Tele-yoga and Dystonia
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 25
- Locations
- 2
- Primary Endpoint
- Craniocervical Dystonia Questionnaire (CDQ-24)
Study Overview
Brief 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.
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
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
- •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)
- •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
- •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
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Pittsburgh Sleep Quality Index (PSQI)(Baseline (0-weeks), post-intervention (6-weeks) and at follow-up (12-weeks))
- Enjoyment/Feedback(Post-intervention testing (at 6-weeks))
- Yoga Status at Follow-up(Follow-up (12 weeks))
- Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS)(Baseline (0-weeks), post-intervention (6-weeks) and at follow-up (12-weeks))
- Usability(Post-intervention testing (at 6-weeks))
- Five Times Sit to Stand Test (FTST)(Baseline (0-weeks), post-intervention (6-weeks) and at follow-up (12-weeks))
- Short form 36 health survey (SF-36)(Baseline (0-weeks), post-intervention (6-weeks) and at follow-up (12-weeks))
- Technical Difficulties Encountered(Between week 0 to week 6)
- Beck Anxiety Scale (BAI)(Baseline (0-weeks), post-intervention (6-weeks) and at follow-up (12-weeks))
- Beck Depression Inventory-II (BDI-II)(Baseline (0-weeks), post-intervention (6-weeks) and at follow-up (12-weeks))
- Adverse Events(Between week 0 to week 6)
- Adherence will be assessed by calculating the total number of yoga sessions attended.(Between week 0 to week 6)
Investigators
Jean-Francois Daneault, Ph.D.
Assistant Professor
Rutgers, The State University of New Jersey