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

NCT ID: NCT07160699

Last Updated: 2025-09-08

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-10-01
• Study Completion Date: 2027-04-30

Brief 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. 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)

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Therapy with Botulinum Neurotoxin and non-pharmacological therapies

Every included patient receive BoNT and non-pharmacological therpies. The participants serve as their own controls.

Group Type: EXPERIMENTAL

Botulinum Neurotoxin Type A

Intervention Type: DRUG

The effectiveness of the combination of BoNT with treatment goal specific non-pharmacological interventions will be evaluated.

Non-pharmacological therapies

Intervention Type: OTHER

Depending on the treatment goal different non-pharmacological therapies as a standard of care will be provided

Interventions

Botulinum Neurotoxin Type A

The effectiveness of the combination of BoNT with treatment goal specific non-pharmacological interventions will be evaluated.

Intervention Type: DRUG

Non-pharmacological therapies

Depending on the treatment goal different non-pharmacological therapies as a standard of care will be provided

Intervention Type: OTHER

Other Intervention Names

physiotherapy; occupational therapy

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Technical University of Bern

OTHER

Sponsor Role: lead

Responsible Party

Clare Maguire

PhD Clinical Lead Physiotherapy

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Margret Hund-Georgiadis, PD Dr.med.

Role: STUDY_DIRECTOR

REHAB Basel, Rehaklinik für Neurorehabilitation und Paraplegiologie

Locations

REHAB Basel

Basel, , Switzerland

Royal Hospital for Neuro-disability

London, West Hill Putney, United Kingdom

Countries

Switzerland; United Kingdom

Central Contacts

Martina Grinzinger

Role: CONTACT

m.grinzinger@rehab.ch

+41613250709

Clare Maguire

Role: CONTACT

c.maguire@rehab.ch

+41 613250761

Facility Contacts

Martina Grinzinger

Role: primary

m.grinzinger@rehab.ch

+41613250709

Clare Maguire

Role: backup

c.maguire@rehab.ch

+41613250761

Teresa Clark, PhD cand.

Role: primary

tclark@rhn.org.uk

no number

Other Identifiers

2025-00282

Identifier Type: -

Identifier Source: org_study_id