Ignite Creation Date:
2024-05-19 @ 5:33 PM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06411197
Status:
RECRUITING
Last Update Posted:
2024-05-16
First Post:
2024-05-08
Brief Title:
Exploration of Gait Biomechanics and Muscle Pain of the Lower Extremity
Sponsor:
Kristian Kjær Petersen
Organization:
Aalborg University
Study Overview
Official Title:
Exploration of Gait Biomechanics and Muscle Pain of the Lower Extremity
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This interventional study aims to test gait biomechanics in healthy individuals with and without experimental muscle pain in the lower extremities The study aims to
A Examine how experimental muscle pain in different types of muscles ankle plantar-flexion knee extension and flexion muscles affects kinematics kinetics and muscle activation
Participants will receive six muscle injections a Hypertonic saline painful condition and b Isotonic saline control condition in 1 m gastrocnemius 2 m semitendinosus and 3 m biceps femoris
A Examine how experimental muscle pain in different types of muscles ankle plantar-flexion knee extension and flexion muscles affects kinematics kinetics and muscle activation
Participants will receive six muscle injections a Hypertonic saline painful condition and b Isotonic saline control condition in 1 m gastrocnemius 2 m semitendinosus and 3 m biceps femoris
Detailed Description:
The proposed study will be a randomized crossover design in which experimental pain will be induced in healthy subjects using hypertonic saline injections to three muscles of the lower extremities The gastrocnemius muscle the vastus medialis muscle and the semitendinosus muscle Participants will be block-randomized to receive an injection in each of the three muscles and will receive either the painful or control condition first for each muscle The participant will always be blinded to the type of injection received
Following the injection there will typically be a 15-minute window of pain 45 Within this timeframe motion capture will be carried out for both the control and painful conditions During motion capture the participants will perform multiple walking trials of approximately 10 meters The participants will be equipped with electromyography EMG sensors on key muscles of the lower extremities The participants will be asked for NRS ratings every 30 seconds throughout the 15 minutes with expected pain There will be a 15-minute washout between the muscle injections
Following the injection there will typically be a 15-minute window of pain 45 Within this timeframe motion capture will be carried out for both the control and painful conditions During motion capture the participants will perform multiple walking trials of approximately 10 meters The participants will be equipped with electromyography EMG sensors on key muscles of the lower extremities The participants will be asked for NRS ratings every 30 seconds throughout the 15 minutes with expected pain There will be a 15-minute washout between the muscle injections
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None