Clinical trial NCT05941962: Use of Hand-held Dynamometry to Obtain Objective Measures of Lower Extremity Force Production With Chronic Stroke
Official title: Use of Hand-held Dynamometry to Obtain Objective Measures of Lower Extremity Rate of Peak Force Production, Cumulative Peak Force Production, and Sustained Peak Force Production Among Patients With Chronic Stroke
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Chronic Stroke
Weakness, Muscle
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
First posted: 2023-07-12
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Age 18 years or older

- Stroke \> 3 months

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

Eligibility criteria: 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

Primary outcomes:
measure: Hand-held Dynamometry Measurement of Average Force Production
timeFrame: 1 year
Secondary outcomes:
measure: Hand-held Dynamometry Measurement of Peak Force Production
timeFrame: 1 year
Other outcomes:
measure: Hand-held Dynamometry Measurement of Time to Peak Force
timeFrame: 1 year
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
References:
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citation: Bohannon RW. Considerations and Practical Options for Measuring Muscle Strength: A Narrative Review. Biomed Res Int. 2019 Jan 17;2019:8194537. doi: 10.1155/2019/8194537. eCollection 2019.
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citation: Mentiplay BF, Tan D, Williams G, Adair B, Pua YH, Bower KJ, Clark RA. Assessment of isometric muscle strength and rate of torque development with hand-held dynamometry: Test-retest reliability and relationship with gait velocity after stroke. J Biomech. 2018 Jun 25;75:171-175. doi: 10.1016/j.jbiomech.2018.04.032. Epub 2018 Apr 27.
citation: Merry K, Napier C, Chung V, Hannigan BC, MacPherson M, Menon C, Scott A. The Validity and Reliability of Two Commercially Available Load Sensors for Clinical Strength Assessment. Sensors (Basel). 2021 Dec 16;21(24):8399. doi: 10.3390/s21248399.
citation: Shefner JM. Strength Testing in Motor Neuron Diseases. Neurotherapeutics. 2017 Jan;14(1):154-160. doi: 10.1007/s13311-016-0472-0.