Use of Hand-held Dynamometry to Obtain Objective Measures... | NCT05941962

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

NCT05941962

Sponsor

Vanderbilt University Medical Center

Status

Completed

Last Update Posted

Feb 11, 2026Actual

Enrollment

20Actual

Phase

Not provided

Conditions

Chronic Stroke
Weakness, Muscle

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 5, 2023Actual

Primary Completion Date

Jul 26, 2025Actual

Completion Date

Jul 26, 2025Actual

First Submitted Date

Jun 5, 2023

First Submission Date that Met QC Criteria

Jul 11, 2023

First Posted Date

Jul 12, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 9, 2026

Last Update Posted Date

Feb 11, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

20Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Average Force Production		Average force production of bilateral lower extremities will be collected using the handheld dynamometer, Activbody Activ5.

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Hand-held Dynamometry Measurement of Average Force Production	Average force production of lower extremity isometric strength measured in pounds (lb)	1 year

Secondary Outcomes

Measure	Description	Time Frame
Hand-held Dynamometry Measurement of Peak Force Production	Peak force production of lower extremity isometric strength measured in pounds (lb)	1 year

Other Outcomes

Measure	Description	Time Frame
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

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Age 18 years or older

- Stroke > 3 months

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Vanderbilt University Medical Center		Nashville	Tennessee	37209-2069	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
12589633	Result	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.
33355879	Result	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.

ID	Term
D009135	Muscular Diseases
D009140	Musculoskeletal Diseases
D020879	Neuromuscular Manifestations
D009461	Neurologic Manifestations