Skip to content

Effectiveness of a standardized physical therapy program in cervical dystonia; a single blind randomized controlled trial.

Effectiveness of a standardized physical therapy program in cervical dystonia; a single blind randomized controlled trial. - Effectiveness of physical therapy in cervical dystonia

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON39863
Enrollment
100
Registered
2012-05-08
Start date
2012-10-22
Completion date
Unknown
Last updated
2024-04-29

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

Conditions

Cervical dystonia spasmodic torticollis

Interventions

Experimental group The experimental group receives a one year PT program according the guideline in combination with BTX injections. The PT program will start two weeks after the injections, when th

Sponsors

Academisch Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - 30 years or older - Treated with Botuline Toxin injections for more than one year

Exclusion criteria

Exclusion criteria: - Secondary (including psychogenic) dystonia - Hereditary (dominant) forms of dystonia - Segmental, hemi-, multifocal or generalized dystonia - Patients who underwent neurosurgery - Inability to understand written and spoken Dutch language - Patients treated with the Bleton method by their physiotherapist at the moment of inclusion

Design outcomes

Primary

MeasureTime frame
Primary outcomes: Disability Disability will be measured with the disability section of the TWSTRS scale. The TWSTRS scale is a valid and reliable tool to measure severity, disability and pain in CD. The disability section is a six point likert scale which consists of six items like driving a car, reading and performing ADL activities (maximal score 30 points).

Secondary

MeasureTime frame
Secondary outcomes Disability The ability to perform daily life tasks will also be measured with the Functional Disability questionnaire. (3)The FDQ is a 27-item scale to measures the impact of CD on activities of daily living (ADL). Questions are asked about the extent to which CD affects the engagement in and performance of a sample of activities at the present time. Each item is rated on a 5-point scale (maximal score 68 points). Severity The severity of CD will be measured with the TSUI-scale, consisting of different aspects of abnormal posture and movements in CD patients. It has a maximal score of 18 points. The TSUI-scale is a widely used and standardized scale to measure the severity of CD. In addition, Active Range Of Motion (AROM) will be measured to determine the ability to voluntary move the head. AROM is measured with a Cervical Range Of Motion Instrument (CROM), a frame with three separate inclinometers to measure AROM in the sagittal, coronal and horizontal planes. Severity of CD will also be measured with the Clinical Global Impressions-Severity of Illness Scale (CGI-S) and the Clinical Global Impression - Improvement scale (CGI-I) Both scales are observer- or patient- rated scale that measures illness severity and global improvement. The CGI is rated on a 7-point scale. Patients will be recorded on video according a video protocol and the TSUI-scale, CGI-S and CGI-I will be scored by a blinded movement disorder specialist. Pain Each patient is asked to rate their pain on a Numeric Rating Scale (NRS). A score of 0 means no pain and a score of 10 means the worst pain imaginable. The NRS is a reliable and validated toot for the assessment of pain. Quality of Life Quality of Life (QoL) will be measured with the cranio-cervical dystonia questionnaire (CDQ-24) The CDQ-24 is a validated and disease specific, self reporting questionnaire to evaluate quality of life of patients with cervical dystonia on a five point likert sc

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)