Effectiveness of an Interprofessional Approach to the Treatment of Spasticity With Botulinum Toxin & Non-pharmacological Therapies

September 1, 2025 updated by: Clare Maguire, Technical University of Bern

To Evaluate the Effectiveness of an Interprofessional, Collaborative Approach to the Treatment of Spasticity Comprising Botulinum Toxin & Non-pharmacological Post-injection Therapy. A Study Protocol of a Multi-Centred N-of-1 Series

Many people with neurological conditions will experience spasticity, a nonvolitional and uncontrollable tightening and/or spasm of muscles. This can impact the person's functioning and independence in everyday tasks and can contribute to contractures. Spasticity and contracture develop and affect each person differently. Treatment is provided by a multi-disciplinary team (MDT), working collaboratively to offer the best combination of medications (including botulinum neurotoxin (BoNT)) and non-pharmacological interventions. There are a wide range of therapy interventions available. Each person's treatment plan is uniquely tailored to them, their individual presentation, and their treatment goals. Evidencing the effectiveness of spasticity and contracture treatment has been difficult. The manifestation and treatment of spasticity is never the same between patients. The experience of the condition and the perceived and observable effectiveness of treatment are unique to the individual. Treatment is most effective when MDT's work together to combine the most appropriate medications and therapies in a treatment plan individualised to the person and their presentation. Understanding how expert teams formulate spasticity treatment and how effectively their expertise influences spasticity outcomes could help inform practice.

The purpose of this multicenter, case study series is to evaluate the effectiveness of two conceptually similar, specialised MDT approaches for the treatment of patients with spasticity in two cross-national neurorehabilitation facilities.

The goal of this study is to investigate the effectiveness of interprofessional treatments of non-drug interventions in combination with botulinum toxin injections in patients who suffer from spasticity.

The main goals of the study are to evaluate:

  1. Describe and evaluate the types of botulinum toxin and therapy treatment choices expert MDTs make when treating people with spasticity.
  2. Evaluate whether a MDT approach to the assessment and treatment of spasticity using BoNT and non-pharmacological interventions is effective at achieving patient goals.
  3. Evaluate whether a MDT approach to the assessment and treatment of spasticity using BoNT and non-pharmacological interventions, improves impairment and activity/participation outcomes using commonly used clinical outcome measures.

There will be no comparison group. The N-of-1, ABC study design allows participants to serve as their own controls.

Participants will undergo assessements to describe their goals and severity of spasticity:

  • Goal Attainment Scale light
  • ArmA & SQoL-6D
  • LegA
  • Modified Ashworth Scale
  • Modifies Tardieu Scale
  • Muscle Strength according to MRC
  • Pain Measurement (NRS, VAS or other)

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Cross-national, multicenter (CH and UK) single case experimental design (SCED), specifically N-of-1 series with an ABC Design (Baseline, Intervention, Follow-up). Patients with focal or multifocal spasticity who the MDT determine that BoNT and concomitant therapies are appropriate interventions based on their multidisciplinary evaluation. As this is a trial with defined pharmacological and non-pharmacological interventions that are an integral part of the individual treatment, all measurements and treatments are included to varying degrees in the standard of care/usual care in the rehabilitation centres. Participants will receive their botulinum toxin and therapy treatments as recommended by their clinical team. Both are a standard care in rehabilitation of spasticity. Included patients receive their BoNT injection and non-pharmacological interventions as indicated. All participating patients will be repeatedly measured at baseline phase A (pre- intervention), during intervention phase B and after completion of the intervention during phase C follow-up. The repeated measurements at baseline allow the participants to serve as their own controls. With this method, the treatment efficacy for individual patients can be estimated, rather than aggregate group effects and therefore the true heterogeneity and varying responses of individual patients is captured.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Switzerland
      • Basel, Switzerland, 4055
        • REHAB Basel
        • Contact:
        • Contact:
        • Principal Investigator:
          • Clare Maguire
  • United Kingdom
    • West Hill Putney
      • London, West Hill Putney, United Kingdom, SW15 3 SW
        • Royal Hospital for Neuro-disability
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age 18 or over
  • male, female or other
  • acute or chronic spasticity
  • patients who have been assessed by the spasticity MDT and whose treatment plan includes Botulinum toxin and non-pharmacological therapies for focal or multi-focal spasticity and who have signed the general consent at entry.

Exclusion Criteria:

  • <18 years
  • Patients with spasticity, who will not receive BoNT
  • Planned re-injection of BoNT before the end of the Phase C Follow-Up
  • Previous BoNT injection within 3 months of baseline measurements

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Therapy with Botulinum Neurotoxin and non-pharmacological therapies
Every included patient receive BoNT and non-pharmacological therpies. The participants serve as their own controls.
Drug: Botulinum Neurotoxin Type A
The effectiveness of the combination of BoNT with treatment goal specific non-pharmacological interventions will be evaluated.
Other: Non-pharmacological therapies
Depending on the treatment goal different non-pharmacological therapies as a standard of care will be provided
Other Names:
  • physiotherapy
  • occupational therapy

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Goal Attainment Scale: A multidisciplinary team (MDT) approach to the assessment and treatment of spasticity using BoNT and non-pharmacological interventions, improve individualised, patient-centred functional outcomes based on collaborative goal setting
Time Frame: From enrollment: Baseline 2 weeks (4 times), Intervention 12 weeks (12 times), Follow-up 6 (1x) and 12 (1x) weeks after completion of intervention

The Goal Attainment Scale (GAS) is a tool to formulate and measure personalized rehabilitation goals on all ICF levels. In this model the following 5-point rating is used:

  • 2 much better than defined

  • 1 better than defined 0 SMART formulated goal is achieved

    • 1 baseline status unchanged
    • 2 worsening of baseline status
From enrollment: Baseline 2 weeks (4 times), Intervention 12 weeks (12 times), Follow-up 6 (1x) and 12 (1x) weeks after completion of intervention

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Leg Activity Measure (LegA): The influence on MDT approach on active or passive care of the affected limb
Time Frame: From enrollment: Baseline 2 weeks (4x), Intervention 12 weeks (6x), Follow-up 6 (1x) and 12 (1x) weeks after completion of intervention
LegA: It is a valid and reliable tool, which measures change in passive and active function of the lower limb due to spasticity related impairment and the impact of these on quality of life. It is a patient or carer-rated outcome measure with 33 items relating to clinically relevant goals from the patient or carer's point of view. It is a 5 point Likert scale with 0 = no difficulties/ not at all and 4 = not able to do/ extremly.
From enrollment: Baseline 2 weeks (4x), Intervention 12 weeks (6x), Follow-up 6 (1x) and 12 (1x) weeks after completion of intervention
Spasticity-related quality of life (SQoL-6D): Influence of the MDT approach on Quality of Life (QoL)
Time Frame: From enrollment: Baseline 2 weeks (4x), Intervention 12 weeks (6x), Follow-up 6 (1x) and 12 (1x) weeks after completion of intervention

Spasticity-related quality of life (SQoL-6D) provides an overall picture of spasticity-related health status following focal treatment of upper limb spasticity. As a valid, reliable and responsive measure of spasticity-related quality of life, the SQoL is designed to record those dimensions that relate to the chosen goal areas. There are six dimensions of the SQoL-6D:

  1. Reduction of pain and discomfort
  2. Control of spasms and other involuntary movements
  3. Maintaining the range of upper limb movements
  4. Passive function: ease of caring for the affected limb
  5. Active function - using the affected limb in activities
  6. Mobility/ balance. Each dimension is assessed using a five-level scale ranging from 0 to 4, whereas 0 = no difficulties and 4 = extremly hard/ not able to do
From enrollment: Baseline 2 weeks (4x), Intervention 12 weeks (6x), Follow-up 6 (1x) and 12 (1x) weeks after completion of intervention
Arm Activity Measure (ArmA): The influence on MDT approach on active or passive care of the affected limb
Time Frame: From enrollment: Baseline 2 weeks (4x), Intervention 12 weeks (6x), Follow-up 6 (1x) and 12 (1x) weeks after completion of intervention

ArmA: It is a valid and reliable tool, which measures changes in passive and active function in the upper limb due to spasticity related impairment. It is a patient or carer rated outcome measure with 20 items relating to clinically relevant goals from the patient or carer's point of view. It is a 5-point Likert scale with 0 = no difficulties and 4 = not able to do.

LegA: It is a valid and reliable tool, which measures change in passive and active function of the lower limb due to spasticity related impairment and the impact of these on quality of life. It is a patient or carer-rated outcome measure with 33 items relating to clinically relevant goals from the patient or carer's point of view. It is a 5 point Likert scale with 0 = no difficulties and 4 = not able to do.
From enrollment: Baseline 2 weeks (4x), Intervention 12 weeks (6x), Follow-up 6 (1x) and 12 (1x) weeks after completion of intervention
Modified Ashworth Scale (MAS): The influence of the MDT approach on spasticity
Time Frame: From enrollment: Baseline 2 weeks (2-4times), Intervention 12 weeks (weekly), Follow-up 6 (1x) and 12 weeks (1x) after completion of intervention
MAS: The MAS measures the severity of spasticity and is a six-point ordinal scale (0 - no difficulty, 4 - unable to do task) with an additional point at +1 (slight increase in muscle tone). The MAS therefore provides a single score to represent spasticity. It has moderate reliability but is widely used in clinical practice due to ease of application.
From enrollment: Baseline 2 weeks (2-4times), Intervention 12 weeks (weekly), Follow-up 6 (1x) and 12 weeks (1x) after completion of intervention
Modified Tardieu Scale (mTS): The influence of the MDT approach on spasticity
Time Frame: From enrollment: Baseline 2 weeks (2-4times), Intervention 12 weeks (weekly), Follow-up 6 (1x) and 12 weeks (1x) after completion of intervention
mTS: The mTS is a reliable measure which quantifies spasticity by assessing the muscle response to different stretch velocities (movements at fast and slow speed passive movement) and by determining the spasticity angle. Additionally, the quality of muscle reaction regarding resistance, clonus or contracture is noted. It is a 5-point ordinal scale with 0=no resistance and 4=clonus > 10sec.
From enrollment: Baseline 2 weeks (2-4times), Intervention 12 weeks (weekly), Follow-up 6 (1x) and 12 weeks (1x) after completion of intervention
The influence of the MDT approach on muscle strength
Time Frame: From enrollment: Baseline 2 weeks (2-4 times), Intervention 12 weeks (weekly), Follow-up 6 (1x) and 12 weeks (1x) after completion of intervention
Muscle strength will be tested manually by the examiner following the Medical Research Council (MRC) as a valid tool. The scale is an ordinal scale and ranges from 0-5 whereas grade 0 to 3 has the highest reliability and with score 0 (no strength at all) to 5 (maximum strength).
From enrollment: Baseline 2 weeks (2-4 times), Intervention 12 weeks (weekly), Follow-up 6 (1x) and 12 weeks (1x) after completion of intervention
Pain - Numeric Rating Scale (NRS): Influence of the MDT approach on pain
Time Frame: From enrollment: Baseline 2 weeks (4x), Intervention 12 weeks (12x), Follow-up 6 (1x) and 12 (1x) weeks after completion of intervention
For conscious patients the Numeric Pain Rating Scale (NRS) will be used. This scale measures the subjective intensity of pain. It is an 11-point scale scored from 0-10, whereas 0 = no pain and 10 = the most intense pain imaginable. It is described having a good sensitivity.
From enrollment: Baseline 2 weeks (4x), Intervention 12 weeks (12x), Follow-up 6 (1x) and 12 (1x) weeks after completion of intervention
Pain - Zürich Observation Pain Assessment (ZOPA): Influence of the MDT approach on pain
Time Frame: From enrollment: Baseline 2 weeks (4x), Intervention 12 weeks (12x), Follow-up 6 (1x) and 12 (1x) weeks after completion of intervention
The Zürich Observation Pain Assessment (ZOPA) is used to external assessment of pain in people with cognitive and/ or conscious impairments in the field of neurosurgery and neurology. The instrument consists of a defined pool of items (behavioural characteristics) and is divided into four categories with a total of 13 subcategories. It provides information about the presence of pain and not about the perceived pain quality. The scale is assessed in various dimensions (e.g. facial expressions, posture, verbal expressions), with each dimension being rated on a five-point scale from 0 (no expression) to 4 (highest degree of pain).
From enrollment: Baseline 2 weeks (4x), Intervention 12 weeks (12x), Follow-up 6 (1x) and 12 (1x) weeks after completion of intervention
Pain - Behavioural Pain Assessment Tool: Influence of the MDT approach on pain
Time Frame: From enrollment: Baseline 2 weeks (4x), Intervention 12 weeks (12x), Follow-up 6 (1x) and 12 (1x) weeks after completion of intervention
The behavioural pain assessment tool for patients in minimal conscious state will be used for the included patients at the Royal Hospital for Neuro-disability. It is a structured framework for recording and monitoring behaviours that may denote experience of pain in patients with prolonged disorders of consciousness. 7 items will be observed by a health-professional and then scored from 0 to 2. Whereas 0 means normal behaviour and 2 means a strong sign which can indicate stronger pain.
From enrollment: Baseline 2 weeks (4x), Intervention 12 weeks (12x), Follow-up 6 (1x) and 12 (1x) weeks after completion of intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Technical University of Bern

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Margret Hund-Georgiadis, PD Dr.med., REHAB Basel, Rehaklinik für Neurorehabilitation und Paraplegiologie

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 19, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 1, 2025

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 8, 2025

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 8, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 1, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2025-00282

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All IPD that underlie results in a publication

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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