Neuromuscular and Biomechanical Control of Lower Limb Loading in Individuals With Chronic Stroke
Primary Purpose
Stroke, Hemiparesis
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Limb Loading
Conventional Training
Sponsored by
About this trial
This is an interventional treatment trial for Stroke focused on measuring biomechanical, kinematic, muscle coactivation, torque
Eligibility Criteria
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.
Sites / Locations
- PTRS Research Lab
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Limb Loading
Conventional Training
Arm Description
This group will be exposed to a sudden unilateral lowering of the supporting surface to induce lateral weight transfer of the paretic limb.
This group will practice weight shifting and step training that focuses on the paretic limb.
Outcomes
Primary Outcome Measures
Gait single stance time asymmetry and duration ratio
single stance time asymmetry and duration ratio
Gait paretic double support/single stance
paretic double support/single stance
Stepping weight transfer time
weight transfer time
Stepping knee angular displacement
knee angular displacement
Stepping peak torque
peak torque
Secondary Outcome Measures
Full Information
NCT ID
NCT03694028
First Posted
September 29, 2018
Last Updated
October 3, 2022
Sponsor
University of Maryland, Baltimore
1. Study Identification
Unique Protocol Identification Number
NCT03694028
Brief Title
Neuromuscular and Biomechanical Control of Lower Limb Loading in Individuals With Chronic Stroke
Official Title
Neuromuscular and Biomechanical Control of Lower Limb Loading in Individuals With Chronic Stroke
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
February 4, 2019 (Actual)
Primary Completion Date
June 2, 2022 (Actual)
Study Completion Date
June 2, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Maryland, Baltimore
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Hemiparesis
Keywords
biomechanical, kinematic, muscle coactivation, torque
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
25 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Limb Loading
Arm Type
Experimental
Arm Description
This group will be exposed to a sudden unilateral lowering of the supporting surface to induce lateral weight transfer of the paretic limb.
Arm Title
Conventional Training
Arm Type
Active Comparator
Arm Description
This group will practice weight shifting and step training that focuses on the paretic limb.
Intervention Type
Other
Intervention Name(s)
Limb Loading
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Conventional Training
Intervention Description
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.
Primary Outcome Measure Information:
Title
Gait single stance time asymmetry and duration ratio
Description
single stance time asymmetry and duration ratio
Time Frame
Post training at 6 weeks
Title
Gait paretic double support/single stance
Description
paretic double support/single stance
Time Frame
Post training at 6 weeks
Title
Stepping weight transfer time
Description
weight transfer time
Time Frame
Post training at 6 weeks
Title
Stepping knee angular displacement
Description
knee angular displacement
Time Frame
Post training at 6 weeks
Title
Stepping peak torque
Description
peak torque
Time Frame
Post training at 6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vicki L Gray, MPT, PhD
Organizational Affiliation
Assistant Professor
Official's Role
Principal Investigator
Facility Information:
Facility Name
PTRS Research Lab
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Neuromuscular and Biomechanical Control of Lower Limb Loading in Individuals With Chronic Stroke
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