NCT05941962

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2023

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 5, 2023

Completed
Same day until next milestone

Study Start

First participant enrolled

June 5, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 12, 2023

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 26, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 26, 2025

Completed
Last Updated

February 11, 2026

Status Verified

May 1, 2025

Enrollment Period

2.1 years

First QC Date

June 5, 2023

Last Update Submit

February 9, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Hand-held Dynamometry Measurement of Average Force Production

    Average force production of lower extremity isometric strength measured in pounds (lb)

    1 year

Secondary Outcomes (1)

  • Hand-held Dynamometry Measurement of Peak Force Production

    1 year

Other Outcomes (1)

  • Hand-held Dynamometry Measurement of Time to Peak Force

    1 year

Study Arms (1)

Average Force Production

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Age 18 years or older \- Stroke \> 3 months

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37209-2069, United States

Location

Related 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

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

Related Links

MeSH Terms

Conditions

Muscle Weakness

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsSigns and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Primary Investigator

Study Record Dates

First Submitted

June 5, 2023

First Posted

July 12, 2023

Study Start

June 5, 2023

Primary Completion

July 26, 2025

Study Completion

July 26, 2025

Last Updated

February 11, 2026

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations