Effects of a Floss Band on Ankle in Stroke

Boung-hyoun Moon

Status: Completed

Conditions: Chronic Stroke

Treatments: Behavioral: Sham (No Treatment); Behavioral: floss band

Study type: Interventional

Funder types: Other

Identifiers

NCT06704412

1041478-2021-HR-022

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

40 participants in 2 patient groups

floss band group

Experimental group

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

Treatment:

Behavioral: floss band

sham group

Sham Comparator group

Description:

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.

Treatment:

Behavioral: Sham (No Treatment)