Effects of a Floss Band on Ankle in Stroke
Effects of Floss Band on Ankle Range of Motion, Balance, and Gait in Chronic Stroke: a Randomized Controlled Study
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Detailed Description
Study Type
Study Type
Enrollment (Actual)
Enrollment
Phase
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Gwangsan-gu
-
Gwangju, Gwangsan-gu, Korea, Republic of, 62271
- Nambu University
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Diagnosed with ischemic or hemorrhagic stroke
- Chronic patients 6 months after stroke onset
- Able to walk 10 meters independently
- Unable to dorsiflexion the ankle on the affected side
- Modified Ashworth scale (MAS) score < G2 for the ankle joint
- Adequate cognitive status Mini-Mental State Examination (MMSE) score of ≥ 23
Exclusion Criteria:
- Impaired lower extremity function due to other causes
- Dizziness
- Hemianopia, or other symptoms indicating vestibular dysfunction
- Serious heart disease or use of a pacemaker
- Unable to tolerate the floss band intervention
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Experimental: floss band group
The floss band intervention used the standard floss band technique, wrapping a floss band (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 floss band intervention used the standard floss band technique, wrapping a floss band (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
|
|
Sham Comparator: sham group
The wrap used in the sham group lacked the elasticity of a floss band; the ankle was wrapped in the same manner, but loosely to facilitate blood circulation.
Similarly, the participants were instructed to perform low-intensity active exercise involving ankle DF and plantar flexion for 2 minutes after applying the sham floss band.
Finally, the sham floss band was removed, and the patient was asked to walk lightly on level ground for about 1 minute under the same conditions as in the floss band group.
|
The wrap used in the sham group lacked the elasticity of a floss band; the ankle was wrapped in the same manner, but loosely to facilitate blood circulation.
Similarly, the participants were instructed to perform low-intensity active exercise involving ankle DF and plantar flexion for 2 minutes after applying the sham floss band.
Finally, the sham floss band was removed, and the patient was asked to walk lightly on level ground for about 1 minute under the same conditions as in the floss band group.
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
1 year
|
|
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.
|
1 year
|
|
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 standing po-sition (10 cm between heels, toe-out of 5°) 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).
Balance measured sway range in millimeters squared.
|
1 year
|
|
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.
|
1 year
|
Collaborators and Investigators
Sponsor
Sponsor
Collaborators
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Actual)
Primary Completion
Study Completion (Actual)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Estimated)
First Posted
Study Record Updates
Last Update Posted (Estimated)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- 1041478-2021-HR-022
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.