Use of Hand-held Dynamometry to Obtain Objective Measures of Lower Extremity Force Production With Chronic Stroke

Recruiting

• Conditions: Weakness, Muscle; Chronic Stroke

• Registration Number: NCT05941962
• Lead Sponsor: Vanderbilt University Medical Center

Brief Summary

This study wants to know if using handheld dynamometry (HHD) to test leg strength in persons who have had a stroke, will reduce mistakes and give therapists better information to use for therapy. This study will collect normal values of leg muscle peak force production, cumulative peak force production, and sustained peak force production in patients with chronic stroke.

Detailed Description

The Activbody Activ5 device will be used for data collection with all information logged and stored through the device's app and transferred to secure files. Assessment of isometric muscle strength and power will be performed as follows:

* Hip flexors with the participant seated and hips and knees flexed at 90 degrees

* Knee extensors with the participant seated and hips and knees flexed at 90 degrees

* Knee flexors with the participant seated and hips and knees flexed at 90 degrees

* Ankle plantarflexors with the participant lying supine with the ankle in plantargrade and hips and knees extended

* Ankle dorsiflexors with the participant lying supine with the ankle relaxed and hips and knees extended

* Hip abductors with the participant lying supine and hips and knees extended

* Hip adductors with the participant lying supine and hips and knees extended

* Hip extensors with the participant lying prone and hips and knees extended 1 session, two trials per side

Study Timeline

• Study Start: 2023-06-05
• Study First Submitted: 2023-06-05
• Study First Submitted QC: 2023-07-11
• Study First Posted: 2023-07-12
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-09
• Last Update Posted: 2025-05-14
• Primary Completion: 2025-07-26
• Study Completion: 2025-07-26

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Age 18 years or older
• Stroke > 3 months
• Ability to follow two-step commands
• Ability to assume all test positions and maintain for duration of testing (i.e. upright seated, prone, side lying, supine)

Exclusion Criteria

• Lower extremity contractures preventing full passive range of motion (ROM)
• Vital signs contraindicated for exercise (i.e. resting heart rate > 100 bpm < 50 bpm, resting systolic blood pressure > 200 mmHg or < 90 mmHg, resting diastolic blood pressure > 110 mmHg, oxygen saturation < 90%)
• Symptoms contraindicated for testing (i.e. shortness of breath, angina, dizziness, severe headache, sudden onset of numbness or weakness, painful calf suggestive of deep vein thrombosis)
• Active infection and/or injury at location of testing site
• Other diagnosed co-morbidities that would impact physical participation

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Hand-held Dynamometry Measurement of Average Force Production	1 year	Average force production of lower extremity isometric strength measured in pounds (lb)

Secondary Outcome Measures

Name	Time	Method
Hand-held Dynamometry Measurement of Peak Force Production	1 year	Peak force production of lower extremity isometric strength measured in pounds (lb)

Trial Locations

Locations (1)

Vanderbilt University Medical Center; 🇺🇸 Nashville, Tennessee, United States