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

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)

Conditions

• Spasticity

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

Sponsors & Collaborators

• Technical University of Bern

  lead OTHER

Principal Investigators

• Margret Hund-Georgiadis, PD Dr.med. · REHAB Basel, Rehaklinik für Neurorehabilitation und Paraplegiologie

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-10-01

Primary Completion

2026-10-31

Completion

2027-04-30

Countries

• Switzerland
• United Kingdom

Study Locations