Tele-yoga and Dystonia

NCT04348669 | Unknown

• 1 other identifier: Pro2020000758
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Cervical Dystonia

Keywords

yoga; cervical dystonia; telerehabilitation

Outcome Measures

Primary Outcomes (3)

• 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)

• 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)

• 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 Outcomes (12)

• Short form 36 health survey (SF-36)

  Baseline (0-weeks), post-intervention (6-weeks) and at follow-up (12-weeks)

• Beck Anxiety Scale (BAI)

  Baseline (0-weeks), post-intervention (6-weeks) and at follow-up (12-weeks)

• Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS)

  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)

• Pittsburgh Sleep Quality Index (PSQI)

  Baseline (0-weeks), post-intervention (6-weeks) and at follow-up (12-weeks)

Study Arms (1)

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.

Other: Tele-yoga

Interventions

Tele-yoga OTHER

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.

Tele-yoga

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• A diagnosis of cervical dystonia
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Rutgers, The State University of New Jersey: lead

Study Sites (1)

Motor Behavior Laboratory

Newark, New Jersey, 07101, United States

RECRUITING

MeSH Terms

Conditions

Torticollis

Condition Hierarchy (Ancestors)

Dystonia; Dyskinesias; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Jean-Francois Daneault

  Rutgers University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jean-Francois Daneault

CONTACT

9739728482; jf.daneault@rutgers.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 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).

Study Record Dates

• First Submitted: April 13, 2020
• First Posted: April 16, 2020
• Study Start: April 28, 2020
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: September 19, 2022

Record last verified: 2022-09

Locations

US (1)