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

Sponsor
Vanderbilt University Medical Center (Other)
Overall Status
Recruiting
CT.gov ID
NCT05941962
Collaborator
(none)
20
Enrollment
1
Location
1
Arm
10.6
Anticipated Duration (Months)
1.9
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Average Force Production
 N/A

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

Study Type:
Interventional
Anticipated Enrollment :
20 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Health Services Research
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
Actual Study Start Date :
Jun 5, 2023
Anticipated Primary Completion Date :
Jul 26, 2023
Anticipated Study Completion Date :
Apr 24, 2024

Arms and Interventions

Arm Intervention/Treatment
Other: Average Force Production

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

Other: Average Force Production
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

Outcome Measures

Primary Outcome Measures

  1. Hand-held Dynamometry Measurement of Average Force Production [1 year]

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

Secondary Outcome Measures

  1. Hand-held Dynamometry Measurement of Peak Force Production [1 year]

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

Other Outcome Measures

  1. Hand-held Dynamometry Measurement of Time to Peak Force [1 year]

    Time required to reach peak force production of lower extremity isometric strength measured in seconds (sec)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Vanderbilt University Medical Center Nashville Tennessee United States 37209-2069

Sponsors and Collaborators

  • Vanderbilt University Medical Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Sarah McDonnell, Primary Investigator, Vanderbilt University Medical Center
ClinicalTrials.gov Identifier:
NCT05941962
Other Study ID Numbers:
  • 230030
First Posted:
Jul 12, 2023
Last Update Posted:
Jul 12, 2023
Last Verified:
Jul 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Muscle Weakness
Stroke

Study Results

No Results Posted as of Jul 12, 2023