Ankle SprainsNCT06390072
Project Hypnos: The Impact of a Brief Hypnosis Intervention on Single-limb Dynamic Balance in People With Chronic Ankle Instability
A study testing Self-Hypnosis and Ankle Education in people with Ankle Sprains and Motor Coordination or Function; Developmental Disorder, run by Ohio University at 1 site in United States.
Trial summary
This study will determine the relationship of one's self-reported awareness of their body and their ankle motor control for people with chronic ankle instability. This study will further identify the correlates between certain psychological characteristics (i.e., fear and anxiety) and autonomic nervous system arousal… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Ankle Sprains, Motor Coordination or Function; Developmental Disorder
- What is being tested?
- Self-Hypnosis and Ankle Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Sep 2023to 27 Nov 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- History of one significant ankle sprain
- Experiences of instability in the ankle, determined by a score of > 11 on the Identification of Functional Ankle Instability (IdFAI) questionnaire
- An overall sensation of disability, determined by a score of < 90% on the Functional Ankle Ability Measure (FAAM) questionnaire
Who cannot join
- If the participant's initial ankle sprain was within the past twelve months or the most recent ankle sprain was within the past three months, the participant was excluded from eligibility
- A history of lower extremity surgery
- A fracture to the lower extremity
- Any acute musculoskeletal injuries to lower extremities in the past three months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Impact of a Brief Hypnosis Intervention on Single-limb Dynamic Balance in People With Chronic Ankle Instability: Enhancing and Limiting Psychological Factors, Perceived and Performance-based Ankle Stability, and Heart-rate Variability
This study will determine the relationship of one's self-reported awareness of their body and their ankle motor control for people with chronic ankle instability. This study will further identify the correlates between certain psychological characteristics (i.e., fear and anxiety) and autonomic nervous system arousal (i.e., heart rate variability). Furthermore, this study will elucidate the potential impact of a brief hypnosis practice on balance performance.
- Being tested
- Self-Hypnosis, Ankle Education
- Keywords
- Interoceptive awareness, Heart rate variability, Anxiety
- Medical subject headings
- Ankle Injuries, Developmental Disabilities, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-HypnosisBehavioural
Participants listened to an 8-minute audio-guided self-hypnosis related to improving their physical performance
Ankle EducationBehavioural
Participants listened to an 8-minute video on ankle sprain diagnosis, prognosis, and treatment
| Study group | Role | What they receive |
|---|---|---|
| Self-hypnosis | Experimental | The audio-guided self-hypnosis practice was sourced from the Reveri App (reveri.com), developed by Dr. David Spiegel, and entitled "Hypnosis Prep for Workout" Receives: Behavioral: Self-Hypnosis; Behavioral: Ankle Education |
| Ankle Education | Active comparator | The ankle education video, entitled "Ankle Sprain Rehab Exercises" was sourced from the Physio Tutors YouTube channel Receives: Behavioral: Self-Hypnosis; Behavioral: Ankle Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Balance test 1
Biodex Stability System
Measured: Through the study completion, up to 8 days from baseline assessment. Assessed at pre-intervention and post-intervention for sessions 1 and 2
Balance test 2
Y-Balance test
Measured: Through the study completion, up to 8 days from baseline assessment. Assessed at pre-intervention and post-intervention for sessions 1 and 2
Heart rate variability
HRV was captured for 5 minutes using a three-lead electrocardiogram at the beginning of each of the two lab sessions
Measured: Through the study completion, up to 8 days from baseline assessment. Assessed at pre-intervention and post-intervention for sessions 1 and 2
Secondary outcomes (7)
Ankle disability measure 1
Identification of Functional Ankle Instability, used for eligibility screening
Measured: T0, Baseline/Enrollment
Ankle disability measure 2
Functional Ankle Ability Measure
Measured: T0, Baseline/Enrollment
Interoceptive awareness measure 1
Mindful Presence - Bodily Awareness
Measured: T0, Baseline/Enrollment
Interoceptive awareness measure 2
Multidimensional Assessment of Interoceptive Awareness (MAIA-2)
Measured: T0, Baseline/Enrollment
Emotional Distress-Anxiety
PROMIS Emotional Distress-Anxiety item bank
Measured: T0, Baseline/Enrollment
Kinesiophobia
Tampa Scale of Kinesiophobia (TSK-11)
Measured: T0, Baseline/Enrollment
Pain self-efficacy
Pain Self-Efficacy Questionnaire (PSEQ-10)
Measured: T0, Baseline/Enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2024
- Study start25 Sep 2023
- Primary completion27 Nov 2023
- Study completion27 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ankle SprainsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- This basic experimental pilot study involved a randomized cross-over design of two brief interventions with a 1:1 allocation ratio
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ohio University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nicholas Karayannis, MPT, PhD, Principal investigator, Ohio University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06390072
- Sponsor's protocol ID
- 23-X-71
- Status last verified
- Apr 2024
- First submitted
- 2 Apr 2024
- Last updated
- 29 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of a Brief Hypnosis Intervention on Single-limb Dynamic Balance in People With Chronic Ankle Instability: Enhancing and Limiting Psychological Factors, Perceived and Performance-based Ankle Stability, and Heart-rate Variability
- ClinicalTrials.gov ID
- NCT06390072
- Acronym / sponsor ID
- 23-X-71
- Keywords
- Interoceptive awareness, Heart rate variability, Anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Ohio UniversityUniversity, hospital or other
- Study start
- 25 Sep 2023 (actual)
- Primary completion
- 27 Nov 2023 (actual)
- Study completion
- 27 Nov 2023 (actual)
- First posted
- 29 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will determine the relationship of one's self-reported awareness of their body and their ankle motor control for people with chronic ankle instability. This study will further identify the correlates between certain psychological characteristics (i.e., fear and anxiety) and autonomic nervous system arousal (i.e., heart rate variability). Furthermore, this study will elucidate the potential impact of a brief hypnosis practice on balance performance.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This basic experimental pilot study involved a randomized cross-over design of two brief interventions with a 1:1 allocation ratio
| Arm | Type | Receives |
|---|---|---|
| Self-hypnosis | Experimental | Behavioral: Self-Hypnosis, Behavioral: Ankle EducationThe audio-guided self-hypnosis practice was sourced from the Reveri App (reveri.com), developed by Dr. David Spiegel, and entitled "Hypnosis Prep for Workout" |
| Ankle Education | Active comparator | Behavioral: Self-Hypnosis, Behavioral: Ankle EducationThe ankle education video, entitled "Ankle Sprain Rehab Exercises" was sourced from the Physio Tutors YouTube channel |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- History of one significant ankle sprain
- Experiences of instability in the ankle, determined by a score of > 11 on the Identification of Functional Ankle Instability (IdFAI) questionnaire
- An overall sensation of disability, determined by a score of < 90% on the Functional Ankle Ability Measure (FAAM) questionnaire
Key exclusion criteria (4 listed)
- If the participant's initial ankle sprain was within the past twelve months or the most recent ankle sprain was within the past three months, the participant was excluded from eligibility
- A history of lower extremity surgery
- A fracture to the lower extremity
- Any acute musculoskeletal injuries to lower extremities in the past three months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Self-HypnosisParticipants listened to an 8-minute audio-guided self-hypnosis related to improving their physical performance | Behavioural | Ankle Education, Self-hypnosis |
| Ankle EducationParticipants listened to an 8-minute video on ankle sprain diagnosis, prognosis, and treatment | Behavioural | Ankle Education, Self-hypnosis |
Primary outcome
Balance test 1
Time frame: Through the study completion, up to 8 days from baseline assessment. Assessed at pre-intervention and post-intervention for sessions 1 and 2
Biodex Stability System
Balance test 2
Time frame: Through the study completion, up to 8 days from baseline assessment. Assessed at pre-intervention and post-intervention for sessions 1 and 2
Y-Balance test
Heart rate variability
Time frame: Through the study completion, up to 8 days from baseline assessment. Assessed at pre-intervention and post-intervention for sessions 1 and 2
HRV was captured for 5 minutes using a three-lead electrocardiogram at the beginning of each of the two lab sessions
7 secondary outcomes
Ankle disability measure 1
Time frame: T0, Baseline/Enrollment
Ankle disability measure 2
Time frame: T0, Baseline/Enrollment
Interoceptive awareness measure 1
Time frame: T0, Baseline/Enrollment
Interoceptive awareness measure 2
Time frame: T0, Baseline/Enrollment
Emotional Distress-Anxiety
Time frame: T0, Baseline/Enrollment
Kinesiophobia
Time frame: T0, Baseline/Enrollment
Pain self-efficacy
Time frame: T0, Baseline/Enrollment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2024.
- Individual participant dataSharing planned: Undecided
Related trials for Ankle Sprains
Not yet recruiting
Functional Recovery After a Recent Lateral Ankle Sprain With Early Initiation of Rehabilitation: Changes in the Ankle-GO Score and Its Association With Return to Sport and Recurrent Sprains.
Ankle Sprain
Recruiting
Enovis High Ankle Sprain Brace Testing
Athletes in Cutting Sports
Recruiting
The Effects of Vestibulo-Ocular Reflex Exercises Added to Postural Stabilization Training in Amateur Athletes With Chronic Ankle Instability
Ankle Sprain, Ankle Sprain Strain
Recruiting
The Effects of Vestibulo-Ocular Reflex Exercises Added to Postural Stabilization Training in Chronic Ankle Instability
Ankle Sprains, Ankle Sprain Strain
Not yet recruiting
Collagen Scaffold Bioaugmentation for ATFL Repair in Chronic Ankle Instability
Chronic Ankle Instability, Ankle Sprain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nicholas Karayannis, MPT, PhD principal investigator
Ohio University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self-Hypnosis and Ankle Education in people with Ankle Sprains and Motor Coordination or Function; Developmental Disorder, run by Ohio University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Balance test 1 (time frame: Through the study completion, up to 8 days from baseline assessment. Assessed at pre-intervention and post-intervention for sessions 1 and 2). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2024.