NCT06205069

Brief Summary

The purpose of this study is to verify the immediate effects of Tissue Flossing on knee flexion range of motion

Trial Health

87
On Track

Trial Health Score

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

Enrollment
58

participants targeted

Target at P50-P75 for not_applicable healthy

Timeline
Completed

Started Feb 2024

Shorter than P25 for not_applicable healthy

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

First Submitted

Initial submission to the registry

January 3, 2024

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 12, 2024

Completed
1 month until next milestone

Study Start

First participant enrolled

February 15, 2024

Completed
26 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 12, 2024

Completed
17 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 29, 2024

Completed
Last Updated

April 4, 2024

Status Verified

April 1, 2024

Enrollment Period

26 days

First QC Date

January 3, 2024

Last Update Submit

April 3, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change of knee range of motion

    Data will be collected in two moments: baseline (M0) and after the intervention/control (M1). The knee flexion range of motion will be measured using a smartphone app "Goniometer Pro". The distance between the lateral femoral epicondyle and the center of the lateral malleolus will be assessed. To measure the knee flexion angle, the participant will be placed in the prone position with the hip and knee extended at 0° (goniometer initial position 0°) with the foot relaxed and the contralateral leg extended. For active range of motion, the participant will be asked to perform maximum knee flexion in the prone position. To measure passive movement, the examiner will perform maximum knee flexion on participants in the same position. The average of three repetitions of ranges of movement will be recorded with 30-second rest intervals.

    [Time Frame: Change from Baseline (M0) to Immediately after intervention or control (M1)]

Study Arms (2)

Intervention group

ACTIVE COMPARATOR

The floss band will be applied to the knee of the dominant lower limb in the intervention group (IG). While the participant will stand and perform a slight knee flexion, the band will be rolled upwards from the tibial tuberosity to 5 cm above the femoral epicondyle. The patella will not be covered. Pressure will be produced by rolling the joint with 50% tension and 50% overlap. After applying the floss band, passive mobilization will be performed - 20 repetitions of knee flexion and extension and an active movement task - 20 squats. Participants will be instructed to perform knee flexion and extension to their extreme range of motion and to complete the mobility exercises within two minutes. After two minutes, the floss band will be removed and participants will be instructed to stand up and walk for a minute to allow blood to flow back to the foot.

Device: Tissue flossing

Control group

NO INTERVENTION

For the CG, after initial assessment, participants without a floss band will perform the same two functional movement tasks (active and passive) with 20 repetitions as the GI for 2 minutes. After two minutes, participants will be instructed to get up and walk for one minute like the intervention group.

Interventions

While the participant will stand and perform a slight knee flexion, the band will be rolled upwards from the tibial tuberosity to 5 cm above the femoral epicondyle. The patella will not be covered. Pressure will be produced by rolling the joint with 50% tension and 50% overlap.

Intervention group

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • healthy people between 18 and 35 years old with normal mobility of the joints of the lower limbs of the body.

You may not qualify if:

  • deformities in the region of the lower limbs of the body, complaints in this region in the last 6 months, surgical procedures, venous thrombotic disease, heart disease, respiratory disease, or neurological, orthopedic, dermatitis, or neuromuscular problems in the lower quadrant that may disrupt musculoskeletal function. Also high blood pressure, latex allergies, lymphedema and individuals taking anticoagulant medication, and cortisteroid therapy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Escola Superior Saúde Fernando Pessoa

Porto, 4200-253 Porto, Portugal

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 3, 2024

First Posted

January 12, 2024

Study Start

February 15, 2024

Primary Completion

March 12, 2024

Study Completion

March 29, 2024

Last Updated

April 4, 2024

Record last verified: 2024-04

Locations