Healthy Participants StudyNCT06708052
Effects of Voodoo Flossing on Ankle in Participants with Limited Ankle Dorsiflexion
A study testing voodoo flossing in people with Healthy Participants Study, run by Boung-hyoun Moon at 1 site in South Korea.
Trial summary
In the case of normal walking patterns, the angle of plantarflexion (PF) at heel contact should be 0 to 5 degrees, the angle of dorsiflexion (DF) in the terminal stance should be 10 degrees, and the angle of PF should be 15-20 degrees when the heel off. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants Study
- What is being tested?
- voodoo flossing
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteSouth Korea
- Study dates
- 14 Jul 2022to 31 Dec 2022
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- less than 10° of dorsiflexion
Who cannot join
- lower extremity orthopedic problems
- unstable steps and balance
- visual impairments
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Voodoo Flossing on Ankle Range of Motion, Balance, Gait Ability in Participants with Limited Ankle Dorsiflexion
In the case of normal walking patterns, the angle of plantarflexion (PF) at heel contact should be 0 to 5 degrees, the angle of dorsiflexion (DF) in the terminal stance should be 10 degrees, and the angle of PF should be 15-20 degrees when the heel off. A therapist can apply a voodoo flossing to enhance range of motion (ROM), pain control, jumping performance, strength, myofascial release, and recovery from fatigue. This study compared the immediate effects of voodoo flossing application on ankle ROM, balance, and gait ability in stroke patients. Outcome measures were ankle ROM, weight bearing lunge test (WBLT) performance, static balance (one leg test), dynamic balance(Y-balance test) and gait ability. Outcome measures were assessed at baseline and immediately after applying the voodoo flossing.
Read the detailed description
The voodoo flossing intervention used the standard voodoo flossing, wrapping a voodoo flossing (lime green Sanctband Comprefloss™, 2" × 3.5 m; PENTEL, Shah Alam, Malaysia) made of natural rubber tightly around the ankle on the affected side. It was started at the fifth metatarsal and wrapped horizontally around the metatarsals twice, in a figure eight to the medial malleolus, over the Achilles tendon and the lateral malleolus three times, and around the medial malleolus again, before being passed twice from the medial mal-leolus over the Achilles tendon to the lateral malleolus, forming an end knot. The participants were instructed to perform low-intensity active exercise involving ankle DF and plantar flexion for 2 minutes after applying the floss band. Then, the floss band was removed and the patient was asked to walk lightly on level ground for about 1 minute to allow reperfusion to normalize blood flow.
- Conditions
- Healthy Participants Study
- Being tested
- voodoo flossing, Control group
- Keywords
- voodoo flossing, limited ankle dorsiflexion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
voodoo flossingBehavioural
The voodoo flossing intervention used the standard voodoo flossing, wrapping a voodoo flossing (lime green Sanctband Comprefloss™, 2" × 3.5 m; PENTEL, Shah Alam, Malaysia) made of natural rubber tightly around the ankle on the affected side. It was started at the fifth metatarsal and wrapped horizontally around the metatarsals twice, in a figure eight to the medial malleolus, over the Achilles tendon and the lateral malleolus three times, and around the medial malleolus again, before being passed twice from the medial mal-leolus over the Achilles tendon to the lateral malleolus, forming an end knot
Control groupBehavioural
The control group did not use voodoo flossing.
| Study group | Role | What they receive |
|---|---|---|
| voodoo flossing intervention | Experimental | The voodoo flossing intervention used the standard voodoo flossing, wrapping a voodoo flossing (lime green Sanctband Comprefloss™, 2" × 3.5 m; PENTEL, Shah Alam, Malaysia) made of natural rubber tightly around the ankle on the affected side. It was started at the fifth metatarsal and wrapped horizontally around the metatarsals twice, in a figure eight to the medial malleolus, over the Achilles tendon and the lateral malleolus three times, and around the medial malleolus again, before being passed twice from the medial mal-leolus over the Achilles tendon to the lateral malleolus, forming an end knot Receives: Behavioral: voodoo flossing |
| control | Sham comparator | The control group did not use voodoo flossing. Receives: Behavioral: Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ankle range of motion
Ankle passive ROM was measured using a universal goniometer in a non-weight bearing position. Subjects were prone with the knee joint at 90° . The ankle joint was set at 0° of eversion and inversion. The goniometer axis was placed beneath the lateral malleolus, and the stationary arm was positioned parallel to the fibula. The movable arm was positioned parallel to the fifth metatarsal, with the ankle in a neutral position. The measurement was repeated three times, and the average value was calculated. DF and PF measured angle.
Measured: 1 year
Weight-bearing lunge test
The WBLT was performed to assess DF in a functional ankle joint. A measuring tape was placed horizontally on the floor perpendicular to a wall. The participants placed their affected-side foot on the tape with their big toe contacting the wall, and were instructed to touch the wall with the knee on the affected side. While maintaining this position, they were instructed to perform lunges by bending their knee, aiming for contact between their knee and the wall while keeping their heel firmly fixed on the floor. Once they were able to maintain knee and heel contact, the affected side foot was moved away from the wall, and they repeated the lunge test. The test was performed with 1-cm increases until knee and heel contact were no longer maintained. The maximum lunge distance was the far-thest distance from the wall to the big toe with the foot staying on the floor (without heel lifting) when the knee touched the wall. WBLT measured distance in centimeters.
Measured: 1 year
Static balance ability
Static balance was assessed using the APDM Mobility Lab™ Opal inertial sensor system (APDM, Portland, OR, USA). The test was conducted in a quiet treatment room. During the test, participants were barefoot and wore three Opal inertial sensors: one over their clothing at the level of the fifth lumbar vertebra and one on each ankle. Each subject was instructed to maintain their balance as stably as possible in a barefoot one leg standing position for 30 seconds. The test was repeated three times at 30-second intervals. The static balance outcome measure was the postural sway area (cm/s2). The signal was sampled, processed automatically, and streamed to a laptop using Mobility Lab™ software (Mobility Lab, Arlington, VA, USA).
Measured: 1 year
dynamic balance ability
The Y-Balance Test Lower Quarter (YBT-LQ; Move2Perform, Evansville, IN, USA) was used to assess dynamic ankle balance. The YBT-LQ device consists of three pipes extending from a central plate, each with a measurement indicator. The pipes are oriented in three directions: anterior (ANT), posterolateral (PL), and posteromedial (PM), forming angles of 135° between the anterior and posterior pipes and 90° between the posterior pipes. Each pipe is marked at 0.5 cm intervals. Participants stood on their measurement foot, aligning their big toe with the plate's red line, and reached maximally with the non-supporting foot to move the indicator along each pipe. The foot had to return to the starting position without losing balance or touching the ground. Incorrect attempts were repeated. The test recorded the indicator's distance, with each direction measured three times. Average values were calculated and normalized for analysis.
Measured: 1 year
Gait ability
The APDM Mobility Lab™ Opal inertial sensor system (APDM) was used to assess gait based on the foot strike (FS) and toe-off (TO) angles. Data were collected from the sensor wirelessly at a sampling rate of 128 Hz and processed to quantify postural sway parameters. The test was conducted in a quiet treatment room. During the test, participants were barefoot and wore three Opal inertial sensors: one over their clothing at the level of the fifth lumbar vertebra and at each ankle. Verbal instructions were given to ensure accuracy. The subject was told to stand still at the start line until the first long tone was heard, at which time they started walking at a comfortable natural pace. When a second tone was heard after 2 minutes, the participants were asked to stop walking. After practicing for 30 seconds to become familiar with the test, participants were asked to walk back and forth along a straight 10-meter corridor at their usual pace for 2 minutes without a walking assist.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2024
- Study start14 Jul 2022
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy Participants StudyStudies 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
- Parallel groups
- Model description
- Ankle application in voodoo flossing and control group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boung-hyoun Moon
- Sponsor type
- Other government
- Collaborators
- Nambu University
- Responsible party
- Sponsor-investigator, Boung-hyoun Moon, Nambu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06708052
- Sponsor's protocol ID
- 1041478-2022-HR-008
- Status last verified
- Nov 2024
- First submitted
- 25 Nov 2024
- Last updated
- 27 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Moon BH, Kim JW. The Effects of Tissue Flossing on Ankle Dorsiflexion Range of Motion, Balance, and Gait in Participants with Limited Ankle Dorsiflexion: A Randomized Controlled Trial. Medicina (Kaunas). 2026 May 7;62(5):906. doi: 10.3390/medicina62050906.
PubMed 42195159
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Voodoo Flossing on Ankle Range of Motion, Balance, Gait Ability in Participants with Limited Ankle Dorsiflexion
- ClinicalTrials.gov ID
- NCT06708052
- Acronym / sponsor ID
- 1041478-2022-HR-008
- Conditions
- Healthy Participants Study
- Keywords
- voodoo flossing, limited ankle dorsiflexion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Boung-hyoun MoonOther government
- Collaborators
- Nambu University
- Study start
- 14 Jul 2022 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 27 Nov 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.
In the case of normal walking patterns, the angle of plantarflexion (PF) at heel contact should be 0 to 5 degrees, the angle of dorsiflexion (DF) in the terminal stance should be 10 degrees, and the angle of PF should be 15-20 degrees when the heel off. A therapist can apply a voodoo flossing to enhance range of motion (ROM), pain control, jumping performance, strength, myofascial release, and recovery from fatigue. This study compared the immediate effects of voodoo flossing application on ankle ROM, balance, and gait ability in stroke patients. Outcome measures were ankle ROM, weight bearing lunge test (WBLT) performance, static balance (one leg test), dynamic balance(Y-balance test) and gait ability. Outcome measures were assessed at baseline and immediately after applying the voodoo flossing.
Detailed description
The voodoo flossing intervention used the standard voodoo flossing, wrapping a voodoo flossing (lime green Sanctband Comprefloss™, 2" × 3.5 m; PENTEL, Shah Alam, Malaysia) made of natural rubber tightly around the ankle on the affected side. It was started at the fifth metatarsal and wrapped horizontally around the metatarsals twice, in a figure eight to the medial malleolus, over the Achilles tendon and the lateral malleolus three times, and around the medial malleolus again, before being passed twice from the medial mal-leolus over the Achilles tendon to the lateral malleolus, forming an end knot. The participants were instructed to perform low-intensity active exercise involving ankle DF and plantar flexion for 2 minutes after applying the floss band. Then, the floss band was removed and the patient was asked to walk lightly on level ground for about 1 minute to allow reperfusion to normalize blood flow.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Ankle application in voodoo flossing and control group
| Arm | Type | Receives |
|---|---|---|
| voodoo flossing intervention | Experimental | Behavioral: voodoo flossingThe voodoo flossing intervention used the standard voodoo flossing, wrapping a voodoo flossing (lime green Sanctband Comprefloss™, 2" × 3.5 m; PENTEL, Shah Alam, Malaysia) made of natural rubber tightly around the ankle on the affected side. It was started at the fifth metatarsal and wrapped horizontally around the metatarsals twice, in a figure eight to the medial malleolus, over the Achilles tendon and the lateral malleolus three times, and around the medial malleolus again, before being passed twice from the medial mal-leolus over the Achilles tendon to the lateral malleolus, forming an end knot |
| control | Sham comparator | Behavioral: Control groupThe control group did not use voodoo flossing. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- less than 10° of dorsiflexion
Key exclusion criteria (3 listed)
- lower extremity orthopedic problems
- unstable steps and balance
- visual impairments
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 |
|---|---|---|
| voodoo flossingThe voodoo flossing intervention used the standard voodoo flossing, wrapping a voodoo flossing (lime green Sanctband Comprefloss™, 2" × 3.5 m; PENTEL, Shah Alam, Malaysia) made of natural rubber tightly around the ankle on the affected side. It was started at the fifth metatarsal and wrapped horizontally around the metatarsals twice, in a figure eight to the medial malleolus, over the Achilles tendon and the lateral malleolus three times, and around the medial malleolus again, before being passed twice from the medial mal-leolus over the Achilles tendon to the lateral malleolus, forming an end knot | Behavioural | voodoo flossing intervention |
| Control groupThe control group did not use voodoo flossing. | Behavioural | control |
Primary outcome
Ankle range of motion
Time frame: 1 year
Ankle passive ROM was measured using a universal goniometer in a non-weight bearing position. Subjects were prone with the knee joint at 90° . The ankle joint was set at 0° of eversion and inversion. The goniometer axis was placed beneath the lateral malleolus, and the stationary arm was positioned parallel to the fibula. The movable arm was positioned parallel to the fifth metatarsal, with the ankle in a neutral position. The measurement was repeated three times, and the average value was calculated. DF and PF measured angle.
Weight-bearing lunge test
Time frame: 1 year
The WBLT was performed to assess DF in a functional ankle joint. A measuring tape was placed horizontally on the floor perpendicular to a wall. The participants placed their affected-side foot on the tape with their big toe contacting the wall, and were instructed to touch the wall with the knee on the affected side. While maintaining this position, they were instructed to perform lunges by bending their knee, aiming for contact between their knee and the wall while keeping their heel firmly fixed on the floor. Once they were able to maintain knee and heel contact, the affected side foot was moved away from the wall, and they repeated the lunge test. The test was performed with 1-cm increases until knee and heel contact were no longer maintained. The maximum lunge distance was the far-thest distance from the wall to the big toe with the foot staying on the floor (without heel lifting) when the knee touched the wall. WBLT measured distance in centimeters.
Static balance ability
Time frame: 1 year
Static balance was assessed using the APDM Mobility Lab™ Opal inertial sensor system (APDM, Portland, OR, USA). The test was conducted in a quiet treatment room. During the test, participants were barefoot and wore three Opal inertial sensors: one over their clothing at the level of the fifth lumbar vertebra and one on each ankle. Each subject was instructed to maintain their balance as stably as possible in a barefoot one leg standing position for 30 seconds. The test was repeated three times at 30-second intervals. The static balance outcome measure was the postural sway area (cm/s2). The signal was sampled, processed automatically, and streamed to a laptop using Mobility Lab™ software (Mobility Lab, Arlington, VA, USA).
dynamic balance ability
Time frame: 1 year
The Y-Balance Test Lower Quarter (YBT-LQ; Move2Perform, Evansville, IN, USA) was used to assess dynamic ankle balance. The YBT-LQ device consists of three pipes extending from a central plate, each with a measurement indicator. The pipes are oriented in three directions: anterior (ANT), posterolateral (PL), and posteromedial (PM), forming angles of 135° between the anterior and posterior pipes and 90° between the posterior pipes. Each pipe is marked at 0.5 cm intervals. Participants stood on their measurement foot, aligning their big toe with the plate's red line, and reached maximally with the non-supporting foot to move the indicator along each pipe. The foot had to return to the starting position without losing balance or touching the ground. Incorrect attempts were repeated. The test recorded the indicator's distance, with each direction measured three times. Average values were calculated and normalized for analysis.
Gait ability
Time frame: 1 year
The APDM Mobility Lab™ Opal inertial sensor system (APDM) was used to assess gait based on the foot strike (FS) and toe-off (TO) angles. Data were collected from the sensor wirelessly at a sampling rate of 128 Hz and processed to quantify postural sway parameters. The test was conducted in a quiet treatment room. During the test, participants were barefoot and wore three Opal inertial sensors: one over their clothing at the level of the fifth lumbar vertebra and at each ankle. Verbal instructions were given to ensure accuracy. The subject was told to stand still at the start line until the first long tone was heard, at which time they started walking at a comfortable natural pace. When a second tone was heard after 2 minutes, the participants were asked to stop walking. After practicing for 30 seconds to become familiar with the test, participants were asked to walk back and forth along a straight 10-meter corridor at their usual pace for 2 minutes without a walking assist.
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 27 Nov 2024.
- Derived from this study: PubMed 42195159Moon BH, Kim JW. The Effects of Tissue Flossing on Ankle Dorsiflexion Range of Motion, Balance, and Gait in Participants with Limited Ankle Dorsiflexion: A Randomized Controlled Trial. Medicina (Kaunas). 2026 May 7;62(5):906. doi: 10.3390/medicina62050906.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing voodoo flossing in people with Healthy Participants Study, run by Boung-hyoun Moon at 1 site in South Korea.
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 1 inclusion and 3 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 27 Nov 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 South Korea. 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. Some participants in this study may receive a placebo. 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?
Ankle range of motion (time frame: 1 year). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06708052, which also lists 1 linked publication.
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 27 Nov 2024.