Chronic StrokeNCT05941962
Use of Hand-held Dynamometry to Obtain Objective Measures of Lower Extremity Force Production With Chronic Stroke
An observational study of Chronic Stroke and Weakness, Muscle, run by Vanderbilt University Medical Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chronic Stroke, Weakness, Muscle
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Jun 2023to 26 Jul 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Age 18 years or older - Stroke > 3 months
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University Medical Center
Nashville, Tennessee, 37209-2069
About this study
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
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.
Read the 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
- Conditions
- Chronic Stroke, Weakness, Muscle
- Medical subject headings
- Muscle Weakness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Average Force Production | Average force production of bilateral lower extremities will be collected using the handheld dynamometer, Activbody Activ5. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hand-held Dynamometry Measurement of Average Force Production
Average force production of lower extremity isometric strength measured in pounds (lb)
Measured: 1 year
Secondary outcomes (1)
Hand-held Dynamometry Measurement of Peak Force Production
Peak force production of lower extremity isometric strength measured in pounds (lb)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2023
- Study start5 Jun 2023
- Primary completion26 Jul 2025
- Study completion26 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Chronic StrokeStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cathey Norton, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05941962
- Sponsor's protocol ID
- 230030
- Status last verified
- May 2025
- First submitted
- 5 Jun 2023
- Last updated
- 11 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 12589633Bakers 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.
PubMed 33355879Bohannon 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.
PubMed 30792998Mentiplay 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.
PubMed 26509265Mentiplay 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.
PubMed 29731325Merry 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.
PubMed 34960492Shefner JM. Strength Testing in Motor Neuron Diseases. Neurotherapeutics. 2017 Jan;14(1):154-160. doi: 10.1007/s13311-016-0472-0.
PubMed 27600518
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05941962
- Acronym / sponsor ID
- 230030
- Conditions
- Chronic Stroke, Weakness, Muscle
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Study start
- 5 Jun 2023 (actual)
- Primary completion
- 26 Jul 2025 (actual)
- Study completion
- 26 Jul 2025 (actual)
- First posted
- 12 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Average Force Production | – | –Average force production of bilateral lower extremities will be collected using the handheld dynamometer, Activbody Activ5. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Age 18 years or older - Stroke > 3 months
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Hand-held Dynamometry Measurement of Average Force Production
Time frame: 1 year
Average force production of lower extremity isometric strength measured in pounds (lb)
1 secondary outcome
Hand-held Dynamometry Measurement of Peak Force Production
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2026.
- Results publication: PubMed 12589633Andrews 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 publication: PubMed 33355879Bakers 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 publication: PubMed 30792998Bohannon 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 publication: PubMed 26509265Mentiplay 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 publication: PubMed 29731325Mentiplay 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 publication: PubMed 34960492Merry 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 publication: PubMed 27600518Shefner JM. Strength Testing in Motor Neuron Diseases. Neurotherapeutics. 2017 Jan;14(1):154-160. doi: 10.1007/s13311-016-0472-0.
- Short-term recovery of limb muscle strength after acute stroke. Archives of Physical Medicine and RehabilitationLink provided by the sponsor.
- Portable fixed dynamometry: Towards remote muscle strength measurements in patients with motor neuron disease.Link provided by the sponsor.
- Assessment of lower limb muscle strength and power using hand-held and fixed dynamometry: A reliability and validity study.Link provided by the sponsor.
- Assessment of isometric muscle strength and rate of torque development with hand-held dynamometry: Test-retest reliability and relationship with gait velocity after stroke.Link provided by the sponsor.
- Strength testing in motor neuron diseases.Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Stroke and Weakness, Muscle, run by Vanderbilt University Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hand-held Dynamometry Measurement of Average Force Production (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05941962, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2026.