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Evaluation of the Safety and Efficacy of a Full-Body Electrostimulation Garment for Individuals With Neurological and Neuromuscular Conditions That Cause Spasticity, Hyperreflexia, and Pain

ConditionsMultiple SclerosisFibromyalgiaNeurologic DisorderNeuromuscular Disorders
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorShirley Ryan AbilityLab

About this trial

The purpose of this study is to to explore the safety and efficacy of the EXOPULSE Mollii suit, a full-body electrostimulation suit, for individuals with neurological or neuromuscular conditions that cause spasticity, hyperreflexia, and/or pain.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 18 to 75 years old

Medical clearance from physician

Individuals who experience spasticity, pain, or hyperreflexia due to neurological or neuromuscular conditions or individuals with a diagnosis of Multiple Sclerosis or Fibromyalgia

having a definite diagnosis for at least one month

Disqualifiers

Implanted medical devices or equipment which can be disrupted by magnets (ex. Shunts)

Swollen, infected, or inflamed areas or skin eruptions (e.g., phlebitis, thrombophlebitis, varicose veins, etc.) in areas where the suit will be used

No established somatic or neuropsychiatric diagnosis prior to enrollment in the study

Pregnant and/or nursing

Trial design

Design model

Crossover

Treatments tested in this trial

  • Active full-body stimulation

    Device

    Participants will receive active stimulation through a full-body suit with embedded electrodes that deliver a low-grade electrical stimulation to muscle groups.

  • Sham full-body stimulation

    Other intervention

    Participants will receive sham stimulation through a full-body suit with embedded electrodes that deliver a low-grade electrical stimulation to muscle groups.

Treatment groups

15 Participants
are divided into 2 treatment groups
Group A: InterventionExperimental treatment 1 intervention
Group B: ShamSham comparator 1 intervention

Trial outcomes

Primary outcomes

1

Berg Balance Scale

The Berg Balance Scale is a 14-item objective measure that assesses static balance and falls risk. The functional abilities that are assessed include sitting and standing balance, transfers, altered bases of support, reaching, turning, and closing eyes.Scores range from 0 - 56, with higher scores indicating improved balance.

Time frame
Baseline 1 (prior to Arm 1)- initial visit, Endpoint 1 (after Arm 1)- at ~2 weeks, Baseline 2 (after 2 week washout and before Arm 2)- at ~4 weeks, Endpoint 2 (after Arm 2)- at ~6 weeks, Follow-Up (2 weeks after Endpoint 2)- at ~8 weeks

Secondary outcomes

1

Manual Muscle Test

A procedure to evaluate the strength of individual muscles relative to gravity and manual resistance. Scores can range from 0 (no contraction) to 5 (full contraction against max resistance)

Time frame
Baseline 1 (prior to Arm 1)- initial visit, Endpoint 1 (after Arm 1)- at ~2 weeks, Baseline 2 (after 2 week washout and before Arm 2)- at ~4 weeks, Endpoint 2 (after Arm 2)- at ~6 weeks, Follow-Up (2 weeks after Endpoint 2)- at ~8 weeks
2

Modified Ashworth Scale

The Modified Ashworth Scale is used to grade the amount of hypertonicity / spasticity in individuals. Tone is scored by passively moving the individual's limb and assessing the amount of resistance to movement felt by the examiner. Scores can range from 0 (no spasticity) to 4 (affected part rigid.)

Time frame
Baseline 1 (prior to Arm 1)- initial visit, Endpoint 1 (after Arm 1)- at ~2 weeks, Baseline 2 (after 2 week washout and before Arm 2)- at ~4 weeks, Endpoint 2 (after Arm 2)- at ~6 weeks, Follow-Up (2 weeks after Endpoint 2)- at ~8 weeks
3

10 Meter Walk Test

Participants are timed as they walk 10 meters at both their self-selected speed, and their fastest but safest speeds.

Time frame
Baseline 1 (prior to Arm 1)- initial visit, Endpoint 1 (after Arm 1)- at ~2 weeks, Baseline 2 (after 2 week washout and before Arm 2)- at ~4 weeks, Endpoint 2 (after Arm 2)- at ~6 weeks, Follow-Up (2 weeks after Endpoint 2)- at ~8 weeks
4

6 Minute Walk Test

A test to measure the distance that a participant can walk over a period of 6 minutes.

Time frame
Baseline 1 (prior to Arm 1)- initial visit, Endpoint 1 (after Arm 1)- at ~2 weeks, Baseline 2 (after 2 week washout and before Arm 2)- at ~4 weeks, Endpoint 2 (after Arm 2)- at ~6 weeks, Follow-Up (2 weeks after Endpoint 2)- at ~8 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Shirley Ryan AbilityLab

Lead sponsor

Otto Bock Healthcare Products GmbH

Collaborator

Source ClinicalTrials.gov
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