NCT02261142

Brief 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. 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
31

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2013

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2013

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

October 1, 2014

Completed
9 days until next milestone

First Posted

Study publicly available on registry

October 10, 2014

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2015

Completed
Last Updated

July 13, 2015

Status Verified

July 1, 2015

Enrollment Period

1.4 years

First QC Date

October 1, 2014

Last Update Submit

July 10, 2015

Conditions

SpasticityStrokeCerebral Palsy

Outcome Measures

Primary Outcomes (3)

  • Goal attainment scaling (GAS)

    1 to 3 goals are defined and evaluated using the original GAS scale by Kiresuk

    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

    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)

    12 weeks

Secondary Outcomes (8)

  • Health related Quality of Life/QALY

    Baseline, week 6, 12, 18, 52

  • Self reported pain and spasticity

    Baseline, week 6, 12, 18, 52

  • Muscle hypertonicity (Spasticity)

    Baseline, week 6, 12, 18, 52

  • Range of Motion

    Baseline, week 6, 12, 18, 52

  • Costs

    Baseline, week 6, 12, 18, 52

  • +3 more secondary outcomes

Study Arms (2)

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

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

Device: Multifocal TENS garment (Mollii®)

Interventions

Multifocal TENS garment (Mollii®)DEVICE

Multifocal transcutaneous electrical stimulation incorporated into a whole-body garment in combination with training

Also known as: Mollii®, Elektrodress, Swedish patent:SE534365.C2
Multifocal TENSSham treatment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Electronic devices
  • Ventriculoperitoneal shunt
  • Arrhythmia
  • Hearth infarction or unstable angina pectoris
  • Symptomatic hyper- or hypotonia
  • Cancer under treatment
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Muscle SpasticityStrokeCerebral Palsy

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesMuscle HypertoniaNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesVascular DiseasesCardiovascular DiseasesBrain Damage, Chronic

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D.

Study Record Dates

First Submitted

October 1, 2014

First Posted

October 10, 2014

Study Start

September 1, 2013

Primary Completion

February 1, 2015

Study Completion

February 1, 2015

Last Updated

July 13, 2015

Record last verified: 2015-07