Hamstring Strain in High School Athletes

NCT03248011 | Completed

• 1 other identifier: 17-003905
• Study Type: interventional
• Target: 196
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the current study is, 1) Determine the effectiveness of injury prevention programs for prevention of hamstring muscle strains, 2) Identify how these programs impact athletes' flexibility, muscle stiffness, strength, and power, and 3) Determine the ability of a state-of-the-art imaging technology, shear wave elastography to predict future hamstring muscle strain injury.

Conditions

Strains Thigh

Keywords

hamstring; ultrasound; intervention

Outcome Measures

Primary Outcomes (1)

• Number of subjects who sustain a hamstring strain

  Physician based diagnosis

  Duration of school basketball season, approximately 4 months

Secondary Outcomes (4)

• Change in thigh strength

  Baseline and post school basketball season, approximately 4 months

• Change in hamstring stiffness

  Baseline, post school basketball season, approximately 4 months

• Change in lower extremity power

  Baseline, post school basketball season, approximately 4 months

• Change in lower extremity hamstring flexibility

  Baseline, post school basketball season, approximately 4 months

Study Arms (4)

Flexibility

EXPERIMENTAL

Stretching exercise

Other: Stretching

Strength

EXPERIMENTAL

Eccentric hamstring strengthening exercise

Other: Strengthening

Neuromuscular

EXPERIMENTAL

Balance exercise

Other: Neuromuscular

Control

NO INTERVENTION

No exercise

Interventions

Stretching OTHER

Lower extremity flexibility exercises will be performed

Flexibility

Strengthening OTHER

Eccentric hamstring strengthening exercises will be performed

Strength

Neuromuscular OTHER

Dynamic lower extremity balance and movement control exercises will be performed

Neuromuscular

Eligibility Criteria

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

You may qualify if:

• member of high school basketball team
• school agreement to participate in study

You may not qualify if:

• inability to ambulate independently
• lower extremity or back surgery within 1 year of study enrollment
• presence of neurological disease

Sponsors & Collaborators

• Mayo Clinic: lead
• General Electric: collaborator
• TRIA Orthopaedic Center: collaborator

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55405, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Interventions

Resistance Training

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Nathan Schilaty, DC, PhD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Group assignment will be masked to investigator.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: This is a prospective, randomized, repeated measures single- blind clinical trial.

Study Record Dates

• First Submitted: August 10, 2017
• First Posted: August 14, 2017
• Study Start: September 27, 2017
• Primary Completion: June 10, 2020
• Study Completion: August 31, 2021
• Last Updated: October 4, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• Time Frame: Co-Investigators will have access to the data as it is collected, for the duration of the study.
• Access Criteria: Secured file transfer protocols will be utilized to transfer files between investigators. Only study co-investigators may access study data.

Locations

US (1)