Cervical DystoniaNCT04348669
Tele-yoga and Dystonia
A study testing Tele-yoga in people with Cervical Dystonia, run by Rutgers, The State University of New Jersey at 1 site in United States.
Trial summary
The purpose of this study is to investigate the effect of yoga delivered remotely on adults with dystonia. This work will have implications related to physical interventions symptom management and quality of life as well as implications related to the role of tele-therapy. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Cervical Dystonia
- What is being tested?
- Tele-yoga
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Apr 2020to Dec 2023
- Phase
- Interventional
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A diagnosis of cervical dystonia
- 18-80 years old
- Ability to communicate verbally and follow directions
- English-Speaking
- Subject has access to WiFi and applicable technological device (computer, laptop, tablet, smartphone etc)
- Subject is willing to be video recorded during the yoga session
Show all 9Show fewer
- Subject is willing to open Zoom on their technological device
- Subject feels comfortable using a technological device for the intervention (ie demonstrates self-reported technological literacy)
- 8) if they are a U.S. resident, they must be a New Jersey resident and will participate in a majority of the intervention sessions from New Jersey. International enrollment will be considered on a case-by-case basis based on the Physical Therapy Licensure regulations of the appropriate Physical Therapy board.
Who cannot join
- Diagnosis of major depressive disorder,
- Injury or condition that could prevent the ability to engage in yoga poses based on self-report
- Cognitive impairment or condition that would prevent the subject from understanding the tasks or communicating with the research team
- Past yoga experience exceeding 5 or more times within the last 2 months
- pregnant women
- No access to a technological device (such as a smartphone, computer, laptop, or tablet) or access to WiFi that can be used to access the teleconferencing medium
- If the subject does not want to be recorded during the yoga sessions
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Motor Behavior Laboratory
Newark, New Jersey, 07101
Jean-Francois Daneault, jf.daneault@rutgers.edu
About this study
The purpose of this study is to investigate the effect of yoga delivered remotely on adults with dystonia. This work will have implications related to physical interventions symptom management and quality of life as well as implications related to the role of tele-therapy.
Read the detailed description
This is a single group intervention study of adults (18-80 years-old) with dystonia symptoms undergoing a 6-week intervention of 30 minute yoga classes delivered remotely through videoconferencing 2-3 times a week. Subjects with cervical dystonia will complete yoga classes delivered at-home with videoconferencing, receiving one-on-one yoga instruction including breathing, postures, and meditation/relaxation for two to three times a week. Data collection will occur remotely via videoconferencing at 0-weeks (baseline), 6-weeks (after the intervention), and 12-weeks (follow-up). Data collection will include demographics, mental health questionnaires, motor assessments, enjoyment, usability, and follow-up yoga status. Each yoga session will be video recorded to aide in recording adherence, adverse events, and challenges.
- Conditions
- Cervical Dystonia
- Being tested
- Tele-yoga
- Keywords
- yoga, cervical dystonia, telerehabilitation
- Medical subject headings
- Torticollis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tele-yogaOther
Subjects will undergo 30-minute yoga sessions delivered remotely 2 times/week for 6-weeks. The yoga sessions will be delivered one-on-one. The sessions will include 5-7 minutes of breathing exercises, 15-20 minutes of postures, and 5-7 minutes of relaxation and meditation exercises.
| Study group | Role | What they receive |
|---|---|---|
| Tele-yoga | Experimental | This is a single group study with all subjects included in this single arm. All subjects will undergo the same telerehabilitation yoga intervention delivered through videoconferencing. Receives: Other: Tele-yoga |
What is being measured
The primary outcome is the main question the study is designed to answer.
Craniocervical Dystonia Questionnaire (CDQ-24)
The 24-question CDQ-24 will be used to measure disease-specific quality of life. It is comprised of five categories, which are stigma, emotional well-being, pain, activities of daily living (ADL), and social and family life. Potential scores range from 0-100 with higher scores indicating worse quality of life.
Measured: Baseline (0-weeks)
Craniocervical Dystonia Questionnaire (CDQ-24)
The 24-question CDQ-24 will be used to measure disease-specific quality of life. It is comprised of five categories, which are stigma, emotional well-being, pain, activities of daily living (ADL), and social and family life. Potential scores range from 0-100 with higher scores indicating worse quality of life.
Measured: Post-intervention (6-weeks)
Craniocervical Dystonia Questionnaire (CDQ-24)
The 24-question CDQ-24 will be used to measure disease-specific quality of life. It is comprised of five categories, which are stigma, emotional well-being, pain, activities of daily living (ADL), and social and family life. Potential scores range from 0-100 with higher scores indicating worse quality of life.
Measured: Follow-up (12-weeks)
Secondary outcomes (12)
Short form 36 health survey (SF-36)
The SF-36 will be used to assess quality of life. It is a 36-item questionnaire that consists of eight domains: physical functioning (PF), role limitations due to physical health (RP), role limitations due to emotional problems (RE), vitality (VT), mental health, social functioning (SF), bodily pain (BP), and general health (GH). With higher scores indicating greater quality of life.
Measured: Baseline (0-weeks), post-intervention (6-weeks) and at follow-up (12-weeks)
Beck Anxiety Scale (BAI)
The BAI will be used to measure symptoms of anxiety. The BAI is a brief measure of anxiety with a focus on somatic symptoms of anxiety. Respondents indicate how much they have been bothered by each symptom over the past week. Responses are rated on a 4-point Likert scale and range from 0 (not at all) to 3 (severely). Potential scores range from 0 to 63 with higher scores indicating greater symptoms of anxiety.
Measured: Baseline (0-weeks), post-intervention (6-weeks) and at follow-up (12-weeks)
Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS)
The TWSTRS- severity scale will be used to assess motor symptoms. The TWSTRS is a comprehensive scale designed to assess objective physical (severity subscale) and subjective findings (disability and pain subscales). With higher scores indicating greater severity of symptoms.
Measured: Baseline (0-weeks), post-intervention (6-weeks) and at follow-up (12-weeks)
Beck Depression Inventory-II (BDI-II)
BDI-II will be used to measure symptoms of depression. The BDI-II is a 21 item self-report measure. For each item the subject must choose one out of 4 statements of increasing severity regarding a specific symptom of depression. It is written approximately at a 5th grade reading level and takes about 5-10 minutes to complete. Potential scores range from 0-63 with higher scores indicating greater severity of depressive symptoms.
Measured: Baseline (0-weeks), post-intervention (6-weeks) and at follow-up (12-weeks)
Pittsburgh Sleep Quality Index (PSQI)
The PSQI will be used to assess sleep dysfunction. The PSQI is a self-rated questionnaire which assesses sleep quality and disturbances over a 1-month time interval. Potential scores range from 0-21 with higher scores indicating greater sleep dysfunction.
Measured: Baseline (0-weeks), post-intervention (6-weeks) and at follow-up (12-weeks)
Five Times Sit to Stand Test (FTST)
The FTST, functional measure, will be administered to assess physical function. It will be administered using a chair in the participants' homes over a one-on-one Zoom videoconference. Participants will be encouraged to have another adult present during this portion of the data collection in case there is any loss of balance. Participants will be encouraged to use an armless chair approximately 63 centimeters from the ground and any deviation from this standard procedure will be documented. Time in seconds it takes the participant to raise from the chair 5 times will be recorded. Longer times will indicate poorer physical function.
Measured: Baseline (0-weeks), post-intervention (6-weeks) and at follow-up (12-weeks)
Adherence will be assessed by calculating the total number of yoga sessions attended.
Adherence to the yoga classes will be recorded each class including if a class is rescheduled. The occurrence, frequency, and brief description of any home yoga practice will also be recorded.
Measured: Between week 0 to week 6
Adverse Events
All adverse events will be documented with a brief description of each adverse event, the potential relationship to the study, and the severity of each event.
Measured: Between week 0 to week 6
Technical Difficulties Encountered
Anything perceived has a challenge by the yoga instructor or participant will be will be documented with severity of the challenge measured by time disrupted at an event level (time disrupted by the single event) and time disrupted from an entire session (time disrupted cumulatively).
Measured: Between week 0 to week 6
Enjoyment/Feedback
Enjoyment/feedback will be assessed via a Qualtrics questionnaire created by the study team inquiring about the subject's opinions about the intervention and a 10-point enjoyment scale.
Measured: Post-intervention testing (at 6-weeks)
Usability
The systems usability scale, a 10-item scale that will be used to assess how usable the subjects feel that the tele-yoga intervention was. Scores are calculated such that a total score of 100 is possible. Higher scores indicate higher usability.
Measured: Post-intervention testing (at 6-weeks)
Yoga Status at Follow-up
Yoga status at follow-up will be assessed via a Qualtrics questionnaire created by the study team asking questions about the subject's current involvement in yoga and other related topics.
Measured: Follow-up (12 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2020
- Study start28 Apr 2020
- Primary completionDec 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical DystoniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a single group intervention study of adults (18-80 years-old) with cervical dystonia undergoing a 6-week intervention of 30-minute yoga classes delivered remotely through videoconferencing 2 times per week. There will be baseline testing (0-weeks), post-intervention testing (6-weeks), and follow-up testing (12-weeks).
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rutgers, The State University of New Jersey
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jean-Francois Daneault, Ph.D., Rutgers, The State University of New Jersey
- Investigators
- Jean-Francois Daneault, Principal investigator, Rutgers University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04348669
- Sponsor's protocol ID
- Pro2020000758
- Status last verified
- Sep 2022
- First submitted
- 13 Apr 2020
- Last updated
- 19 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tele-yoga and Dystonia
- ClinicalTrials.gov ID
- NCT04348669
- Acronym / sponsor ID
- Pro2020000758
- Conditions
- Cervical Dystonia
- Keywords
- yoga, cervical dystonia, telerehabilitation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Rutgers, The State University of New JerseyUniversity, hospital or other
- Study start
- 28 Apr 2020 (actual)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 16 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to investigate the effect of yoga delivered remotely on adults with dystonia. This work will have implications related to physical interventions symptom management and quality of life as well as implications related to the role of tele-therapy.
Detailed description
This is a single group intervention study of adults (18-80 years-old) with dystonia symptoms undergoing a 6-week intervention of 30 minute yoga classes delivered remotely through videoconferencing 2-3 times a week. Subjects with cervical dystonia will complete yoga classes delivered at-home with videoconferencing, receiving one-on-one yoga instruction including breathing, postures, and meditation/relaxation for two to three times a week. Data collection will occur remotely via videoconferencing at 0-weeks (baseline), 6-weeks (after the intervention), and 12-weeks (follow-up). Data collection will include demographics, mental health questionnaires, motor assessments, enjoyment, usability, and follow-up yoga status. Each yoga session will be video recorded to aide in recording adherence, adverse events, and challenges.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a single group intervention study of adults (18-80 years-old) with cervical dystonia undergoing a 6-week intervention of 30-minute yoga classes delivered remotely through videoconferencing 2 times per week. There will be baseline testing (0-weeks), post-intervention testing (6-weeks), and follow-up testing (12-weeks).
| Arm | Type | Receives |
|---|---|---|
| Tele-yoga | Experimental | Other: Tele-yogaThis is a single group study with all subjects included in this single arm. All subjects will undergo the same telerehabilitation yoga intervention delivered through videoconferencing. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- A diagnosis of cervical dystonia
- 18-80 years old
- Ability to communicate verbally and follow directions
- English-Speaking
- Subject has access to WiFi and applicable technological device (computer, laptop, tablet, smartphone etc)
Key exclusion criteria (7 listed)
- Diagnosis of major depressive disorder,
- Injury or condition that could prevent the ability to engage in yoga poses based on self-report
- Cognitive impairment or condition that would prevent the subject from understanding the tasks or communicating with the research team
- Past yoga experience exceeding 5 or more times within the last 2 months
- pregnant women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tele-yogaSubjects will undergo 30-minute yoga sessions delivered remotely 2 times/week for 6-weeks. The yoga sessions will be delivered one-on-one. The sessions will include 5-7 minutes of breathing exercises, 15-20 minutes of postures, and 5-7 minutes of relaxation and meditation exercises. | Other | Tele-yoga |
Primary outcome
Craniocervical Dystonia Questionnaire (CDQ-24)
Time frame: Baseline (0-weeks)
The 24-question CDQ-24 will be used to measure disease-specific quality of life. It is comprised of five categories, which are stigma, emotional well-being, pain, activities of daily living (ADL), and social and family life. Potential scores range from 0-100 with higher scores indicating worse quality of life.
Craniocervical Dystonia Questionnaire (CDQ-24)
Time frame: Post-intervention (6-weeks)
The 24-question CDQ-24 will be used to measure disease-specific quality of life. It is comprised of five categories, which are stigma, emotional well-being, pain, activities of daily living (ADL), and social and family life. Potential scores range from 0-100 with higher scores indicating worse quality of life.
Craniocervical Dystonia Questionnaire (CDQ-24)
Time frame: Follow-up (12-weeks)
The 24-question CDQ-24 will be used to measure disease-specific quality of life. It is comprised of five categories, which are stigma, emotional well-being, pain, activities of daily living (ADL), and social and family life. Potential scores range from 0-100 with higher scores indicating worse quality of life.
12 secondary outcomes
Short form 36 health survey (SF-36)
Time frame: Baseline (0-weeks), post-intervention (6-weeks) and at follow-up (12-weeks)
Beck Anxiety Scale (BAI)
Time frame: Baseline (0-weeks), post-intervention (6-weeks) and at follow-up (12-weeks)
Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS)
Time frame: Baseline (0-weeks), post-intervention (6-weeks) and at follow-up (12-weeks)
Beck Depression Inventory-II (BDI-II)
Time frame: Baseline (0-weeks), post-intervention (6-weeks) and at follow-up (12-weeks)
Pittsburgh Sleep Quality Index (PSQI)
Time frame: Baseline (0-weeks), post-intervention (6-weeks) and at follow-up (12-weeks)
Five Times Sit to Stand Test (FTST)
Time frame: Baseline (0-weeks), post-intervention (6-weeks) and at follow-up (12-weeks)
Adherence will be assessed by calculating the total number of yoga sessions attended.
Time frame: Between week 0 to week 6
Adverse Events
Time frame: Between week 0 to week 6
Technical Difficulties Encountered
Time frame: Between week 0 to week 6
Enjoyment/Feedback
Time frame: Post-intervention testing (at 6-weeks)
Usability
Time frame: Post-intervention testing (at 6-weeks)
Yoga Status at Follow-up
Time frame: Follow-up (12 weeks)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean-Francois Daneault principal investigator
Rutgers University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tele-yoga in people with Cervical Dystonia, run by Rutgers, The State University of New Jersey at 1 site in United States.
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 9 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 19 Sep 2022. 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 United States. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jean-Francois Daneault (9739728482, jf.daneault@rutgers.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Craniocervical Dystonia Questionnaire (CDQ-24) (time frame: Baseline (0-weeks)). The study lists 3 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 19 Sep 2022; AzTrials last refreshed its copy on 29 Oct 2026.