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

Abstract: Background/Objectives: Stroke patients generally have balance and gait dysfunction due to decreased range of motion (ROM) and muscle strength of the ankle joint. A therapist can apply a floss band to enhance ROM, pain control, jumping performance, strength, myofascial release, and recovery from fatigue. This study compared the immediate effects of floss band application on ankle ROM, balance, and gait ability in stroke patients.; Methods: This study randomized 40 chronic stroke patients to either the floss (n = 20) or sham (n = 20) band group. Outcome measures were ankle ROM, weight bearing lunge test (WBLT) performance, standing balance, and gait ability. Outcome measures were assessed at baseline and immediately after applying the floss or placebo band.

Study Overview

• Status: Completed
• Conditions: Chronic Stroke
• Intervention / Treatment: Behavioral: floss band; Behavioral: Sham (No Treatment)

Detailed Description

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 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 Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Gwangsan-gu
    • Gwangju, Gwangsan-gu, Korea, Republic of, 62271
      • Nambu University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

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

2

Arms and Interventions

Participant Group / Arm	Intervention / 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	Behavioral: floss band; 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.	Behavioral: Sham (No Treatment); 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

Outcome Measure	Measure Description	Time Frame
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 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	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: Boung-hyoun Moon
• Collaborators: Nambu University

Study record dates

Study Major Dates

• Study Start (Actual): November 23, 2021
• Primary Completion (Actual): August 31, 2022
• Study Completion (Actual): August 31, 2022

Study Registration Dates

• First Submitted: November 4, 2024
• First Submitted That Met QC Criteria: November 23, 2024
• First Posted (Estimated): November 26, 2024

Study Record Updates

• Last Update Posted (Estimated): November 26, 2024
• Last Update Submitted That Met QC Criteria: November 23, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: floss band; ankle intervention
• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Stroke
• Other Study ID Numbers: 1041478-2021-HR-022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No