Tele-yoga and Dystonia

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Primary Purpose

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Tele-yoga

About this trial

This is an interventional treatment trial for Cervical Dystonia focused on measuring yoga, cervical dystonia, telerehabilitation

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

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:

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

Sites / Locations

Motor Behavior LaboratoryRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Tele-yoga

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

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.

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.

Secondary Outcome Measures

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.

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.

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.

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.

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.

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.

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.

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.

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).

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.

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.

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.

Full Information

NCT ID

NCT04348669

First Posted

April 13, 2020

Last Updated

September 16, 2022

Sponsor

Rutgers, The State University of New Jersey

1. Study Identification

Unique Protocol Identification Number

NCT04348669

Brief Title

Tele-yoga and Dystonia

Official Title

Tele-yoga and Dystonia

Study Type

Interventional

2. Study Status

Record Verification Date

September 2022

Overall Recruitment Status

Recruiting

Study Start Date

April 28, 2020 (Actual)

Primary Completion Date

December 2023 (Anticipated)

Study Completion Date

December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Rutgers, The State University of New Jersey

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

No

Data Monitoring Committee

No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cervical Dystonia

Keywords

yoga, cervical dystonia, telerehabilitation

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

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).

Masking

None (Open Label)

Allocation

N/A

Enrollment

25 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Tele-yoga

Arm Type

Experimental

Arm Description

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.

Intervention Type

Other

Intervention Name(s)

Tele-yoga

Intervention Description

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.

Primary Outcome Measure Information:

Title

Craniocervical Dystonia Questionnaire (CDQ-24)

Description

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.

Time Frame

Baseline (0-weeks)

Title

Craniocervical Dystonia Questionnaire (CDQ-24)

Description

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.

Time Frame

Post-intervention (6-weeks)

Title

Craniocervical Dystonia Questionnaire (CDQ-24)

Description

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.

Time Frame

Follow-up (12-weeks)

Secondary Outcome Measure Information:

Title

Short form 36 health survey (SF-36)

Description

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.

Time Frame