NCT05250076

Brief Summary

The purpose of this study is to verify the immediate effects of Kinesio Tape on median nerve's mechanosensitivity, measured by the upper limb neurodynamic test 1 (ULNT1) in healthy participants.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P50-P75 for not_applicable healthy

Timeline
Completed

Started Feb 2022

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 13, 2022

Completed
29 days until next milestone

Study Start

First participant enrolled

February 11, 2022

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 22, 2022

Completed
4 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 26, 2022

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 26, 2022

Completed
Last Updated

May 20, 2022

Status Verified

May 1, 2022

Enrollment Period

15 days

First QC Date

January 13, 2022

Last Update Submit

May 19, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • change in elbow extension range of motion measured by smartphone

    Data will be collected in two moments: baseline (Moment 0) and after the application of Kinesio Tape for intervention group or after a resting period for control group (Moment 1). Moment 0 will consist in performing the ULNT1 on the dominant upper limb for each participant. The participants will remain in a supine position on a treatment table with the body aligned, exposing the test forearm for the placement of the smartphone through an armband. The head and cervical spine will be stabilized at the maximum comfortable lateral inclination using a foam pillow. The ULNT1 sequence used was: (1) maximum contralateral cervical inclination; (2) arm at 90º of shoulder abduction preventing scapular elevation; (3) 90º of external rotation of the shoulder and elbow flexion at 90º (defined as the initial position or 0º of range of motion under test); (4) supination of the forearm; (5) wrist and fingers extension; and (6) elbow extension.

    [Time Frame: Baseline (Moment 0), Immediately after intervention or control (Moment 1) .]]

Study Arms (2)

Intervention Group

ACTIVE COMPARATOR

The beige Kinesio Tape (Prim Tape®) will be applied, from distal to proximal, 5cm wide, cut in "I" and with tension below 50%. The Kinesio Tape will be placed along the entire path of the median nerve, from the wrist to the armpit. The participants will remain in the supine position on a treatment table (Posturarte® Olympic), without inclination (Posturarte® Olympic). To clean the participant's skin, cotton (MASMI®) will be passed with ethyl alcohol (Fergus®). Scissor (Maped®) will be used to cut the Kinesio Tape.

Device: Kinesio Tape

Control Group

NO INTERVENTION

The participants will remain at rest in a supine position on a treatment table (Posturarte® Olympic) without inclination for 5 minutes.

Interventions

The beige Kinesio Tape (Prim Tape®) will be applied, from distal to proximal, 5cm wide, cut in "I" and with tension below 50%. The Kinesio Tape will be placed along the entire path of the median nerve, from the wrist to the armpit. The participants will remain in the supine position on a treatment table (Posturarte® Olympic), without inclination.

Intervention Group

Eligibility Criteria

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

You may qualify if:

  • Healthy university students of both genders with normal mobility of the joints of the upper quadrant of the body

You may not qualify if:

  • Deformities in the upper quadrant region of the body;
  • Complaints in this region in the last 6 months;
  • Surgical procedures or musculoskeletal, cardiac, renal, metabolic, neurological and or oncological pathologies of the upper quadrant that may disturb nerve function;
  • Not present any mechanosensitive response to ULNT1;
  • Pregnant women;
  • Ingestion of non-steroidal anti-inflammatory drugs or consumption of any type of narcotic drugs and participants who have drunk alcohol in the last 12 hours.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ricardo Cardoso

Porto, 4200-253 Porto, Portugal

Location

MeSH Terms

Interventions

Athletic Tape

Intervention Hierarchy (Ancestors)

BandagesEquipment and SuppliesOrthotic DevicesOrthopedic EquipmentSurgical Equipment

Study Officials

  • Ricardo Cardoso, PhD

    Fernando Pessoa University

    PRINCIPAL INVESTIGATOR

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
SPONSOR

Study Record Dates

First Submitted

January 13, 2022

First Posted

February 22, 2022

Study Start

February 11, 2022

Primary Completion

February 26, 2022

Study Completion

March 26, 2022

Last Updated

May 20, 2022

Record last verified: 2022-05

Locations