StrokeNCT03694028
Neuromuscular and Biomechanical Control of Lower Limb Loading in Individuals With Chronic Stroke
A study testing Limb Loading and Conventional Training in people with Stroke and Hemiparesis, run by University of Maryland, Baltimore at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Hemiparesis
- What is being tested?
- Limb Loading and Conventional Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Feb 2019to 2 Jun 2022
- Phase
- Interventional
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Stroke, Hemiparesis
- Being tested
- Limb Loading, Conventional Training
- Keywords
- biomechanical, kinematic, muscle coactivation, torque
- Medical subject headings
- Stroke, Paresis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Limb LoadingOther
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.
Conventional TrainingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Limb Loading | Experimental | This group will be exposed to a sudden unilateral lowering of the supporting surface to induce lateral weight transfer of the paretic limb. Receives: Other: Limb Loading |
| Conventional Training | Active comparator | This group will practice weight shifting and step training that focuses on the paretic limb. Receives: Other: Conventional Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gait single stance time asymmetry and duration ratio
single stance time asymmetry and duration ratio
Measured: Post training at 6 weeks
Gait paretic double support/single stance
paretic double support/single stance
Measured: Post training at 6 weeks
Stepping weight transfer time
weight transfer time
Measured: Post training at 6 weeks
Stepping knee angular displacement
knee angular displacement
Measured: Post training at 6 weeks
Stepping peak torque
peak torque
Measured: Post training at 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2018
- Study start4 Feb 2019
- Primary completion2 Jun 2022
- Study completion2 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by University of Maryland, BaltimoreThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vicki Gray, University of Maryland, Baltimore
- Investigators
- Vicki L Gray, MPT, PhD, Principal investigator, Assistant Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03694028
- Sponsor's protocol ID
- HP-00072173
- Status last verified
- Oct 2022
- First submitted
- 29 Sep 2018
- Last updated
- 4 Oct 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuromuscular and Biomechanical Control of Lower Limb Loading in Individuals With Chronic Stroke
- ClinicalTrials.gov ID
- NCT03694028
- Acronym / sponsor ID
- HP-00072173
- Conditions
- Stroke, Hemiparesis
- Keywords
- biomechanical, kinematic, muscle coactivation, torque
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Study start
- 4 Feb 2019 (actual)
- Primary completion
- 2 Jun 2022 (actual)
- Study completion
- 2 Jun 2022 (actual)
- First posted
- 3 Oct 2018 (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.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Limb Loading | Experimental | Other: Limb LoadingThis group will be exposed to a sudden unilateral lowering of the supporting surface to induce lateral weight transfer of the paretic limb. |
| Conventional Training | Active comparator | Other: Conventional TrainingThis group will practice weight shifting and step training that focuses on the paretic limb. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Limb LoadingParticipants 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. | Other | Limb Loading |
| Conventional TrainingParticipants 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. | Other | Conventional Training |
Primary outcome
Gait single stance time asymmetry and duration ratio
Time frame: Post training at 6 weeks
single stance time asymmetry and duration ratio
Gait paretic double support/single stance
Time frame: Post training at 6 weeks
paretic double support/single stance
Stepping weight transfer time
Time frame: Post training at 6 weeks
weight transfer time
Stepping knee angular displacement
Time frame: Post training at 6 weeks
knee angular displacement
Stepping peak torque
Time frame: Post training at 6 weeks
peak torque
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 4 Oct 2022.
- Individual participant dataSharing planned: No
Related trials for Stroke
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Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
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Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
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Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
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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.
Vicki L Gray, MPT, PhD principal investigator
Assistant Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Limb Loading and Conventional Training in people with Stroke and Hemiparesis, run by University of Maryland, Baltimore 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 3 inclusion and 3 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 4 Oct 2022. 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?
Gait single stance time asymmetry and duration ratio (time frame: Post training at 6 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Oct 2022.