NCT06708052

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 14, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

November 25, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 27, 2024

Completed
Last Updated

November 27, 2024

Status Verified

November 1, 2024

Enrollment Period

6 months

First QC Date

November 25, 2024

Last Update Submit

November 25, 2024

Conditions

Keywords

voodoo flossinglimited ankle dorsiflexion

Outcome Measures

Primary Outcomes (5)

  • 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.

    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.

    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).

    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.

    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.

    1 year

Study Arms (2)

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

Behavioral: voodoo flossing

control

SHAM COMPARATOR

The control group did not use voodoo flossing.

Behavioral: Control group

Interventions

voodoo flossingBEHAVIORAL

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

voodoo flossing intervention
Control groupBEHAVIORAL

The control group did not use voodoo flossing.

control

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • less than 10° of dorsiflexion

You may not qualify if:

  • lower extremity orthopedic problems
  • unstable steps and balance
  • visual impairments

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nambu University

Gwangju, Gwangsan-gu, 62271, South Korea

Location

MeSH Terms

Interventions

Control Groups

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Ankle application in voodoo flossing and control group
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

November 25, 2024

First Posted

November 27, 2024

Study Start

July 14, 2022

Primary Completion

December 31, 2022

Study Completion

December 31, 2022

Last Updated

November 27, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

Locations