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)
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.
<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
Single group
Botulinum Neurotoxin Type A
DrugThe effectiveness of the combination of BoNT with treatment goal specific non-pharmacological interventions will be evaluated.
Non-pharmacological therapies
Other interventionDepending on the treatment goal different non-pharmacological therapies as a standard of care will be provided
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
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.
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: 1. Reduction of pain and discomfort 2. Control of spasms and other involuntary movements 3. Maintaining the range of upper limb movements 4. Passive function: ease of caring for the affected limb 5. Active function - using the affected limb in activities 6. 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
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.
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.
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