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

NCT07160699 | Not Yet Recruiting DMC

• 1 other identifier: 2025-00282
• Study Type: interventional
• Target: 30
• Locations: 2 countries
• Sites: 2

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:

• 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

Keywords

spasticity; neurorehabilitation; botulinium toxin; non-pharmacological interventions; multi-disciplinary

Outcome Measures

Primary Outcomes (1)

• 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

  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

  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)

  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

  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

  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

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

Study Arms (1)

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.

Drug: Botulinum Neurotoxin Type A; Other: Non-pharmacological therapies

Interventions

Botulinum Neurotoxin Type A DRUG

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

Therapy with Botulinum Neurotoxin and non-pharmacological therapies

Non-pharmacological therapies OTHER

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

Also known as: physiotherapy, occupational therapy

Therapy with Botulinum Neurotoxin and non-pharmacological therapies

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• \<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

Sponsors & Collaborators

• Technical University of Bern: lead

Study Sites (2)

REHAB Basel

Basel, 4055, Switzerland

Location

Royal Hospital for Neuro-disability

London, West Hill Putney, SW15 3 SW, United Kingdom

Location

MeSH Terms

Conditions

Muscle Spasticity

Interventions

Botulinum Toxins, Type A; Physical Therapy Modalities; Occupational Therapy

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Muscle Hypertonia; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors; Therapeutics; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care

Study Officials

• Margret Hund-Georgiadis, PD Dr.med.

  REHAB Basel, Rehaklinik für Neurorehabilitation und Paraplegiologie

  STUDY DIRECTOR

Central Study Contacts

Martina Grinzinger

CONTACT

+41613250709; m.grinzinger@rehab.ch

Clare Maguire

CONTACT

+41 613250761; c.maguire@rehab.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD Clinical Lead Physiotherapy

Model Details: After the injection with BoNT, individualised, goal-specific non-pharmacological therapies will be provided.

Study Record Dates

• First Submitted: January 19, 2025
• First Posted: September 8, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): April 1, 2027
• Last Updated: September 8, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share

Locations

CH (1); GB (1)