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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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.

United States1 site
  • PTRS Research Lab

    Baltimore, Maryland, 21201

Other trials in United States

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 groups in NCT03694028
Study groupRoleWhat they receive
Limb LoadingExperimentalThis 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 TrainingActive comparatorThis 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.

  1. Gait single stance time asymmetry and duration ratio

    single stance time asymmetry and duration ratio

    Measured: Post training at 6 weeks

  2. Gait paretic double support/single stance

    paretic double support/single stance

    Measured: Post training at 6 weeks

  3. Stepping weight transfer time

    weight transfer time

    Measured: Post training at 6 weeks

  4. Stepping knee angular displacement

    knee angular displacement

    Measured: Post training at 6 weeks

  5. 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.

  1. First posted3 Oct 2018
  2. Study start4 Feb 2019
  3. Primary completion2 Jun 2022
  4. Study completion2 Jun 2022

Resources

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)
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

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.

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