Brainwave Activity Response on Common Physical Therapy Intervention

NCT04542707 | Completed FDA Device

• 1 other identifier: 2020-64
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

This study is designed to evaluate the if there is a predictable patterns in brainwave activity and to see how this changes with external physical therapy interventions such as manipulation, soft tissue massage, and exercise.

Conditions

Pain

Keywords

Brain wave activity; Exercise; Joint manipulation; Soft tissue massage; Pupillometry

Outcome Measures

Primary Outcomes (2)

• Brain wave activity

  EEG power in alpha, beta, delta, and gamma bands

  1 hour

• Pupilometry

  ANS response by measuring pupil diameter with automatic device

  5 minutes

Study Arms (3)

Joint manipulation

EXPERIMENTAL

Grade V-Thrust manipulation with audible sound and without audible sounds of C1-C2, T7, MTP 2 and MCP2 joints.

Procedure: joint manipulation

Exercise

EXPERIMENTAL

Aerobic, anaerobic, and yoga exercises

Procedure: Exercise

Soft tissue massage

EXPERIMENTAL

Instrument assisted soft tissue massage

Device: Soft tissue massage

Interventions

joint manipulation PROCEDURE

Thrust manipulation to the spine, hand, and foot

Joint manipulation

Exercise PROCEDURE

Strength training, bike aerobic training, and yoga exercise

Exercise

Soft tissue massage DEVICE

Graston tool

Soft tissue massage

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects will be between the ages of 18-60.
• The subjects for the manipulation group should have no history of thoracic spine pain in the last 6 months, no thoracic spine injuries within the past 6 months.
• The subjects for the exercise groups should be novice exercisers that do not workout often and can tolerate a 15 minute moderate intensity exercises.

You may not qualify if:

• A history of concussion, traumatic brain injury, stroke, or any known central nervous system disorder TBI, or brain damage.

Sponsors & Collaborators

• Florida Gulf Coast University: lead

Study Sites (1)

Florida Gulf Coast University

Fort Myers, Florida, 33965, United States

Location

MeSH Terms

Conditions

Pain; Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Rob Sillevis

  FGCU

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The treating clinician will not be aware off the brainwave and pupilometry data
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: This experiment will be cross sectional study. Convenience sampling technique asymptomatic healthy subjects

Study Record Dates

• First Submitted: August 26, 2020
• First Posted: September 9, 2020
• Study Start: August 20, 2020
• Primary Completion: July 1, 2025
• Study Completion: July 1, 2025
• Last Updated: August 7, 2025

Record last verified: 2025-08

Locations

US (1)