Clinical trial NCT06704412: Effects of a Floss Band on Ankle in Stroke
Official title: Effects of Floss Band on Ankle Range of Motion, Balance, and Gait in Chronic Stroke: a Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Stroke
Keywords: floss band
ankle intervention
Lead sponsor: Nambu University
Sponsor class: OTHER_GOV
Collaborators: name: Nambu University
First posted: 2024-11-26
Enrollment: 40
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Ankle application in floss band group and sham group
Primary purpose: TREATMENT

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Ankle range of motion
timeFrame: 1 year
measure: Weight-bearing lunge test
timeFrame: 1 year
measure: Static balance ability
timeFrame: 1 year
measure: Gait ability
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Gwangju
country: Korea, Republic of
facility: Nambu University
state: Gwangsan-gu
Study officials:
References: