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An observational study of functional screening tests in people with cervical dystonia.

An observational study of functional screening tests in people with cervical dystonia

Status
Terminated
Phases
Unknown
Study type
Observational
Source
ANZCTR
Registry ID
ACTRN12618000384257
Enrollment
22
Registered
2018-03-14
Start date
2017-05-25
Completion date
2019-12-10
Last updated
2021-12-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This study aims to assess balance, function, falls and gait in people with cervical dystonia (CD), using standardized physical assessment scales. Improving understanding of where people with CD differ from normal in balance and walking will allow targeted physiotherapy interventions to be developed and tested in a subsequent clinical study. Furthermore, the findings will highlight if people with CD present a falls risk similar to other movement disorder populations and provide objective methods of screening. The study will be observational in design, employing a single group of people living with cervical dystonia and will be conducted at Westmead Hospital. This study will be conducted at Westmead Hospital, in the Physiotherapy department. Adults with CD of unknown cause who can walk unaided are invited to join. Interventions: Participants will be assessed by 2 physiotherapists on a series of physical assessments of balance, walking and upper arm function. Participants will also be asked to complete 3 questionnaires on fear of falling and usual physical activity. The assessment will be conducted in the same week as scheduled Botox injections, to reduce the effect of botox on the assessment results. Participants who are able will be asked to return for a second assessment of the same physical scales within the same week. Finally, participants will be asked to complete a falls diary for the next 6 months, noting any falls they have had and the circumstances surrounding the fall Data will be compared with data from healthy people and data from people with other neurological conditions. .

Interventions

Participants will be screened by a neurologist for eligibility to join the study at their routine clinic appointment for Botox injections. Participants will then complete the study at Westmead Hospital in the same week as their Botox injection. Participants will have baseline measures of dystonia severity, current levels of exercise, cognition and involvement of the cerebellum assessed using the Toronto Western Spasmodic Rating Scale (TWSTRS), the Incidental and Planned Exercise Questionnaire (I

Participants will be screened by a neurologist for eligibility to join the study at their routine clinic appointment for Botox injections. Participants will then complete the study at Westmead Hospital in the same week as their Botox injection. Participants will have baseline measures of dystonia severity, current levels of exercise, cognition and involvement of the cerebellum assessed using the Toronto Western Spasmodic Rating Scale (TWSTRS), the Incidental and Planned Exercise Questionnaire (IPEQ), the Montreal Cognitive Assessment (MoCA) and the Scale for the Assessment and Rating of Ataxia (SARA). Participants will be assessed by 2 physiotherapists on the following standardised physical assessments of balance, walking and upper arm function: Functional Gait Assessment (formerly Dynamic Gait Index) Balance Evaluation Systems Test - MiniBEST 5 x sit to stand test 4 squares step test Figure of Eight test – time to walk a standardized figure of eight Box and Block test Coin rotation test Participants will also complete 2 questionnaires assessing fear of falling and balance confidence as follows: Activities Balance Confidence Scale (self-reported item) Falls self-efficacy international scale (self-reported item) Assessments will take approximately 2 hours to complete. Participants who are able will repeat the assessment on a second occasion within one week of the botox injection. Participants will then be asked to keep a falls diary for the following 6 months.

Sponsors

Melani Boyce
Lead SponsorIndividual

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Participants will be invited to join the study if they are over 18 years, have been diagnosed with cervical dystonia of unknown cause, can speak English, and are able to walk unaided.

Exclusion criteria

People with other musculoskeletal or neurological disorders besides dystonia affecting the lower limbs will be excluded.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026