact of Home-based Electrical Stimulation Program in people with Spasticity as Sequela of Stroke, run by University of Malaya at 1 site in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tze Yang Chung (+60192226593, chungty@ummc.edu.my), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Retention Rate (time frame: 4 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jun 2021.