SpasticityNCT02261142
Efficacy and Cost-effectiveness of Spasticity Treatment With Multifocal TENS
A study testing Multifocal TENS garment (Mollii®) in people with Spasticity and Stroke, run by Linkoeping University.
Trial summary
Spasticity is a common consequence of injury to the central nervous system and can be a major problem in motor function and everyday activities. A method for treating spasticity that applies low-amplitude electrical stimulation through a garment with built-in electrodes, Mollii® (Elektrodress), has been developed. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spasticity, Stroke, Cerebral Palsy
- What is being tested?
- Multifocal TENS garment (Mollii®)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 31 participants
- Where
- No sites listed yet
- Study dates
- Sep 2013to Feb 2015
- 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
- Spasticity due to stroke or Cerebral Palsy
- Have some preserved walking ability, with or without walking aids
- Be able to understand the treatment and instruments/interviews used
- For stroke participants, two years should have elapsed since their injury/insult
Who cannot join
- Electronic devices
- Ventriculoperitoneal shunt
- Arrhythmia
- Hearth infarction or unstable angina pectoris
- Symptomatic hyper- or hypotonia
- Cancer under treatment
Show all 13Show fewer
- Unstable psychiatric disease
- Lung disease, affecting daily life
- Unstable epileptic disease
- Orthopedic surgery last year
- Obesity with BMI > 35
- Infectious disease with longstanding treatment
- Pregnancy
About this study
Official title: Evaluation of Efficacy and Cost-effectiveness of Spasticity Treatment With Multifocal Transcutaneous Electrical Stimulation, Through a Garment With built-in Electrodes in Combination With Training.
Spasticity is a common consequence of injury to the central nervous system and can be a major problem in motor function and everyday activities. A method for treating spasticity that applies low-amplitude electrical stimulation through a garment with built-in electrodes, Mollii® (Elektrodress), has been developed. The garment is to be used in combination with individualized training and the stimulation is mainly given to antagonists of spastic muscles.
The general objective of this study is to evaluate the efficacy of and costs associated with the Mollii® treatment of spasticity due to stroke or cerebral palsy.
Read more
Primary objectives are;
- to study whether treatment with the Mollii® improves function and activity
- to evaluate the cost-effectiveness of the treatment, from both a health-care perspective and a societal perspective.
Secondary objectives are;
- to study whether there are differences in treatment effect between the stroke and the Cerebral Palsy groups in a subgroup-analysis
- to assess compliance with treatment
- to report any adverse effects.
Read the detailed description
This study is designed as a double-blinded, randomized, cross-over trial (RCT). This part of the study takes 12 weeks (6 weeks of active treatment and 6 weeks of non-active treatment) and is followed by a wash-out period of 6 weeks. An uncontrolled,open phase starts after week 18, where patients are followed one year after inclusion.
30 participants with spasticity due to Stroke and Cerebral Palsy will be included.
Two centers are recruiting participants and are collecting data.
Outcome measures are chosen to reflect the different dimensions in the International Classification of Functioning, Disability and Health (ICF) and patient reported outcome measures (PROM).
- Conditions
- Spasticity, Stroke, Cerebral Palsy
- Being tested
- Multifocal TENS garment (Mollii®)
- Medical subject headings
- Muscle Spasticity, Stroke, Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multifocal TENS garment (Mollii®)Device
Also called Mollii®, Elektrodress, Swedish patent:SE534365.C2
Multifocal transcutaneous electrical stimulation incorporated into a whole-body garment in combination with training
| Study group | Role | What they receive |
|---|---|---|
| Multifocal TENS | Experimental | Multifocal TENS given in the garment Mollii® (Elektrodress) 1 hour every second day together with individualized training exercises. The steering unit counts down 60 minutes visible for the patient Receives: Device: Multifocal TENS garment (Mollii®) |
| Sham treatment | Sham comparator | Use of the garment Mollii® (Elektrodress) but without the electrical stimulation combined with the individualized training exercises. The steering unit counts down 60 minutes visible for the patient Receives: Device: Multifocal TENS garment (Mollii®) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Goal attainment scaling (GAS)
1 to 3 goals are defined and evaluated using the original GAS scale by Kiresuk
Measured: 12 weeks
Arm-hand ability (ARAT + WMFT tasks 1&2)
Action Research Arm Test (ARAT)measuring grasp, grip, pinch and gross movement and this is complemented by Wolf Motor Function Test (WMFT) tasks 1 and 2 measuring active shoulder abduction
Measured: 12 weeks
Mobility
10 meter walking test, divided into comfortable gait test (CGT) and fast gait test (FGT). Outcome is velocity, cadence and stride length.
Timed Up \& Go (TUG)
Measured: 12 weeks
Secondary outcomes (8)
Health related Quality of Life/QALY
SF-36 and EQ-VAS
Measured: Baseline, week 6, 12, 18, 52
Self reported pain and spasticity
Numeric rating scale (NRS)
Measured: Baseline, week 6, 12, 18, 52
Muscle hypertonicity (Spasticity)
Modified Ashworth scale (0-5)
Measured: Baseline, week 6, 12, 18, 52
Range of Motion
Goniometer
Measured: Baseline, week 6, 12, 18, 52
Costs
Costs directly related to intervention Baseline, week 6, 12, 18 Costs from a societal perspective at baseline and week 52
Measured: Baseline, week 6, 12, 18, 52
Goal Attainment Scaling (GAS)
1 to 3 goals are defined and evaluated using the original GAS scale by Kiresuk
Measured: 52 weeks
Arm-hand ability (ARAT + WMFT tasks 1&2)
Action Research Arm Test (ARAT)measuring grasp, grip, pinch and gross movement and this is complemented by Wolf Motor Function Test (WMFT) tasks 1 and 2 measuring active shoulder abduction
Measured: 52 weeks
Mobility
10 meter walking test, divided into comfortable gait test (CGT) and fast gait test (FGT). Outcome is velocity, cadence and stride length.
Timed Up \& Go (TUG)
Measured: 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2014 (estimated)
- Study startSep 2013
- Primary completionFeb 2015
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SpasticityStudies of the same condition, open and under way.
- More trials run by Linkoeping UniversityThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Linkoeping University
- Sponsor type
- Other government
- Collaborators
- University of Borås, University Hospital, Linkoeping, Sodra Alvsborgs Hospital
- Responsible party
- Principal investigator, Per Ertzgaard, Linkoeping University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02261142
- Sponsor's protocol ID
- LIU-ED2013
- Status last verified
- Jul 2015
- First submitted
- 1 Oct 2014
- Last updated
- 13 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Efficacy and Cost-effectiveness of Spasticity Treatment With Multifocal Transcutaneous Electrical Stimulation, Through a Garment With built-in Electrodes in Combination With Training.
- ClinicalTrials.gov ID
- NCT02261142
- Acronym / sponsor ID
- LIU-ED2013
- Conditions
- Spasticity, Stroke, Cerebral Palsy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Linkoeping UniversityOther government
- Collaborators
- University of Borås, University Hospital, Linkoeping, Sodra Alvsborgs Hospital
- Study start
- Sep 2013
- Primary completion
- Feb 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 10 Oct 2014 (estimated)
- 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 consequence of injury to the central nervous system and can be a major problem in motor function and everyday activities. A method for treating spasticity that applies low-amplitude electrical stimulation through a garment with built-in electrodes, Mollii® (Elektrodress), has been developed. The garment is to be used in combination with individualized training and the stimulation is mainly given to antagonists of spastic muscles.
The general objective of this study is to evaluate the efficacy of and costs associated with the Mollii® treatment of spasticity due to stroke or cerebral palsy.
Primary objectives are;
- to study whether treatment with the Mollii® improves function and activity
- to evaluate the cost-effectiveness of the treatment, from both a health-care perspective and a societal perspective.
Secondary objectives are;
- to study whether there are differences in treatment effect between the stroke and the Cerebral Palsy groups in a subgroup-analysis
- to assess compliance with treatment
- to report any adverse effects.
Detailed description
This study is designed as a double-blinded, randomized, cross-over trial (RCT). This part of the study takes 12 weeks (6 weeks of active treatment and 6 weeks of non-active treatment) and is followed by a wash-out period of 6 weeks. An uncontrolled,open phase starts after week 18, where patients are followed one year after inclusion.
30 participants with spasticity due to Stroke and Cerebral Palsy will be included.
Two centers are recruiting participants and are collecting data.
Outcome measures are chosen to reflect the different dimensions in the International Classification of Functioning, Disability and Health (ICF) and patient reported outcome measures (PROM).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Multifocal TENS | Experimental | Device: Multifocal TENS garment (Mollii®)Multifocal TENS given in the garment Mollii® (Elektrodress) 1 hour every second day together with individualized training exercises. The steering unit counts down 60 minutes visible for the patient |
| Sham treatment | Sham comparator | Device: Multifocal TENS garment (Mollii®)Use of the garment Mollii® (Elektrodress) but without the electrical stimulation combined with the individualized training exercises. The steering unit counts down 60 minutes visible for the patient |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Spasticity due to stroke or Cerebral Palsy
- Have some preserved walking ability, with or without walking aids
- Be able to understand the treatment and instruments/interviews used
- For stroke participants, two years should have elapsed since their injury/insult
Key exclusion criteria (13 listed)
- Electronic devices
- Ventriculoperitoneal shunt
- Arrhythmia
- Hearth infarction or unstable angina pectoris
- Symptomatic hyper- or hypotonia
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 |
|---|---|---|
| Multifocal TENS garment (Mollii®)Also: Mollii®, Elektrodress, Swedish patent:SE534365.C2Multifocal transcutaneous electrical stimulation incorporated into a whole-body garment in combination with training | Device | Multifocal TENS, Sham treatment |
Primary outcome
Goal attainment scaling (GAS)
Time frame: 12 weeks
1 to 3 goals are defined and evaluated using the original GAS scale by Kiresuk
Arm-hand ability (ARAT + WMFT tasks 1&2)
Time frame: 12 weeks
Action Research Arm Test (ARAT)measuring grasp, grip, pinch and gross movement and this is complemented by Wolf Motor Function Test (WMFT) tasks 1 and 2 measuring active shoulder abduction
Mobility
Time frame: 12 weeks
10 meter walking test, divided into comfortable gait test (CGT) and fast gait test (FGT). Outcome is velocity, cadence and stride length. Timed Up \& Go (TUG)
8 secondary outcomes
Health related Quality of Life/QALY
Time frame: Baseline, week 6, 12, 18, 52
Self reported pain and spasticity
Time frame: Baseline, week 6, 12, 18, 52
Muscle hypertonicity (Spasticity)
Time frame: Baseline, week 6, 12, 18, 52
Range of Motion
Time frame: Baseline, week 6, 12, 18, 52
Costs
Time frame: Baseline, week 6, 12, 18, 52
Goal Attainment Scaling (GAS)
Time frame: 52 weeks
Arm-hand ability (ARAT + WMFT tasks 1&2)
Time frame: 52 weeks
Mobility
Time frame: 52 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2015.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Multifocal TENS garment (Mollii®) in people with Spasticity and Stroke, run by Linkoeping University.
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 4 inclusion and 13 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: finished, as of the sponsor's last update on 13 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Goal attainment scaling (GAS) (time frame: 12 weeks). The study lists 3 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 13 Jul 2015.