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

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

Overview

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.

Interventions

• 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

Primary outcome measures

• 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]

Secondary outcome measures (9)

• 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]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

Switzerland · 1 center

• REHAB Basel — Basel

United Kingdom · 1 center

• Royal Hospital for Neuro-disability — London

Identifiers

NCT: NCT07160699 · 2025-00282

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗