Tele-yoga and Dystonia

NCT ID: NCT04348669

Last Updated: 2022-09-19

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-04-28
• Study Completion Date: 2023-12-31

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.

Conditions

Cervical Dystonia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Tele-yoga

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.

Group Type: EXPERIMENTAL

Tele-yoga

Intervention Type: 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.

Interventions

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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rutgers, The State University of New Jersey

OTHER

Sponsor Role: lead

Responsible Party

Jean-Francois Daneault, Ph.D.

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jean-Francois Daneault

Role: PRINCIPAL_INVESTIGATOR

Rutgers University

Locations

Motor Behavior Laboratory

Newark, New Jersey, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Jean-Francois Daneault

Role: CONTACT

jf.daneault@rutgers.edu

9739728482

Facility Contacts

Jean-Francois Daneault

Role: primary

jf.daneault@rutgers.edu

Other Identifiers

Pro2020000758

Identifier Type: -

Identifier Source: org_study_id