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SpasticityNCT06956534

Definition, Assessment and Treatment of Spasticity According to Physiotherapists and Occupational Therapists in Flanders, Belgium: A Cross-sectional Qualitative Study.

An observational study of Spasticity, run by Universiteit Antwerpen at 1 site in Belgium.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The definition of spasticity described by Lance in 1980 provided a strong academic foundation for characterizing this neurological symptom. However, there are doubts about its value in clinical practice for evaluating and treating spasticity. Read more about this study

Who is it for?
Ages 21 years and olderHealthy volunteers can take part
Conditions the study is for
Spasticity
What is being tested?
Questionnaire and Physical Exam
How many people
90 participants
Where
1 siteBelgium
Study dates
16 Sep 2024to 28 Feb 2025
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: The included respondent group consisted of Dutch-speaking Belgian adults with a degree in physiotherapy or occupational therapy, who completed the full online questionnaire on spasticity. Respondents who did not meet these criteria or who did not confirm the informed consent, were excluded. Experience in the work field was not a requirement to participate in this study. The researchers chose to only include fully completed questionnaires, even if a partially completed questionnaire had some relevant information to process. This was done to be consistent in the number of responses and the data analysis. It is also not known why a respondent chose to stop without filling out all the questions. In Belgium, occupational therapy is offered as a three-year bachelor's program. Physical therapy, which was originally a three-year bachelor's degree as well, became an academic program of four years in 1998 and was subsequently extended to a five-year master's program in 2002.

Who may be able to join

  • Licensed Occupational Therapists or Physiotherapists
  • Dutch Speaking
  • Working in Flanders

Who cannot join

  • Questionnaire not completed
  • Informed Consent not given

Trial locations and contacts

1 site in 1 country.

Belgium1 site
  • Department of Rehabilitation sciences and physiotherapy (MOVANT)

    Antwerp, Antwerp, 2020

Other trials in Belgium

About this study

The definition of spasticity described by Lance in 1980 provided a strong academic foundation for characterizing this neurological symptom. However, there are doubts about its value in clinical practice for evaluating and treating spasticity. This "upper motor neuron syndrome" is highly complex and does not exist in isolation. Beyond the various definitions that have been attributed to it, spasticity correlates with sensory input, movement, muscle properties, and the continuity of the central nervous system. This has led to an ongoing academic debate regarding how spasticity should be classified and how it should be treated correctly.

This study aims to improve quality by gaining a better understanding of how healthcare providers (physiotherapists \& occupational therapists) perceive the definition, evaluation, and treatment of spasticity. The questionnaire is based on the existing study by Blanchette et al. (2017), which was conducted in Canada and surveyed both English- and French-speaking physiotherapists and occupational therapists. That study examined sociodemographic data, work environment, satisfaction with measurement tools for spasticity, and treatment preferences. This study adopts these components while adding an extra item: the definition of spasticity. The research team included this item to explore how healthcare providers interpret spasticity. This will be assessed through multiple-choice and open-ended questions.

The research will be conducted under the supervision of Prof. Dr. Steven Truijen (Universiteitsplein 1, 2610 Wilrijk, Belgium, steven.truijen@uantwerpen.be) and Prof. Dr. Wim Saeys (Universiteitsplein 1, 2610 Wilrijk, Belgium, wim.saeys@uantwerpen.be), organized by the University of Antwerp. During this study, no costs or reimbursements will be expected from participants, health insurance, or the research environment.

Read the detailed description

The questionnaire will be distributed online using the REDCAP data collection system on social media platform, via mail and Linkedin. Official representative groups (occupational therapists and physiotherapists) will be contacted to distribute the Questionnaire QR-code or link to their members.

Participants will be first asked for their consent and informed this study followed all the European GDPR guidelines.

The included respondent group consisted of Dutch-speaking Belgian adults with a degree in physiotherapy or occupational therapy, who completed the full online questionnaire on spasticity. Respondents who did not meet these criteria or who did not confirm the informed consent, were excluded. Experience in the work field was not a requirement to participate in this study. The researchers chose to only include fully completed questionnaires, even if a partially completed questionnaire had some relevant information to process. This was done to be consistent in the number of responses and the data analysis. It is also not known why a respondent chose to stop without filling out all the questions.

In Belgium, occupational therapy is offered as a three-year bachelor's program. Physical therapy, which was originally a three-year bachelor's degree as well, became an academic program of four years in 1998 and was subsequently extended to a five-year master's program in 2002.

Recruitment was carried out by sharing the questionnaires URL link and QR-code on social media and with professional associations for PTs and OTs in Flanders (Axxon and ergotherapie-belgium.be). Additionally, the questionnaire was distributed by email to personal contacts of the researchers, all of whom hold qualifications in physiotherapy or occupational therapy.

To ensure anonymity, each respondent was assigned a chronological identification number, which made it impossible to identify the respondents from the data collected. The data was only processed by the researchers for the purpose of answering the research question in this study. Participation was completely voluntary, and respondents could terminate filling out the questionnaire at any moment without consequences for them. Respondents did not receive a personal benefit for completing the questionnaire. Respondents were also not automatically notified of the results from this study.

Questionnaire and outcome variables The questionnaire was made through 'Research Electronic Data Capture Platform' (REDCAP), which is a secure, online software platform that is in accordance with the General Data Protection Regulation (GDPR). Before filling out the questionnaire, respondents had to provide informed consent.

The questionnaire is based on the work of Blanchette et al. (2017) and consisted of five sections. Because respondents consisted of PTs and OTs in Flanders, which is the Dutch speaking part of Belgium, the questionnaire was created in Dutch. But since this study will be compiled in English, all questions and answers were translated (attachment 1, table 5).

The first section consists of eight questions on the sociodemographic characteristics of the respondents: profession, gender, age (open-ended question), years of experience in the work field, percentage of neurological patients (NPs) in the respondent's clientele, work environment, specialization and highest level of education. For work environment and specialization there was an 'others' option. If there was no appropriate option listed for that respondent, they could fill this in themselves through an open-ended question. These variables were used to categorize respondents into different groups for further analysis.

The second section is about the interpretation and definition of spasticity and was added compared to the questionnaire of Blanchette et al. (2017). First, respondents were asked to describe spasticity in an open-ended question. To mitigate potential bias in responses to the open-ended question, respondents were required to complete this question before gaining access to the multiple-choice question. This consisted of five definitions - originally formulated by Lance (1980), Young (1994), Pandyan et al. (2005), Dressler et al. (2018) and Li et al. (2021) - or 'none of the above', where they had to indicate which one they preferred.

The evaluation of spasticity was questioned through multiple-choice questions in the third section. First, four multiple-choice questions were shown, namely: 'Who is responsible for the evaluation of spasticity?', 'When does it need to take place?', 'How important is the use of validated and reliable assessment methods?', and 'Which assessment methods do you use to evaluate spasticity?'. For the first and fourth answer there was also an option for 'others' if the respondent wanted to add something. For the fourth question, indicating multiple answers was possible. Next, there was a question about how satisfied the respondent is with six listed measurement tools (range of motion (ROM), clonus, modified Ashworth scale (MAS), modified Tardieu scale (MTS), deep tendon reflexes, functional scales). For each tool they could choose between 'not at all satisfied', 'not satisfied', 'satisfied' or 'very satisfied'.

Finally, there was a section consisting of one multiple-choice question regarding the preferred treatment of spasticity. Here, indicating multiple options was also accepted and 'others' was also possible. However, this section was not shown if the respondent indicated that they do not work with NPs.

Questions are as followed:

Therapist Questionnaire Therapist Sociodemographic Characteristics

  1. Profession
  • Occupational Therapist
  • Physiotherapist
  • Trained in both professions
  1. Gender
  • Male
  • Female
  • Unknown
  1. Age __________________________________
  2. How many years of experience do you have in clinical practice overall?
  • Less than 1 year
  • Approximately 1 to 3 years
  • Between 4 and 10 years
  • More than 10 years
  1. What percentage of your clientele consists of neurological patients?
  • None
  • Less than 30% Therapist Questionnaire
  • 31% - 75%
  • More than 75%
  1. How would you best describe your work environment? (multiple answers possible)
  • Hospital
  • Rehabilitation center
  • Institute
  • Private practice
  • Medical-pedagogical institute for children
  • Mental health institute
  • School
  • University
  • University college
  • Home care
  • Other: _____________________________
  1. What is your current field of work? (multiple answers possible)
  • Neurology
  • Orthopedics
  • Pediatrics
  • Pulmonology
  • Physical Activity
  • Sports
  • Geriatrics Therapist Questionnaire
  • Psychiatry
  1. Highest level of professional education
  • Master's degree
  • Bachelor's degree
  1. What is your area of specialization?
  • Neurology
  • Orthopedics/Sports
  • Pediatrics
  • Geriatrics
  • Physical Activity
  • Other: _____________________________ Interpretation and Definition of Spasticity
  1. How would you describe spasticity? __________________________________________
  2. Which of the following definitions of spasticity seems most appropriate to you?
  • [ ] Spasticity is a motor disorder characterized by a velocity-dependent increase in tonic stretch reflexes...
  • [ ] A motor disorder due to abnormal intraspinal processing of primary afferent input.
  • [ ] Impaired sensorimotor control from an upper motor neuron lesion causing involuntary muscle activation.
  • [ ] Involuntary muscle hyperactivity in the presence of central paresis, including various components. Therapist Questionnaire
  • [ ] A speed- and length-dependent increase in resistance due to hyperexcitable pathways.
  • [ ] None of the above Evaluation of Spasticity
  1. Which healthcare provider should be responsible for evaluating spasticity?
  • Physician
  • Physiotherapist
  • Occupational Therapist
  • Nurse
  • Other: _____________________________
  1. When should the evaluation/testing take place?
  • At intake
  • After 3 weeks
  • At hospital discharge (returning home)
  • Periodically
  • During rehabilitation
  1. How important is it to use validated and reliable measurement tools for spasticity?
  • Very important
  • Important
  • Neutral
  • Unimportant Therapist Questionnaire
  • Not important at all
  1. Which of the following measurement tools do you use to evaluate spasticity?
  • Range of Motion
  • Modified Ashworth Scale
  • Deep Tendon Reflexes
  • Functional Scales
  • Ashworth Scale
  • Torque Measurements
  • Modified Tardieu Scale
  • Clinical Score of Tone
  • Spasm Frequency Scale
  • Composite Spasticity Index
  • Clonus Scale
  • Pendulum Test
  • EMG
  • Other: _____________________________
  1. How satisfied are you with the following measurement tools?
  • Tool | Not at all | Not satisfied | Satisfied | Very satisfied |
  • Range of Motion | [ ] | [ ] | [ ] | [ ] |
  • Clonus | [ ] | [ ] | [ ] | [ ] |
  • Modified Ashworth Scale | [ ] | [ ] | [ ] | [ ] | Therapist Questionnaire
  • Modified Tardieu Scale | [ ] | [ ] | [ ] | [ ] |
  • Deep Tendon Reflex | [ ] | [ ] | [ ] | [ ] |
  • Functional Scales | [ ] | [ ] | [ ] | [ ] | Treatment of Spasticity
  1. How do you currently treat spasticity?
  • Long-term stretching
  • Long-term ice application
  • Sensory-level stimulation (TENS)
  • Motor-level stimulation
  • Vibration
  • Splinting
  • Positioning
  • Traction
  • Other: _____________________________
Conditions
Spasticity
Being tested
Questionnaire and Physical Exam
Keywords
spasticity, questionnaire, occupational therapy, physiotherapy
Medical subject headings
Muscle Spasticity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Questionnaire and Physical ExamOther

    online digital questionnaire

Study groups in NCT06956534
Study groupRoleWhat they receive
caregiversphysiotherapists and occupational therapists
Receives: Other: Questionnaire and Physical Exam

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Demographics of professional (Occupational therapists & Physiotherapists)

    1. Profession
    • Occupational Therapist
    • Physiotherapist
    • Trained in both professions
    1. Gender
    • Male
    • Female
    • Unknown
    1. Age
    2. How many years of experience do you have in clinical practice overall?
    • Less than 1 year
    • Approximately 1 to 3 years
    • Between 4 and 10 years
    • More than 10 years
    1. What percentage of your clientele consists of neurological patients?
    • None
    • Less than 30%
    • 31% - 75%
    • More than 75%
    1. How would you best describe your work environment? (multiple answers possible)
    • Hospital
    • Rehabilitation center
    • Institute
    • Private practice
    • Medical-pedagogical institute for children
    • Mental health institute
    • School
    • University
    • University college
    • Home care
    • Other:
    1. What is your current field of work? (multiple answers possible)
    • Neurology
    • Orthopedics
    • Pediatrics
    • Pulmonology
    • Physical Activity
    • Sports
    • Geriatrics
    • Psychiatry
    1. High level of professional education
    • Master's degree
    • Bachelor's degree
    1. What is your area of specialization?

    Measured: Once in questionnaire

  2. Interpretation and Definition of Spasticity

    1. How would you describe spasticity?

    __________________________________________ 11. Which of the following definitions of spasticity seems most appropriate to you?

    • [ ] Spasticity is a motor disorder characterized by a velocity-dependent increase in tonic stretch reflexes...
    • [ ] A motor disorder due to abnormal intraspinal processing of primary afferent input.
    • [ ] Impaired sensorimotor control from an upper motor neuron lesion causing involuntary muscle activation.
    • [ ] Involuntary muscle hyperactivity in the presence of central paresis, including various components.
    • [ ] A speed- and length-dependent increase in resistance due to hyperexcitable pathways.
    • [ ] None of the above

    Measured: Once in questionnaire

  3. Spasticity Assessment

    1. Which healthcare provider should be responsible for evaluating spasticity?
    • Physician
    • Physiotherapist
    • Occupational Therapist
    • Nurse
    • Other:
    1. When should the evaluation/testing take place?
    • At intake
    • After 3 weeks
    • At hospital discharge (returning home)
    • Periodically
    • During rehabilitation 14. How important is it to use validated and reliable measurement tools for spasticity?
    • Very important
    • Important
    • Neutral
    • Unimportant Therapist Questionnaire
    • Not important at all 15. Which of the following measurement tools do you use to evaluate spasticity?
    • Range of Motion
    • Modified Ashworth Scale Deep Tendon Reflexes
    • Functional Scales
    • Ashworth Scale
    • Torque Measurements
    • Modified Tardieu Scale
    • Clinical Score of Tone
    • Spasm Frequency Scale
    • Composite Spasticity Index
    • Clonus Scale
    • Pendulum Test
    • EMG
    • Other:
    1. How satisfied are you with the following measurement tools? Range of Motion Clonus Modified Ashworth Scale Deep Tendon Reflex Functional Scal

    Measured: Once in questionnaire

  4. Spasticity Management

    1. How do you currently treat spasticity?
    • Long-term stretching
    • Long-term ice application
    • Sensory-level stimulation (TENS)
    • Motor-level stimulation
    • Vibration
    • Splinting
    • Positioning
    • Traction
    • Other: _____________________________

    Measured: Once in questionnaire

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 May 2025
  2. Study start16 Sep 2024
  3. Primary completion28 Feb 2025
  4. Study completion28 Feb 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Prospective
Enrolment
90 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06956534
Sponsor's protocol ID
6901
Status last verified
Apr 2025
First submitted
24 Apr 2025
Last updated
4 May 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
Yes: Data Available on REDCAP platform. Link and entry approval can be asked to our DPO commisioner

Questions about this trial

What is this clinical trial studying?

An observational study of Spasticity, run by Universiteit Antwerpen at 1 site in Belgium.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Demographics of professional (Occupational therapists & Physiotherapists) (time frame: Once in questionnaire). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2025.

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