NCT05965791

Brief Summary

This study will use electromyography and nerve conduction studies to evaluate median nerve function during the Phalen's wrist flexion test in different wrist positions.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jul 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

July 20, 2023

Completed
5 days until next milestone

Study Start

First participant enrolled

July 25, 2023

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 28, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 25, 2023

Completed
20 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2023

Completed
Last Updated

July 28, 2023

Status Verified

July 1, 2023

Enrollment Period

4 months

First QC Date

July 20, 2023

Last Update Submit

July 20, 2023

Conditions

Outcome Measures

Primary Outcomes (3)

  • Thenar Muscle Activation

    Mean EMG activity of the thenar muscles during the Phalen's test at different wrist angles. Measured in microvolts (μV).

    Baseline

  • Median Nerve Conduction Velocity during Phalen's Test

    Median nerve conduction velocity (measured in meters per second, m/s) assessed using surface electrodes at the wrist and elbow during the Phalen's test wrist flexion maneuver. Measured bilaterally at each wrist flexion angle during a single study visit.

    Baseline

  • Median Nerve Distal Latency during Phalen's Test

    Median nerve distal latency (measured in milliseconds, ms) assessed using surface electrodes over the abductor pollicis brevis and stimulating the median nerve at the wrist during the Phalen's test. Measured bilaterally at each wrist flexion angle during a single study visit.

    Baseline

Study Arms (1)

Healthy Adults

30 healthy adult participants aged 18-45 years performing the Phalen's wrist flexion test

Diagnostic Test: Phalen's wrist flexion test

Interventions

The Phalen's test will be performed at different wrist flexion angles from 0 to 90 degrees.

Healthy Adults

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Healthy men and women aged 18-45 recruited from the local community.

You may qualify if:

  • Healthy adults aged 18-45 years
  • No history of hand/wrist disorders

You may not qualify if:

  • Contraindications to EMG or NCV
  • Neurological or muscular disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Outpatient clinic of faculty of physical therapy, Ahram Canadian University

Al Ḩayy Ath Thāmin, Giza Governorate, 3221405, Egypt

RECRUITING

MeSH Terms

Conditions

Carpal Tunnel Syndrome

Condition Hierarchy (Ancestors)

Median NeuropathyMononeuropathiesPeripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesNerve Compression SyndromesCumulative Trauma DisordersSprains and StrainsWounds and Injuries

Study Officials

  • Amal Fawzy, Ph.d

    Faculty of Physical Therapy, Ahram Canadian University

    STUDY CHAIR

Central Study Contacts

Mohamed M ElMeligie, Ph.d

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of Physical Therapy and Director of Electromyography Lab

Study Record Dates

First Submitted

July 20, 2023

First Posted

July 28, 2023

Study Start

July 25, 2023

Primary Completion

November 25, 2023

Study Completion

December 15, 2023

Last Updated

July 28, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Locations