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Post-Stroke Chronic Upper Limb SpasticitySMART-NISNCT05224349

Effectiveness and Safety of SMART [Spastic Muscle Palpation by Anatomic Landscape for BoNT-A (Botulinumtoxin-A) Injection to Reduce Muscle Tone] BoNT-A Therapy With Dysport® in Patients With Post-stroke Chronic Upper Limb Spasticity (ULS) in Real-life Setting.

An observational study of Post-Stroke Chronic Upper Limb Spasticity, run by Ipsen at 31 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to collect data for Dysport® SMART BoNT-A therapy usage in an office-based setting in post-stroke participants with chronic (> 6 months) focal Upper Limb Spasticity who have been under stable oral antispastics treatment or patients with no current anti-spasticity treatment. Read more about this study

Who is it for?
Ages 18 years and older
Type of treatment
Pill or oral medicine
How many people
121 participants
Where
31 sitesGermany
Study dates
9 May 2022to 4 Jul 2025
Phase
Observational

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

Study population: Participants with post-stroke chronic upper limb spasticity treated with Dysport® according to SMART guidelines.

Who may be able to join

  • Male or female patients ≥18 years with the capacity to consent.
  • Subjects with a post-stroke medium to severe focal upper limb spasticity for at least 6 months. Medium to severe focal upper limb spasticity is defined as MAS ≥2 in the PTMG and DAS ≥2 in the PTT.
  • Cohort according to SMART guidelines. The SMART injection concept is designed to be used only in patients suffering from simple patterns ("easy to diagnose spasticity pattern") of adult ULS, where Abobotulinumtoxin-A (AboBoNT-A) (Dysport®) injection can be simplified, by recognizing common spasticity patterns and key muscles for injection, identifying those muscles by palpation, and appropriate injection points of the suggested muscles using anatomic landmarks.
  • Subjects with treatment goals as reduction of pain, reduction of muscle tone, improvement of care (hygiene/dressing) and/or improvement of passive motion.
  • Subjects with the intention to be treated with Dysport® according to the current local Summary of Product Characteristics (SmPC) (Germany) and injection according to SMART must be taken prior to the entry in the study.
  • Physiotherapy should remain unchanged within 4 weeks before study start.

Who cannot join

  • Patients treated with intrathecal Baclofen or BoNT-A within the last 6 months
  • If treated with oral spasticity medication, change of oral spasticity medication within the last 4 weeks
  • Patients with active hand functions or patients with treatment goals of active functions.
  • Patients with any contraindication for Dysport® according to SmPC.
  • Patients in whom SMART therapy is not appropriate (e.g. spasticity pattern other than specified in SMART guidelines).
  • Participation in an interventional trial at the same time and/or within 3 months before baseline.
  • Diagnosed contracture/contracted muscle.

Trial locations and contacts

31 sites in 1 country.

31 sites in 1 country

Germany31 sites

  • Nervenarztpraxis

    Altdorf

  • Neurologisches Zentrum

    Berlin

  • Neurozentrum Erding

    Erding

  • Praxis für Neurochirurgie und Schmerztherapie

    Essen

  • Fürth; Medzentrum Fürth (MVZ)

    Fürth

  • Neuropraxis Fuerth

    Fürth

  • Neuropraxis Fürth

    Fürth

  • Evangelisches Klinikum Gelsenkirchen GmbH

    Gelsenkirchen

  • Universitätsmedizin Greifswald

    Greifswald

  • Herford; Klinikum Herford

    Herford

  • Praxis Sojka-Raytscheff

    Kiel

  • Neurologie am Funkerberg

    Königs Wusterhausen

  • MVZ Lakumed gGMBH

    Landshut

  • Praxis

    Leipzig

  • UK Schleswig-Holstein Campus Lübeck

    Lübeck

  • Fuerth; Medzentrum Fuerth

    Ludwigsburg

  • Neuropraxis Mannheim

    Mannheim

  • Neurozentrum Arabellapark

    München

  • ABC Ambulantes BehandlungsCentrum GmbH

    Nuremberg

  • ABC Moegeldorf

    Nuremberg

  • Nürnberg; Praxis

    Nuremberg

  • Gesundheitszentrum Quickborn

    Quickborn

  • Medicum. Tegernsee

    Rottach

  • Medicum. tegernsee - Rottach-Weissach

    Rottach-Egern

  • ZNS Südpfalz

    Rülzheim

  • St. Lukas Klinik GmbH

    Solingen

  • Praxis

    Sonneberg

  • Stadtroda; Asklepios Fachklinikum Stadtroda

    Stadtroda

  • Gemeinschaftspraxis

    Straubing

  • MVZ Neurologie am St. Johannes Sieglar

    Troisdorf

  • Neurologie im Denkmal

    Wuelfrath

Other trials in Germany

About this study

Official title: Effectiveness and Safety of SMART BoNT-A Therapy With Dysport® in Patients With Post-stroke Chronic Upper Limb Spasticity in Real-life Setting.

The purpose of this study is to collect data for Dysport® SMART BoNT-A therapy usage in an office-based setting in post-stroke participants with chronic (> 6 months) focal Upper Limb Spasticity who have been under stable oral antispastics treatment or patients with no current anti-spasticity treatment.

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT05224349
Study groupRoleWhat they receive
Group AParticipants with stable oral anti-spasticity treatment for at least 4 weeks prior to study entry
Group BParticipants with no anti-spasticity therapy for at least 4 weeks prior to study entry

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change from baseline of Disability Assessment Scale (DAS) score in Principle Target of Treatment (PTT) for the upper limb.

    The PTT will be pre-selected from the 4 DAS domains: hygiene, dressing, limb position and pain of the upper limb at Visit 1. The extent of functional impairment in the PTT will be assessed on a four-point scale (range 0 to 3, where 0=no disability, and 3=severe disability) at each visit.

    Measured: At 12 weeks to 16 weeks after injection at Visit 1

Secondary outcomes (5)

  1. Change from baseline of Modified Ashworth Scale (MAS) Primary Target Muscle Group (PTMG)

    Muscle tone will be evaluated using the MAS. The PTMG (shoulder adductors, elbow flexors, wrist flexors or finger flexors) will be pre-selected at Visit 1. The muscle tone in the PTMG will be assessed from 0 (no increase in tone) to 4 (affected part(s) rigid in flexion or extension) at each visit.

    Measured: At 12 weeks to 16 weeks

  2. Change from baseline of pain assessed with Visual Analogue Scale (VAS)

    Pain (from 0 (no pain) to 10 (maximum pain) in upper limb extremity will be assessed at each visit.

    Measured: At 12 weeks to 16 weeks

  3. Change from baseline of Spasticity Related Quality of Life Tool (SQoL-6D)

    The questionnaire covers six dimensions: Pain/ discomfort, involuntary movement or spasms, restricted range of movement, caring for the affected limb, using the affected limb, mobility/balance. Each dimension is assessed using a five-point scale ranging from 0 to 4, with higher scores meaning worse outcome.

    Measured: At 12 weeks to 16 weeks

  4. Incidence of Adverse Events (AEs)

    Measured: Up to 32 weeks

  5. Incidence of Special Situations (SS)

    Measured: Up to 32 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Feb 2022
  2. Study start9 May 2022
  3. Primary completion9 Apr 2025
  4. Study completion4 Jul 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
121 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05224349
Sponsor's protocol ID
CLIN-52120-456
Other IDs
EUPAS107722
Acronym
SMART-NIS
Status last verified
Jul 2025
First submitted
25 Jan 2022
Last updated
1 Aug 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, annotated case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of study participants. Any requests should be submitted to www.vivli.org for assessment by an independent scientific review board.

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