Functional Resistance Training to Improve Knee Function After ACL Reconstruction

NCT03282565 | Completed Results

• 2 other identifiers: HUM00133860R21HD092614
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Anterior Cruciate Ligament Injury

Keywords

ACL; Quadriceps; Muscle; Resistance Training

Outcome Measures

Primary Outcomes (1)

• Quadriceps Muscle Strength

  Isometric quadriceps strength was measured with the knee at 60 degrees using an isokinetic dynamometer prior to the intervention and immediately after the intervention. Post-test minus pre-test change scores were calculated.

  Pre-test measurements were taken at ~9-10 weeks after ACL reconstruction and Post-test measurements were taken at ~18-20 weeks after ACL reconstruction.

Secondary Outcomes (3)

• Quadriceps Voluntary Activation

  Immediately after the intervention or approximately 18-20 weeks after ACL reconstruction

• Knee Flexion Angle Symmetry

  Pre-intervention values were recorded at ~9-10 weeks after ACL reconstruction and before the start of the intervention. Post-intervention values were recorded after the 8-week intervention (~18-20 weeks after ACL reconstruction)

• Knee Moment Symmetry

  Pre-intervention scores were recorded prior to the start of the intervention and approximately 9-10 weeks after ACL reconstruction. Post-intervention scores were recorded after the 8 week intervention or approximately 18-20 weeks after ACL reconstruction

Study Arms (3)

Functional Resistance Training with a Brace

EXPERIMENTAL

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

Other: Functional Resistance Training with Brace

Functional Resistance Training with Elastic Band

EXPERIMENTAL

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.

Other: Functional Resistance Training with Elastic Band

Control

SHAM COMPARATOR

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

Other: Control

Interventions

Functional Resistance Training with Brace 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 a Brace

Control OTHER

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

Control

Functional Resistance Training with Elastic Band OTHER

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

Functional Resistance Training with Elastic Band

Eligibility Criteria

• Age: 14 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.).

Sponsors & Collaborators

• University of Michigan: lead
• National Institutes of Health (NIH): collaborator
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Interventions

Braces

Condition Hierarchy (Ancestors)

Knee Injuries; Leg Injuries; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Orthotic Devices; Orthopedic Equipment; Surgical Equipment; Equipment and Supplies

Results Point of Contact

• Title: Dr. Riann Palmieri-Smith
• Organization: University of Michigan

riannp@umich.edu

734-615-3154

Study Officials

• Riann Palmieri-Smith, PhD

  University of Michigan

  PRINCIPAL INVESTIGATOR

• Chandramouli Krishnan, PhD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

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

Study Record Dates

• First Submitted: September 12, 2017
• First Posted: September 14, 2017
• Study Start: March 17, 2018
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2020
• Last Updated: January 18, 2022
• Results First Posted: January 18, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)