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Neuromuscular and Biomechanical Control of Lower Limb Loading in Individuals With Chronic Stroke

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ClinicalTrials.gov Identifier: NCT03694028
Recruitment Status : Recruiting
First Posted : October 3, 2018
Last Update Posted : November 13, 2020
Sponsor:
Information provided by (Responsible Party):
Vicki Gray, University of Maryland, Baltimore

Tracking Information
First Submitted Date  ICMJE September 29, 2018
First Posted Date  ICMJE October 3, 2018
Last Update Posted Date November 13, 2020
Actual Study Start Date  ICMJE February 4, 2019
Estimated Primary Completion Date May 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 11, 2020)
  • 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
Original Primary Outcome Measures  ICMJE
 (submitted: October 1, 2018)
  • Gait [ Time Frame: Post training at 6 weeks ]
    single stance time asymmetry and duration ratio
  • Gait [ Time Frame: Post training at 6 weeks ]
    paretic double support/single stance
  • Stepping [ Time Frame: Post training at 6 weeks ]
    weight transfer time
  • Stepping [ Time Frame: Post training at 6 weeks ]
    knee angular displacement
  • Stepping [ Time Frame: Post training at 6 weeks ]
    peak torque
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Neuromuscular and Biomechanical Control of Lower Limb Loading in Individuals With Chronic Stroke
Official Title  ICMJE Neuromuscular and Biomechanical Control of Lower Limb Loading in Individuals With Chronic Stroke
Brief 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. 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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Stroke
  • Hemiparesis
Intervention  ICMJE
  • Other: Limb Loading
    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.
  • Other: Conventional Training
    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 Arms  ICMJE
  • 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.
    Intervention: Other: Limb Loading
  • Active Comparator: Conventional Training
    This group will practice weight shifting and step training that focuses on the paretic limb.
    Intervention: Other: Conventional Training
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 1, 2018)
36
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2021
Estimated Primary Completion Date May 31, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Vicki Gray, PhD 410-706-3778 vicki.gray@som.umaryland.edu
Contact: Janice Abarro, B.S. 410-706-0856 jabarro@som.umaryland.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03694028
Other Study ID Numbers  ICMJE HP-00072173
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Vicki Gray, University of Maryland, Baltimore
Study Sponsor  ICMJE University of Maryland, Baltimore
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Vicki L Gray, MPT, PhD Assistant Professor
PRS Account University of Maryland, Baltimore
Verification Date November 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP