Functional Resistance Training to Improve Knee Function After ACL Reconstruction

NCT ID: NCT03282565

Last Updated: 2022-01-18

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-17

Study Completion Date

2020-12-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this study is to examine if thigh muscle weakness and the lack of muscle activation that accompanies ACL injury and reconstruction can be improved with functional resistance training.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Profound quadriceps weakness is ubiquitous after anterior cruciate ligament (ACL) reconstruction, and current rehabilitation approaches are not successful in optimizing quadriceps strength and knee function even years after the surgery. We hypothesize that suboptimal strength and functional outcomes after ACL surgery are due to the lack of task-specific exercise elements during strength training. This application seeks to assess whether progressive functional resistance training during gait will significantly improve quadriceps function, neural excitability, and knee mechanics during gait. The proposed studies will not only lay the foundation for a novel training paradigm, but will also improve our understanding of the mechanisms mediating neuromuscular and biomechanical changes after functional resistance training.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Anterior Cruciate Ligament Injury

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Functional Resistance Training with a Brace

Participants will receive functional resistance training via a knee brace while walking on a treadmill 2-3 times a week for about 8 weeks.

Group Type EXPERIMENTAL

Functional Resistance Training with Brace

Intervention Type OTHER

A brace will be strapped to the leg and apply resistance across the knee while subjects walk on a treadmill.

Functional Resistance Training with Elastic Band

Participants will receive functional resistance training via an elastic band attached at the ankle while walking on a treadmill 2-3 times a week for about 8 weeks.

Group Type EXPERIMENTAL

Functional Resistance Training with Elastic Band

Intervention Type OTHER

An elastic band will be strapped to the leg and apply resistance across the knee while subjects walk on a treadmill.

Control

Participants will while on a treadmill without an applied resistance 2-3 times a week for about 8 weeks.

Group Type SHAM_COMPARATOR

Control

Intervention Type OTHER

A brace will be strapped to the leg and will not apply resistance across the knee while subjects walk on a treadmill.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Functional Resistance Training with Brace

A brace will be strapped to the leg and apply resistance across the knee while subjects walk on a treadmill.

Intervention Type OTHER

Control

A brace will be strapped to the leg and will not apply resistance across the knee while subjects walk on a treadmill.

Intervention Type OTHER

Functional Resistance Training with Elastic Band

An elastic band will be strapped to the leg and apply resistance across the knee while subjects walk on a treadmill.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* aged 14-40 years
* suffered an acute, complete ACL rupture
* willingness to participate in testing and follow-up as outlined in the protocol
* English-speaking

Exclusion Criteria

* inability to provide written informed consent
* female subjects who are pregnant or are planning to become pregnant
* previous ACL injury
* previous surgery to either knee
* bony fracture accompanying ACL injury
* patients who experienced a knee dislocation;
* patients who are contraindicated for transcranial magnetic stimulation (e.g., metal implants in head, unexplained recurrent headaches, history of seizures, epileptogenic drugs, active psychiatric illness, etc.).
Minimum Eligible Age

14 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

National Institutes of Health (NIH)

NIH

Sponsor Role collaborator

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

Sponsor Role collaborator

University of Michigan

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Riann Palmieri-Smith

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Riann Palmieri-Smith, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Chandramouli Krishnan, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of Michigan

Ann Arbor, Michigan, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

HUM00133860

Identifier Type: -

Identifier Source: org_study_id

R21HD092614

Identifier Type: NIH

Identifier Source: secondary_id

View Link

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.