Validating a New Writer s Cramp Scale
Status: | Completed |
---|---|
Conditions: | Neurology, Orthopedic |
Therapuetic Areas: | Neurology, Orthopedics / Podiatry |
Healthy: | No |
Age Range: | 18 - 99 |
Updated: | 3/1/2019 |
Start Date: | March 21, 2012 |
End Date: | October 25, 2016 |
Validating a New Writer's Cramp Scale
Background:
- People with writer s cramp develop tightness in arm muscles and abnormal hand posture when
writing, which makes writing difficult or impossible. At present, there is no suitable rating
scale to measure the symptoms of or disability associated with writer s cramp. Researchers
want to videotape people performing simple writing tasks. They will then compare the
performance of people with writer s cramp on these tasks to those of people without writer s
cramp. This information will help develop a rating scale to evaluate writer s cramp.
Objectives:
- To develop a new rating scale for writer s cramp.
Eligibility:
- Individuals at least 18 years of age who have writer s cramp.
Design:
- Participants will be screened with a physical exam and medical history.
- Participants will have one outpatient study visit that will last about 3 hours.
- Participants will perform tasks related to writing, such as writing passages and drawing
spirals and loops. They will be videotaped during these tasks. They will repeat some of
the writing tasks three more times; on paper attached to a writing tablet, directly on
the writing tablet, and on a computer tablet.
- The angles made by the joints will be measured at rest not while writing
healthy volunteers.
- People with writer s cramp develop tightness in arm muscles and abnormal hand posture when
writing, which makes writing difficult or impossible. At present, there is no suitable rating
scale to measure the symptoms of or disability associated with writer s cramp. Researchers
want to videotape people performing simple writing tasks. They will then compare the
performance of people with writer s cramp on these tasks to those of people without writer s
cramp. This information will help develop a rating scale to evaluate writer s cramp.
Objectives:
- To develop a new rating scale for writer s cramp.
Eligibility:
- Individuals at least 18 years of age who have writer s cramp.
Design:
- Participants will be screened with a physical exam and medical history.
- Participants will have one outpatient study visit that will last about 3 hours.
- Participants will perform tasks related to writing, such as writing passages and drawing
spirals and loops. They will be videotaped during these tasks. They will repeat some of
the writing tasks three more times; on paper attached to a writing tablet, directly on
the writing tablet, and on a computer tablet.
- The angles made by the joints will be measured at rest not while writing
healthy volunteers.
Objective: Writer s cramp (WC) causes significant discomfort and disability to those
afflicted by this condition. Studies on WC have been hampered by the lack of objective,
validated rating scales. In this study, we will test and validate new instruments to rate WC;
the WC impairment scale (WCIS) and a new disability scale (WCDS).We will also collect
exploratory data about biomechanics of the hand.
Study population: The study population will consist of 20 subjects. Ten patients with WC and
10 age and handedness matched HVs will constitute the study population.
Design: 10 patients with WC and 10 age- and handedness-matched HV will be videotaped while
writing. The WCIS scores will be given to each subject by four blinded raters (Drs. Mark
Hallett, Barbara Karp, Katherine Alter, and Camilo Toro) based on the videos. The patients
will complete the WCDS. In addition, each individual will be asked to repeat some basic
elements of the scale while writing on the screen of a tablet PC, and on the surface of a
detached digitizing tablet in order to generate high temporal and spatial resolution pen tip
position samples for further numerical analyses and scoring. The biomechanics of the hand
will be measured using a published scale.
Outcome measures: Using the WCIS, inter and intra-rater reliability, internal consistency
(Cronbach s alpha) face validity, and reproducibility will be measured in addition to other
secondary outcomes. The ease of use by the raters will be assessed for each subject.
Reproducibility of writing on tablet, writing on paper placed on a writing tablet, and
writing on a tablet PC will be assessed. Finally, biomechanics of the hands of patients with
WC will be compared with those of the unaffected healthy volunteers.
afflicted by this condition. Studies on WC have been hampered by the lack of objective,
validated rating scales. In this study, we will test and validate new instruments to rate WC;
the WC impairment scale (WCIS) and a new disability scale (WCDS).We will also collect
exploratory data about biomechanics of the hand.
Study population: The study population will consist of 20 subjects. Ten patients with WC and
10 age and handedness matched HVs will constitute the study population.
Design: 10 patients with WC and 10 age- and handedness-matched HV will be videotaped while
writing. The WCIS scores will be given to each subject by four blinded raters (Drs. Mark
Hallett, Barbara Karp, Katherine Alter, and Camilo Toro) based on the videos. The patients
will complete the WCDS. In addition, each individual will be asked to repeat some basic
elements of the scale while writing on the screen of a tablet PC, and on the surface of a
detached digitizing tablet in order to generate high temporal and spatial resolution pen tip
position samples for further numerical analyses and scoring. The biomechanics of the hand
will be measured using a published scale.
Outcome measures: Using the WCIS, inter and intra-rater reliability, internal consistency
(Cronbach s alpha) face validity, and reproducibility will be measured in addition to other
secondary outcomes. The ease of use by the raters will be assessed for each subject.
Reproducibility of writing on tablet, writing on paper placed on a writing tablet, and
writing on a tablet PC will be assessed. Finally, biomechanics of the hands of patients with
WC will be compared with those of the unaffected healthy volunteers.
- INCLUSION CRITERIA:
- Inclusion criteria for patients with WC and age and handedness-matched HVs:
- Subjects must be at least 18 years of age.
- Subjects must be willing to be videotaped while writing.
- Subjects must have regular hand function with the ability to write without an
assistive device
EXCLUSION CRITERIA:
- Patients with WC:
- Botulinum toxin (BTX) administration within 3 months of participation.
- Unable to provide consent.
- Patients taking oral medications for WC including muscle relaxants or other
centrally-active medications such as antidepressants which may enhance tremors.
- Medical conditions that affect hand function, such as stroke, nerve entrapment,
tremor, parkinsonism, chorea, ataxia affecting the dominant hand.
- HVs:
- Unable to provide consent.
- Healthy volunteers taking oral medications that may affect motor function such as
muscle relaxants or centrally-active medications including medications for
psychiatric conditions like antidepressants and antipsychotics.
- Healthy volunteers with abnormal hand function including medical conditions that
may influence hand function, e.g., strokes, nerve entrapments, tremor,
parkinsonism, chorea, ataxia and psychiatric conditions (such as psychosis and
depression) affecting the dominant hand.
- Have history of hand surgery and or hand trauma.
- Have abnormal findings on medical history and physical exam.
We found this trial at
1
site
9000 Rockville Pike
Bethesda, Maryland 20892
Bethesda, Maryland 20892
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