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

Chronic Stroke Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05941962
• Other study ID #: 230030
• Status: Recruiting
• Start date: June 5, 2023
• Est. completion date: July 26, 2025

Study information

• Verified date: January 2024
• Source: Vanderbilt University Medical Center
• Contact: Cathey Norton
• Phone: 615-460-6715
• Email: cathey.norton[@]belmont.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: July 26, 2025
• Est. primary completion date: July 26, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Stroke
• Muscle Weakness
• Stroke
• Weakness, Muscle

Locations

Country	Name	City	State
United States	Vanderbilt University Medical Center	Nashville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Vanderbilt University Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (7)

Andrews AW, Bohannon RW. Short-term recovery of limb muscle strength after acute stroke. Arch Phys Med Rehabil. 2003 Jan;84(1):125-30. doi: 10.1053/apmr.2003.50003. — View Citation

Bakers JNE, van den Berg LH, Ajeks TG, Holleman MJ, Verhoeven J, Beelen A, Visser-Meily JMA, van Eijk RPA. Portable fixed dynamometry: towards remote muscle strength measurements in patients with motor neuron disease. J Neurol. 2021 May;268(5):1738-1746. — View 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. — View Citation

Mentiplay BF, Perraton LG, Bower KJ, Adair B, Pua YH, Williams GP, McGaw R, Clark RA. Assessment of Lower Limb Muscle Strength and Power Using Hand-Held and Fixed Dynamometry: A Reliability and Validity Study. PLoS One. 2015 Oct 28;10(10):e0140822. doi: 1 — View 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. 2 — View 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. — View Citation

Shefner JM. Strength Testing in Motor Neuron Diseases. Neurotherapeutics. 2017 Jan;14(1):154-160. doi: 10.1007/s13311-016-0472-0. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Hand-held Dynamometry Measurement of Time to Peak Force	Time required to reach peak force production of lower extremity isometric strength measured in seconds (sec)	1 year
Primary	Hand-held Dynamometry Measurement of Average Force Production	Average force production of lower extremity isometric strength measured in pounds (lb)	1 year
Secondary	Hand-held Dynamometry Measurement of Peak Force Production	Peak force production of lower extremity isometric strength measured in pounds (lb)	1 year

External Links

•   Assessment of isometric muscle strength and rate of torque development with hand-held dynamometry: Test-retest reliability and relationship with gait velocity after stroke.
•   Assessment of lower limb muscle strength and power using hand-held and fixed dynamometry: A reliability and validity study.
•   Considerations and practical options for measuring Muscle Strength: A narrative review. BioMed Research International
•   Portable fixed dynamometry: Towards remote muscle strength measurements in patients with motor neuron disease.
•   Short-term recovery of limb muscle strength after acute stroke. Archives of Physical Medicine and Rehabilitation
•   Strength testing in motor neuron diseases.
•   The validity and reliability of two commercially available load sensors for Clinical Strength Assessment. Sensors