Clinical trial NCT04348669: Tele-yoga and Dystonia
Official title: Tele-yoga and Dystonia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cervical Dystonia
Keywords: yoga
cervical dystonia
telerehabilitation
Lead sponsor: Rutgers, The State University of New Jersey
Sponsor class: OTHER
First posted: 2020-04-16
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention 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).
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Craniocervical Dystonia Questionnaire (CDQ-24)
timeFrame: Baseline (0-weeks)
measure: Craniocervical Dystonia Questionnaire (CDQ-24)
timeFrame: Post-intervention (6-weeks)
measure: Craniocervical Dystonia Questionnaire (CDQ-24)
timeFrame: Follow-up (12-weeks)
Secondary outcomes:
measure: Short form 36 health survey (SF-36)
timeFrame: Baseline (0-weeks), post-intervention (6-weeks) and at follow-up (12-weeks)
measure: Beck Anxiety Scale (BAI)
timeFrame: Baseline (0-weeks), post-intervention (6-weeks) and at follow-up (12-weeks)
measure: Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS)
timeFrame: Baseline (0-weeks), post-intervention (6-weeks) and at follow-up (12-weeks)
measure: Beck Depression Inventory-II (BDI-II)
timeFrame: Baseline (0-weeks), post-intervention (6-weeks) and at follow-up (12-weeks)
measure: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: Baseline (0-weeks), post-intervention (6-weeks) and at follow-up (12-weeks)
measure: Five Times Sit to Stand Test (FTST)
timeFrame: Baseline (0-weeks), post-intervention (6-weeks) and at follow-up (12-weeks)
measure: Adherence will be assessed by calculating the total number of yoga sessions attended.
timeFrame: Between week 0 to week 6
measure: Adverse Events
timeFrame: Between week 0 to week 6
measure: Technical Difficulties Encountered
timeFrame: Between week 0 to week 6
measure: Enjoyment/Feedback
timeFrame: Post-intervention testing (at 6-weeks)
measure: Usability
timeFrame: Post-intervention testing (at 6-weeks)
measure: Yoga Status at Follow-up
timeFrame: Follow-up (12 weeks)
Other outcomes:
Locations:
city: Newark
country: United States
facility: Motor Behavior Laboratory
state: New Jersey
Study officials:
affiliation: Rutgers University
name: Jean-Francois Daneault
role: PRINCIPAL_INVESTIGATOR
References: