SpasticityNCT07160699
Effectiveness of an Interprofessional Approach to the Treatment of Spasticity With Botulinum Toxin & Non-pharmacological Therapies
A study testing Botulinum Neurotoxin Type A and Non-pharmacological therapies in people with Spasticity, run by Technical University of Bern at 2 sites in 2 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spasticity
- What is being tested?
- Botulinum Neurotoxin Type A and Non-pharmacological therapies
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 1 Oct 2025to Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
Who may be able to join
- 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.
Who cannot join
- <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
Trial locations and contacts
2 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
2 sites in 2 countries
Switzerland1 site
REHAB Basel
Basel, 4055
Martina Grinzinger, +41613250709, m.grinzinger@rehab.ch
Clare Maguire, +41613250761, c.maguire@rehab.ch
United Kingdom1 site
Royal Hospital for Neuro-disability
London, West Hill Putney, SW15 3 SW
Teresa Clark, PhD cand., no number, tclark@rhn.org.uk
About this study
Official title: 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.
Read more
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:
- Describe and evaluate the types of botulinum toxin and therapy treatment choices expert MDTs make when treating people with spasticity.
- Evaluate whether a MDT approach to the assessment and treatment of spasticity using BoNT and non-pharmacological interventions is effective at achieving patient goals.
- 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)
Read the 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.
- Conditions
- Spasticity
- Being tested
- Botulinum Neurotoxin Type A, Non-pharmacological therapies
- Keywords
- spasticity, neurorehabilitation, botulinium toxin, non-pharmacological interventions, multi-disciplinary
- Medical subject headings
- Muscle Spasticity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Botulinum Neurotoxin Type ADrug
The effectiveness of the combination of BoNT with treatment goal specific non-pharmacological interventions will be evaluated.
Non-pharmacological therapiesOther
Also called physiotherapy, occupational therapy
Depending on the treatment goal different non-pharmacological therapies as a standard of care will be provided
| Study group | Role | What they receive |
|---|---|---|
| Therapy with Botulinum Neurotoxin and non-pharmacological therapies | Experimental | Every included patient receive BoNT and non-pharmacological therpies. The participants serve as their own controls. Receives: Drug: Botulinum Neurotoxin Type A; Other: Non-pharmacological therapies |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
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
Measured: 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 outcomes (9)
Leg Activity Measure (LegA): The influence on MDT approach on active or passive care of the affected limb
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.
Measured: 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)
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:
- Reduction of pain and discomfort
- Control of spasms and other involuntary movements
- Maintaining the range of upper limb movements
- Passive function: ease of caring for the affected limb
- Active function - using the affected limb in activities
- 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
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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).
Measured: 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
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.
Measured: 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
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).
Measured: 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
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.
Measured: From enrollment: Baseline 2 weeks (4x), Intervention 12 weeks (12x), Follow-up 6 (1x) and 12 (1x) weeks after completion of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2025
- Study start1 Oct 2025 (estimated)
- Primary completionOct 2026 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SpasticityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- After the injection with BoNT, individualised, goal-specific non-pharmacological therapies will be provided.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Technical University of Bern
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Clare Maguire, Technical University of Bern
- Investigators
- Margret Hund-Georgiadis, PD Dr.med., Study director, REHAB Basel, Rehaklinik für Neurorehabilitation und Paraplegiologie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07160699
- Sponsor's protocol ID
- 2025-00282
- Other IDs
- 2025
- Status last verified
- Sep 2025
- First submitted
- 19 Jan 2025
- Last updated
- 8 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07160699
- Acronym / sponsor ID
- 2025-00282
- Conditions
- Spasticity
- Keywords
- spasticity, neurorehabilitation, botulinium toxin, non-pharmacological interventions, multi-disciplinary
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Technical University of BernUniversity, hospital or other
- Study start
- 1 Oct 2025 (estimated)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 8 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Describe and evaluate the types of botulinum toxin and therapy treatment choices expert MDTs make when treating people with spasticity.
- Evaluate whether a MDT approach to the assessment and treatment of spasticity using BoNT and non-pharmacological interventions is effective at achieving patient goals.
- 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)
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- After the injection with BoNT, individualised, goal-specific non-pharmacological therapies will be provided.
| Arm | Type | Receives |
|---|---|---|
| Therapy with Botulinum Neurotoxin and non-pharmacological therapies | Experimental | Drug: Botulinum Neurotoxin Type A, Other: Non-pharmacological therapiesEvery included patient receive BoNT and non-pharmacological therpies. The participants serve as their own controls. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- <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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Botulinum Neurotoxin Type AThe effectiveness of the combination of BoNT with treatment goal specific non-pharmacological interventions will be evaluated. | Drug | Therapy with Botulinum Neurotoxin and non-pharmacological therapies |
| Non-pharmacological therapiesAlso: physiotherapy, occupational therapyDepending on the treatment goal different non-pharmacological therapies as a standard of care will be provided | Other | Therapy with Botulinum Neurotoxin and non-pharmacological therapies |
Primary outcome
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
9 secondary outcomes
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
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
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
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
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
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
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
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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2025.
- Individual participant dataSharing planned: Yes. All IPD that underlie results in a publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Margret Hund-Georgiadis, PD Dr.med. study director
REHAB Basel, Rehaklinik für Neurorehabilitation und Paraplegiologie
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Botulinum Neurotoxin Type A and Non-pharmacological therapies in people with Spasticity, run by Technical University of Bern at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 8 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Switzerland, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Martina Grinzinger (+41613250709, m.grinzinger@rehab.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2025.