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

NCT03694028 | Completed DMC

• 1 other identifier: HP-00072173
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke; Hemiparesis

Keywords

biomechanical; kinematic; muscle coactivation; torque

Outcome Measures

Primary Outcomes (5)

• Gait single stance time asymmetry and duration ratio

  single stance time asymmetry and duration ratio

  Post training at 6 weeks

• Gait paretic double support/single stance

  paretic double support/single stance

  Post training at 6 weeks

• Stepping weight transfer time

  weight transfer time

  Post training at 6 weeks

• Stepping knee angular displacement

  knee angular displacement

  Post training at 6 weeks

• Stepping peak torque

  peak torque

  Post training at 6 weeks

Study Arms (2)

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.

Other: Limb Loading

Conventional Training

ACTIVE COMPARATOR

This group will practice weight shifting and step training that focuses on the paretic limb.

Other: Conventional Training

Interventions

Limb Loading OTHER

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.

Limb Loading

Conventional Training OTHER

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 Training

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Maryland, Baltimore: lead

Study Sites (1)

PTRS Research Lab

Baltimore, Maryland, 21201, United States

Location

MeSH Terms

Conditions

Stroke; Paresis

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Vicki L Gray, MPT, PhD

  Assistant Professor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: September 29, 2018
• First Posted: October 3, 2018
• Study Start: February 4, 2019
• Primary Completion: June 2, 2022
• Study Completion: June 2, 2022
• Last Updated: October 4, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)