- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03694028
Neuromuscular and Biomechanical Control of Lower Limb Loading in Individuals With Chronic Stroke
October 3, 2022 updated by: Vicki Gray, University of Maryland, Baltimore
Stroke is the leading cause of long-term disability in the U.S. Individuals with hemiparesis due to stroke often have difficulty bearing weight on their legs and transferring weight from one leg to the other.
The ability to bear weight on the legs is important during functional movements such as rising from a chair, standing and walking.
Diminished weight transfer contributes to asymmetries during walking which commonly leads to greater energy expenditure.
Moreover, deficits in bearing weight on the paretic leg contribute to lateral instability and are associated with decreased walking speed and increased risk of falling in individuals post-stroke.
These functional limitations affect community participation and life quality.
Thus, restoring the ability to bear weight on the legs, i.e., limb loading, is a critical goal for rehabilitation post-stroke.
The purpose of this research is to identify the impairments in neuromechanical mechanisms of limb loading and determine whether limb loading responses can be retrained by induced forced limb loading.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Stroke is the leading cause of long-term disability in the U.S. Individuals with hemiparesis due to stroke often have difficulty bearing weight on the paretic lower extremity and transferring weight from one leg to the other.
Impaired weight transfer and limb loading contribute to lateral instability and are associated with decreased walking speed and increased risk of falling.
Consequently, restoring limb loading ability is an important goal for rehabilitation post-stroke.
Despite considerable rehabilitation efforts aimed at enhancing paretic limb loading, their effectiveness on improving neuromotor and functional outcomes remains limited possibly due to poorly understood limb loading mechanisms and the reluctance to use the paretic limb.
The coordination of neuromuscular actions to regulate loading force during weight acceptance is an important component of functional limb loading.
Because altered neuromuscular control is common in persons with stroke, it is possible that these abnormalities may impair limb loading ability.
The long-term objective of this project is to develop a mechanism-based framework for designing and testing the effectiveness of novel rehabilitation interventions to enhance lower limb weight transfer and limb loading to improve balance and mobility.
This project aims to (1) identify the neuromuscular and biomechanical abnormalities in limb loading responses in individuals post-stroke, (2) determine the underlying mechanisms responsible for the deficits in limb loading, and (3) test the short-term effectiveness of a 6-week perturbation-induced limb load training program on improving limb loading responses and mobility function.
The investigators propose to apply a sudden unilateral lowering of the supporting surface to induce lateral weight transfer that forces limb loading.
Kinetic, kinematic, and lower extremity muscle activation patterns will be recorded.
The investigators expect that, compared to healthy controls, individuals with stroke will show increased muscle co-activation of the knee musculature with decreased knee flexion and torque production, and irregular impact force regulation during loading that will disrupt weight transfer and loading of the paretic limb.
Furthermore, the investigators hypothesize that compared to a conventional clinical weight-shift rehabilitation training program, the imposed limb loading group will show greater improvements during voluntary stepping and walking following training.
Specifically, the investigators expect the knee muscle co-activation duration will be reduced, with increased knee joint torque, and the paretic single stance/double support time will increase, reflecting improved paretic limb loading ability during gait following training.
Study Type
Interventional
Enrollment (Actual)
25
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Maryland
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Baltimore, Maryland, United States, 21201
- PTRS Research Lab
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Hemiparesis as a result of a stroke greater than 6 months previous to the study if participants with stroke.
- Able to walk 10 meters with or without a walking aid.
- Able to stand unsupported for 5 minutes.
Exclusion Criteria:
- Medical condition precluding participation in regular exercises, such as acute cardiac or respiratory conditions limiting activity and other health conditions significantly impacting the ability to walk beyond the effects of the stroke, such as other neurological conditions or peripheral neuropathies.
- Not able to follow commands.
- Pregnancy by self-report.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: FACTORIAL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Limb Loading
This group will be exposed to a sudden unilateral lowering of the supporting surface to induce lateral weight transfer of the paretic limb.
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Participants will be assigned to one of two interventions.
The intervention will occur 3 times a week for six weeks (18 sessions) each session for one hour.
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Active Comparator: Conventional Training
This group will practice weight shifting and step training that focuses on the paretic limb.
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Participants will be assigned to one of two interventions.
The intervention will occur 3 times a week for six weeks (18 sessions) each session for one hour.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Gait single stance time asymmetry and duration ratio
Time Frame: Post training at 6 weeks
|
single stance time asymmetry and duration ratio
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Post training at 6 weeks
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Gait paretic double support/single stance
Time Frame: Post training at 6 weeks
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paretic double support/single stance
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Post training at 6 weeks
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Stepping weight transfer time
Time Frame: Post training at 6 weeks
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weight transfer time
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Post training at 6 weeks
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Stepping knee angular displacement
Time Frame: Post training at 6 weeks
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knee angular displacement
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Post training at 6 weeks
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Stepping peak torque
Time Frame: Post training at 6 weeks
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peak torque
|
Post training at 6 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Vicki L Gray, MPT, PhD, Assistant Professor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 4, 2019
Primary Completion (Actual)
June 2, 2022
Study Completion (Actual)
June 2, 2022
Study Registration Dates
First Submitted
September 29, 2018
First Submitted That Met QC Criteria
October 1, 2018
First Posted (Actual)
October 3, 2018
Study Record Updates
Last Update Posted (Actual)
October 4, 2022
Last Update Submitted That Met QC Criteria
October 3, 2022
Last Verified
October 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- HP-00072173
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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