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

Primary Purpose

Chronic Stroke, Weakness, Muscle

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Average Force Production
Sponsored by
Vanderbilt University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Chronic Stroke

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Vanderbilt University Medical CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Average Force Production

Arm Description

Average force production of bilateral lower extremities will be collected using the handheld dynamometer, Activbody Activ5.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
June 5, 2023
Last Updated
July 11, 2023
Sponsor
Vanderbilt University Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT05941962
Brief Title
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
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 5, 2023 (Actual)
Primary Completion Date
July 26, 2023 (Anticipated)
Study Completion Date
April 24, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vanderbilt University Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Stroke, Weakness, Muscle

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Average Force Production
Arm Type
Other
Arm Description
Average force production of bilateral lower extremities will be collected using the handheld dynamometer, Activbody Activ5.
Intervention Type
Other
Intervention Name(s)
Average Force Production
Intervention Description
Average force production will be collected using the hand-held dynamometer, Activbody Activ5. 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
Primary Outcome Measure Information:
Title
Hand-held Dynamometry Measurement of Average Force Production
Description
Average force production of lower extremity isometric strength measured in pounds (lb)
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Hand-held Dynamometry Measurement of Peak Force Production
Description
Peak force production of lower extremity isometric strength measured in pounds (lb)
Time Frame
1 year
Other Pre-specified Outcome Measures:
Title
Hand-held Dynamometry Measurement of Time to Peak Force
Description
Time required to reach peak force production of lower extremity isometric strength measured in seconds (sec)
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sarah McDonnell
Phone
615-936-5048
Email
sarah.f.mcdonnell@vumc.org
First Name & Middle Initial & Last Name or Official Title & Degree
Cathey Norton
Phone
615-460-6715
Email
cathey.norton@belmont.edu
Facility Information:
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37209-2069
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sarah McDonnell, PT, DPT
Phone
615-936-5048
Email
sarah.f.mcdonnell@vumc.org
First Name & Middle Initial & Last Name & Degree
Cathey Norton
Phone
615-460-6715
Email
cathey.norton@belmont.edu

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
12589633
Citation
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.
Results Reference
result
PubMed Identifier
33355879
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. doi: 10.1007/s00415-020-10366-9. Epub 2020 Dec 23.
Results Reference
result
PubMed Identifier
30792998
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.
Results Reference
result
PubMed Identifier
26509265
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: 10.1371/journal.pone.0140822. eCollection 2015.
Results Reference
result
PubMed Identifier
29731325
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.
Results Reference
result
PubMed Identifier
34960492
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.
Results Reference
result
PubMed Identifier
27600518
Citation
Shefner JM. Strength Testing in Motor Neuron Diseases. Neurotherapeutics. 2017 Jan;14(1):154-160. doi: 10.1007/s13311-016-0472-0.
Results Reference
result
Links:
URL
https://doi.org/10.1053/apmr.2003.50003
Description
Short-term recovery of limb muscle strength after acute stroke. Archives of Physical Medicine and Rehabilitation
URL
https://doi.org/10.1007/s00415-020-10366-9
Description
Portable fixed dynamometry: Towards remote muscle strength measurements in patients with motor neuron disease.
URL
https://doi.org/10.1155/2019/8194537
Description
Considerations and practical options for measuring Muscle Strength: A narrative review. BioMed Research International
URL
https://doi.org/10.1371/journal.pone.0140822
Description
Assessment of lower limb muscle strength and power using hand-held and fixed dynamometry: A reliability and validity study.
URL
https://doi.org/10.1016/j.jbiomech.2018.04.032
Description
Assessment of isometric muscle strength and rate of torque development with hand-held dynamometry: Test-retest reliability and relationship with gait velocity after stroke.
URL
https://doi.org/10.3390/s21248399
Description
The validity and reliability of two commercially available load sensors for Clinical Strength Assessment. Sensors
URL
https://doi.org/10.1007/s13311-016-0472-0
Description
Strength testing in motor neuron diseases.

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

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