Tele-yoga and Dystonia

Cervical Dystonia Clinical Trial

Official title:

Tele-yoga and Dystonia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04348669
• Other study ID #: Pro2020000758
• Status: Recruiting
• Phase: N/A
• Start date: April 28, 2020
• Est. completion date: December 2023

Study information

• Verified date: September 2022
• Source: Rutgers, The State University of New Jersey
• Contact: Jean-Francois Daneault
• Phone: 9739728482
• Email: jf.daneault[@]rutgers.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 25
• Est. completion date: December 2023
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

1. A diagnosis of cervical dystonia

2. 18-80 years old

3. Ability to communicate verbally and follow directions

4. English-Speaking

5. Subject has access to WiFi and applicable technological device (computer, laptop, tablet, smartphone etc)

6. Subject is willing to be video recorded during the yoga session

7. Subject is willing to open Zoom on their technological device

8. 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.

Exclusion Criteria:

1. Diagnosis of major depressive disorder,

2. Injury or condition that could prevent the ability to engage in yoga poses based on self-report

3. Cognitive impairment or condition that would prevent the subject from understanding the tasks or communicating with the research team

4. Past yoga experience exceeding 5 or more times within the last 2 months

5. pregnant women

6. 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

7. If the subject does not want to be recorded during the yoga sessions

Related Conditions & MeSH terms

• Cervical Dystonia
• Dystonia
• Dystonic Disorders
• Torticollis

Intervention

Other:
• Tele-yoga
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.

Locations

Country	Name	City	State
United States	Motor Behavior Laboratory	Newark	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Rutgers, The State University of New Jersey

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline (0-weeks)
Primary	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.	Post-intervention (6-weeks)
Primary	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.	Follow-up (12-weeks)
Secondary	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.	Baseline (0-weeks), post-intervention (6-weeks) and at follow-up (12-weeks)
Secondary	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.	Baseline (0-weeks), post-intervention (6-weeks) and at follow-up (12-weeks)
Secondary	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.	Baseline (0-weeks), post-intervention (6-weeks) and at follow-up (12-weeks)
Secondary	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.	Baseline (0-weeks), post-intervention (6-weeks) and at follow-up (12-weeks)
Secondary	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.	Baseline (0-weeks), post-intervention (6-weeks) and at follow-up (12-weeks)
Secondary	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.	Baseline (0-weeks), post-intervention (6-weeks) and at follow-up (12-weeks)
Secondary	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.	Between week 0 to week 6
Secondary	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.	Between week 0 to week 6
Secondary	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).	Between week 0 to week 6
Secondary	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.	Post-intervention testing (at 6-weeks)
Secondary	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.	Post-intervention testing (at 6-weeks)
Secondary	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.	Follow-up (12 weeks)