Efficacy of the Exopulse Mollii Suit on spasticity, mobility, and pain in patients with hereditary spastic paraplegia (HSP): a double-blind, placebo-controlled crossover pilot study.

Efficacy of the Exopulse Mollii Suit on spasticity, mobility, and pain in patients with hereditary spastic paraplegia (HSP): a double-blind, placebo-controlled crossover pilot study. - Exopulse Mollii Suit in Hereditary Spastic Paraplegia

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00040320

Enrollment

Registered

2026-05-13

Start date

2026-05-18

Completion date

Unknown

Last updated

2026-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

G11.4

Interventions

Group 1: As part of the study, all participants will receive two stimulation applications with the Exopulse Mollii Suit. One application will be performed as verum stimulation, meaning active therapeu

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: a. Confirmed diagnosis of HSP b. Presence of clinically relevant spasticity c. Ability to participate in the outpatient study on four to five consecutive days d. Sufficient cognitive and language skills to understand the study procedures and follow instructions e. Capacity to provide consent and written informed consent obtained f. Preserved walking ability, with or without assistive devices, for at least 50 m g. Age > 18 years

Exclusion criteria

Exclusion criteria: a. Other neurological disorder b. Cardiovascular disease or other relevant internal medical conditions c. Malignant diseases/cancer d. Acute infectious diseases e. Fever f. Epilepsy g. Skin diseases, rashes, or other skin problems in the area of stimulation application h. Pregnancy i. BMI > 35 kg/m² j. Pacemaker k. Ventriculoperitoneal shunt l. Baclofen pump m. Concurrent use of another medical device that could impair the safety or function of the electrical stimulation.

Design outcomes

Primary

Measure	Time frame
•10-Meter Walk Test •Timed Up and Go Test (TUG) •Berg Balance Scale •Spasticity assessment using the Modified Tardieu Scale These assessments will be performed daily from Monday to Thursday. On Monday and Wednesday, the stimulation days, the assessments will be performed before stimulation with the Exopulse Mollii Suit and again two hours after stimulation. On Tuesday and Thursday, these assessments will be performed only once each day. These assessments are performed by trained clinical staff. The examiner is blinded.	—

Measure

Time frame

•10-Meter Walk Test •Timed Up and Go Test (TUG) •Berg Balance Scale •Spasticity assessment using the Modified Tardieu Scale These assessments will be performed daily from Monday to Thursday. On Monday and Wednesday, the stimulation days, the assessments will be performed before stimulation with the Exopulse Mollii Suit and again two hours after stimulation. On Tuesday and Thursday, these assessments will be performed only once each day. These assessments are performed by trained clinical staff. The examiner is blinded.

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Secondary

Measure	Time frame
• Visual Analogue Scale (VAS) for pain assessment • Spastic Paraplegia Rating Scale (SPRS) • Smartphone video recording of the 10-metre walk test for subsequent markerless kinematic movement analysis using software from Subsequent These assessments will be performed daily from Monday to Thursday. On Monday and Wednesday, the stimulation days, the assessments will be performed before stimulation with the Exopulse Mollii Suit and again two hours after stimulation. On Tuesday and Thursday, these assessments will be performed only once each day. These assessments are performed by trained clinical staff. The examiner is blinded. • Neurophysiological assessments: Motor evoked potentials (MEP) Somatosensory evoked potentials (SSEP) Neurophysiological measurements are always performed on Tuesdays by trained clinical staff. The examiner is blinded. • User satisfaction evaluation questionnaire (USEQ) The questionnaire is completed by the patients on Thursday.	—

Measure

Time frame

• Visual Analogue Scale (VAS) for pain assessment • Spastic Paraplegia Rating Scale (SPRS) • Smartphone video recording of the 10-metre walk test for subsequent markerless kinematic movement analysis using software from Subsequent These assessments will be performed daily from Monday to Thursday. On Monday and Wednesday, the stimulation days, the assessments will be performed before stimulation with the Exopulse Mollii Suit and again two hours after stimulation. On Tuesday and Thursday, these assessments will be performed only once each day. These assessments are performed by trained clinical staff. The examiner is blinded. • Neurophysiological assessments: Motor evoked potentials (MEP) Somatosensory evoked potentials (SSEP) Neurophysiological measurements are always performed on Tuesdays by trained clinical staff. The examiner is blinded. • User satisfaction evaluation questionnaire (USEQ) The questionnaire is completed by the patients on Thursday.

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Countries

Germany

Contacts

Public ContactJoachim Liepert

Lurija Institut Kliniken Schmieder Allensbach

j.liepert@kliniken-schmieder.de+4975338081236

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Jun 11, 2026